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

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Cardiac Ablation Devices Pipeline Market Report Overview

Cardiac ablation devices use radiofrequency energy to destroy cardiac tissues which propagate incorrect electrical signals to cause an abnormal heart rhythm. The cardiac ablation 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 Territories ·        The US

·        China

·        Europe

·        Canada

·        Japan

Key Regulatory Paths ·        NMPA

·        PMA

·        510(k)

·        CE

·        MDL

Leading Companies ·        Abbott Medical

·        AblaCor Medical Corporation

·        AccuPulse Medical Technology Co Ltd

·        Acutus Medical Inc

·        AFreeze GmbH

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Cardiac Ablation Devices Pipeline Market Segmentation by Territories

A few of the key territories for the cardiac ablation devices pipeline market are the US, China, Europe, Canada, and Japan. As of March 2024, the US accounted for the highest number of pipeline products.

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

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

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Cardiac Ablation Devices Pipeline Market Segmentation by Regulatory Paths

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

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

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

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Cardiac Ablation Devices Pipeline Market – Competitive Landscape

A few of the key companies associated with the cardiac ablation devices pipeline market are Abbott Medical, AblaCor Medical Corporation, AccuPulse Medical Technology Co Ltd, Acutus Medical Inc, and AFreeze GmbH, among others.

Acutus Medical Inc: Acutus Medical is headquartered in Carlsbad, California, the US. It is an arrhythmia management company that designs, manufactures, and markets various tools for catheter-based ablation procedures. Acutus Medical’s electro-functional mapping systems provide solutions to diagnose and treat atrial fibrillation. The company products enable physicians to visualize CT-quality scans, map real-time dipole density, and identify infected locations causing arrhythmia.

AFreeze GmbH: AFreeze is headquartered in Innsbruck, Tirol, Austria. It is a medical device company that develops, manufactures, and markets cryoablation systems for the treatment of atrial fibrillation. The company serves physicians, patients, and hospitals.

Cardiac Ablation Devices Pipeline Market Analysis by Companies, 2024

Cardiac Ablation Devices Pipeline Market Analysis by Companies, 2024

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Segments Covered in the Report

Cardiac Ablation Devices Pipeline Market Territories Outlook

  • The US
  • China
  • Europe
  • Canada
  • Japan

Cardiac Ablation Devices Pipeline Market Regulatory Paths Outlook

  • NMPA
  • PMA
  • 510(k)
  • CE
  • MDL

Scope

This report provides:

  • Extensive coverage of the cardiac ablation devices under development.
  • 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 ablation 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 ablation 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 Medical
AblaCor Medical Corporation
AccuPulse Medical Technology Co Ltd
Acutus Medical Inc
Adagio Medical Inc.
Affera Inc
AFreeze GmbH
AngioDynamics Inc
APT Medical Inc
Arga Medtech SA
Atrian Medical Ltd
AtriCure Inc
Axon Therapies Inc
Baylis Medical Company Inc
Biosense Webster Inc
Corfigo Inc
Coridea, LLC
CPSI Biotech
Cryofocus Medtech Shanghai Co Ltd
CyberHeart Inc
ElectroPhysiology Frontiers S.p.A.
Epiendoaf Inc
Field Medical Inc
Galaxy Medical Products Inc
Hadassah Medical Center
Hangzhou Nuocheng Medical Technology Co Ltd
Hangzhou Nuomao Medical Technology Co Ltd
Helical Solutions, Inc. (Inactive)
Huifeng Biotechnology (Shanghai) Co Ltd
Insight Lifetech Co Ltd
Johns Hopkins University
Kardium Inc
LuxCath, LLC
LuxMed Systems Inc
Medtronic Plc
National Science and Technology Development Agency
Northwestern University
Pavmed Inc
Pulse Biosciences Inc
Shanghai Antec Medical Technology Co Ltd
Shanghai Hantong Medical Technology Co Ltd
Shanghai HeartCare Medical Technology Co Ltd
Shanghai Keku Medical Technology Co Ltd
Shanghai Ruidao Medical Technology Co Ltd
Shanghai Weiqi Medical Equipment Co Ltd
Shanghai Xuanyu Medical Equipment Co Ltd
Shenzhen Huitai Medical Equipment Co Ltd
Shenzhen Maiwei Medical Technology Co Ltd
Sichuan Jinjiang Electronic Science and Technology Co Ltd
SIGT LLC
Suzhou Aikemai Medical Technology Co Ltd
Tau Pnu Medical Co., Ltd.
The Chaim Sheba Medical Center
Thermedical Inc
Tianjin Intelligent Health Medical Co Ltd
Toray Medical Co Ltd
Tufts Medical Center
University of California Los Angeles
University of Chicago
University of Iowa
Varian Medical Systems Inc
Virginia Polytechnic Institute and State University
VytronUS Inc (Inactive)

Table of Contents

1 Table of Contents 3

1.1 List of Tables 8

1.2 List of Figures 15

2 Introduction 16

2.1 Cardiac Ablation Devices Overview 16

3 Products under Development 17

3.1 Cardiac Ablation Devices – Pipeline Products by Stage of Development 17

3.2 Cardiac Ablation Devices – Pipeline Products by Territory 18

3.3 Cardiac Ablation Devices – Pipeline Products by Regulatory Path 19

3.4 Cardiac Ablation Devices – Pipeline Products by Estimated Approval Date 20

3.5 Cardiac Ablation Devices – Ongoing Clinical Trials 21

4 Cardiac Ablation Devices – Pipeline Products under Development by Companies 22

4.1 Cardiac Ablation Devices Companies – Pipeline Products by Stage of Development 22

4.2 Cardiac Ablation Devices – Pipeline Products by Stage of Development 25

5 Cardiac Ablation Devices Companies and Product Overview 28

5.1 Abbott Medical Company Overview 28

5.1.1 Abbott Medical Pipeline Products & Ongoing Clinical Trials Overview 28

5.2 AblaCor Medical Corporation Company Overview 31

5.2.1 AblaCor Medical Corporation Pipeline Products & Ongoing Clinical Trials Overview 31

5.3 AccuPulse Medical Technology Co Ltd Company Overview 33

5.3.1 AccuPulse Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 33

5.4 Acutus Medical Inc Company Overview 36

5.4.1 Acutus Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 36

5.5 Adagio Medical Inc. Company Overview 37

5.5.1 Adagio Medical Inc. Pipeline Products & Ongoing Clinical Trials Overview 37

5.6 Affera Inc Company Overview 44

5.6.1 Affera Inc Pipeline Products & Ongoing Clinical Trials Overview 44

5.7 AFreeze GmbH Company Overview 51

5.7.1 AFreeze GmbH Pipeline Products & Ongoing Clinical Trials Overview 51

5.8 AngioDynamics Inc Company Overview 52

5.8.1 AngioDynamics Inc Pipeline Products & Ongoing Clinical Trials Overview 52

5.9 APT Medical Inc Company Overview 53

5.9.1 APT Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 53

5.10 Arga Medtech SA Company Overview 55

5.10.1 Arga Medtech SA Pipeline Products & Ongoing Clinical Trials Overview 55

5.11 Atrian Medical Ltd Company Overview 59

5.11.1 Atrian Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 59

5.12 AtriCure Inc Company Overview 60

5.12.1 AtriCure Inc Pipeline Products & Ongoing Clinical Trials Overview 60

5.13 Axon Therapies Inc Company Overview 64

5.13.1 Axon Therapies Inc Pipeline Products & Ongoing Clinical Trials Overview 64

5.14 Baylis Medical Company Inc Company Overview 67

5.14.1 Baylis Medical Company Inc Pipeline Products & Ongoing Clinical Trials Overview 67

5.15 Biosense Webster Inc Company Overview 68

5.15.1 Biosense Webster Inc Pipeline Products & Ongoing Clinical Trials Overview 68

5.16 Corfigo Inc Company Overview 74

5.16.1 Corfigo Inc Pipeline Products & Ongoing Clinical Trials Overview 74

5.17 Coridea, LLC Company Overview 75

5.17.1 Coridea, LLC Pipeline Products & Ongoing Clinical Trials Overview 75

5.18 CPSI Biotech Company Overview 76

5.18.1 CPSI Biotech Pipeline Products & Ongoing Clinical Trials Overview 76

5.19 Cryofocus Medtech Shanghai Co Ltd Company Overview 79

5.19.1 Cryofocus Medtech Shanghai Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 79

5.20 CyberHeart Inc Company Overview 81

5.20.1 CyberHeart Inc Pipeline Products & Ongoing Clinical Trials Overview 81

5.21 ElectroPhysiology Frontiers S.p.A. Company Overview 82

5.21.1 ElectroPhysiology Frontiers S.p.A. Pipeline Products & Ongoing Clinical Trials Overview 82

5.22 Epiendoaf Inc Company Overview 83

5.22.1 Epiendoaf Inc Pipeline Products & Ongoing Clinical Trials Overview 83

5.23 Field Medical Inc Company Overview 84

5.23.1 Field Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 84

5.24 Galaxy Medical Products Inc Company Overview 87

5.24.1 Galaxy Medical Products Inc Pipeline Products & Ongoing Clinical Trials Overview 87

5.25 Hadassah Medical Center Company Overview 90

5.25.1 Hadassah Medical Center Pipeline Products & Ongoing Clinical Trials Overview 90

5.26 Hangzhou Nuocheng Medical Technology Co Ltd Company Overview 91

5.26.1 Hangzhou Nuocheng Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 91

5.27 Hangzhou Nuomao Medical Technology Co Ltd Company Overview 94

5.27.1 Hangzhou Nuomao Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 94

5.28 Helical Solutions, Inc. (Inactive) Company Overview 97

5.28.1 Helical Solutions, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 97

5.29 Huifeng Biotechnology (Shanghai) Co Ltd Company Overview 98

5.29.1 Huifeng Biotechnology (Shanghai) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 98

5.30 Insight Lifetech Co Ltd Company Overview 99

5.30.1 Insight Lifetech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 99

5.31 Johns Hopkins University Company Overview 103

5.31.1 Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 103

5.32 Kardium Inc Company Overview 104

5.32.1 Kardium Inc Pipeline Products & Ongoing Clinical Trials Overview 104

5.33 LuxCath, LLC Company Overview 110

5.33.1 LuxCath, LLC Pipeline Products & Ongoing Clinical Trials Overview 110

5.34 LuxMed Systems Inc Company Overview 111

5.34.1 LuxMed Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 111

5.35 Medtronic Plc Company Overview 112

5.35.1 Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 112

5.36 National Science and Technology Development Agency Company Overview 118

5.36.1 National Science and Technology Development Agency Pipeline Products & Ongoing Clinical Trials Overview 118

5.37 Northwestern University Company Overview 119

5.37.1 Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 119

5.38 Pavmed Inc Company Overview 120

5.38.1 Pavmed Inc Pipeline Products & Ongoing Clinical Trials Overview 120

5.39 Pulse Biosciences Inc Company Overview 122

5.39.1 Pulse Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 122

5.40 Shanghai Antec Medical Technology Co Ltd Company Overview 126

5.40.1 Shanghai Antec Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 126

5.41 Shanghai Hantong Medical Technology Co Ltd Company Overview 128

5.41.1 Shanghai Hantong Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 128

5.42 Shanghai HeartCare Medical Technology Co Ltd Company Overview 129

5.42.1 Shanghai HeartCare Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 129

5.43 Shanghai Keku Medical Technology Co Ltd Company Overview 130

5.43.1 Shanghai Keku Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 130

5.44 Shanghai Ruidao Medical Technology Co Ltd Company Overview 131

5.44.1 Shanghai Ruidao Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 131

5.45 Shanghai Weiqi Medical Equipment Co Ltd Company Overview 132

5.45.1 Shanghai Weiqi Medical Equipment Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 132

5.46 Shanghai Xuanyu Medical Equipment Co Ltd Company Overview 135

5.46.1 Shanghai Xuanyu Medical Equipment Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 135

5.47 Shenzhen Huitai Medical Equipment Co Ltd Company Overview 136

5.47.1 Shenzhen Huitai Medical Equipment Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 136

5.48 Shenzhen Maiwei Medical Technology Co Ltd Company Overview 137

5.48.1 Shenzhen Maiwei Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 137

5.49 Sichuan Jinjiang Electronic Science and Technology Co Ltd Company Overview 138

5.49.1 Sichuan Jinjiang Electronic Science and Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 138

5.50 SIGT LLC Company Overview 139

5.50.1 SIGT LLC Pipeline Products & Ongoing Clinical Trials Overview 139

5.51 Suzhou Aikemai Medical Technology Co Ltd Company Overview 140

5.51.1 Suzhou Aikemai Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 140

5.52 Tau Pnu Medical Co., Ltd. Company Overview 142

5.52.1 Tau Pnu Medical Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 142

5.53 The Chaim Sheba Medical Center Company Overview 145

5.53.1 The Chaim Sheba Medical Center Pipeline Products & Ongoing Clinical Trials Overview 145

5.54 Thermedical Inc Company Overview 146

5.54.1 Thermedical Inc Pipeline Products & Ongoing Clinical Trials Overview 146

5.55 Tianjin Intelligent Health Medical Co Ltd Company Overview 150

5.55.1 Tianjin Intelligent Health Medical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 150

5.56 Toray Medical Co Ltd Company Overview 151

5.56.1 Toray Medical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 151

5.57 Tufts Medical Center Company Overview 152

5.57.1 Tufts Medical Center Pipeline Products & Ongoing Clinical Trials Overview 152

5.58 University of California Los Angeles Company Overview 153

5.58.1 University of California Los Angeles Pipeline Products & Ongoing Clinical Trials Overview 153

5.59 University of Chicago Company Overview 154

5.59.1 University of Chicago Pipeline Products & Ongoing Clinical Trials Overview 154

5.60 University of Iowa Company Overview 155

5.60.1 University of Iowa Pipeline Products & Ongoing Clinical Trials Overview 155

5.61 Varian Medical Systems Inc Company Overview 156

5.61.1 Varian Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 156

5.62 Virginia Polytechnic Institute and State University Company Overview 159

5.62.1 Virginia Polytechnic Institute and State University Pipeline Products & Ongoing Clinical Trials Overview 159

5.63 VytronUS Inc (Inactive) Company Overview 160

5.63.1 VytronUS Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 160

6 Cardiac Ablation Devices- Recent Developments 163

6.1 Mar 14, 2024: Methodist Le Bonheur Healthcare first in Tennessee to offer “Paradigm-Shifting” Technology for AFib patients 163

6.2 Mar 12, 2024: Medtronic To Present At Barclays Global Healthcare Conference 163

6.3 Mar 07, 2024: Overlake First in Pacific Northwest to Treat Atrial Fibrillation With New FDA-Approved Pulsed Field Ablation 163

6.4 Mar 01, 2024: Biosense Webster secures CE mark for Varipulse PFA system 164

6.5 Mar 01, 2024: SMH Physicians Using Break-Through Device to Treat Patients with AFib 165

6.6 Mar 01, 2024: WRH Electrophysiology Performs Innovative Procedure 165

6.7 Feb 28, 2024: Catheter Precision Announces the First Use of VIVO With a Pediatric Patient in Turkey 166

6.8 Feb 28, 2024: Boston Scientific Raises $2.2B to Support Purchase of California Medical Device Company 166

6.9 Feb 23, 2024: Medical Tech Leader, Boston Scientific (BSX), Announces Notes Offering 166

6.10 Feb 19, 2024: Boston Scientific Appoints Madan Krishnan to Lead India Subcontinent 166

6.11 Feb 14, 2024: Farapulse Obtains Pre-Market Approval (PMA) for FARAPULSE Pulsed Field Ablation (PFA) System 166

6.12 Feb 14, 2024: Pulse Biosciences Announces Positive 60-Day Follow-Up Evaluations for Initial Patients treated in the CellFX nsPFA 360° Cardiac Catheter First-in-Human Feasibility Study 167

6.13 Feb 08, 2024: Biosense Webster Supports Collaborative Studies That Aim to Expand Knowledge in Pulsed Field Ablation 167

6.14 Feb 06, 2024: J&J unveils Varipulse data at AF Symposium 168

6.15 Feb 02, 2024: Biosense Webster Presents Late-Breaking Data from inspIRE and admIRE Clinical Trials at AF Symposium 169

6.16 Jan 31, 2024: Boston Scientific Receives FDA Approval for FARAPULSE Pulsed Field Ablation System 171

6.17 Jan 31, 2024: Pulse Biosciences Announces Preliminary Findings from Its CellFX nsPFA 360 Cardiac Catheter First-in-Human Feasibility Study to Be Featured in Podium Presentation at the AF Symposium 172

6.18 Jan 31, 2024: Boston Scientific Announces Results for Fourth Quarter and Full Year 2023 172

6.19 Jan 18, 2024: Abbott Announces First Global Procedures in a Clinical Trial of its Volt Pulsed Field Ablation System to Treat Patients with Abnormal Heart Rhythms 174

6.20 Jan 09, 2024: Biosense Webster Announces Regulatory Approval of VARIPULSE Pulsed Field Ablation (PFA) Platform in Japan 175

6.21 Jan 05, 2024: Boston Scientific Announces Conference Call Discussing Fourth Quarter 2023 Results 175

6.22 Jan 05, 2024: AngioDynamics Reports Fiscal Year 2024 Second Quarter Financial Results; Revises Fiscal Year 2024 Guidance 176

6.23 Dec 28, 2023: Boston Scientific Initiates Avant Guard Clinical Trial to Evaluate Farapulse Pulsed Field Ablation System as First-Line Treatment for Persistent Atrial Fibrillation 178

6.24 Dec 21, 2023: Pulse Biosciences concludes procedures with cardiac catheter in study 179

6.25 Dec 14, 2023: Medtronic obtains US FDA approval for PulseSelect PFA system 179

6.26 Dec 13, 2023: Medtronic creates history with FDA approval of its novel PulseSelect Pulsed Field Ablation System to treat atrial fibrillation 180

6.27 Nov 21, 2023: Pulse Biosciences Files 510(k) Submission with U.S. FDA for its CellFX nsPFA Percutaneous Electrode 181

6.28 Nov 20, 2023: Catheter Precision’s (VTAK) First Successful VIVO Cases Completed in Croatia Sets Stage for Expansion into South-Eastern Europe 182

6.29 Oct 26, 2023: Boston Scientific Announces Results for Third Quarter 2023 182

6.30 Oct 10, 2023: Thermedical Awarded $3 Million NIH Grant to Study Promising Treatment for Ventricular Tachycardia, a Leading Cause of Sudden Cardiac Death 184

6.31 Oct 08, 2023: Late-Breaking Data Confirms Safety of Axon Therapies’ Innovative Heart Failure Procedure and Identifies Patients Most Likely to Benefit from SAVM Therapy 184

6.32 Oct 04, 2023: Stereotaxis Robotic Technology to be Featured during 7th Annual Meeting of the Society for Cardiac Robotic Navigation 185

6.33 Oct 04, 2023: Medtronic Names Paolo Di Vincenzo President of the Neuromodulation Business 186

6.34 Oct 02, 2023: Pulse Biosciences and Cardionxt to Collaborate on nsPFA First-In-Human Study 186

6.35 Sep 29, 2023: Pulse Biosciences’ Nanosecond Pulsed Field Ablation (nsPFA™) Circumferential Catheter System to be Featured in a Presentation at the Global EP Summit 187

6.36 Sep 27, 2023: Pulse Biosciences’ First Study in a Surgical Application of Nanosecond Pulsed Field Ablation (nsPFA) Technology to be Featured in Two Poster Presentations at the American Thyroid Association Annual Meeting 187

6.37 Sep 19, 2023: Canadian First – Abbott’s TactiFlex Ablation Catheter Used to Treat AFib 188

6.38 Sep 18, 2023: Biosense Webster Begins Evaluation of Large-tip Focal Pulsed Field Ablation Catheter in Omny-IRE Clinical Trial in Europe 189

6.39 Aug 27, 2023: ADVENT Study of the FARAPULSE Pulsed Field Ablation System Meets Primary Efficacy and Safety Endpoints 190

6.40 Aug 26, 2023: Medtronic Q2 2024 Earnings Estimates Increased by William Blair 190

6.41 Aug 09, 2023: FDA grants approval for Boston Scientific’s cryoablation system 190

6.42 Aug 08, 2023: Medtronic to Announce Financial Results for its First Quarter of Fiscal Year 2024 191

6.43 Jul 24, 2023: Ra Medical System’s Electrophysiology Division Has Increased Demand for Its Non-invasive Mapping System 191

6.44 Jul 19, 2023: Boston Scientific lays off 52 workers as it closes another Silicon Valley facility 192

6.45 May 31, 2023: Kardium announces first US procedures in PULSAR study of Globe Pulsed Field System 192

6.46 May 22, 2023: Abbott gets FDA nod for TactiFlex Ablation Catheter to treat AFib 193

6.47 May 20, 2023: Data at Heart Rhythm 2023 highlight key Boston Scientific therapies 193

6.48 May 19, 2023: Varian announces first participant treated in RADIATE-VT clinical trial of cardiac radioablation for patients with Refractory Ventricular Tachycardia 195

6.49 May 19, 2023: Biosense Webster presents new data from pulsed field ablation investigational studies at Heart Rhythm 2023 195

6.50 May 19, 2023: Medtronic PulseSelect Pulsed Field Ablation System results in low Atrial arrhythmia burden for AFib patients 196

6.51 May 18, 2023: Pulse Biosciences’ Nanosecond Pulsed Field Ablation (nsPFA) technology to be featured in several presentations at The Heart Rhythm 2023 Annual Meeting 198

6.52 May 18, 2023: Pre-clinical Pulsed-Field Ablation (PFA) Using a Single-Shot Circular Linear Ablation Catheter for PV Isolation 198

6.53 May 11, 2023: Medtronic to announce financial results for its fourth quarter and full fiscal year 2023 199

6.54 May 03, 2023: Adagio Medical announces completion of enrollment in Cryocure-VT trial, maps the pathway to CE-Mark of vCLAS VT ablation catheter 199

6.55 Apr 17, 2023: Ra Medical electrophysiology division is participating in EHRA Congress 200

6.56 Apr 12, 2023: Medtronic has a layoff in California 200

7 Appendix 201

7.1 Methodology 201

7.2 About GlobalData 204

7.3 Contact Us 204

7.4 Disclaimer 204

Table

Cardiac Ablation Devices – Pipeline Products by Stage of Development 16

Cardiac Ablation Devices – Pipeline Products by Territory 17

Cardiac Ablation Devices – Pipeline Products by Regulatory Path 18

Cardiac Ablation Devices – Pipeline Products by Estimated Approval Date 19

Cardiac Ablation Devices – Ongoing Clinical Trials 20

Cardiac Ablation Devices Companies – Pipeline Products by Stage of Development 21

Cardiac Ablation Devices – Pipeline Products by Stage of Development 24

Abbott Medical Pipeline Products & Ongoing Clinical Trials Overview 27

Volt Pulsed Field Ablation System – Product Status 27

Volt Pulsed Field Ablation System – Product Description 27

Abbott Medical – Ongoing Clinical Trials Overview 28

Volt Pulsed Field Ablation System – A Pre-market, Multi-centered Clinical Study to Evaluate the Safety and Effectiveness of Volt Pulsed Field Ablation System 29

AblaCor Medical Corporation Pipeline Products & Ongoing Clinical Trials Overview 30

AutoBlator – Product Status 30

AutoBlator – Product Description 30

CircumBlator AF Catheter Ablation System – Product Status 30

CircumBlator AF Catheter Ablation System – Product Description 31

AccuPulse Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 32

PFA Pulsed Electric Field Ablation System – Product Status 32

PFA Pulsed Electric Field Ablation System – Product Description 32

AccuPulse Medical Technology Co Ltd – Ongoing Clinical Trials Overview 33

PFA Pulsed Electric Field Ablation System – Feasibility and Safety Evaluation of the Pulsed Electric Field Ablation System on Patients with Chronic Bronchitis 34

Acutus Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 35

AcQBlate Force Sensing Ablation Catheter – Product Status 35

AcQBlate Force Sensing Ablation Catheter – Product Description 35

Adagio Medical Inc. Pipeline Products & Ongoing Clinical Trials Overview 36

iCLAS System – Product Status 36

iCLAS System – Product Description 36

PFCA (Pulsed Field Cryoablation) System – Product Status 37

PFCA (Pulsed Field Cryoablation) System – Product Description 37

Adagio Medical Inc. – Ongoing Clinical Trials Overview 38

iCLAS System – A First-in-human Study of Pulsed Field Cryoablation for the Treatment of Patients with Atrial Fibrillation 39

iCLAS System – Cryoablation for Monomorphic Ventricular Tachycardia 39

iCLAS System – Cryoablation for Monomorphic Ventricular Tachycardia Early Feasibility Study (EFS) 39

iCLAS System – iCLAS Cryoablation System Post-Market Clinical Follow-up (PMCF) Study 39

iCLAS System – iCLAS for Persistent Atrial Fibrillation 40

iCLAS System – PARALELL – Pulsed Field Ablation and Pulsed Field CRyoAbLation in PErsistent AtriaL FibrilLation 40

PFCA (Pulsed Field Cryoablation) System – PARALELL – Pulsed Field Ablation and Pulsed Field CRyoAbLation in PErsistent AtriaL FibrilLation 41

Affera Inc Pipeline Products & Ongoing Clinical Trials Overview 42

Affera Mapping and Ablation System – Product Status 42

Affera Mapping and Ablation System – Product Description 42

HexaGEN Ablation System – Product Status 43

HexaGEN Ablation System – Product Description 43

Sphere9 Catheter – Product Status 43

Sphere9 Catheter – Product Description 43

SpherePVI – Product Status 44

SpherePVI – Product Description 44

Affera Inc – Ongoing Clinical Trials Overview 45

Sphere9 Catheter – Study to Evaluate the Safety and Efficacy of Lattice Sphere Catheter to Reduce Complication Risk During Cardiac Ablation 46

Affera Mapping and Ablation System – First-in-human Study Evaluating the Safety and Effectiveness of the SpherePVI Catheter and Affera System in Patients with Atrial Fibrillation 47

Affera Mapping and Ablation System – The Affera Global Registry Is A Prospective, Global, Multi-center, Observational Post-Market Registry (PMR) 47

Affera Mapping and Ablation System – Treatment of Persistent Atrial Fibrillation with the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System 47

SpherePVI – A Safety and Performance Assessment of the Affera SpherePVI Multi-Ablation System to Treat Paroxysmal Atrial Fibrillation 48

SpherePVI – A Safety and Performance Assessment of the SpherePVI Catheter and the Affera Mapping and Ablation System to Treat Paroxysmal Atrial Fibrillation 48

SpherePVI – First-in-human Study Evaluating the Safety and Effectiveness of the SpherePVI Catheter and Affera System in Patients with Atrial Fibrillation 48

AFreeze GmbH Pipeline Products & Ongoing Clinical Trials Overview 49

Tip-Catheter – Product Status 49

Tip-Catheter – Product Description 49

AngioDynamics Inc Pipeline Products & Ongoing Clinical Trials Overview 50

Non-Thermal Vein Ablation Device – Product Status 50

Non-Thermal Vein Ablation Device – Product Description 50

APT Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 51

Pulse Ablation Generator – Product Status 51

Pulse Ablation Generator – Product Description 51

Ring Pulse Ablation Catheter – Product Status 51

Ring Pulse Ablation Catheter – Product Description 52

Arga Medtech SA Pipeline Products & Ongoing Clinical Trials Overview 53

Coherent Sine-Burst Electroporation Ablation System – Product Status 53

Coherent Sine-Burst Electroporation Ablation System – Product Description 53

Non-Thermal Cardiac Ablation System – Product Status 53

Non-Thermal Cardiac Ablation System – Product Description 54

Arga Medtech SA – Ongoing Clinical Trials Overview 55

Coherent Sine-Burst Electroporation Ablation System – An IDE Study Coherent Sine-Burst Pulsed Field Ablation (PFA) System in Treatment of Atrial Fibrillation 56

Atrian Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 57

mPEF Device – Atrial Fibrillation – Product Status 57

mPEF Device – Atrial Fibrillation – Product Description 57

AtriCure Inc Pipeline Products & Ongoing Clinical Trials Overview 58

AtriCure Bipolar System – Product Status 58

AtriCure Bipolar System – Product Description 58

AtriCure Isolator Synergy Surgical Ablation System – Inappropriate Sinus Tachycardia (IST) – Product Status 59

AtriCure Isolator Synergy Surgical Ablation System – Inappropriate Sinus Tachycardia (IST) – Product Description 59

AtriCure Inc – Ongoing Clinical Trials Overview 60

AtriCure Bipolar System – Combined Endoscopic Epicardial and Percutaneous Endocardial Ablation Versus Repeated Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation 61

Axon Therapies Inc Pipeline Products & Ongoing Clinical Trials Overview 62

Satera Ablation System – Product Status 62

Satera Ablation System – Product Description 62

Axon Therapies Inc – Ongoing Clinical Trials Overview 63

Satera Ablation System – Endovascular Ablation of the Right Greater Splanchnic Nerve in Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having HFpEF: Feasibility Study: Randomized Controlled Feasibility Trial – Rebalance-HF Study 64

Baylis Medical Company Inc Pipeline Products & Ongoing Clinical Trials Overview 65

Cardiac Ablation Mitigating Device – Product Status 65

Cardiac Ablation Mitigating Device – Product Description 65

Biosense Webster Inc Pipeline Products & Ongoing Clinical Trials Overview 66

Omnypulse Bi-Directional Catheter – Product Status 66

Omnypulse Bi-Directional Catheter – Product Description 66

VARIPULSE Catheter – Product Status 67

VARIPULSE Catheter – Product Description 67

VARIPULSE Platform – Product Status 67

VARIPULSE Platform – Product Description 67

Biosense Webster Inc – Ongoing Clinical Trials Overview 69

VARIPULSE Catheter – Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation with the BWI IRE Ablation System (AdmIRE) 70

VARIPULSE Catheter – Versatility of a Circular Multielectrode Catheter in the Individualized Recognition & Treatment of Atrial Fibrillation and Related Arrhythmias Using Pulsed Field Energy 70

Omnypulse Bi-Directional Catheter – Safety and Effectiveness Evaluation of the OMNYPULSE Catheter With the TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF) 71

Corfigo Inc Pipeline Products & Ongoing Clinical Trials Overview 72

HeArTPAD – Product Status 72

HeArTPAD – Product Description 72

Coridea, LLC Pipeline Products & Ongoing Clinical Trials Overview 73

Cardiac Sympathetic Denervation Device – Product Status 73

Cardiac Sympathetic Denervation Device – Product Description 73

CPSI Biotech Pipeline Products & Ongoing Clinical Trials Overview 74

ICEolate Catheter – Product Status 74

ICEolate Catheter – Product Description 74

ICEolate Catheter With Spot Ablation Tip – Product Status 75

ICEolate Catheter With Spot Ablation Tip – Product Description 75

ICEolate Surgical Probe With Control Handle – Product Status 75

ICEolate Surgical Probe With Control Handle – Product Description 75

ICEolate Surgical Probe With Flexible Ablation Tip – Product Status 76

ICEolate Surgical Probe With Flexible Ablation Tip – Product Description 76

Cryofocus Medtech Shanghai Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 77

Cryo-RDN System – Product Status 77

Cryo-RDN System – Product Description 77

Pulmonary Hypertension Cryoablation System – Product Status 77

Pulmonary Hypertension Cryoablation System – Product Description 78

CyberHeart Inc Pipeline Products & Ongoing Clinical Trials Overview 79

CyberHeart System – Product Status 79

CyberHeart System – Product Description 79

ElectroPhysiology Frontiers S.p.A. Pipeline Products & Ongoing Clinical Trials Overview 80

Fiore Catheter – Product Status 80

Fiore Catheter – Product Description 80

Epiendoaf Inc Pipeline Products & Ongoing Clinical Trials Overview 81

EpiEndoAF Device – Product Status 81

EpiEndoAF Device – Product Description 81

Field Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 82

FieldForce Ablation System – Product Status 82

FieldForce Ablation System – Product Description 82

Field Medical Inc – Ongoing Clinical Trials Overview 83

FieldForce Ablation System – A Pre-Market, First-In-Human, Pilot, Interventional, Clinical Investigation to Evaluate Safety and Feasibility of the FieldForce™ Ablation System in Symptomatic Patients With Ventricular Arrhythmia 84

Galaxy Medical Products Inc Pipeline Products & Ongoing Clinical Trials Overview 85

Centauri System – Product Status 85

Centauri System – Product Description 85

Galaxy Medical Products Inc – Ongoing Clinical Trials Overview 86

Centauri System – Study Evaluating the Safety and Efficacy of the Centauri system (ECLIPSE-AF) 87

Centauri System – Study Evaluating the Safety and Efficacy of the Centauri System in Patients with Persistent Atrial Fibrillation: SPACE-AF 87

Hadassah Medical Center Pipeline Products & Ongoing Clinical Trials Overview 88

Qualiblate – Product Status 88

Qualiblate – Product Description 88

Hangzhou Nuocheng Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 89

Liwen RF Ablation System – Product Status 89

Liwen RF Ablation System – Product Description 89

Hangzhou Nuocheng Medical Technology Co Ltd – Ongoing Clinical Trials Overview 90

Liwen RF Ablation System – Confirmatory Clinical Study of Liwen RF Ablation System 91

Hangzhou Nuomao Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 92

CardioPulse Field Ablation System – Product Status 92

CardioPulse Field Ablation System – Product Description 92

Hangzhou Nuomao Medical Technology Co Ltd – Ongoing Clinical Trials Overview 93

CardioPulse Field Ablation System – An Exploratory Study of Focal Pulse Ablation System in the Treatment of Typical Atrial Flutter 94

CardioPulse Field Ablation System – First in Man Study to Evaluate Safety and Efficacy of Left Atrial Appendage Pulsed Field Ablation Occluder for Simultaneous Pulsed Field Ablation and Mechanical Closure of the Left Atrial Appendage in Patients With Nonvalvular Atrial Fibrillation 94

CardioPulse Field Ablation System – The Effectiveness and Safety of CardioPulse Pulse Ablation System in the Treatment of Paroxysmal Atrial Fibrillation 94

Helical Solutions, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 95

Catheter-Based Ablation Device – Product Status 95

Catheter-Based Ablation Device – Product Description 95

Huifeng Biotechnology (Shanghai) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 96

Atrial Fibrillation Pulsed Field Ablation System – Product Status 96

Atrial Fibrillation Pulsed Field Ablation System – Product Description 96

Insight Lifetech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 97

Pulsed Field Ablation Catheter – Product Status 97

Pulsed Field Ablation Catheter – Product Description 97

Pulsed Field Ablation System – Product Status 97

Pulsed Field Ablation System – Product Description 98

Insight Lifetech Co Ltd – Ongoing Clinical Trials Overview 99

Pulsed Field Ablation System – A Prospective, Multicenter, Randomized, and Controlled Study of Pulsed Field Ablation System 100

Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 101

Catheter Guiding Computational Modeling Tool – Product Status 101

Catheter Guiding Computational Modeling Tool – Product Description 101

Kardium Inc Pipeline Products & Ongoing Clinical Trials Overview 102

CHS – Coated Globe Mapping And Ablation System – Product Status 102

CHS – Coated Globe Mapping And Ablation System – Product Description 102

Globe Mapping And Ablation System – Product Status 103

Globe Mapping And Ablation System – Product Description 103

Globe PF System – Product Status 103

Globe PF System – Product Description 104

Kardium Inc – Ongoing Clinical Trials Overview 105

Globe Mapping And Ablation System – An Investigational Clinical Study of Globe Mapping and Ablation System in Treatment of Patients with Atrial Fibrillation 106

Globe Mapping And Ablation System – PULSE-EU – A Prospective, Non-randomized Clinical Pilot Study to Assess Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation 106

Globe PF System – A Prospective, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Globe Pulsed Field System for Treating Patients with Symptomatic Paroxysmal or Persistent Atrial Fibrillation 107

LuxCath, LLC Pipeline Products & Ongoing Clinical Trials Overview 108

OmniView Light-Guided Ablation Catheter – Product Status 108

OmniView Light-Guided Ablation Catheter – Product Description 108

LuxMed Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 109

Next Generation Percutaneous Catheter – Product Status 109

Next Generation Percutaneous Catheter – Product Description 109

Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 110

Cardioblate Irrigated RF (IRF) System – Non-Paroxysmal Atrial Fibrillation – Product Status 110

Cardioblate Irrigated RF (IRF) System – Non-Paroxysmal Atrial Fibrillation – Product Description 110

CryoFlex Surgical Ablation System – Non-Paroxysmal Atrial Fibrillation – Product Status 111

CryoFlex Surgical Ablation System – Non-Paroxysmal Atrial Fibrillation – Product Description 111

PulseSelect PFA System – Product Status 111

PulseSelect PFA System – Product Description 112

Medtronic Plc – Ongoing Clinical Trials Overview 113

Cardioblate Irrigated RF (IRF) System – Non-Paroxysmal Atrial Fibrillation – Irrigated Radio Frequency Ablation to Terminate Non-paroxysmal Atrial Fibrillation: Terminate AF Study 114

PulseSelect PFA System – A Study to Evaluate the Efficacy of Pulsed Field Ablation Treatment in Subjects with Atrial Fibrillation 115

National Science and Technology Development Agency Pipeline Products & Ongoing Clinical Trials Overview 116

Cardiac Ablation Device – Product Status 116

Cardiac Ablation Device – Product Description 116

Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 117

Cardiac Tissue Ablation Device – Product Status 117

Cardiac Tissue Ablation Device – Product Description 117

Pavmed Inc Pipeline Products & Ongoing Clinical Trials Overview 118

Caldus – Renal Denervation – Product Status 118

Caldus – Renal Denervation – Product Description 118

Caldus – Traditional Tissue Ablation – Product Status 119

Caldus – Traditional Tissue Ablation – Product Description 119

Pulse Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 120

Cardiac Ablation Catheter – Product Status 120

Cardiac Ablation Catheter – Product Description 120

CellFX nsPFA Cardiac Clamp – Product Status 121

CellFX nsPFA Cardiac Clamp – Product Description 121

Pulse Biosciences Inc – Ongoing Clinical Trials Overview 122

Cardiac Ablation Catheter – A First-In-Human Feasibility Study to Evaluate Efficacy of CellFX Nanosecond Pulsed Field (nsPFA) Technology in the Treatment of Atrial Fibrillation 123

Cardiac Ablation Catheter – A First-in-human Study of Nanosecond Pulsed Field Ablation (nsPFA) Cardiac Catheter on the Treatment of Atrial Fibrillation 123

Shanghai Antec Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 124

Cryoballoon Ablation System – Product Status 124

Cryoballoon Ablation System – Product Description 124

Pulsed Electric Field Ablation System – Product Status 124

Pulsed Electric Field Ablation System – Product Description 125

Shanghai Hantong Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 126

Next-Generation Ultrasound Ablation System – Heart Failure – Product Status 126

Next-Generation Ultrasound Ablation System – Heart Failure – Product Description 126

Shanghai HeartCare Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 127

Cryoablation Device – Product Status 127

Cryoablation Device – Product Description 127

Shanghai Keku Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 128

Cardiac Ablation Device – Atrial Fibrillation – Product Status 128

Cardiac Ablation Device – Atrial Fibrillation – Product Description 128

Shanghai Ruidao Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 129

Irreversible Electroporation Ablation Device – Atrial Fibrillation – Product Status 129

Irreversible Electroporation Ablation Device – Atrial Fibrillation – Product Description 129

Shanghai Weiqi Medical Equipment Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 130

Cardiac Cryoablation System – Product Status 130

Cardiac Cryoablation System – Product Description 130

Shanghai Weiqi Medical Equipment Co Ltd – Ongoing Clinical Trials Overview 131

Cardiac Cryoablation System – A Prospective, Multicenter, Single-arm Clinical Trial Evaluating the Safety and Efficacy of a Cardiac Cryoablation System for the Treatment of Paroxysmal Atrial Fibrillation 132

Shanghai Xuanyu Medical Equipment Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 133

Multi-Channel Pulsed Electric Field Ablation Instrument – Product Status 133

Multi-Channel Pulsed Electric Field Ablation Instrument – Product Description 133

Shenzhen Huitai Medical Equipment Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 134

Cardiac Pulse Electric Field Ablation System – Product Status 134

Cardiac Pulse Electric Field Ablation System – Product Description 134

Shenzhen Maiwei Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 135

Nanosecond Pulsed Electric Field Ablation (nsPFA) Device – Product Status 135

Nanosecond Pulsed Electric Field Ablation (nsPFA) Device – Product Description 135

Sichuan Jinjiang Electronic Science and Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 136

Cardiac Ablation System – Product Status 136

Cardiac Ablation System – Product Description 136

SIGT LLC Pipeline Products & Ongoing Clinical Trials Overview 137

Pulsed Field Ablation and Lesion Assessment System – Product Status 137

Pulsed Field Ablation and Lesion Assessment System – Product Description 137

Suzhou Aikemai Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 138

PFA Pulsed Electric Field Ablation System – Atrial Fibrillation – Product Status 138

PFA Pulsed Electric Field Ablation System – Atrial Fibrillation – Product Description 138

PFA Pulsed Electric Field Ablation System – Premature Ventricular Contraction – Product Status 138

PFA Pulsed Electric Field Ablation System – Premature Ventricular Contraction – Product Description 139

Tau Pnu Medical Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 140

Tira Catheter – Product Status 140

Tira Catheter – Product Description 140

Tau Pnu Medical Co., Ltd. – Ongoing Clinical Trials Overview 141

Tira Catheter – A Multicenter, Open, Single Design, Researcher-led, Phase 1 Exploratory Study to Evaluate the Safety and Efficacy of Vein of Marshall RF Ablation Using TIRA(VA510 and Other 3 Types) in Patients with Persistent Atrial Fibrillation 142

Tira Catheter – The Study for Evaluation of Safety and Efficacy of Transcatheter RF Ablation System (TIRA Catheter) to Treat Hypertrophic Obstructive Cardiomyopathy: Multi-center, Open Label, Single Arm, Investigator Initiated Exploratory Pilot Study 142

The Chaim Sheba Medical Center Pipeline Products & Ongoing Clinical Trials Overview 143

Transcatheter Septal Myectomy Device – Product Status 143

Transcatheter Septal Myectomy Device – Product Description 143

Thermedical Inc Pipeline Products & Ongoing Clinical Trials Overview 144

Durablate Ablation Catheter – Product Status 144

Durablate Ablation Catheter – Product Description 144

SERF Ablation System – Ventricular Tachycardia – Product Status 145

SERF Ablation System – Ventricular Tachycardia – Product Description 145

Thermedical Inc – Ongoing Clinical Trials Overview 146

SERF Ablation System – Ventricular Tachycardia – Saline Enhanced Radiofrequency (SERF) Needle Ablation for Refractory VT 147

Tianjin Intelligent Health Medical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 148

Pulsed-Field Ablation System – Paroxysmal Atrial Fibrillation – Product Status 148

Pulsed-Field Ablation System – Paroxysmal Atrial Fibrillation – Product Description 148

Toray Medical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 149

Satake HotBalloon Catheter – Product Status 149

Satake HotBalloon Catheter – Product Description 149

Tufts Medical Center Pipeline Products & Ongoing Clinical Trials Overview 150

Tissue Ablation Device – Product Status 150

Tissue Ablation Device – Product Description 150

University of California Los Angeles Pipeline Products & Ongoing Clinical Trials Overview 151

Cryogenic Anchor – Product Status 151

Cryogenic Anchor – Product Description 151

University of Chicago Pipeline Products & Ongoing Clinical Trials Overview 152

DVT Histotripsy System – Product Status 152

DVT Histotripsy System – Product Description 152

University of Iowa Pipeline Products & Ongoing Clinical Trials Overview 153

Sheath Delivery System – Atrioventricular Nodal Ablation – Product Status 153

Sheath Delivery System – Atrioventricular Nodal Ablation – Product Description 153

Varian Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 154

Cardiac Radioablation System – Product Status 154

Cardiac Radioablation System – Product Description 154

Varian Medical Systems Inc – Ongoing Clinical Trials Overview 155

Cardiac Radioablation System – Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia 156

Virginia Polytechnic Institute and State University Pipeline Products & Ongoing Clinical Trials Overview 157

Irreversible Electroporation Ablation System – Product Status 157

Irreversible Electroporation Ablation System – Product Description 157

VytronUS Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 158

Low-Intensity Collimated Ultrasound (LICU) Cardiac Mapping and Ablation System – Product Status 158

Low-Intensity Collimated Ultrasound (LICU) Cardiac Mapping and Ablation System – Product Description 158

VytronUS Inc (Inactive) – Ongoing Clinical Trials Overview 159

Low-Intensity Collimated Ultrasound (LICU) Cardiac Mapping and Ablation System – Early Feasibility Study of Automated Ultrasound Technology for the Treatment of Persistent Atrial Fibrillation 160

Glossary 203

Figures

Cardiac Ablation Devices – Pipeline Products by Stage of Development 17

Cardiac Ablation Devices – Pipeline Products by Territory 18

Cardiac Ablation Devices – Pipeline Products by Regulatory Path 19

Cardiac Ablation Devices – Pipeline Products by Estimated Approval Date 20

Cardiac Ablation Devices – Ongoing Clinical Trials 21

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