Cardiac Assist Devices Pipeline by Development Stages, Segments, Region and Countries, Regulatory Path and Key Companies

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Published: August 26, 2024 Report Code: GDME1813EPD-ST

Report Overview
Key Players
Table of Contents
Table
Figures
FAQs

Cardiac Assist Devices Pipeline Market Report Overview

Cardiac assist devices are used to support the failing heart which cannot be managed with standard medical therapy. These devices can be used for both short-term and long-term purposes allowing the heart to rest long enough so that it can return to normal.

The cardiac assist devices pipeline market research report provides a comprehensive understanding of the pipeline products along with their comparative analysis at various stages of development. The report also includes information about the territories wherein the clinical trials are in progress, the regulatory paths followed by the trials, and the companies associated with the trials.

Key Segments	· Left Ventricular Assist Devices · Mechanical Circulatory Support Devices · Total Artificial Heart · Extracorporeal Membrane Oxygenation Devices · ECMO Oxygenators
Key Territories	· The US · Europe · China · Australia · Japan
Key Regulatory Paths	· PMA · CE · NMPA · 510(k) · TGA
Leading Companies	· Abbott Vascular Inc · Abiomed Inc · Acorn Cardiovascular, Inc. (Inactive) · AdjuCor GmbH · Aerospace Taixin Technology Co Ltd
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Cardiac Assist Devices Pipeline Market by Segments

A few of the key segments of the cardiac assist devices pipeline market are left ventricular assist devices, mechanical circulatory support devices, total artificial heart, extracorporeal membrane oxygenation devices, and ECMO oxygenators, among others. As of August 2024, the left ventricular assist devices accounted for the highest share of pipeline products. An implantable left ventricular assist device is intended for the treatment of end-stage heart failure. It assists the left ventricle by pumping oxygenated blood to the body and can be used to treat the right ventricle in some cases as well.

Cardiac Assist Devices Pipeline Market Analysis by Segments, 2024 (%)

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Cardiac Assist Devices Pipeline Market Segmentation by Territories

A few of the key territories with the cardiac assist devices pipeline market are the US, Europe, China,

Australia, and Japan. As of August 2024, the US accounted for the highest number of pipeline products.

Cardiac Assist Devices Pipeline Market Analysis by Territories, 2024 (%)

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Cardiac Assist Devices Pipeline Market Segmentation by Regulatory Paths

A few of the key regulatory paths in the cardiac assist devices pipeline products market are PMA, CE, NMPA, 510(k), and TGA. As of August 2024, PMA was the most followed pathway for pipeline products in the cardiac assist devices market.

Cardiac Assist Devices Pipeline Market Analysis by Regulatory Paths, 2024 (%)

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Cardiac Assist Devices Pipeline Market – Competitive Landscape

A few of the key companies associated with the cardiac assist devices pipeline market are Abbott Vascular Inc., Abiomed Inc., Acorn Cardiovascular, Inc. (Inactive), AdjuCor GmbH, and Aerospace Taixin Technology Co Ltd, among others.

Abbott Vascular Inc.: Abbott Vascular is headquartered in Santa Clara, California, the US. It is a medical device company that develops, manufactures, and markets cardiovascular devices. The company offers coronary intervention, peripheral intervention, and structural heart products. Moreover, Abbott Vascular provides minimally invasive treatment for mitral regurgitation and other structural defects of the heart. It also offers education and training services for healthcare professionals.

Abiomed Inc.: Abiomed is headquartered in Danvers, Massachusetts, the US. It is a medical device company that develops, manufactures, and markets circulatory support devices. The devices replace or assist the pumping function in a failing heart. The company’s heart support and recovery product portfolio includes Impella heart pumps and the Breethe system. Abiomed also offers online clinical support through Impella Connect, on-call assistance, and on-site assistance for health workers in hospitals.

Cardiac Assist Devices Pipeline Market Analysis by Companies, 2024

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Segments Covered in the Report

Cardiac Assist Devices Pipeline Market Segments Outlook (2024)

Left Ventricular Assist Devices
Mechanical Circulatory Support Devices
Total Artificial Heart
Extracorporeal Membrane Oxygenation Devices
ECMO Oxygenators

Cardiac Assist Devices Pipeline Market Territories Outlook (2024)

The US
Europe
China
Australia
Japan

Cardiac Assist Devices Pipeline Market Regulatory Paths Outlook (2024)

PMA
CE
NMPA
510(k)
TGA

Scope

This report provides:

Extensive coverage of the cardiac assist devices under development.

An exhaustive list of major pipeline products and their details, including product description, licensing and collaboration details, and other developmental activities.

Reviews of major players involved in the development of cardiac assist devices and lists all their pipeline projects.

Coverage of pipeline products based on various stages of development ranging from early development to approved/issued stage.

Key clinical trial data of ongoing clinical trials specific to pipeline products.

Recent developments in the segment/industry.

Reasons to Buy

Formulate significant competitor information, analysis, and insights to improve R&D strategies.

Identify emerging players with potentially strong product portfolios and create effective counter strategies to gain a competitive advantage.

Identify and understand important and diverse types of cardiac assist devices under development.

Develop market-entry and market-expansion strategies.

Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline.

Carry out an in-depth analysis of the product’s current stage of development, territory, and estimated launch date.

Abbott Vascular Inc
Abiomed Inc
Acorn Cardiovascular, Inc. (Inactive)
AdjuCor GmbH
Aerospace Taixin Technology Co Ltd
AngioDynamics Inc
Anhui Tongling Bionic Technology Co Ltd
APK Advanced Medical Technologies, Inc.
Aria CV Inc
Arrow International Cr, A.S.
Auflows CardioTech Pvt Ltd
Beijing Yuewei Medical Technology Co Ltd
Berlin Heart GmbH
Bicakcilar AS
BioLife4D Corp
BioQ Devices Pty Ltd
Biosurfaces Inc
BioVentrix Inc
BiVacor Pty Ltd
Bonde Innovations LLC
Boston Scientific Corp
Boundless Science LLC
Braile Biomedica Ltda
BrioHealth Solutions Inc
Calon Cardio-Technology Ltd
Cardiac Success Ltd
CardiacAssist Inc
CardiacBooster BV
Cardiak Ltd.
CARDIAnove Inc
CardioBridge GmbH
Cardiost Inc
Cardiovascular Systems Inc
Carmat SAS
Carnegie Mellon University
Chongqing Yongrenxin Medical Devices Co Ltd
Cleveland Clinic Hospital
Cleveland Clinic Lerner College of Medicine
Cleveland Heart Inc
Collplant Biotechnologies Ltd
Colorado State University
Concordia University
CorasMedical
CorAssist Cardiovascular Ltd
CorInnova, Inc.
CoRISMA MCS Systems Inc
Corvion Inc
CorWave SA
CVD Equipment Corp
Daidalos Solutions BV
DHS Medical
Dongguan Kewei Medical Instrument Co Ltd
Dongguan Tiantianxiang Medical Technology Co Ltd
Drexel University
Duke University
Elsius Biomedical Inc
Ension, Inc.
Fengkaili Medical Devices (Shanghai) Co Ltd
FineHeart
Foster-Miller Inc (Inactive)
FreeFlow Medical Devices LLC
Fundacion para la Investigacion Biomedica del Hospital Gregorio Maranon
Georgia Institute of Technology
Griffith University
Grupo Vitalmex SA de CV
Haemair Ltd
Hangzhou Shengshi Technology Co Ltd
Harvard University
HeartWare International Inc
Hemovent GmbH
I.M. Sechenov First Moscow State Medical University
Indian Institute of Technology, Kanpur
Indiana University
Innova Vascular Inc
Innovative BioTherapies Inc
Inspira Technologies Oxy Bhn Ltd
Inspired Therapeutics LLC
Jarvik Heart Inc
Jiangsu STMed Technologies Co
Johns Hopkins University
Kindai University
LaunchPoint Technologies Inc
Lausanne University Hospital
Leviticus Cardio Ltd
Levram Medical Systems Ltd
Lifeshield Medical
Lingbo Biotechnology (Hangzhou) Co Ltd
LivaNova PLC
Magenta Medical Ltd
Mayo Clinic
MedArray Inc.
Medtronic Plc
Michigan Critical Care Consultants Inc
MicroPort Scientific Corp
Microstim GmbH
Monash University
MyoCardioCare, Inc.
Myotech, LLC (Inactive)
Naval Medical Research Center
NeoCardial Technologies, LLC
Neurescue Aps
Nikkiso Co Ltd
Nipro Corp
Northern Research Pty Ltd
Novapump GmbH
NuPulseCV, Inc.
OrbusNeich
OregonHeart Inc (Inactive)
Orqis Medical Corp (Inactive)
Pavmed Inc
Penn State Milton S Hershey Medical Center
Pennsylvania State University
Percassist Inc
Perfusion Solution Inc
Pleioflow Hellas SA
PlugMed Heart SAS
Procyrion Inc
PulseCath BV
Pumpinheart Ltd
Purdue University
Puzzle Medical Devices Inc
Qfluidics Inc
ReliantHeart, Inc.
Resuscitec GmbH
RT Cardiac Systems Inc
Rutgers The State University of New Jersey
Saint Louis University
Scandinavian Real Heart AB
Second Heart Assist Inc
Shandong University
Shandong Weigao Blood Purification Products Co Ltd
Shanghai MicroPort EP MedTech Co Ltd
Shanghai Xinhengrui Medical Technology Co Ltd
Sree Chitra Tirunal Institute for Medical Sciences & Technology
St. Jude Medical LLC
Sun Medical Technology Research Corp
Sunshine Heart Company, Pty. Ltd.
Supira Medical Inc
Suzhou LungShield Medical Tech Co Ltd
Suzhou Xinling Med Medical Technology Co Ltd
Suzhou Xinqing Medical Technology Co Ltd
Syncardia Systems LLC
Syntach AB
TCN Prime Inc
The Artificial Heart Laboratory of Foundation for Cardiac Surgery Development
The Charles Stark Draper Laboratory Inc
The Cleveland Clinic Foundation
Thoratec LLC
Tokyo Medical and Dental University
U.S. Stem Cell Inc
University of California Irvine
University of California San Francisco
University of Colorado Anschutz Medical Campus
University of Florida
University of Louisville
University of New South Wales
University of Pittsburgh
University of South Florida
University of Tokyo
University of Vienna
University of Virginia
Vadovations Inc
VASCOR Inc
VenstraMedical Pty Ltd
VentriFlo Inc
Vienna University of Technology
Windmill Cardiovascular Systems, Inc.
W-Z BIOTECH, LLC
Xenios AG
Yale University

|1 Table of Contents……………………………………………………………………………………… 3

|1.1 List of Tables……………………………………………………………………………………. 13

|1.2 List of Figures…………………………………………………………………………………… 28

2 Introduction…………………………………………………………………………………………….. 29

2.1 Cardiac Assist Devices Overview………………………………………………………….. 29

3 Products under Development…………………………………………………………………….. 31

3.1 Cardiac Assist Devices – Pipeline Products by Stage of Development……….. 31

3.2 Cardiac Assist Devices – Pipeline Products by Segment…………………………… 32

3.3 Cardiac Assist Devices – Pipeline Products by Territory…………………………… 33

3.4 Cardiac Assist Devices – Pipeline Products by Regulatory Path………………… 34

3.5 Cardiac Assist Devices – Pipeline Products by Estimated Approval Date……. 35

3.6 Cardiac Assist Devices – Ongoing Clinical Trials………………………………………. 36

4 Cardiac Assist Devices – Pipeline Products under Development by Companies… 37

4.1 Cardiac Assist Devices Companies – Pipeline Products by Stage of Development………………………………………………………………………………………….. 37

4.2 Cardiac Assist Devices – Pipeline Products by Stage of Development……….. 44

5 Cardiac Assist Devices Companies and Product Overview……………………………… 51

5.1 Abbott Vascular Inc Company Overview……………………………………………….. 51

5.1.1 Abbott Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………. 51

5.2 Abiomed Inc Company Overview…………………………………………………………. 52

5.2.1 Abiomed Inc Pipeline Products & Ongoing Clinical Trials Overview…… 52

5.3 Acorn Cardiovascular, Inc. (Inactive) Company Overview……………………….. 60

5.3.1 Acorn Cardiovascular, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………… 60

5.4 AdjuCor GmbH Company Overview……………………………………………………… 61

5.4.1 AdjuCor GmbH Pipeline Products & Ongoing Clinical Trials Overview.. 61

5.5 Aerospace Taixin Technology Co Ltd Company Overview……………………….. 64

5.5.1 Aerospace Taixin Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………… 64

5.6 AngioDynamics Inc Company Overview………………………………………………… 65

5.6.1 AngioDynamics Inc Pipeline Products & Ongoing Clinical Trials Overview…………………………………………………………………………………………………………. 65

5.7 Anhui Tongling Bionic Technology Co Ltd Company Overview………………… 66

5.7.1 Anhui Tongling Bionic Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………… 66

5.8 APK Advanced Medical Technologies, Inc. Company Overview……………….. 68

5.8.1 APK Advanced Medical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………… 68

5.9 Aria CV Inc Company Overview……………………………………………………………. 69

5.9.1 Aria CV Inc Pipeline Products & Ongoing Clinical Trials Overview……… 69

5.10 Arrow International Cr, A.S. Company Overview…………………………………. 72

5.10.1 Arrow International Cr, A.S. Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………. 72

5.11 Auflows CardioTech Pvt Ltd Company Overview………………………………….. 73

5.11.1 Auflows CardioTech Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………. 73

5.12 Beijing Yuewei Medical Technology Co Ltd Company Overview…………….. 74

5.12.1 Beijing Yuewei Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview…………………………………………………………… 74

5.13 Berlin Heart GmbH Company Overview……………………………………………… 76

5.13.1 Berlin Heart GmbH Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………. 76

5.14 Bicakcilar AS Company Overview……………………………………………………….. 77

5.14.1 Bicakcilar AS Pipeline Products & Ongoing Clinical Trials Overview…. 77

5.15 BioLife4D Corp Company Overview……………………………………………………. 78

5.15.1 BioLife4D Corp Pipeline Products & Ongoing Clinical Trials Overview 78

5.16 BioQ Devices Pty Ltd Company Overview……………………………………………. 80

5.16.1 BioQ Devices Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………. 80

5.17 Biosurfaces Inc Company Overview……………………………………………………. 82

5.17.1 Biosurfaces Inc Pipeline Products & Ongoing Clinical Trials Overview 82

5.18 BioVentrix Inc Company Overview……………………………………………………… 83

5.18.1 BioVentrix Inc Pipeline Products & Ongoing Clinical Trials Overview.. 83

5.19 BiVacor Pty Ltd Company Overview……………………………………………………. 84

5.19.1 BiVacor Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 84

5.20 Bonde Innovations LLC Company Overview………………………………………… 87

5.20.1 Bonde Innovations LLC Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………. 87

5.21 Boston Scientific Corp Company Overview………………………………………….. 88

5.21.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………. 88

5.22 Boundless Science LLC Company Overview…………………………………………. 89

5.22.1 Boundless Science LLC Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………. 89

5.23 Braile Biomedica Ltda Company Overview………………………………………….. 90

5.23.1 Braile Biomedica Ltda Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………. 90

5.24 BrioHealth Solutions Inc Company Overview………………………………………. 91

5.24.1 BrioHealth Solutions Inc Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………. 91

5.25 Calon Cardio-Technology Ltd Company Overview………………………………… 94

5.25.1 Calon Cardio-Technology Ltd Pipeline Products & Ongoing Clinical Trials Overview…………………………………………………………………………………… 94

5.26 Cardiac Success Ltd Company Overview……………………………………………… 97

5.26.1 Cardiac Success Ltd Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………. 97

5.27 CardiacAssist Inc Company Overview……………………………………………….. 100

5.27.1 CardiacAssist Inc Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………………….. 100

5.28 CardiacBooster BV Company Overview…………………………………………….. 101

5.28.1 CardiacBooster BV Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 101

5.29 Cardiak Ltd. Company Overview………………………………………………………. 102

5.29.1 Cardiak Ltd. Pipeline Products & Ongoing Clinical Trials Overview… 102

5.30 CARDIAnove Inc Company Overview………………………………………………… 103

5.30.1 CARDIAnove Inc Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………………….. 103

5.31 CardioBridge GmbH Company Overview…………………………………………… 104

5.31.1 CardioBridge GmbH Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 104

5.32 Cardiost Inc Company Overview………………………………………………………. 106

5.32.1 Cardiost Inc Pipeline Products & Ongoing Clinical Trials Overview… 106

5.33 Cardiovascular Systems Inc Company Overview………………………………… 107

5.33.1 Cardiovascular Systems Inc Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 107

5.34 Carmat SAS Company Overview………………………………………………………. 110

5.34.1 Carmat SAS Pipeline Products & Ongoing Clinical Trials Overview… 110

5.35 Carnegie Mellon University Company Overview………………………………… 114

5.35.1 Carnegie Mellon University Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 114

5.36 Chongqing Yongrenxin Medical Devices Co Ltd Company Overview…….. 116

5.36.1 Chongqing Yongrenxin Medical Devices Co Ltd Pipeline Products & Ongoing Clinical Trials Overview…………………………………………………………. 116

5.37 Cleveland Clinic Hospital Company Overview……………………………………. 117

5.37.1 Cleveland Clinic Hospital Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 117

5.38 Cleveland Clinic Lerner College of Medicine Company Overview…………. 118

5.38.1 Cleveland Clinic Lerner College of Medicine Pipeline Products & Ongoing Clinical Trials Overview…………………………………………………………. 118

5.39 Cleveland Heart Inc Company Overview……………………………………………. 120

5.39.1 Cleveland Heart Inc Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 120

5.40 Collplant Biotechnologies Ltd Company Overview……………………………… 122

5.40.1 Collplant Biotechnologies Ltd Pipeline Products & Ongoing Clinical Trials Overview…………………………………………………………………………………. 122

5.41 Colorado State University Company Overview…………………………………… 123

5.41.1 Colorado State University Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 123

5.42 Concordia University Company Overview…………………………………………. 124

5.42.1 Concordia University Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 124

5.43 CorasMedical Company Overview……………………………………………………. 125

5.43.1 CorasMedical Pipeline Products & Ongoing Clinical Trials Overview 125

5.44 CorAssist Cardiovascular Ltd Company Overview………………………………. 126

5.44.1 CorAssist Cardiovascular Ltd Pipeline Products & Ongoing Clinical Trials Overview…………………………………………………………………………………. 126

5.45 CorInnova, Inc. Company Overview………………………………………………….. 128

5.45.1 CorInnova, Inc. Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………………….. 128

5.46 CoRISMA MCS Systems Inc Company Overview…………………………………. 133

5.46.1 CoRISMA MCS Systems Inc Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 133

5.47 Corvion Inc Company Overview……………………………………………………….. 134

5.47.1 Corvion Inc Pipeline Products & Ongoing Clinical Trials Overview…. 134

5.48 CorWave SA Company Overview……………………………………………………… 135

5.48.1 CorWave SA Pipeline Products & Ongoing Clinical Trials Overview.. 135

5.49 CVD Equipment Corp Company Overview…………………………………………. 137

5.49.1 CVD Equipment Corp Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 137

5.50 Daidalos Solutions BV Company Overview………………………………………… 141

5.50.1 Daidalos Solutions BV Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 141

5.51 DHS Medical Company Overview……………………………………………………… 142

5.51.1 DHS Medical Pipeline Products & Ongoing Clinical Trials Overview.. 142

5.52 Dongguan Kewei Medical Instrument Co Ltd Company Overview………… 143

5.52.1 Dongguan Kewei Medical Instrument Co Ltd Pipeline Products & Ongoing Clinical Trials Overview…………………………………………………………. 143

5.53 Dongguan Tiantianxiang Medical Technology Co Ltd Company Overview 144

5.53.1 Dongguan Tiantianxiang Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………… 144

5.54 Drexel University Company Overview………………………………………………. 145

5.54.1 Drexel University Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………………….. 145

5.55 Duke University Company Overview…………………………………………………. 147

5.55.1 Duke University Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………………….. 147

5.56 Elsius Biomedical Inc Company Overview………………………………………….. 148

5.56.1 Elsius Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 148

5.57 Ension, Inc. Company Overview……………………………………………………….. 149

5.57.1 Ension, Inc. Pipeline Products & Ongoing Clinical Trials Overview…. 149

5.58 Fengkaili Medical Devices (Shanghai) Co Ltd Company Overview………… 152

5.58.1 Fengkaili Medical Devices (Shanghai) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview…………………………………………………………. 152

5.59 FineHeart Company Overview…………………………………………………………. 155

5.59.1 FineHeart Pipeline Products & Ongoing Clinical Trials Overview…… 155

5.60 Foster-Miller Inc (Inactive) Company Overview…………………………………. 156

5.60.1 Foster-Miller Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 156

5.61 FreeFlow Medical Devices LLC Company Overview…………………………….. 157

5.61.1 FreeFlow Medical Devices LLC Pipeline Products & Ongoing Clinical Trials Overview…………………………………………………………………………………. 157

5.62 Fundacion para la Investigacion Biomedica del Hospital Gregorio Maranon Company Overview……………………………………………………………………………….. 158

5.62.1 Fundacion para la Investigacion Biomedica del Hospital Gregorio Maranon Pipeline Products & Ongoing Clinical Trials Overview……………… 158

5.63 Georgia Institute of Technology Company Overview………………………….. 159

5.63.1 Georgia Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview…………………………………………………………………………………. 159

5.64 Griffith University Company Overview……………………………………………… 160

5.64.1 Griffith University Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………………….. 160

5.65 Grupo Vitalmex SA de CV Company Overview…………………………………… 162

5.65.1 Grupo Vitalmex SA de CV Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 162

5.66 Haemair Ltd Company Overview……………………………………………………… 163

5.66.1 Haemair Ltd Pipeline Products & Ongoing Clinical Trials Overview.. 163

5.67 Hangzhou Shengshi Technology Co Ltd Company Overview………………… 164

5.67.1 Hangzhou Shengshi Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………. 164

5.68 Harvard University Company Overview…………………………………………….. 165

5.68.1 Harvard University Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 165

5.69 HeartWare International Inc Company Overview………………………………. 166

5.69.1 HeartWare International Inc Pipeline Products & Ongoing Clinical Trials Overview…………………………………………………………………………………. 166

5.70 Hemovent GmbH Company Overview………………………………………………. 173

5.70.1 Hemovent GmbH Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………………….. 173

5.71 I.M. Sechenov First Moscow State Medical University Company Overview……………………………………………………………………………………………………………. 176

5.71.1 I.M. Sechenov First Moscow State Medical University Pipeline Products & Ongoing Clinical Trials Overview………………………………………… 176

5.72 Indian Institute of Technology, Kanpur Company Overview………………… 177

5.72.1 Indian Institute of Technology, Kanpur Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………. 177

5.73 Indiana University Company Overview……………………………………………… 178

5.73.1 Indiana University Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 178

5.74 Innova Vascular Inc Company Overview……………………………………………. 179

5.74.1 Innova Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 179

5.75 Innovative BioTherapies Inc Company Overview……………………………….. 180

5.75.1 Innovative BioTherapies Inc Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 180

5.76 Inspira Technologies Oxy Bhn Ltd Company Overview………………………… 181

5.76.1 Inspira Technologies Oxy Bhn Ltd Pipeline Products & Ongoing Clinical Trials Overview…………………………………………………………………………………. 181

5.77 Inspired Therapeutics LLC Company Overview…………………………………… 185

5.77.1 Inspired Therapeutics LLC Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 185

5.78 Jarvik Heart Inc Company Overview…………………………………………………. 186

5.78.1 Jarvik Heart Inc Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………………….. 186

5.79 Jiangsu STMed Technologies Co Company Overview………………………….. 192

5.79.1 Jiangsu STMed Technologies Co Pipeline Products & Ongoing Clinical Trials Overview…………………………………………………………………………………. 192

5.80 Johns Hopkins University Company Overview……………………………………. 193

5.80.1 Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 193

5.81 Kindai University Company Overview……………………………………………….. 194

5.81.1 Kindai University Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………………….. 194

5.82 LaunchPoint Technologies Inc Company Overview…………………………….. 195

5.82.1 LaunchPoint Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview…………………………………………………………………………………. 195

5.83 Lausanne University Hospital Company Overview……………………………… 197

5.83.1 Lausanne University Hospital Pipeline Products & Ongoing Clinical Trials Overview…………………………………………………………………………………. 197

5.84 Leviticus Cardio Ltd Company Overview……………………………………………. 198

5.84.1 Leviticus Cardio Ltd Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 198

5.85 Levram Medical Systems Ltd Company Overview………………………………. 200

5.85.1 Levram Medical Systems Ltd Pipeline Products & Ongoing Clinical Trials Overview…………………………………………………………………………………. 200

5.86 Lifeshield Medical Company Overview……………………………………………… 201

5.86.1 Lifeshield Medical Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 201

5.87 Lingbo Biotechnology (Hangzhou) Co Ltd Company Overview…………….. 202

5.87.1 Lingbo Biotechnology (Hangzhou) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………. 202

5.88 LivaNova PLC Company Overview……………………………………………………. 203

5.88.1 LivaNova PLC Pipeline Products & Ongoing Clinical Trials Overview 203

5.89 Magenta Medical Ltd Company Overview…………………………………………. 206

5.89.1 Magenta Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 206

5.90 Mayo Clinic Company Overview………………………………………………………. 209

5.90.1 Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview… 209

5.91 MedArray Inc. Company Overview…………………………………………………… 212

5.91.1 MedArray Inc. Pipeline Products & Ongoing Clinical Trials Overview 212

5.92 Medtronic Plc Company Overview……………………………………………………. 215

5.92.1 Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 215

5.93 Michigan Critical Care Consultants Inc Company Overview…………………. 216

5.93.1 Michigan Critical Care Consultants Inc Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………. 216

5.94 MicroPort Scientific Corp Company Overview……………………………………. 219

5.94.1 MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 219

5.95 Microstim GmbH Company Overview………………………………………………. 224

5.95.1 Microstim GmbH Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………………….. 224

5.96 Monash University Company Overview…………………………………………….. 225

5.96.1 Monash University Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 225

5.97 MyoCardioCare, Inc. Company Overview………………………………………….. 227

5.97.1 MyoCardioCare, Inc. Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 227

5.98 Myotech, LLC (Inactive) Company Overview……………………………………… 229

5.98.1 Myotech, LLC (Inactive) Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 229

5.99 Naval Medical Research Center Company Overview…………………………… 230

5.99.1 Naval Medical Research Center Pipeline Products & Ongoing Clinical Trials Overview…………………………………………………………………………………. 230

5.100 NeoCardial Technologies, LLC Company Overview…………………………… 231

5.100.1 NeoCardial Technologies, LLC Pipeline Products & Ongoing Clinical Trials Overview…………………………………………………………………………………. 231

5.101 Neurescue Aps Company Overview………………………………………………… 232

5.101.1 Neurescue Aps Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………………….. 232

5.102 Nikkiso Co Ltd Company Overview…………………………………………………. 235

5.102.1 Nikkiso Co Ltd Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………………….. 235

5.103 Nipro Corp Company Overview……………………………………………………… 236

5.103.1 Nipro Corp Pipeline Products & Ongoing Clinical Trials Overview.. 236

5.104 Northern Research Pty Ltd Company Overview……………………………….. 239

5.104.1 Northern Research Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 239

5.105 Novapump GmbH Company Overview……………………………………………. 240

5.105.1 Novapump GmbH Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 240

5.106 NuPulseCV, Inc. Company Overview……………………………………………….. 242

5.106.1 NuPulseCV, Inc. Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………………….. 242

5.107 OrbusNeich Company Overview…………………………………………………….. 244

5.107.1 OrbusNeich Pipeline Products & Ongoing Clinical Trials Overview. 244

5.108 OregonHeart Inc (Inactive) Company Overview……………………………….. 246

5.108.1 OregonHeart Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 246

5.109 Orqis Medical Corp (Inactive) Company Overview……………………………. 247

5.109.1 Orqis Medical Corp (Inactive) Pipeline Products & Ongoing Clinical Trials Overview…………………………………………………………………………………. 247

5.110 Pavmed Inc Company Overview…………………………………………………….. 248

5.110.1 Pavmed Inc Pipeline Products & Ongoing Clinical Trials Overview. 248

5.111 Penn State Milton S Hershey Medical Center Company Overview……… 249

5.111.1 Penn State Milton S Hershey Medical Center Pipeline Products & Ongoing Clinical Trials Overview…………………………………………………………. 249

5.112 Pennsylvania State University Company Overview…………………………… 250

5.112.1 Pennsylvania State University Pipeline Products & Ongoing Clinical Trials Overview…………………………………………………………………………………. 250

5.113 Percassist Inc Company Overview………………………………………………….. 252

5.113.1 Percassist Inc Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………………….. 252

5.114 Perfusion Solution Inc Company Overview………………………………………. 255

5.114.1 Perfusion Solution Inc Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 255

5.115 Pleioflow Hellas SA Company Overview………………………………………….. 258

5.115.1 Pleioflow Hellas SA Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 258

5.116 PlugMed Heart SAS Company Overview………………………………………….. 262

5.116.1 PlugMed Heart SAS Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 262

5.117 Procyrion Inc Company Overview…………………………………………………… 263

5.117.1 Procyrion Inc Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………………….. 263

5.118 PulseCath BV Company Overview…………………………………………………… 266

5.118.1 PulseCath BV Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………………….. 266

5.119 Pumpinheart Ltd Company Overview……………………………………………… 268

5.119.1 Pumpinheart Ltd Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………………….. 268

5.120 Purdue University Company Overview……………………………………………. 269

5.120.1 Purdue University Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 269

5.121 Puzzle Medical Devices Inc Company Overview……………………………….. 270

5.121.1 Puzzle Medical Devices Inc Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 270

5.122 Qfluidics Inc Company Overview……………………………………………………. 273

5.122.1 Qfluidics Inc Pipeline Products & Ongoing Clinical Trials Overview 273

5.123 ReliantHeart, Inc. Company Overview…………………………………………….. 274

5.123.1 ReliantHeart, Inc. Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 274

5.124 Resuscitec GmbH Company Overview…………………………………………….. 277

5.124.1 Resuscitec GmbH Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 277

5.125 RT Cardiac Systems Inc Company Overview…………………………………….. 282

5.125.1 RT Cardiac Systems Inc Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 282

5.126 Rutgers The State University of New Jersey Company Overview………… 283

5.126.1 Rutgers The State University of New Jersey Pipeline Products & Ongoing Clinical Trials Overview…………………………………………………………. 283

5.127 Saint Louis University Company Overview………………………………………. 285

5.127.1 Saint Louis University Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 285

5.128 Scandinavian Real Heart AB Company Overview……………………………… 287

5.128.1 Scandinavian Real Heart AB Pipeline Products & Ongoing Clinical Trials Overview…………………………………………………………………………………. 287

5.129 Second Heart Assist Inc Company Overview……………………………………. 290

5.129.1 Second Heart Assist Inc Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 290

5.130 Shandong University Company Overview………………………………………… 292

5.130.1 Shandong University Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 292

5.131 Shandong Weigao Blood Purification Products Co Ltd Company Overview……………………………………………………………………………………………………………. 293

5.131.1 Shandong Weigao Blood Purification Products Co Ltd Pipeline Products & Ongoing Clinical Trials Overview………………………………………… 293

5.132 Shanghai MicroPort EP MedTech Co Ltd Company Overview…………….. 294

5.132.1 Shanghai MicroPort EP MedTech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………. 294

5.133 Shanghai Xinhengrui Medical Technology Co Ltd Company Overview… 297

5.133.1 Shanghai Xinhengrui Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview…………………………………………………………. 297

5.134 Sree Chitra Tirunal Institute for Medical Sciences & Technology Company Overview……………………………………………………………………………………………… 300

5.134.1 Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview……………………………. 300

5.135 St. Jude Medical LLC Company Overview………………………………………… 303

5.135.1 St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 303

5.136 Sun Medical Technology Research Corp Company Overview…………….. 305

5.136.1 Sun Medical Technology Research Corp Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………. 305

5.137 Sunshine Heart Company, Pty. Ltd. Company Overview……………………. 309

5.137.1 Sunshine Heart Company, Pty. Ltd. Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………. 309

5.138 Supira Medical Inc Company Overview…………………………………………… 310

5.138.1 Supira Medical Inc Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 310

5.139 Suzhou LungShield Medical Tech Co Ltd Company Overview…………….. 314

5.139.1 Suzhou LungShield Medical Tech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………. 314

5.140 Suzhou Xinling Med Medical Technology Co Ltd Company Overview…. 317

5.140.1 Suzhou Xinling Med Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview…………………………………………………………. 317

5.141 Suzhou Xinqing Medical Technology Co Ltd Company Overview………… 318

5.141.1 Suzhou Xinqing Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview…………………………………………………………. 318

5.142 Syncardia Systems LLC Company Overview……………………………………… 321

5.142.1 Syncardia Systems LLC Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 321

5.143 Syntach AB Company Overview……………………………………………………… 325

5.143.1 Syntach AB Pipeline Products & Ongoing Clinical Trials Overview.. 325

5.144 TCN Prime Inc Company Overview…………………………………………………. 326

5.144.1 TCN Prime Inc Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………………….. 326

5.145 The Artificial Heart Laboratory of Foundation for Cardiac Surgery Development Company Overview…………………………………………………………… 327

5.145.1 The Artificial Heart Laboratory of Foundation for Cardiac Surgery Development Pipeline Products & Ongoing Clinical Trials Overview……….. 327

5.146 The Charles Stark Draper Laboratory Inc Company Overview……………. 328

5.146.1 The Charles Stark Draper Laboratory Inc Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………. 328

5.147 The Cleveland Clinic Foundation Company Overview……………………….. 329

5.147.1 The Cleveland Clinic Foundation Pipeline Products & Ongoing Clinical Trials Overview…………………………………………………………………………………. 329

5.148 Thoratec LLC Company Overview…………………………………………………… 330

5.148.1 Thoratec LLC Pipeline Products & Ongoing Clinical Trials Overview 330

5.149 Tokyo Medical and Dental University Company Overview………………… 334

5.149.1 Tokyo Medical and Dental University Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………. 334

5.150 U.S. Stem Cell Inc Company Overview…………………………………………….. 335

5.150.1 U.S. Stem Cell Inc Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 335

5.151 University of California Irvine Company Overview……………………………. 336

5.151.1 University of California Irvine Pipeline Products & Ongoing Clinical Trials Overview…………………………………………………………………………………. 336

5.152 University of California San Francisco Company Overview………………… 337

5.152.1 University of California San Francisco Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………. 337

5.153 University of Colorado Anschutz Medical Campus Company Overview. 338

5.153.1 University of Colorado Anschutz Medical Campus Pipeline Products & Ongoing Clinical Trials Overview…………………………………………………………. 338

5.154 University of Florida Company Overview………………………………………… 339

5.154.1 University of Florida Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 339

5.155 University of Louisville Company Overview……………………………………… 340

5.155.1 University of Louisville Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 340

5.156 University of New South Wales Company Overview…………………………. 341

5.156.1 University of New South Wales Pipeline Products & Ongoing Clinical Trials Overview…………………………………………………………………………………. 341

5.157 University of Pittsburgh Company Overview……………………………………. 342

5.157.1 University of Pittsburgh Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 342

5.158 University of South Florida Company Overview……………………………….. 343

5.158.1 University of South Florida Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 343

5.159 University of Tokyo Company Overview………………………………………….. 344

5.159.1 University of Tokyo Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 344

5.160 University of Vienna Company Overview………………………………………… 345

5.160.1 University of Vienna Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 345

5.161 University of Virginia Company Overview……………………………………….. 346

5.161.1 University of Virginia Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 346

5.162 Vadovations Inc Company Overview………………………………………………. 347

5.162.1 Vadovations Inc Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………………….. 347

5.163 VASCOR Inc Company Overview…………………………………………………….. 348

5.163.1 VASCOR Inc Pipeline Products & Ongoing Clinical Trials Overview. 348

5.164 VenstraMedical Pty Ltd Company Overview……………………………………. 349

5.164.1 VenstraMedical Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 349

5.165 VentriFlo Inc Company Overview……………………………………………………. 350

5.165.1 VentriFlo Inc Pipeline Products & Ongoing Clinical Trials Overview 350

5.166 Vienna University of Technology Company Overview……………………….. 351

5.166.1 Vienna University of Technology Pipeline Products & Ongoing Clinical Trials Overview…………………………………………………………………………………. 351

5.167 Windmill Cardiovascular Systems, Inc. Company Overview……………….. 352

5.167.1 Windmill Cardiovascular Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………. 352

5.168 W-Z BIOTECH, LLC Company Overview……………………………………………. 354

5.168.1 W-Z BIOTECH, LLC Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 354

5.169 Xenios AG Company Overview……………………………………………………….. 357

5.169.1 Xenios AG Pipeline Products & Ongoing Clinical Trials Overview…. 357

5.170 Yale University Company Overview………………………………………………… 358

5.170.1 Yale University Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………………….. 358

6 Cardiac Assist Devices- Recent Developments……………………………………………. 361

6.1 Aug 16, 2024: LivaNova USA Receives FDA 510(k) Clearance for SMARxT Tubing And Connector…………………………………………………………………………… 361

6.2 Aug 13, 2024: Inspira Approached by Large Medical Company to Evaluate Operation of their Key Product with INSPIRA ART100 – Results Exceed 100% at Maximum Flow……………………………………………………………………………………… 361

6.3 Aug 12, 2024: Abiomed Celebrates 25 Years of Heart Recovery with Impella……………………………………………………………………………………………………………. 361

6.4 Aug 12, 2024: Heart Pump Recall: Abiomed Removes Certain Impella CP with SmartAssist Systems due to Failed Quality Inspections………………………………. 362

6.5 Aug 01, 2024: Merit Medical Systems Announces Q2 2024 Results and Raises Full-Year Guidance………………………………………………………………………………… 363

6.6 Jul 30, 2024: Inspira Technologies Introduces the INSPIRA Cardi-ART, Aiming to Provide Oxygen to the Brain During Cardiac Arrest……………………………….. 365

6.7 Jul 29, 2024: The Texas Heart Institute Implants BiVACOR Total Artificial Heart……………………………………………………………………………………………………. 365

6.8 Jul 25, 2024: 20 Years after Landmark FDA Approval, SynCardia Remains World’s Only Commercially Approved Total Artificial Heart……………………….. 366

6.9 Jul 25, 2024: Second Heart Assist Announces an Impressive Successful Completion of a First-In-Human Case Study in Central America with its Whisper Device………………………………………………………………………………………………….. 367

6.10 Jul 17, 2024: Eurosets: Newborn Baby Saved From Acute Bronchiolitis in Martinique by Colibri Third-Generation Life-Support Device………………………. 367

6.11 Jul 09, 2024: CARMAT Accelerates Its Sales Momentum and Reiterates Its Confidence in Its Development Outlook…………………………………………………… 368

6.12 Jul 04, 2024: KFSH&RC Achieves Remarkable 98% Survival Rate in 400 Robotic Cardiac Surgeries………………………………………………………………………. 370

6.13 Jun 25, 2024: Abbott Laboratories obtains Additional Humanitarian Device Exemption (HDE) clearance For Levitronix CentriMag Right Ventricular Assist System (RVAS)………………………………………………………………………………………. 370

6.14 Jun 18, 2024: Qura Receives Additional 510(K) Clearance For Quantum Perfusion Dual Lumen Cannula……………………………………………………………….. 371

6.15 Jun 18, 2024: Merit Medical Systems to Announce Second Quarter 2024 Results on August 1, 2024………………………………………………………………………. 371

6.16 Jun 14, 2024: Teleflex and Arrow recall IAB catheter kits due to risk of injury or death………………………………………………………………………………………. 371

6.17 Jun 13, 2024: Medtronic Confirms Global Layoffs………………………………. 372

6.18 Jun 10, 2024: Inspira Technologies Oxy Bhn Receives 510(K) Clearance For Inspira ART (Augmented Respiration Technology) System…………………………. 372

6.19 May 29, 2024: FDA approves Terumo’s CDI OneView Monitoring System……………………………………………………………………………………………………………. 372

6.20 May 28, 2024: Terumo Cardiovascular Announces 510(K) Clearance For The CDI OneView Monitoring System…………………………………………………………….. 373

6.21 May 24, 2024: MOBYBOX, the World’s First Integrated Portable Pneumatic ECMO Product, Completes Its Initial Commercial Applications in Europe…….. 374

6.22 May 17, 2024: Abbott Laboratories Receives Additional Humanitarian Device Exemption (HDE) clearance for Levitronix CentriMag Right Ventricular Assist System (RVAS)……………………………………………………………………………… 375

6.23 May 17, 2024: Philips Presents Study Results At Heart Rhythm Annual Meeting Demonstrating Benefits Of Its Ai-powered Cardiac Monitoring Solutions……………………………………………………………………………………………………………. 375

6.24 May 16, 2024: Cape Cod Hospital to Pay $24.3 Million to Resolve False Claims Act Allegations Concerning Its Failure to Comply with Medicare Rules for Cardiac Procedures……………………………………………………………………………….. 377

6.25 May 15, 2024: Abbott Recalls Heartmate 3 Left Ventricular Assist System (LVAS) Implant Kit for Risk of Blood Leakage or Air Entering System Between Inflow Cannula and Apical Cuff……………………………………………………………….. 378

6.26 May 08, 2024: Abbott Laboratories Receives Additional Humanitarian Device Exemption (HDE) clearance for Levitronix CentriMag Right Ventricular Assist System (RVAS)……………………………………………………………………………… 379

6.27 May 08, 2024: Thoratec Receives Additional Humanitarian Device Exemption (HDE) clearance for CentriMag Right Ventricular Assist System (RVAS)………………………………………………………………………………………………….. 379

6.28 May 06, 2024: CARMAT Continues to Build on Its Momentum in the EFICAS Study and Reiterates Confidence in Its 2024 Outlook………………………………… 380

6.29 May 02, 2024: Inspira Announces Start of Production of the INSPIRA ART100………………………………………………………………………………………………… 381

6.30 May 01, 2024: BrioHealth Solutions Secures Nod from FDA to Begin the INNOVATE Trial Featuring the BrioVAD System for Advanced Heart Failure…. 381

6.31 May 01, 2024: New Study Shows Copan’s Colibrí Automates MALDI-TOF Sample Preparation with High Accuracy…………………………………………………… 381

6.32 Apr 30, 2024: NuvoAir Medical Partners with Privia Medical Group — Georgia to Help Transform Cardiopulmonary Care with Virtual-First Care Model……………………………………………………………………………………………………………. 382

6.33 Apr 28, 2024: Medtronic Receives Additional 510(K) Clearance For Bio-Medicus Life Support Catheter And Introducer…………………………………………. 383

6.34 Apr 25, 2024: Inspira Receives CSA Certification of Compliance to U.S. Standards for the INSPIRA ART100………………………………………………………….. 383

6.35 Apr 18, 2024: Karoo Health Launches Proprietary Technology Platform Kohere.ai to Supercharge Its Cardiac Value-based Care Model…………………… 384

6.36 Apr 15, 2024: Abbott/Thoratec Corp. Recalls HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) due to Long-term Buildup Causing an Obstruction………………………………………………………………………………………….. 385

6.37 Apr 08, 2024: Getinge Invites Fund Managers, Analysts, And Media to Q1 Report 2024 Conference Call………………………………………………………………….. 386

6.38 Apr 07, 2024: Randomized Controlled Trial Confirms Impella CP Improves Survival in Heart Attack with Cardiogenic Shock……………………………………….. 386

6.39 Apr 03, 2024: Inspira Announces Program to Pioneer the Applicable Use of the INSPIRA ART100 Device for an Artificial Womb…………………………………… 386

6.40 Apr 02, 2024: Carium and CareDirections Partner to Launch Post-Acute Stroke Care Solution Developed by Atrium Health Wake Forest Baptist………. 387

6.41 Mar 28, 2024: Ventripoint Diagnostics Provides Corporate Update and Announces Conference Call……………………………………………………………………. 387

6.42 Mar 27, 2024: TUV SUD suspends CE-certificate for Getinge’s Cardiosave……………………………………………………………………………………………………………. 389

6.43 Mar 25, 2024: Stony Brook Professor George Leibowitz Assumes Role from Interim Dean Richard L. Edwards…………………………………………………………….. 390

6.44 Mar 18, 2024: Inspira Announces AMAR Regulatory Submission of the INSPIRA ART100, to Enter the Southeast Asia and South American Markets… 391

6.45 Mar 12, 2024: Medtronic To Present At Barclays Global Healthcare Conference…………………………………………………………………………………………… 391

6.46 Mar 11, 2024: PulseCath Achieves MDR CE Certification for iVAC 2L, Paving the Way for Complex High-Risk Percutaneous Coronary Interventions………… 391

6.47 Mar 11, 2024: Abbott Recalls HeartMate Touch Communication System for Unintentional Pump Start and Stop…………………………………………………………. 392

6.48 Mar 11, 2024: Patent Covering Innovative Total Artificial Heart Design Granted to Syncardia…………………………………………………………………………….. 393

6.49 Mar 04, 2024: Medtronic Receives Additional 510(K) Clearance For MYOtherm XP Cardioplegia Delivery System With Cortiva BioActive Surface.. 393

6.50 Mar 04, 2024: Sorin Group Receives Additional 510(K) Clearance For R502 Aortic Root Cannula With Vent Line………………………………………………………… 394

6.51 Mar 04, 2024: Inspira Announces Plans to Report the Primary Results for a Core Blood Oxygenation Technology Within Days…………………………………….. 394

6.52 Mar 04, 2024: LivaNova to Present at the Barclays Global Healthcare Conference…………………………………………………………………………………………… 395

6.53 Mar 04, 2024: Blood pressure cuffs available through the Washoe County Library System………………………………………………………………………………………. 395

6.54 Mar 01, 2024: Sorin Group Italia Receives Additional FDA 510(K) Clearance for R501 Aortic Root Cannula Without Vent Line………………………………………. 395

6.55 Mar 01, 2024: Medtronic Receives Additional FDA 510(k) Clearance for MYOtherm XP Cardioplegia Delivery System With Cortiva BioActive Surface.. 396

6.56 Mar 01, 2024: TÜV SÜD is temporarily suspending Getinge’s CE certificate for Cardiosave………………………………………………………………………………………. 396

6.57 Mar 01, 2024: TUV SUD Is Temporarily Suspending Getinge’s Ce Certificate for Cardiosave………………………………………………………………………………………. 397

6.58 Feb 28, 2024: Providence St. Patrick Hospital Offers Advanced Life-Support for Patients in Critical Care…………………………………………………………………….. 397

6.59 Feb 27, 2024: Aria CV Announces First Patient Successfully Implanted with Second-Generation Pulmonary Hypertension System……………………………….. 398

6.60 Feb 23, 2024: Edwards Lifesciences to Present at the 44th Annual TD Cowen Healthcare Conference……………………………………………………………….. 398

6.61 Feb 22, 2024: Inspira Introduces High-End Platform for Bio-Mimicking Blood Parameters for Development and Testing of Core Technologies……….. 399

6.62 Feb 21, 2024: $50 Million for the World’s Most Advanced Artificial Heart……………………………………………………………………………………………………………. 399

6.63 Feb 20, 2024: Revolutionary Artificial Heart a Lifeline for Heart Failure Patients………………………………………………………………………………………………… 399

6.64 Feb 20, 2024: Fineheart Widens International IP Protection for Flowmaker……………………………………………………………………………………………………………. 401

6.65 Feb 20, 2024: BiVACOR Receives $13 Million to Support Clinical Trials for the Company’s Total Artificial Heart………………………………………………………… 402

6.66 Feb 15, 2024: Edwards Lifesciences Receives Additional 510(K) Clearance For EndoReturn Arterial Cannula…………………………………………………………….. 402

6.67 Feb 15, 2024: Inspira’s blood oxygenation system receives US patent approval……………………………………………………………………………………………….. 403

6.68 Feb 14, 2024: A new test could predict how heart attack patients will respond to mechanical pumps………………………………………………………………… 403

6.69 Feb 08, 2024: Teleflex Announces Fourth Quarter 2023 Earnings Conference Call Information…………………………………………………………………… 405

6.70 Feb 05, 2024: Abbott Medical Receives Additional FDA 510(k) Clearance for CentriMag Acute Circulatory Support System…………………………………………… 405

6.71 Feb 05, 2024: Syncardia Systems Announces Publication of Patent Application Covering Innovative Total Artificial Heart Design……………………… 405

6.72 Feb 05, 2024: Harvard Names Ex-Merck CEO Frazier, KKR’s Bae to Its Board……………………………………………………………………………………………………………. 406

6.73 Jan 29, 2024: CardiacAssist Receives Additional FDA 510(k) Clearance for LifeSPARC System………………………………………………………………………………….. 406

6.74 Jan 29, 2024: Copan Colibri Receives Third FDA Clearance, Further Expanding Automated ID/AST Workup Capabilities…………………………………… 406

6.75 Jan 15, 2024: CARMAT Achieves a Pivotal Year in 2023 by Reaching the Milestone of 50 Implants of the Aeson Artificial Heart and Presents Its Development Prospects…………………………………………………………………………. 407

6.76 Jan 10, 2024: Copan Wasp Received Additional 510(K) Clearance For Colibri System…………………………………………………………………………………………………. 409

6.77 Jan 09, 2024: Inspira Announces Plans to Launch and Target Single-Use Disposable Blood Oxygenation Kit for a New Disposable Perfusion Market Opportunity………………………………………………………………………………………….. 410

6.78 Dec 28, 2023: Carmat Announces a Software Enhancement which Significantly Improves the Safety Profile of its Aeson Artificial Heart…………… 410

6.79 Dec 24, 2023: Medtronic Receives 510(k) Clearance for DLP Silicone Coronary Artery Ostial Cannulae…………………………………………………………….. 411

6.80 Dec 11, 2023: Carmat Announces the First Implant of the Aeson Artificial Heart in a Patient Suffering from a Cardiac Tumor……………………………………. 411

6.81 Dec 08, 2023: Getinge Recalls Cardiohelp Emergency Drive Due to an Impaired or Inability to Turn the Drive…………………………………………………….. 411

6.82 Dec 08, 2023: Clinical Trial for World’s Smallest Heart Pump………………. 412

6.83 Nov 30, 2023: BiVACOR wins IDE to start first-in-human study for artificial heart……………………………………………………………………………………………………. 413

6.84 Nov 30, 2023: Procyrion Announces First Patient Enrollments in the DRAIN-HF Pivotal IDE Trial for Aortix Percutaneous Mechanical Circulatory Support Technology…………………………………………………………………………………………… 414

6.85 Nov 29, 2023: Sorin Group Receives 510(K) Clearance For D100 KIDS Oxygenator…………………………………………………………………………………………… 415

6.86 Nov 29, 2023: magAssist Attended 2023 ISMCS to Showcase its Next-Gen Medical Solutions that Improve Treatment Outcomes of Critical Heart Diseases……………………………………………………………………………………………………………. 415

6.87 Nov 24, 2023: Ventripoint Announces Date and Timing for Release of Q3 2023 Financial Results and Webinar………………………………………………………… 416

6.88 Nov 22, 2023: Houston Housing Authority Partners With Cardiac Solutions to Pioneer Life-Saving Initiative: Install Aeds in All Public Housing Complexes 416

6.89 Nov 21, 2023: Supira Medical, a Shifamed Portfolio Company, Receives FDA Breakthrough Device Designation as the Company Closed $40M in Series D Financing……………………………………………………………………………………………… 417

6.90 Nov 21, 2023: National Heart Centre Singapore partners Mede………….. 417

6.91 Nov 13, 2023: Realheart Provides an Update on the Development and Commercialization of Its Artificial Heart…………………………………………………… 418

6.92 Nov 13, 2023: Late-Breaking Data Show an Aspirin-Free Medication Regimen Benefits People with Abbott’s HeartMate 3 Heart Pump……………… 419

6.93 Nov 02, 2023: Applied BioMath Announces Participation at the 14th American Conference on Pharmacometrics……………………………………………… 420

6.94 Nov 01, 2023: Realheart has Successfully Established a Novel Test System to Evaluate Hemolysis of its Total Artificial Heart……………………………………… 421

6.95 Oct 25, 2023: MC3 Receives 510(K) Clearance For Nautilus VF ECMO Oxygenator…………………………………………………………………………………………… 422

6.96 Oct 25, 2023: Inspira Granted U.S. Patent for INSPIRA ART500 Medical Device………………………………………………………………………………………………….. 422

6.97 Oct 25, 2023: Magenta Medical Reports Positive Results for US Early Feasibility Study of Elevate Heart Pump in Providing Temporary Mechanical Circulatory Support During High-Risk PCI Procedures Results presented at TCT 2023 in San Francisco…………………………………………………………………………….. 422

6.98 Oct 23, 2023: Abiomed to Highlight Data Analysis Identifying Complex Clinical Profile of Patients Receiving Impella-Supported HRPCI at TCT Symposium……………………………………………………………………………………………………………. 424

6.99 Oct 23, 2023: Ventripoint to Hold Annual General Meeting of Shareholders on November 1, 2023…………………………………………………………………………….. 425

6.100 Oct 20, 2023: Supira Medical’s Next Generation Percutaneous Ventricular Assist Device (pVAD) System to be Highlighted in a Live Case and Multiple Sessions at the Upcoming TCT 2023 Conference……………………………………….. 425

6.101 Oct 18, 2023: Edwards Lifesciences to Host Earnings Conference Call on October 25, 2023…………………………………………………………………………………… 426

6.102 Oct 18, 2023: Cook Awarded Third Contract with Veterans Affairs for Implanted Devices…………………………………………………………………………………. 426

6.103 Oct 10, 2023: Inspira Enters into a Distribution Agreement in Central America with CIO MED GROUP……………………………………………………………….. 426

6.104 Oct 10, 2023: Results from Magenta Medical’s US Early Feasibility Study of the World’s Smallest and Most Powerful Heart Pump to be Highlighted at TCT 2023…………………………………………………………………………………………………….. 427

6.105 Oct 09, 2023: CorWave Announces the Grand Opening of Its Manufacturing Facility on the Banks of the Seine, next to Paris………………….. 428

6.106 Oct 04, 2023: Biome Analytics Unveils Next-Generation Echo Quality and Patient Monitoring Tool…………………………………………………………………………. 428

6.107 Oct 03, 2023: FineHeart Obtains Czech Health Authority Approval to Commence First in Human Clinical Study…………………………………………………. 429

6.108 Oct 03, 2023: Getinge Invites Fund Managers, Analysts, and Media to Q3 Report 2023 Conference Call………………………………………………………………….. 430

6.109 Oct 03, 2023: St. Joseph’s Children’s Hospital Implants 250th Pulmonary Valve Without Open-Heart Surgery…………………………………………………………. 430

6.110 Sep 29, 2023: Inspira to unveil new INSPIRA ART medical devices……… 431

6.111 Sep 28, 2023: PercAssist Announces First Patient Treated in EUREKA Study of PSCA System for Hemodynamic Support in Chronic Heart Failure…………… 431

6.112 Sep 14, 2023: LivaNova Deutschland Receives Additional 510(k) Clearance for Essenz HLM System………………………………………………………………………….. 432

6.113 Sep 13, 2023: Inspira Announces 510(K) FDA Submission of Inspira ART100 Towards Commercialization……………………………………………………………………. 432

6.114 Sep 08, 2023: Michigan Critical Care Consultants Receives 510(k) Clearance for VitalFlow Centrifugal Pump………………………………………………… 433

6.115 Sep 08, 2023: Michigan Critical Care Consultants Receives 510(k) Clearance for VitalFlow Console……………………………………………………………… 433

6.116 Sep 07, 2023: Procyrion Secures New Medicare Payment Codes Applicable to its Aortix Percutaneous Mechanical Circulatory Support Technology………. 433

6.117 Sep 05, 2023: First Patient With Nyokassist Interventional Ventricular Assist Device: Dr. Junbo Ge’s Team Successfully Completed the First High-Risk PCI Treatment Supported by the New Generation of Interventional VAD……. 434

6.118 Aug 31, 2023: Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Power Failures When Device is Unseated from Cart……………………………………………………………………………….. 435

6.119 Aug 30, 2023: LivaNova Unveils Essenz In-Line Blood Monitor with U.S. FDA 510(k) Clearance and CE Mark…………………………………………………………. 436

6.120 Aug 29, 2023: Inspira Signs Agreement Expansion with Innovimed for Clinical Trials of INSPIRA ART Respiratory Medical Devices………………………… 437

6.121 Aug 28, 2023: Edwards Lifesciences to Present at the 2023 Wells Fargo Healthcare Conference………………………………………………………………………….. 437

7 Appendix……………………………………………………………………………………………….. 438

7.1 Methodology…………………………………………………………………………………… 438

7.2 About GlobalData…………………………………………………………………………….. 441

7.3 Contact Us………………………………………………………………………………………. 441

7.4 Disclaimer……………………………………………………………………………………….. 441

Table

Cardiac Assist Devices – Pipeline Products by Stage of Development…………………. 31

Cardiac Assist Devices – Pipeline Products by Segment…………………………………….. 32

Cardiac Assist Devices – Pipeline Products by Territory…………………………………….. 33

Cardiac Assist Devices – Pipeline Products by Regulatory Path………………………….. 34

Cardiac Assist Devices – Pipeline Products by Estimated Approval Date…………….. 35

Cardiac Assist Devices – Ongoing Clinical Trials……………………………………………….. 36

Cardiac Assist Devices Companies – Pipeline Products by Stage of Development… 37

Cardiac Assist Devices – Pipeline Products by Stage of Development…………………. 44

Abbott Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview…………. 51

Fully Implantable Left Ventricular Assist System – Product Status……………………… 51

Fully Implantable Left Ventricular Assist System – Product Description……………… 51

Abiomed Inc Pipeline Products & Ongoing Clinical Trials Overview…………………… 52

AbioCor II – Product Status……………………………………………………………………………. 52

AbioCor II – Product Description……………………………………………………………………. 52

Impella BTR – Product Status………………………………………………………………………… 53

Impella BTR – Product Description…………………………………………………………………. 53

Impella ECP – Product Status…………………………………………………………………………. 53

Impella ECP – Product Description…………………………………………………………………. 54

Next Generation Impella CP – STEMI – Product Status………………………………………. 54

Next Generation Impella CP – STEMI – Product Description………………………………. 54

Symphony Heart Pump – Product Status………………………………………………………… 55

Symphony Heart Pump – Product Description…………………………………………………. 55

Abiomed Inc – Ongoing Clinical Trials Overview………………………………………………. 56

Impella ECP – Use of the Impella ECP in Patients Undergoing an Elective High-risk Percutaneous Coronary Intervention: An Early Feasibility Study……………………….. 57

Impella ECP – Use of the Impella ECP in Patients Undergoing an Elective or Urgent High-Risk Percutaneous Coronary Intervention Impella ECP Continued Access Protocol……………………………………………………………………………………………………… 57

Next Generation Impella CP – STEMI – Primary Unloading and Delayed Reperfusion in St-elevation Myocardial Infarction: The STEMI-DTU Trial……………………………… 58

Impella BTR – Use of the Impella BTR in Patients with Heart Failure: An Early Feasibility Study………………………………………………………………………………………….. 59

Acorn Cardiovascular, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………………. 60

CorCap Cardiac Support Device – Product Status…………………………………………….. 60

CorCap Cardiac Support Device – Product Description……………………………………… 60

AdjuCor GmbH Pipeline Products & Ongoing Clinical Trials Overview………………… 61

reBEAT – Product Status……………………………………………………………………………….. 61

reBEAT – Product Description……………………………………………………………………….. 61

AdjuCor GmbH – Ongoing Clinical Trials Overview…………………………………………… 62

reBEAT – Mission-Rebeat: A Pilot Clinical Investigation (First-In-Human) Of A Novel Mechanical Circulatory Support System Without Blood Contact, The Rebeat System, In Advanced Heart Failure Patients……………………………………………………. 63

Aerospace Taixin Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………………. 64

HeartCon II – Product Status…………………………………………………………………………. 64

HeartCon II – Product Description………………………………………………………………….. 64

AngioDynamics Inc Pipeline Products & Ongoing Clinical Trials Overview………….. 65

AngioVac – Generation 4 – Product Status………………………………………………………. 65

AngioVac – Generation 4 – Product Description……………………………………………….. 65

Anhui Tongling Bionic Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………………. 66

Interventional Cardiac Catheter Pump (pVAD) – Product Status………………………… 66

Interventional Cardiac Catheter Pump (pVAD) – Product Description………………… 66

Intra-Aortic Balloon Counterpulsation System (IABP) – Product Status………………. 67

Intra-Aortic Balloon Counterpulsation System (IABP) – Product Description……….. 67

APK Advanced Medical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………. 68

Apical Access System – Product Status…………………………………………………………… 68

Apical Access System – Product Description……………………………………………………. 68

Aria CV Inc Pipeline Products & Ongoing Clinical Trials Overview……………………… 69

Aria CV PH System – Product Status……………………………………………………………….. 69

Aria CV PH System – Product Description……………………………………………………….. 69

Aria CV Inc – Ongoing Clinical Trials Overview…………………………………………………. 70

Aria CV PH System – An Early Feasibility Study Assessing Treatment of Pulmonary Arterial Hypertension Using the Aria CV Pulmonary Hypertension System………… 71

Arrow International Cr, A.S. Pipeline Products & Ongoing Clinical Trials Overview 72

CorAide Left Ventricular Assist System – Product Status…………………………………… 72

CorAide Left Ventricular Assist System – Product Description…………………………… 72

Auflows CardioTech Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 73

Pulmonary Circulation Assist Implant – Product Status…………………………………….. 73

Pulmonary Circulation Assist Implant – Product Description…………………………….. 73

Beijing Yuewei Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview……………………………………………………………………………………………. 74

Femoral Arteriovenous Cardiopulmonary Bypass Catheter – Product Status………. 74

Femoral Arteriovenous Cardiopulmonary Bypass Catheter – Product Description. 74

Left Ventricular Assist System – Product Status……………………………………………….. 75

Left Ventricular Assist System – Product Description……………………………………….. 75

Berlin Heart GmbH Pipeline Products & Ongoing Clinical Trials Overview………….. 76

Careflow Pump – Product Status……………………………………………………………………. 76

Careflow Pump – Product Description……………………………………………………………. 76

Bicakcilar AS Pipeline Products & Ongoing Clinical Trials Overview…………………… 77

Heart-Lung Machine – Product Status…………………………………………………………….. 77

Heart-Lung Machine – Product Description…………………………………………………….. 77

BioLife4D Corp Pipeline Products & Ongoing Clinical Trials Overview………………… 78

Mini-Heart – Product Status………………………………………………………………………….. 78

Mini-Heart – Product Description…………………………………………………………………… 78

Viable Heart – Product Status………………………………………………………………………… 79

Viable Heart – Product Description………………………………………………………………… 79

BioQ Devices Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview………… 80

BIOQ CA – Product Status……………………………………………………………………………… 80

BIOQ CA – Product Description……………………………………………………………………… 80

BioQ IntraAortic Counterpulsation Prosthesis – Product Status…………………………. 81

BioQ IntraAortic Counterpulsation Prosthesis – Product Description…………………. 81

Biosurfaces Inc Pipeline Products & Ongoing Clinical Trials Overview………………… 82

Artificial Heart Assist Device Conduit – Product Status…………………………………….. 82

Artificial Heart Assist Device Conduit – Product Description……………………………… 82

BioVentrix Inc Pipeline Products & Ongoing Clinical Trials Overview…………………. 83

PliCath HF – Product Status…………………………………………………………………………… 83

PliCath HF – Product Description……………………………………………………………………. 83

BiVacor Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview……………….. 84

BiVACOR Device – Product Status………………………………………………………………….. 84

BiVACOR Device – Product Description…………………………………………………………… 84

BiVacor Pty Ltd – Ongoing Clinical Trials Overview…………………………………………… 85

BiVACOR Device – BiVACOR Total Artificial Heart Early Feasibility Study…………….. 86

Bonde Innovations LLC Pipeline Products & Ongoing Clinical Trials Overview…….. 87

Blood Pump Maintenance System – Product Status…………………………………………. 87

Blood Pump Maintenance System – Product Description…………………………………. 87

Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview……… 88

Vitalist – Product Status………………………………………………………………………………… 88

Vitalist – Product Description………………………………………………………………………… 88

Boundless Science LLC Pipeline Products & Ongoing Clinical Trials Overview……… 89

Blood Oxygenation System – Product Status…………………………………………………… 89

Blood Oxygenation System – Product Description……………………………………………. 89

Braile Biomedica Ltda Pipeline Products & Ongoing Clinical Trials Overview………. 90

Blood Pump – Product Status………………………………………………………………………… 90

Blood Pump – Product Description………………………………………………………………… 90

BrioHealth Solutions Inc Pipeline Products & Ongoing Clinical Trials Overview…… 91

BrioVAD System – Product Status………………………………………………………………….. 91

BrioVAD System – Product Description…………………………………………………………… 91

BrioHealth Solutions Inc – Ongoing Clinical Trials Overview………………………………. 92

BrioVAD System – A Study to Evaluate the Effectiveness and Safety of BrioVAD System in the Treatment of Refractory Left Ventricular Heart Failure……………….. 93

Calon Cardio-Technology Ltd Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………………………….. 94

Calon MiniVAD – Product Status……………………………………………………………………. 94

Calon MiniVAD – Product Description…………………………………………………………….. 94

CathVAD – Product Status…………………………………………………………………………….. 95

CathVAD – Product Description……………………………………………………………………… 95

MicroVAD – Product Status…………………………………………………………………………… 95

MicroVAD – Product Description……………………………………………………………………. 96

Cardiac Success Ltd Pipeline Products & Ongoing Clinical Trials Overview…………. 97

V-Sling Device – Product Status……………………………………………………………………… 97

V-Sling Device – Product Description……………………………………………………………… 97

Cardiac Success Ltd – Ongoing Clinical Trials Overview…………………………………….. 98

V-Sling Device – Vsling III: Clinical Evaluation of the Vsling Device for Ventricular Repair in Patients With Heart Failure…………………………………………………………….. 99

CardiacAssist Inc Pipeline Products & Ongoing Clinical Trials Overview……………. 100

Pediatric pVAD – Product Status………………………………………………………………….. 100

Pediatric pVAD – Product Description…………………………………………………………… 100

CardiacBooster BV Pipeline Products & Ongoing Clinical Trials Overview…………. 101

Intra-Aortic Balloon Pump – Product Status………………………………………………….. 101

Intra-Aortic Balloon Pump – Product Description…………………………………………… 101

Cardiak Ltd. Pipeline Products & Ongoing Clinical Trials Overview…………………… 102

Akpulsor – Product Status…………………………………………………………………………… 102

Akpulsor – Product Description……………………………………………………………………. 102

CARDIAnove Inc Pipeline Products & Ongoing Clinical Trials Overview…………….. 103

CARDIAnove Pump – Product Status…………………………………………………………….. 103

CARDIAnove Pump – Product Description…………………………………………………….. 103

CardioBridge GmbH Pipeline Products & Ongoing Clinical Trials Overview……….. 104

10F RCP System – Product Status…………………………………………………………………. 104

10F RCP System – Product Description…………………………………………………………. 104

14F RCP System – Product Status…………………………………………………………………. 105

14F RCP System – Product Description…………………………………………………………. 105

Cardiost Inc Pipeline Products & Ongoing Clinical Trials Overview…………………… 106

Left Atrium Unloading Device – Product Status……………………………………………… 106

Left Atrium Unloading Device – Product Description………………………………………. 106

Cardiovascular Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 107

cPCI Hemodynamic Support System – Product Status…………………………………….. 107

cPCI Hemodynamic Support System – Product Description…………………………….. 107

MCS System – Product Status………………………………………………………………………. 108

MCS System – Product Description………………………………………………………………. 108

Propel – Product Status………………………………………………………………………………. 108

Propel – Product Description……………………………………………………………………….. 109

Carmat SAS Pipeline Products & Ongoing Clinical Trials Overview…………………… 110

Aeson – Product Status……………………………………………………………………………….. 110

Aeson – Product Description……………………………………………………………………….. 111

Carmat SAS – Ongoing Clinical Trials Overview………………………………………………. 112

Aeson – Multicentric Prospective Cohort Study in Patients with Irreversible Biventricular Heart Failure to Assess the Efficacy and Safety of Carmat TAH, Its Clinical Utility and Cost, as a Bridge to Transplantation………………………………….. 113

Carnegie Mellon University Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………………………… 114

Non-Blood Contacting Muscle Powered VAD – Product Status………………………… 114

Non-Blood Contacting Muscle Powered VAD – Product Description………………… 114

tVAD – Heart Failure – Product Status…………………………………………………………… 115

tVAD – Heart Failure – Product Description……………………………………………………. 115

Chongqing Yongrenxin Medical Devices Co Ltd Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 116

EVA-Pulsar – Product Status………………………………………………………………………… 116

EVA-Pulsar – Product Description…………………………………………………………………. 116

Cleveland Clinic Hospital Pipeline Products & Ongoing Clinical Trials Overview… 117

PediPump – Product Status…………………………………………………………………………. 117

PediPump – Product Description………………………………………………………………….. 117

Cleveland Clinic Lerner College of Medicine Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 118

Continuous-Flow Total Artificial Heart – Product Status………………………………….. 118

Continuous-Flow Total Artificial Heart – Product Description………………………….. 118

Pediatric Continuous-Flow Total Artificial Heart – Product Status……………………. 119

Pediatric Continuous-Flow Total Artificial Heart – Product Description…………….. 119

Cleveland Heart Inc Pipeline Products & Ongoing Clinical Trials Overview……….. 120

SmartHeart LVAD – Product Status………………………………………………………………. 120

SmartHeart LVAD – Product Description……………………………………………………….. 120

SmartHeart TAH – Product Status………………………………………………………………… 121

SmartHeart TAH – Product Description…………………………………………………………. 121

Collplant Biotechnologies Ltd Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………………………… 122

3D Printed Heart – Product Status……………………………………………………………….. 122

3D Printed Heart – Product Description………………………………………………………… 122

Colorado State University Pipeline Products & Ongoing Clinical Trials Overview. 123

Flexible Multilayered Pump – Product Status………………………………………………… 123

Flexible Multilayered Pump – Product Description…………………………………………. 123

Concordia University Pipeline Products & Ongoing Clinical Trials Overview……… 124

Transcatheter Complete Heart Assist Device – Product Status………………………… 124

Transcatheter Complete Heart Assist Device – Product Description…………………. 124

CorasMedical Pipeline Products & Ongoing Clinical Trials Overview………………… 125

CORAS Hotor – Product Status…………………………………………………………………….. 125

CORAS Hotor – Product Description……………………………………………………………… 125

CorAssist Cardiovascular Ltd Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………………………… 126

CORolla – Product Status…………………………………………………………………………….. 126

CORolla – Product Description…………………………………………………………………….. 126

ImCardia – Product Status…………………………………………………………………………… 127

ImCardia – Product Description……………………………………………………………………. 127

CorInnova, Inc. Pipeline Products & Ongoing Clinical Trials Overview……………… 128

Cardiacstar – Bridge To Decision – Product Status………………………………………….. 128

Cardiacstar – Bridge To Decision – Product Description…………………………………… 128

Cardiacstar – Bridge To Recovery – Product Status…………………………………………. 129

Cardiacstar – Bridge To Recovery – Product Description………………………………….. 129

Cardiacstar – Bridge To Transplant – Product Status……………………………………….. 129

Cardiacstar – Bridge To Transplant – Product Description……………………………….. 130

Cardiacstar – Destination Therapy – Product Status……………………………………….. 130

Cardiacstar – Destination Therapy – Product Description………………………………… 130

Cardiacstar – Heart Rehabilitation – Product Status………………………………………… 131

Cardiacstar – Heart Rehabilitation – Product Description………………………………… 131

EpicHeart – Soft Robotic Heart Device – Product Status………………………………….. 131

EpicHeart – Soft Robotic Heart Device – Product Description…………………………… 132

CoRISMA MCS Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 133

CoRISMA – Product Status…………………………………………………………………………… 133

CoRISMA – Product Description…………………………………………………………………… 133

Corvion Inc Pipeline Products & Ongoing Clinical Trials Overview……………………. 134

Nautilus Pump – Product Status…………………………………………………………………… 134

Nautilus Pump – Product Description…………………………………………………………… 134

CorWave SA Pipeline Products & Ongoing Clinical Trials Overview………………….. 135

CorWave LVAD – Product Status………………………………………………………………….. 135

CorWave LVAD – Product Description…………………………………………………………… 135

CorWave Nemo – Product Status…………………………………………………………………. 136

CorWave Nemo – Product Description………………………………………………………….. 136

CVD Equipment Corp Pipeline Products & Ongoing Clinical Trials Overview……… 137

c-VACNT Extracorporeal Membrane Oxygenation (ECMO) Device – Product Status………………………………………………………………………………………………………………… 137

c-VACNT Extracorporeal Membrane Oxygenation (ECMO) Device – Product Description……………………………………………………………………………………………….. 137

Large Adults FAB-Oxygenator – Product Status……………………………………………… 138

Large Adults FAB-Oxygenator – Product Description………………………………………. 138

Neonatal FAB-Oxygenator – Product Status………………………………………………….. 138

Neonatal FAB-Oxygenator – Product Description…………………………………………… 139

Pediatric FAB-Oxygenator – Product Status…………………………………………………… 139

Pediatric FAB-Oxygenator – Product Description…………………………………………… 139

Small Adults FAB-Oxygenator – Product Status……………………………………………… 140

Small Adults FAB-Oxygenator – Product Description………………………………………. 140

Daidalos Solutions BV Pipeline Products & Ongoing Clinical Trials Overview…….. 141

Cardiac Assist Device Connector – Product Status………………………………………….. 141

Cardiac Assist Device Connector – Product Description………………………………….. 141

DHS Medical Pipeline Products & Ongoing Clinical Trials Overview…………………. 142

Implantable Device – Diastolic Heart Failure – Product Status………………………….. 142

Implantable Device – Diastolic Heart Failure – Product Description………………….. 142

Dongguan Kewei Medical Instrument Co Ltd Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 143

VitaSprings Membrane Oxygenator – Product Status……………………………………… 143

VitaSprings Membrane Oxygenator – Product Description……………………………… 143

Dongguan Tiantianxiang Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………. 144

IAB Balloon Catheter – Product Status………………………………………………………….. 144

IAB Balloon Catheter – Product Description………………………………………………….. 144

Drexel University Pipeline Products & Ongoing Clinical Trials Overview…………… 145

Intravascular Blood Pump – Product Status…………………………………………………… 145

Intravascular Blood Pump – Product Description…………………………………………… 145

Right Ventricle-Pulmonary Artery/Left Ventricle-Aorta Conduit – Product Status 146

Right Ventricle-Pulmonary Artery/Left Ventricle-Aorta Conduit – Product Description……………………………………………………………………………………………….. 146

Duke University Pipeline Products & Ongoing Clinical Trials Overview…………….. 147

Para-Aortic Blood Pump – Product Status……………………………………………………… 147

Para-Aortic Blood Pump – Product Description……………………………………………… 147

Elsius Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview……… 148

ECMO Portable Device – Product Status……………………………………………………….. 148

ECMO Portable Device – Product Description………………………………………………… 148

Ension, Inc. Pipeline Products & Ongoing Clinical Trials Overview…………………… 149

CardioFlowPQ – Product Status……………………………………………………………………. 149

CardioFlowPQ – Product Description……………………………………………………………. 149

Magnetic Levitation Motor – Product Status…………………………………………………. 150

Magnetic Levitation Motor – Product Description………………………………………….. 150

Portable Cardiopulmonary Assist System – Product Status……………………………… 150

Portable Cardiopulmonary Assist System – Product Description……………………… 151

Fengkaili Medical Devices (Shanghai) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 152

SynFlow-3.0 – Product Status………………………………………………………………………. 152

SynFlow-3.0 – Product Description………………………………………………………………. 152

Fengkaili Medical Devices (Shanghai) Co Ltd – Ongoing Clinical Trials Overview… 153

SynFlow-3.0 – A Prospective, Multicenter, Randomized, Non-Inferiority, Controlled, Study to Evaluate the Safety and Efficacy of Percutaneous Ventricular Assist Systems for High-Risk PCI……………………………………………………………………………. 154

SynFlow-3.0 – Percutaneous Transvalvular Ventricular Assist System for High-risk PCI: A Prospective, Single-center, Single-arm Clinical Study……………………………. 154

FineHeart Pipeline Products & Ongoing Clinical Trials Overview……………………… 155

ICOMS FLOWMAKER – Product Status………………………………………………………….. 155

ICOMS FLOWMAKER – Product Description…………………………………………………… 155

Foster-Miller Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 156

Magscrew Total Artificial Heart – Product Status…………………………………………… 156

Magscrew Total Artificial Heart – Product Description……………………………………. 156

FreeFlow Medical Devices LLC Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………………………… 157

TLP-Oxygenator – Product Status…………………………………………………………………. 157

TLP-Oxygenator – Product Description…………………………………………………………. 157

Fundacion para la Investigacion Biomedica del Hospital Gregorio Maranon Pipeline Products & Ongoing Clinical Trials Overview…………………………………………………. 158

Ventricular Assist Device – Product Status…………………………………………………….. 158

Ventricular Assist Device – Product Description…………………………………………….. 158

Georgia Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………….. 159

OptiFlo – Product Status……………………………………………………………………………… 159

OptiFlo – Product Description……………………………………………………………………… 159

Griffith University Pipeline Products & Ongoing Clinical Trials Overview………….. 160

Left Ventricle Assist Device (LVAD) – Product Status………………………………………. 160

Left Ventricle Assist Device (LVAD) – Product Description………………………………. 160

Next Generation Artificial Heart – Product Status………………………………………….. 161

Next Generation Artificial Heart – Product Description…………………………………… 161

Grupo Vitalmex SA de CV Pipeline Products & Ongoing Clinical Trials Overview.. 162

Vitacor – UVAD – Product Status………………………………………………………………….. 162

Vitacor – UVAD – Product Description…………………………………………………………… 162

Haemair Ltd Pipeline Products & Ongoing Clinical Trials Overview………………….. 163

Extracorporeal Membrane Oxygenation (ECMO) Device – Product Status………… 163

Extracorporeal Membrane Oxygenation (ECMO) Device – Product Description… 163

Hangzhou Shengshi Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………….. 164

Mechanical Circulation Auxiliary Device – Product Status……………………………….. 164

Mechanical Circulation Auxiliary Device – Product Description……………………….. 164

Harvard University Pipeline Products & Ongoing Clinical Trials Overview…………. 165

Implantable Direct Cardiac Compression Device – Product Status……………………. 165

Implantable Direct Cardiac Compression Device – Product Description……………. 165

HeartWare International Inc Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………………………… 166

BiVAD – Product Status……………………………………………………………………………….. 166

BiVAD – Product Description……………………………………………………………………….. 166

HeartWare IV-VAD – Product Status…………………………………………………………….. 167

HeartWare IV-VAD – Product Description……………………………………………………… 167

HVAD System – Destination Therapy – Product Status…………………………………….. 167

HVAD System – Destination Therapy – Product Description…………………………….. 168

Levacor Rotary VAD – Product Status……………………………………………………………. 168

Levacor Rotary VAD – Product Description……………………………………………………. 168

Longhorn – Product Status………………………………………………………………………….. 169

Longhorn – Product Description…………………………………………………………………… 169

MiFlow VAD – Product Status………………………………………………………………………. 169

MiFlow VAD – Product Description………………………………………………………………. 170

Miniaturized Ventricular Assist Device (MVAD) Pump – Product Status……………. 170

Miniaturized Ventricular Assist Device (MVAD) Pump – Product Description……. 171

Synergy Pocket Micro-Pump – Pediatric System – Product Status…………………….. 171

Synergy Pocket Micro-Pump – Pediatric System – Product Description…………….. 171

VCAN Trans-Mitral – Product Status…………………………………………………………….. 172

VCAN Trans-Mitral – Product Description……………………………………………………… 172

Hemovent GmbH Pipeline Products & Ongoing Clinical Trials Overview…………… 173

Mobybox – Product Status………………………………………………………………………….. 173

Mobybox – Product Description…………………………………………………………………… 173

Hemovent GmbH – Ongoing Clinical Trials Overview……………………………………… 174

Mobybox – A Post Market Surveillance Study of the Hemovent Extracorporeal Cardiopulmonary Support System:The MOBYBOX Trial………………………………….. 175

I.M. Sechenov First Moscow State Medical University Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………. 176

Cardiac Assist Device – Children – Product Status…………………………………………… 176

Cardiac Assist Device – Children – Product Description……………………………………. 176

Indian Institute of Technology, Kanpur Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………….. 177

Left Ventricular Assist Device – Product Status………………………………………………. 177

Left Ventricular Assist Device – Product Description………………………………………. 177

Indiana University Pipeline Products & Ongoing Clinical Trials Overview………….. 178

Bi-Conical Heart Pump – Product Status……………………………………………………….. 178

Bi-Conical Heart Pump – Product Description………………………………………………… 178

Innova Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview……….. 179

Mechanical Circulatory Support System – Product Status……………………………….. 179

Mechanical Circulatory Support System – Product Description……………………….. 179

Innovative BioTherapies Inc Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………………………… 180

Selective Cytopheretic Device – CHF – Product Status…………………………………….. 180

Selective Cytopheretic Device – CHF – Product Description……………………………… 180

Inspira Technologies Oxy Bhn Ltd Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………….. 181

ALICE Device – Product Status……………………………………………………………………… 181

ALICE Device – Product Description……………………………………………………………… 182

Inspira ART (Augmented Respiration Technology) System – Product Status……… 182

Inspira ART (Augmented Respiration Technology) System – Product Description. 183

Inspira Disposable Kit – Product Status…………………………………………………………. 183

Inspira Disposable Kit – Product Description…………………………………………………. 184

Inspired Therapeutics LLC Pipeline Products & Ongoing Clinical Trials Overview. 185

Neomate System – Product Status……………………………………………………………….. 185

Neomate System – Product Description……………………………………………………….. 185

Jarvik Heart Inc Pipeline Products & Ongoing Clinical Trials Overview……………… 186

Jarvik 2000 Heart – Bridge To Transplant – Product Status………………………………. 186

Jarvik 2000 Heart – Bridge To Transplant – Product Description………………………. 186

Jarvik 2000 Heart – Destination Therapy – Product Status……………………………….. 187

Jarvik 2000 Heart – Destination Therapy – Product Description……………………….. 187

Jarvik 2015 – Product Status………………………………………………………………………… 187

Jarvik 2015 – Product Description………………………………………………………………… 188

Jarvik Heart Inc – Ongoing Clinical Trials Overview…………………………………………. 189

Jarvik 2000 Heart – Destination Therapy – Evaluation of the Jarvik 2000 Left Ventricular Assist System with Post-auricular Connector–destination Therapy Study……………………………………………………………………………………………………….. 190

Jarvik 2015 – Circulatory Support in Pediatric Heart Failure Patients Using the Jarvik 2015 LVAD: A Pivotal………………………………………………………………………………….. 191

Jarvik 2015 – Pumps for Kids, Infants, and Neonates………………………………………. 191

Jiangsu STMed Technologies Co Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………….. 192

Oassist ECMO System – Product Status…………………………………………………………. 192

Oassist ECMO System – Product Description…………………………………………………. 192

Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview.. 193

RV-PA Conduit Implant – Product Status……………………………………………………….. 193

RV-PA Conduit Implant – Product Description……………………………………………….. 193

Kindai University Pipeline Products & Ongoing Clinical Trials Overview……………. 194

Semi-Automatic Circulation Control System – Product Status…………………………. 194

Semi-Automatic Circulation Control System – Product Description………………….. 194

LaunchPoint Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………………………… 195

Pediaflow Pediatric VAD – Product Status…………………………………………………….. 195

Pediaflow Pediatric VAD – Product Description……………………………………………… 195

Streamliner VAD – Product Status………………………………………………………………… 196

Streamliner VAD – Product Description………………………………………………………… 196

Lausanne University Hospital Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………………………… 197

RollingHeart – Product Status………………………………………………………………………. 197

RollingHeart – Product Description………………………………………………………………. 197

Leviticus Cardio Ltd Pipeline Products & Ongoing Clinical Trials Overview……….. 198

FiVAD System – Product Status……………………………………………………………………. 198

FiVAD System – Product Description…………………………………………………………….. 198

Hybrid FILVAS – Product Status……………………………………………………………………. 199

Hybrid FILVAS – Product Description…………………………………………………………….. 199

Levram Medical Systems Ltd Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………………………… 200

Levram – Ventricular Assist Device – Product Status……………………………………….. 200

Levram – Ventricular Assist Device – Product Description……………………………….. 200

Lifeshield Medical Pipeline Products & Ongoing Clinical Trials Overview………….. 201

pVAD System – Product Status…………………………………………………………………….. 201

pVAD System – Product Description…………………………………………………………….. 201

Lingbo Biotechnology (Hangzhou) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………….. 202

Artificial Blood Vessel – Heart Bypass Surgery – Product Status……………………….. 202

Artificial Blood Vessel – Heart Bypass Surgery – Product Description………………… 202

LivaNova PLC Pipeline Products & Ongoing Clinical Trials Overview……………….. 203

LBATS – Product Status……………………………………………………………………………….. 203

LBATS – Product Description……………………………………………………………………….. 203

Next Generation ECMO System – Product Status…………………………………………… 204

Next Generation ECMO System – Product Description……………………………………. 204

Next Generation Heart-Lung Machine – Product Status………………………………….. 204

Next Generation Heart-Lung Machine – Product Description………………………….. 204

NINO – Product Status………………………………………………………………………………… 205

NINO – Product Description………………………………………………………………………… 205

Magenta Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview…….. 206

Elevate Percutaneous Left Ventricular Assist Device – Product Status……………… 206

Elevate Percutaneous Left Ventricular Assist Device – Product Description………. 206

Magenta Medical Ltd – Ongoing Clinical Trials Overview………………………………… 207

Elevate Percutaneous Left Ventricular Assist Device – A Pivotal Study to Evaluate the Efficacy of Elevate Percutaneous Left Ventricular Assist Device in Subjects Undergoing High-Risk Percutaneous Coronary Intervention…………………………… 208

Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview…………………… 209

Cardiac Device – Diastolic Heart Failure – Product Status………………………………… 209

Cardiac Device – Diastolic Heart Failure – Product Description………………………… 209

Heart-Lung Machine Reservoir Sensor – Product Status…………………………………. 210

Heart-Lung Machine Reservoir Sensor – Product Description………………………….. 210

Implantable Left Ventricular Assist Device – Product Status……………………………. 210

Implantable Left Ventricular Assist Device – Product Description…………………….. 211

MedArray Inc. Pipeline Products & Ongoing Clinical Trials Overview……………….. 212

ECMO Oxygenator – Adult – Product Status…………………………………………………… 212

ECMO Oxygenator – Adult – Product Description…………………………………………… 212

ECMO Oxygenator – Neonatal – Product Status……………………………………………… 213

ECMO Oxygenator – Neonatal – Product Description……………………………………… 213

ECMO Oxygenator – Pediatric – Product Status……………………………………………… 213

ECMO Oxygenator – Pediatric – Product Description………………………………………. 214

Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview……………….. 215

Fully Implantable Left Ventricular Assist Device – Product Status…………………….. 215

Fully Implantable Left Ventricular Assist Device – Product Description…………….. 215

Michigan Critical Care Consultants Inc Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………….. 216

BioVAD – Product Status…………………………………………………………………………….. 216

BioVAD – Product Description……………………………………………………………………… 216

Pediatric Mpulse – Product Status……………………………………………………………….. 217

Pediatric Mpulse – Product Description………………………………………………………… 217

PedOxy – Product Status…………………………………………………………………………….. 217

PedOxy – Product Description……………………………………………………………………… 218

MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview.. 219

Anchor Balloon – Product Status………………………………………………………………….. 219

Anchor Balloon – Product Description………………………………………………………….. 220

Double Lumen Cannula – Product Status………………………………………………………. 220

Double Lumen Cannula – Product Description………………………………………………. 220

Intra-aortic Balloon Pump – Product Status…………………………………………………… 221

Intra-aortic Balloon Pump – Product Description…………………………………………… 221

MOBYO ECMO Oxygenator – Product Status…………………………………………………. 221

MOBYO ECMO Oxygenator – Product Description…………………………………………. 222

Scoring Balloon – Product Status………………………………………………………………….. 222

Scoring Balloon – Product Description………………………………………………………….. 222

Transseptal Cannula – Product Status…………………………………………………………… 223

Transseptal Cannula – Product Description…………………………………………………… 223

Microstim GmbH Pipeline Products & Ongoing Clinical Trials Overview…………… 224

MyoSen Muscle Stimulator System – Product Status……………………………………… 224

MyoSen Muscle Stimulator System – Product Description………………………………. 224

Monash University Pipeline Products & Ongoing Clinical Trials Overview………… 225

Cardio By-Pass Machine – Product Status……………………………………………………… 225

Cardio By-Pass Machine – Product Description……………………………………………… 225

ECMO Cannula – Product Status…………………………………………………………………… 226

ECMO Cannula – Product Description…………………………………………………………… 226

Heart-Assist Pump – Product Status……………………………………………………………… 226

Heart-Assist Pump – Product Description……………………………………………………… 226

MyoCardioCare, Inc. Pipeline Products & Ongoing Clinical Trials Overview………. 227

MCC3000 Heart Pump – Product Status………………………………………………………… 227

MCC3000 Heart Pump – Product Description………………………………………………… 227

MCC3000 Heart Pump – Pediatrics – Product Status……………………………………….. 228

MCC3000 Heart Pump – Pediatrics – Product Description……………………………….. 228

Myotech, LLC (Inactive) Pipeline Products & Ongoing Clinical Trials Overview….. 229

Myotech Circulatory Support System – Product Status…………………………………… 229

Myotech Circulatory Support System – Product Description……………………………. 229

Naval Medical Research Center Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………….. 230

Temporary Aortic Occlusion Device – Product Status……………………………………… 230

Temporary Aortic Occlusion Device – Product Description……………………………… 230

NeoCardial Technologies, LLC Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………………………… 231

eHeart Extra Ventricular Assist Device – Product Status…………………………………. 231

eHeart Extra Ventricular Assist Device – Product Description………………………….. 231

Neurescue Aps Pipeline Products & Ongoing Clinical Trials Overview………………. 232

Neurescue Device – Product Status………………………………………………………………. 232

Neurescue Device – Product Description………………………………………………………. 232

Neurescue Aps – Ongoing Clinical Trials Overview…………………………………………. 233

Neurescue Device – A Feasibility Study of the NEURESCUE Device as an Adjunct to In-Hospital Cardiac Arrest…………………………………………………………………………… 234

Nikkiso Co Ltd Pipeline Products & Ongoing Clinical Trials Overview……………….. 235

Cardiopulmonary Bypass Pump – Product Status…………………………………………… 235

Cardiopulmonary Bypass Pump – Product Description……………………………………. 235

Nipro Corp Pipeline Products & Ongoing Clinical Trials Overview……………………. 236

BR16010 – Product Status…………………………………………………………………………… 236

BR16010 – Product Description……………………………………………………………………. 236

Extracorporeal Membrane Oxygenator – Product Status………………………………… 237

Extracorporeal Membrane Oxygenator – Product Description………………………… 237

Implantable Left Ventricular Assist Device – Product Status……………………………. 237

Implantable Left Ventricular Assist Device – Product Description…………………….. 238

Northern Research Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 239

PulseVad – Product Status…………………………………………………………………………… 239

PulseVad – Product Description…………………………………………………………………… 239

Novapump GmbH Pipeline Products & Ongoing Clinical Trials Overview………….. 240

PERKAT Biventricular Heart Pump – Product Status……………………………………….. 240

PERKAT Biventricular Heart Pump – Product Description………………………………… 240

PERKAT RV – Product Status………………………………………………………………………… 241

PERKAT RV – Product Description………………………………………………………………… 241

NuPulseCV, Inc. Pipeline Products & Ongoing Clinical Trials Overview…………….. 242

NuPulseCV iVAS – Product Status…………………………………………………………………. 242

NuPulseCV iVAS – Product Description…………………………………………………………. 242

PediPulse – Product Status………………………………………………………………………….. 243

PediPulse – Product Description…………………………………………………………………… 243

OrbusNeich Pipeline Products & Ongoing Clinical Trials Overview…………………… 244

ECMO Left Ventricular Assist Device – Product Status…………………………………….. 244

ECMO Left Ventricular Assist Device – Product Description…………………………….. 244

IABP Catheter – Product Status……………………………………………………………………. 245

IABP Catheter – Product Description…………………………………………………………….. 245

OregonHeart Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 246

Next Generation Total Artificial Heart – Product Status………………………………….. 246

Next Generation Total Artificial Heart – Product Description…………………………… 246

Orqis Medical Corp (Inactive) Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………………………… 247

Exeleras System – Product Status…………………………………………………………………. 247

Exeleras System – Product Description…………………………………………………………. 247

Pavmed Inc Pipeline Products & Ongoing Clinical Trials Overview…………………… 248

FlexMo – Product Status……………………………………………………………………………… 248

FlexMo – Product Description……………………………………………………………………… 248

Penn State Milton S Hershey Medical Center Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 249

Fontan Circulatory Assist Device – Product Status………………………………………….. 249

Fontan Circulatory Assist Device – Product Description………………………………….. 249

Pennsylvania State University Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………………………… 250

Blood Pump – Product Status………………………………………………………………………. 250

Blood Pump – Product Description………………………………………………………………. 250

Pediatric Heart-Assist Device – Product Status………………………………………………. 251

Pediatric Heart-Assist Device – Product Description……………………………………….. 251

Percassist Inc Pipeline Products & Ongoing Clinical Trials Overview………………… 252

PercAssist Percutaneous Synchronized Cardiac Assist (PSCA) System – Product Status……………………………………………………………………………………………………….. 252

PercAssist Percutaneous Synchronized Cardiac Assist (PSCA) System – Product Description……………………………………………………………………………………………….. 252

Percassist Inc – Ongoing Clinical Trials Overview……………………………………………. 253

PercAssist Percutaneous Synchronized Cardiac Assist (PSCA) System – First-in-Human Clinical Study to Assess the PercAssist Percutaneous Synchronized Cardiac Assist (PSCA) System to Provide Hemodynamic Support………………………………… 254

Perfusion Solution Inc Pipeline Products & Ongoing Clinical Trials Overview……. 255

Cavopulmonary Assist System – Product Status…………………………………………….. 255

Cavopulmonary Assist System – Product Description……………………………………… 255

Right Ventricular Assist Device – Long Term Care – Product Status…………………… 256

Right Ventricular Assist Device – Long Term Care – Product Description…………… 256

Transapical LVAD – Product Status……………………………………………………………….. 256

Transapical LVAD – Product Description……………………………………………………….. 257

Pleioflow Hellas SA Pipeline Products & Ongoing Clinical Trials Overview………… 258

Pleioflow-HF – Product Status……………………………………………………………………… 258

Pleioflow-HF – Product Description………………………………………………………………. 258

Pleioflow-RF – Product Status……………………………………………………………………… 259

Pleioflow-RF – Product Description………………………………………………………………. 259

Pleioflow Hellas SA – Ongoing Clinical Trials Overview……………………………………. 260

Pleioflow-RF – Non Randomised, Prospective, Single Center Clinical Study to Evaluate the Safety and Procedural Feasibility of an Innovative Flow Assist Device, Pleioflow-RF……………………………………………………………………………………………… 261

PlugMed Heart SAS Pipeline Products & Ongoing Clinical Trials Overview……….. 262

Implantable Left Ventricular Assist Device – Product Status……………………………. 262

Implantable Left Ventricular Assist Device – Product Description…………………….. 262

Procyrion Inc Pipeline Products & Ongoing Clinical Trials Overview…………………. 263

Aortix Device – Product Status…………………………………………………………………….. 263

Aortix Device – Product Description……………………………………………………………… 263

Procyrion Inc – Ongoing Clinical Trials Overview……………………………………………. 264

Aortix Device – DRAIN-HF: Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure…………………………………………………………………………………………….. 265

PulseCath BV Pipeline Products & Ongoing Clinical Trials Overview………………… 266

iVAC 2L – Product Status……………………………………………………………………………… 266

iVAC 2L – Product Description……………………………………………………………………… 267

Pumpinheart Ltd Pipeline Products & Ongoing Clinical Trials Overview……………. 268

PReduction – Product Status……………………………………………………………………….. 268

PReduction – Product Description………………………………………………………………… 268

Purdue University Pipeline Products & Ongoing Clinical Trials Overview………….. 269

Viscous Impeller Pump – Infants – Product Status………………………………………….. 269

Viscous Impeller Pump – Infants – Product Description…………………………………… 269

Puzzle Medical Devices Inc Pipeline Products & Ongoing Clinical Trials Overview 270

ModulHeart – Product Status………………………………………………………………………. 270

ModulHeart – Product Description………………………………………………………………. 270

Puzzle Medical Devices Inc – Ongoing Clinical Trials Overview………………………… 271

ModulHeart – Early Feasibility Study to Mechanically Support Cardiorenal Function in Acute Decompensated Heart Failure With Diuretic Resistance……………………. 272

Qfluidics Inc Pipeline Products & Ongoing Clinical Trials Overview………………….. 273

Qpump – Product Status……………………………………………………………………………… 273

Qpump – Product Description……………………………………………………………………… 273

ReliantHeart, Inc. Pipeline Products & Ongoing Clinical Trials Overview…………… 274

aVAD Liberty System – Product Status………………………………………………………….. 274

aVAD Liberty System – Product Description………………………………………………….. 274

Pulse Less Total Artificial Heart – Product Status……………………………………………. 275

Pulse Less Total Artificial Heart – Product Description……………………………………. 275

VAD Maintenance System – Product Status…………………………………………………… 275

VAD Maintenance System – Product Description…………………………………………… 276

Resuscitec GmbH Pipeline Products & Ongoing Clinical Trials Overview…………… 277

CARL Cooler – Product Status………………………………………………………………………. 277

CARL Cooler – Product Description………………………………………………………………. 277

CARL Mox – Product Status…………………………………………………………………………. 278

CARL Mox – Product Description………………………………………………………………….. 278

Resuscitec GmbH – Ongoing Clinical Trials Overview……………………………………… 279

CARL Cooler – Controlled Automated Reperfusion of the Whole Body (CARL) PMCF Registry Study…………………………………………………………………………………………… 280

CARL Mox – Controlled Automated Reperfusion of the Whole Body (CARL) PMCF Registry Study…………………………………………………………………………………………… 281

RT Cardiac Systems Inc Pipeline Products & Ongoing Clinical Trials Overview…… 282

Percutaneous Mechanical Circulatory Support System – Product Status…………… 282

Percutaneous Mechanical Circulatory Support System – Product Description…… 282

Rutgers The State University of New Jersey Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 283

Temporary Percutaneous Ventricular Assist Device – Product Status……………….. 283

Temporary Percutaneous Ventricular Assist Device – Product Description……….. 284

Saint Louis University Pipeline Products & Ongoing Clinical Trials Overview…….. 285

Percutaneously Implantable Cardiovascular Support Device – Product Status…… 285

Percutaneously Implantable Cardiovascular Support Device – Product Description………………………………………………………………………………………………………………… 285

TURBOCARDIA – Product Status…………………………………………………………………… 286

TURBOCARDIA – Product Description…………………………………………………………… 286

Scandinavian Real Heart AB Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………………………… 287

Realheart PulsePump – Product Status…………………………………………………………. 287

Realheart PulsePump – Product Description…………………………………………………. 287

Realheart TAH – Product Status…………………………………………………………………… 288

Realheart TAH – Product Description……………………………………………………………. 288

RealVAD – Product Status……………………………………………………………………………. 288

RealVAD – Product Description……………………………………………………………………. 289

Total Artificial Heart – Clinical Version – Product Status………………………………….. 289

Total Artificial Heart – Clinical Version – Product Description…………………………… 289

Second Heart Assist Inc Pipeline Products & Ongoing Clinical Trials Overview….. 290

Catheter-Based Temporary Assist Pump – Product Status………………………………. 290

Catheter-Based Temporary Assist Pump – Product Description……………………….. 290

Wirelessly Powered Circulatory Assist Pump – Product Status………………………… 291

Wirelessly Powered Circulatory Assist Pump – Product Description…………………. 291

Shandong University Pipeline Products & Ongoing Clinical Trials Overview……… 292

ECMO Device – Product Status…………………………………………………………………….. 292

ECMO Device – Product Description…………………………………………………………….. 292

Shandong Weigao Blood Purification Products Co Ltd Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………. 293

Membrane Oxygenator Membrane – Product Status……………………………………… 293

Membrane Oxygenator Membrane – Product Description……………………………… 293

Shanghai MicroPort EP MedTech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………….. 294

ECMO Device – Product Status…………………………………………………………………….. 294

ECMO Device – Product Description…………………………………………………………….. 294

Shanghai MicroPort EP MedTech Co Ltd – Ongoing Clinical Trials Overview……… 295

ECMO Device – A Prospective, Multicenter, Single Arm First Human Clinical Trial to Evaluate the Safety and Effectiveness of MicroPort Surgical Extracorporeal Cardiopulmonary Support System (ECMO) for Providing Extracorporeal Cardiopulmonary Support Assistance to Subjects with Cardiac and/or Respiratory Dysfunction………………………………………………………………………………………………. 296

Shanghai Xinhengrui Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………. 297

Double-Heart Assist Device – Product Status…………………………………………………. 297

Double-Heart Assist Device – Product Description…………………………………………. 297

Implantable Ventricular Assist Device – Product Status………………………………….. 298

Implantable Ventricular Assist Device – Product Description…………………………… 298

OmniHeart Percutaneous Ventricular Assist Device – Product Status……………….. 298

OmniHeart Percutaneous Ventricular Assist Device – Product Description……….. 299

Total Artificial Heart – Product Status…………………………………………………………… 299

Total Artificial Heart – Product Description…………………………………………………… 299

Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………….. 300

Centrifugal Blood Pump – Product Status……………………………………………………… 300

Centrifugal Blood Pump – Product Description………………………………………………. 300

Paediatric And Neonatal Arterial Filter – Product Status…………………………………. 301

Paediatric And Neonatal Arterial Filter – Product Description…………………………. 301

Paracorporeal Left Ventricle Assist Device – Product Status……………………………. 301

Paracorporeal Left Ventricle Assist Device – Product Description…………………….. 301

Pediatric And Neonatal Membrane Oxygenator – Product Status……………………. 302

Pediatric And Neonatal Membrane Oxygenator – Product Description…………….. 302

St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview………. 303

UltraMag Adult Ventricular Assist System – Product Status…………………………….. 303

UltraMag Adult Ventricular Assist System – Product Description…………………….. 303

UltraMag Pediatric Ventricular Assist System – Product Status……………………….. 304

UltraMag Pediatric Ventricular Assist System – Product Description………………… 304

Sun Medical Technology Research Corp Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………….. 305

EVAHEART 1 Left Ventricular Assist System – Product Status………………………….. 305

EVAHEART 1 Left Ventricular Assist System – Product Description…………………… 305

EVAHEART 2 Left Ventricular Assist System – Product Status………………………….. 306

EVAHEART 2 Left Ventricular Assist System – Product Description…………………… 306

Sun Medical Technology Research Corp – Ongoing Clinical Trials Overview………. 307

EVAHEART 2 Left Ventricular Assist System – Prospective Multi-Center Randomized Study for Evaluating the EVAHEART2 Left Ventricular Assist System: the COMPETENCE Trial…………………………………………………………………………………….. 308

Sunshine Heart Company, Pty. Ltd. Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………….. 309

C-Pulse – Wireless Version – Product Status…………………………………………………… 309

C-Pulse – Wireless Version – Product Description…………………………………………… 309

Supira Medical Inc Pipeline Products & Ongoing Clinical Trials Overview…………. 310

Supira System – Product Status……………………………………………………………………. 310

Supira System – Product Description……………………………………………………………. 310

Supira Medical Inc – Ongoing Clinical Trials Overview…………………………………….. 311

Supira System – A Pivotal Clinical Study to Assess the Efficacy of the Next-generation Percutaneous Ventricular Assist Device (pVAD)……………………………. 312

Supira System – Early Feasibility Study of the Supira System in Patients Undergoing High-Risk Percutaneous Coronary Intervention (HRPCI) – The SUPPORT I Trial….. 312

Supira System – Feasibility Study SA of the Supira System for HRPCI……………….. 312

Supira System – First-in-Human Study to Evaluate the Safety and Performance of Supira’s Low-profile, High-flow Percutaneous Ventricular Assist Device…………… 313

Suzhou LungShield Medical Tech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………….. 314

ECMO Oxygenator Kit – Product Status…………………………………………………………. 314

ECMO Oxygenator Kit – Product Description…………………………………………………. 314

Extracorporeal Carbon dioxide Removal System – Product Status……………………. 315

Extracorporeal Carbon dioxide Removal System – Product Description……………. 315

Left Ventricular Assist System – Product Status……………………………………………… 315

Left Ventricular Assist System – Product Description……………………………………… 316

Suzhou Xinling Med Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………. 317

Percutaneous Ventricular Assist Device – Product Status……………………………….. 317

Percutaneous Ventricular Assist Device – Product Description………………………… 317

Suzhou Xinqing Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………….. 318

Extracorporeal Membrane Oxygenation System – Product Status……………………. 318

Extracorporeal Membrane Oxygenation System – Product Description……………. 318

MoyoAssist – Product Status……………………………………………………………………….. 319

MoyoAssist – Product Description………………………………………………………………… 319

NyokAssist Percutaneous VAD – Product Status…………………………………………….. 319

NyokAssist Percutaneous VAD – Product Description…………………………………….. 320

Syncardia Systems LLC Pipeline Products & Ongoing Clinical Trials Overview……. 321

10cc Ventricular Assist Device – Product Status…………………………………………….. 321

10cc Ventricular Assist Device – Product Description……………………………………… 321

30cc Ventricular Assist Device – Product Status…………………………………………….. 322

30cc Ventricular Assist Device – Product Description……………………………………… 322

60cc Ventricular Assist Device – Product Status…………………………………………….. 322

60cc Ventricular Assist Device – Product Description……………………………………… 323

SynCardia 50cc Temporary Total Artificial Heart – Destination Therapy – Product Status……………………………………………………………………………………………………….. 323

SynCardia 50cc Temporary Total Artificial Heart – Destination Therapy – Product Description……………………………………………………………………………………………….. 323

SynCardia 70cc Temporary Total Artificial Heart – Destination Therapy – Product Status……………………………………………………………………………………………………….. 324

SynCardia 70cc Temporary Total Artificial Heart – Destination Therapy – Product Description……………………………………………………………………………………………….. 324

Syntach AB Pipeline Products & Ongoing Clinical Trials Overview……………………. 325

Syntach CS – Product Status………………………………………………………………………… 325

Syntach CS – Product Description…………………………………………………………………. 325

TCN Prime Inc Pipeline Products & Ongoing Clinical Trials Overview……………….. 326

ECMO Catheter – Product Status…………………………………………………………………. 326

ECMO Catheter – Product Description………………………………………………………….. 326

The Artificial Heart Laboratory of Foundation for Cardiac Surgery Development Pipeline Products & Ongoing Clinical Trials Overview…………………………………….. 327

ReligaHeart EXT – Product Status…………………………………………………………………. 327

ReligaHeart EXT – Product Description…………………………………………………………. 327

The Charles Stark Draper Laboratory Inc Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………….. 328

Lung Assist – Product Status………………………………………………………………………… 328

Lung Assist – Product Description………………………………………………………………… 328

The Cleveland Clinic Foundation Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………….. 329

Mini-Mixed Flow Cardiac Assist Pump – Product Status………………………………….. 329

Mini-Mixed Flow Cardiac Assist Pump – Product Description………………………….. 329

Thoratec LLC Pipeline Products & Ongoing Clinical Trials Overview…………………. 330

Apica VAD SIS Device – Product Status…………………………………………………………. 330

Apica VAD SIS Device – Product Description………………………………………………….. 330

DuraHeart II – Product Status………………………………………………………………………. 331

DuraHeart II – Product Description………………………………………………………………. 331

Fully Implantable Ventricular Assist System – Product Status………………………….. 331

Fully Implantable Ventricular Assist System – Product Description………………….. 332

HeartMate X – Product Status……………………………………………………………………… 332

HeartMate X – Product Description……………………………………………………………… 332

PediPL System – Product Status…………………………………………………………………… 333

PediPL System – Product Description……………………………………………………………. 333

Tokyo Medical and Dental University Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………….. 334

TinyPump – Product Status………………………………………………………………………….. 334

TinyPump – Product Description………………………………………………………………….. 334

U.S. Stem Cell Inc Pipeline Products & Ongoing Clinical Trials Overview…………… 335

SVAD – Product Status………………………………………………………………………………… 335

SVAD – Product Description………………………………………………………………………… 335

University of California Irvine Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………………………… 336

Cardiac Assist Sleeve Pump – Product Status…………………………………………………. 336

Cardiac Assist Sleeve Pump – Product Description…………………………………………. 336

University of California San Francisco Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………….. 337

ECMO Oxygenator – Product Status……………………………………………………………… 337

ECMO Oxygenator – Product Description……………………………………………………… 337

University of Colorado Anschutz Medical Campus Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………. 338

LVAD Apical Cuff Implantation Device – Product Status………………………………….. 338

LVAD Apical Cuff Implantation Device – Product Description………………………….. 338

University of Florida Pipeline Products & Ongoing Clinical Trials Overview………. 339

Ventricular Assist Device Monitor – Product Status……………………………………….. 339

Ventricular Assist Device Monitor – Product Description………………………………… 339

University of Louisville Pipeline Products & Ongoing Clinical Trials Overview…… 340

Paediatric Heart Pump – Product Status……………………………………………………….. 340

Paediatric Heart Pump – Product Description………………………………………………… 340

University of New South Wales Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………….. 341

Total Artificial Heart – Product Status…………………………………………………………… 341

Total Artificial Heart – Product Description…………………………………………………… 341

University of Pittsburgh Pipeline Products & Ongoing Clinical Trials Overview….. 342

Portable Emergency Cardiopulmonary Bypass Device – Product Status……………. 342

Portable Emergency Cardiopulmonary Bypass Device – Product Description……. 342

University of South Florida Pipeline Products & Ongoing Clinical Trials Overview 343

Intra-Cardiac Pulsatile Ventricular Assist Device – Product Status……………………. 343

Intra-Cardiac Pulsatile Ventricular Assist Device – Product Description…………….. 343

University of Tokyo Pipeline Products & Ongoing Clinical Trials Overview………… 344

Helical Flow Total Artificial Heart – Product Status…………………………………………. 344

Helical Flow Total Artificial Heart – Product Description…………………………………. 344

University of Vienna Pipeline Products & Ongoing Clinical Trials Overview………. 345

Smart Pump – Product Status………………………………………………………………………. 345

Smart Pump – Product Description………………………………………………………………. 345

University of Virginia Pipeline Products & Ongoing Clinical Trials Overview……… 346

VADStent – Product Status………………………………………………………………………….. 346

VADStent – Product Description…………………………………………………………………… 346

Vadovations Inc Pipeline Products & Ongoing Clinical Trials Overview…………….. 347

REVOLUTION – Product Status…………………………………………………………………….. 347

REVOLUTION – Product Description……………………………………………………………… 347

VASCOR Inc Pipeline Products & Ongoing Clinical Trials Overview…………………… 348

Vascor LVAD – Product Status……………………………………………………………………… 348

Vascor LVAD – Product Description………………………………………………………………. 348

VenstraMedical Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview….. 349

SAVA System – Product Status…………………………………………………………………….. 349

SAVA System – Product Description……………………………………………………………… 349

VentriFlo Inc Pipeline Products & Ongoing Clinical Trials Overview…………………. 350

VentriFlo True Pulse Pump – Product Status………………………………………………….. 350

VentriFlo True Pulse Pump – Product Description………………………………………….. 350

Vienna University of Technology Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………….. 351

Pneumatic Heart Catheter Pump – Product Status…………………………………………. 351

Pneumatic Heart Catheter Pump – Product Description…………………………………. 351

Windmill Cardiovascular Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview………………………………………………………………………………………………….. 352

Pediatric TORVAD – Product Status………………………………………………………………. 352

Pediatric TORVAD – Product Description………………………………………………………. 352

TORVAD – Product Status……………………………………………………………………………. 353

TORVAD – Product Description……………………………………………………………………. 353

W-Z BIOTECH, LLC Pipeline Products & Ongoing Clinical Trials Overview………….. 354

Double Lumen Cannula-Based Left Ventricular Assist Device – Product Status….. 354

Double Lumen Cannula-Based Left Ventricular Assist Device – Product Description………………………………………………………………………………………………………………… 354

SppVAD – Product Status…………………………………………………………………………….. 355

SppVAD – Product Description…………………………………………………………………….. 355

VAD System – Pediatric Heart Failure – Product Status……………………………………. 355

VAD System – Pediatric Heart Failure – Product Description……………………………. 356

Xenios AG Pipeline Products & Ongoing Clinical Trials Overview…………………….. 357

Xtralung – Product Status……………………………………………………………………………. 357

Xtralung – Product Description…………………………………………………………………….. 357

Yale University Pipeline Products & Ongoing Clinical Trials Overview………………. 358

BoLetz Pump – Product Status……………………………………………………………………… 358

BoLetz Pump – Product Description……………………………………………………………… 358

CAP RVAD Pump – Product Status………………………………………………………………… 359

CAP RVAD Pump – Product Description………………………………………………………… 359

Heart Failure Recovery (HFR) Device – Product Status……………………………………. 359

Heart Failure Recovery (HFR) Device – Product Description…………………………….. 360

Glossary……………………………………………………………………………………………………. 440

Figures

Cardiac Assist Devices – Pipeline Products by Stage of Development 31

Cardiac Assist Devices – Pipeline Products by Segment 32

Cardiac Assist Devices – Pipeline Products by Territory 33

Cardiac Assist Devices – Pipeline Products by Regulatory Path 34

Cardiac Assist Devices – Pipeline Products by Estimated Approval Date 35

Cardiac Assist Devices – Ongoing Clinical Trials 36

Frequently asked questions

Which segment had the highest share in the cardiac assist devices pipeline market as of August 2024?

As of August 2024, left ventricular assist devices accounted for the highest share of the cardiac assist devices pipeline products.
Which territory had the highest number of products in the cardiac assist devices pipeline market as of August 2024?

As of August 2024, the US accounted for the highest number of pipeline products in the cardiac assist devices market.
Which was the most followed regulatory pathway in the cardiac assist devices pipeline market as of August 2024?

As of August 2024, PMA was the most followed pathway for pipeline products in the cardiac assist devices market.
Which are the major companies operating in the cardiac assist devices pipeline market?

A few of the key companies associated with the cardiac assist devices pipeline market are Abbott Vascular Inc., Abiomed Inc., Acorn Cardiovascular, Inc. (Inactive), AdjuCor GmbH, and Aerospace Taixin Technology Co Ltd, among others.

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