Clot Management Devices Pipeline by Development Stages, Segments, Region and Countries, Regulatory Path and Key Companies

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Published: February 27, 2024 Report Code: GDME1713EPD-ST

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Clot Management Devices Pipeline Market Report Overview

Clot Management Devices are used for the removal or dissolution of a clot from a blood vessel to restore proper blood circulation. This device is used as a routine procedure while performing percutaneous coronary intervention and for treating potentially life-threatening complications.
The clot management devices pipeline market research report provides comprehensive information on the products with their comparative segment-wise analysis in various stages of development. The report also covers the regional and country-wise clot management devices’ clinical trials outlook. The regulatory paths followed for conducting the clot management devices pipeline research are extensively highlighted in the report. Leading companies involved in the clot management devices pipeline development are also enlisted in this research report for better understanding of the competitive landscape.

Key Segments ·        Thrombectomy Systems (Catheters)

·        Retrievable IVCF

·        Inferior Vena Cava Filters (IVCF)

·        Embolectomy Balloon Catheters

·        Manual Aspiration Thrombectomy Devices

·        Permanent IVCF

·        IVCF Retrieval Devices
Key Territories ·        The US

·        China

·        Japan

·        Europe

·        Mexico
Key Regulatory Paths ·        510(k)

·        NMPA

·        Ninsho

·        ANVISA

·        CE
Leading Companies ·        AorticLab Sarl

·        APT Medical Inc

·        Boston Scientific Corp

·        Caeli Vascular LLC

·        Capture Vascular Inc

·        Embolx, Inc.

·        Inari Medical Inc
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Clot Management Devices Pipeline Market by Segments

The key segments in the clot management devices pipeline market are Thrombectomy Systems (Catheters), Retrievable IVCF, Inferior Vena Cava Filters (IVCF), Embolectomy Balloon Catheters, Manual Aspiration Thrombectomy Devices, Permanent IVCF, and IVCF Retrieval Devices. As of February 2024, the Thrombectomy Systems (Catheters) segment held the highest number of pipeline products.

Clot Management Devices Pipeline Market Analysis by Segments, 2024 (%)

Clot Management Devices Pipeline Market Analysis by Segments, 2024 (%)

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Clot Management Devices Pipeline Market Segmentation by Territories

The key territories in the clot management devices market are the United States, China, Japan, Mexico, and Europe among others. As of February 2024, the United States accounted for the highest number of clot management devices in the development pipeline.

Clot Management Devices Pipeline Market Analysis by Territories, 2024 (%)

Clot Management Devices Pipeline Market Analysis by Territories, 2024 (%)

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Clot Management Devices Pipeline Market Segmentation by Regulatory Paths

The key regulatory paths in the clot management devices pipeline market are 510(k), NMPA, Ninsho, ANVISA, and CE among others. As of February 2024, 510(k) was the most followed pathway for pipeline products in the market.

Clot Management Devices Pipeline Market Analysis by Regulatory Paths, 2024 (%)

Clot Management Devices Pipeline Market Analysis by Regulatory Paths, 2024 (%)

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Clot Management Devices Pipeline Market – Competitive Landscape

The companies in the clot management devices pipeline market are:

  • AorticLab Sarl
  • APT Medical Inc
  • Boston Scientific Corp
  • Caeli Vascular LLC
  • Capture Vascular Inc
  • Embolx, Inc.
  • Inari Medical Inc.

AorticLab Sarl: AorticLab Sarl, headquartered in Italy, provides medical and technological innovations developing next-generation devices for safe and effective transcatheter treatment of the stenotic aortic native valve. The company offers GEMINI, a Transcatheter Debridement Device (TDD) intended for peripheral artery disease management. It is designed to break and fragment the calcific plaques present on the aortic and bioprosthetic leaflets. It is obtained by double ultrasound frequency treatment generating a cavitation effect inside the leaflet tissue.

Clot Management Devices Pipeline Market Analysis by Companies, 2024

Clot Management Devices Pipeline Market Analysis by Companies, 2024

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Segments Covered in the Report

Clot Management Devices Pipeline Market Segments Outlook

  • Thrombectomy Systems (Catheters)
  • Retrievable IVCF
  • Inferior Vena Cava Filters (IVCF)
  • Embolectomy Balloon Catheters
  • Manual Aspiration Thrombectomy Devices
  • Permanent IVCF
  • IVCF Retrieval Devices

Clot Management Devices Pipeline Market Territories Outlook

  • The US
  • Europe
  • China
  • Japan
  • Mexico

Clot Management Devices Pipeline Market Regulatory Paths Outlook

  • 510(k)
  • NMPA
  • CE
  • MDITAC
  • Ninsho

Scope

This report provides:

  • Extensive coverage of the clot management devices under development.

  • Details of major pipeline products which include product description, licensing and collaboration details and other developmental activities.

  • Reviews of major players involved in the development of clot management 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.

  • Provides key clinical trial data related to 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 portfolio and create effective counter strategies to gain a competitive advantage.

  • Identify and understand important and diverse types of clot management devices under development.

  • Develop market-entry and market-expansion strategies.

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

  • In-depth analysis of the product’s current stage of development, territory, and estimated launch date.

Acotec Scientific Holdings Ltd
Adient Medical Inc.
Akura Medical Inc
AngioDynamics Inc
AorticLab Sarl
APT Medical Inc
Boston Scientific Corp
Caeli Vascular LLC
Capture Vascular Inc
Contego Medical LLC
CyndRX LLC
Embolx, Inc.
Endovascular Engineering Inc
Flow Medical Solutions Inc
Inari Medical Inc
Innova Vascular Inc
Interventional & Surgical Innovations, LLC
Jiangsu Zhenyi Medical Technology Co Ltd
Kaleidoscope
Koninklijke Philips NV
Lazarus Effect, Inc
LeMaitre Vascular Inc
Liquet Medical Inc
Lithotech Medical Ltd
Magneto Thrombectomy Solutions Ltd
Merit Medical Systems Inc
MicroPort Scientific Corp
Morningside (Nantong) Medical Co Ltd
NexGen Medical Systems Inc
OrbusNeich
OsciFlex LLC
Penumbra Inc
Shanghai Changde Medical Technology Co Ltd
Shanghai HeartCare Medical Technology Co Ltd
Shanghai MicroPort Endovascular MedTech Group Co Ltd
Shenzhen Tendfo Medical Technology Co Ltd
Shenzhen Tengfu Medical Technology Co Ltd
Suzhou Tianhong Shengjie Medical Co Ltd
TransMed7 LLC
University of Arizona
University of California Los Angeles
University of Michigan
University of Toledo
University of Wolverhampton
VeinWay Ltd
Veniti Inc
VueKlar Cardiovascular Ltd (Inactive)
Wallaby Medical Inc
WaveClear Inc
Zylox-Tonbridge Medical Technology Co Ltd

Table of Contents

1 Table of Contents 3

1.1 List of Tables 7

1.2 List of Figures 13

2 Introduction 14

2.1 Clot Management Devices Overview 14

3 Products under Development 16

3.1 Clot Management Devices – Pipeline Products by Stage of Development 16

3.2 Clot Management Devices – Pipeline Products by Segment 17

3.3 Clot Management Devices – Pipeline Products by Territory 18

3.4 Clot Management Devices – Pipeline Products by Regulatory Path 19

3.5 Clot Management Devices – Pipeline Products by Estimated Approval Date 20

3.6 Clot Management Devices – Ongoing Clinical Trials 21

4 Clot Management Devices – Pipeline Products under Development by Companies 22

4.1 Clot Management Devices Companies – Pipeline Products by Stage of Development 22

4.2 Clot Management Devices – Pipeline Products by Stage of Development 24

5 Clot Management Devices Companies and Product Overview 27

5.1 Acotec Scientific Holdings Ltd Company Overview 27

5.1.1 Acotec Scientific Holdings Ltd Pipeline Products & Ongoing Clinical Trials Overview 27

5.2 Adient Medical Inc. Company Overview 29

5.2.1 Adient Medical Inc. Pipeline Products & Ongoing Clinical Trials Overview 29

5.3 Akura Medical Inc Company Overview 32

5.3.1 Akura Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 32

5.4 AngioDynamics Inc Company Overview 33

5.4.1 AngioDynamics Inc Pipeline Products & Ongoing Clinical Trials Overview 33

5.5 AorticLab Sarl Company Overview 40

5.5.1 AorticLab Sarl Pipeline Products & Ongoing Clinical Trials Overview 40

5.6 APT Medical Inc Company Overview 41

5.6.1 APT Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 41

5.7 Boston Scientific Corp Company Overview 42

5.7.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 42

5.8 Caeli Vascular LLC Company Overview 46

5.8.1 Caeli Vascular LLC Pipeline Products & Ongoing Clinical Trials Overview 46

5.9 Capture Vascular Inc Company Overview 47

5.9.1 Capture Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 47

5.10 Contego Medical LLC Company Overview 50

5.10.1 Contego Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 50

5.11 CyndRX LLC Company Overview 51

5.11.1 CyndRX LLC Pipeline Products & Ongoing Clinical Trials Overview 51

5.12 Embolx, Inc. Company Overview 52

5.12.1 Embolx, Inc. Pipeline Products & Ongoing Clinical Trials Overview 52

5.13 Endovascular Engineering Inc Company Overview 53

5.13.1 Endovascular Engineering Inc Pipeline Products & Ongoing Clinical Trials Overview 53

5.14 Flow Medical Solutions Inc Company Overview 54

5.14.1 Flow Medical Solutions Inc Pipeline Products & Ongoing Clinical Trials Overview 54

5.15 Inari Medical Inc Company Overview 55

5.15.1 Inari Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 55

5.16 Innova Vascular Inc Company Overview 67

5.16.1 Innova Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 67

5.17 Interventional & Surgical Innovations, LLC Company Overview 71

5.17.1 Interventional & Surgical Innovations, LLC Pipeline Products & Ongoing Clinical Trials Overview 71

5.18 Jiangsu Zhenyi Medical Technology Co Ltd Company Overview 72

5.18.1 Jiangsu Zhenyi Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 72

5.19 Kaleidoscope Company Overview 73

5.19.1 Kaleidoscope Pipeline Products & Ongoing Clinical Trials Overview 73

5.20 Koninklijke Philips NV Company Overview 74

5.20.1 Koninklijke Philips NV Pipeline Products & Ongoing Clinical Trials Overview 74

5.21 Lazarus Effect, Inc Company Overview 75

5.21.1 Lazarus Effect, Inc Pipeline Products & Ongoing Clinical Trials Overview 75

5.22 LeMaitre Vascular Inc Company Overview 76

5.22.1 LeMaitre Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 76

5.23 Liquet Medical Inc Company Overview 81

5.23.1 Liquet Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 81

5.24 Lithotech Medical Ltd Company Overview 82

5.24.1 Lithotech Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 82

5.25 Magneto Thrombectomy Solutions Ltd Company Overview 83

5.25.1 Magneto Thrombectomy Solutions Ltd Pipeline Products & Ongoing Clinical Trials Overview 83

5.26 Merit Medical Systems Inc Company Overview 86

5.26.1 Merit Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 86

5.27 MicroPort Scientific Corp Company Overview 87

5.27.1 MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 87

5.28 Morningside (Nantong) Medical Co Ltd Company Overview 88

5.28.1 Morningside (Nantong) Medical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 88

5.29 NexGen Medical Systems Inc Company Overview 91

5.29.1 NexGen Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 91

5.30 OrbusNeich Company Overview 92

5.30.1 OrbusNeich Pipeline Products & Ongoing Clinical Trials Overview 92

5.31 OsciFlex LLC Company Overview 93

5.31.1 OsciFlex LLC Pipeline Products & Ongoing Clinical Trials Overview 93

5.32 Penumbra Inc Company Overview 94

5.32.1 Penumbra Inc Pipeline Products & Ongoing Clinical Trials Overview 94

5.33 Shanghai Changde Medical Technology Co Ltd Company Overview 102

5.33.1 Shanghai Changde Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 102

5.34 Shanghai HeartCare Medical Technology Co Ltd Company Overview 104

5.34.1 Shanghai HeartCare Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 104

5.35 Shanghai MicroPort Endovascular MedTech Group Co Ltd Company Overview 105

5.35.1 Shanghai MicroPort Endovascular MedTech Group Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 105

5.36 Shenzhen Tendfo Medical Technology Co Ltd Company Overview 107

5.36.1 Shenzhen Tendfo Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 107

5.37 Shenzhen Tengfu Medical Technology Co Ltd Company Overview 108

5.37.1 Shenzhen Tengfu Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 108

5.38 Suzhou Tianhong Shengjie Medical Co Ltd Company Overview 109

5.38.1 Suzhou Tianhong Shengjie Medical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 109

5.39 TransMed7 LLC Company Overview 112

5.39.1 TransMed7 LLC Pipeline Products & Ongoing Clinical Trials Overview 112

5.40 University of Arizona Company Overview 113

5.40.1 University of Arizona Pipeline Products & Ongoing Clinical Trials Overview 113

5.41 University of California Los Angeles Company Overview 114

5.41.1 University of California Los Angeles Pipeline Products & Ongoing Clinical Trials Overview 114

5.42 University of Michigan Company Overview 115

5.42.1 University of Michigan Pipeline Products & Ongoing Clinical Trials Overview 115

5.43 University of Toledo Company Overview 116

5.43.1 University of Toledo Pipeline Products & Ongoing Clinical Trials Overview 116

5.44 University of Wolverhampton Company Overview 118

5.44.1 University of Wolverhampton Pipeline Products & Ongoing Clinical Trials Overview 118

5.45 VeinWay Ltd Company Overview 119

5.45.1 VeinWay Ltd Pipeline Products & Ongoing Clinical Trials Overview 119

5.46 Veniti Inc Company Overview 120

5.46.1 Veniti Inc Pipeline Products & Ongoing Clinical Trials Overview 120

5.47 VueKlar Cardiovascular Ltd (Inactive) Company Overview 121

5.47.1 VueKlar Cardiovascular Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 121

5.48 Wallaby Medical Inc Company Overview 122

5.48.1 Wallaby Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 122

5.49 WaveClear Inc Company Overview 123

5.49.1 WaveClear Inc Pipeline Products & Ongoing Clinical Trials Overview 123

5.50 Zylox-Tonbridge Medical Technology Co Ltd Company Overview 124

5.50.1 Zylox-Tonbridge Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 124

6 Clot Management Devices- Recent Developments 129

6.1 Feb 14, 2024: Penumbra Obtains Additional 510(K) Clearance For Indigo Aspiration System – Lightning Flash 129

6.2 Feb 14, 2024: Inari Medical Receives FDA 510(k) Clearance For VenaCore Thrombectomy Catheter (46-101) 129

6.3 Feb 08, 2024: Innova announces Laguna system’s early commercial use in patients 129

6.4 Jan 31, 2024: Boston Scientific Announces Results for Fourth Quarter and Full Year 2023 130

6.5 Jan 29, 2024: William Cook Europe Receives Additional FDA 510(k) Clearance for Celect Platinum Vena Cava Filter Sets 132

6.6 Jan 11, 2024: Endovascular Engineering’s Helo Thrombectomy System Receives IDE Approval to Start ENGULF Pivotal Trial for the Treatment of Pulmonary Embolism 132

6.7 Jan 05, 2024: Inari Medical Receives FDA 510(k) Clearance for ClotTriever13 Gen 3 Sheath 133

6.8 Jan 05, 2024: Boston Scientific Announces Conference Call Discussing Fourth Quarter 2023 Results 133

6.9 Jan 04, 2024: Walk Vascular Receives 510(K) Clearance For JETi Hydrodynamic Thrombectomy System 133

6.10 Dec 07, 2023: AngioDynamics Completes Patient Enrollment in APEX-AV Study Assessing AlphaVac F1885 System in Treatment of Pulmonary Embolism 133

6.11 Nov 29, 2023: Penumbra enrols first patient in trial of Lightning Flash 135

6.12 Nov 28, 2023: Inari Medical enrols first patient in FlowTriever System trial 135

6.13 Nov 15, 2023: Inquis Medical Receives 510(K) Clearance For Aventus Thrombectomy System 136

6.14 Nov 08, 2023: Peripheral Thrombus Aspiration Catheter Obtained Official Registration Approval by The China NMPA 136

6.15 Nov 01, 2023: New Late Breaking Data Demonstrate Penumbra’s Computer Assisted Vacuum Thrombectomy Technology for Pulmonary Embolism Improved Patient Outcomes 137

6.16 Oct 26, 2023: Boston Scientific Announces Results for Third Quarter 2023 138

6.17 Oct 25, 2023: Boston Scientific’s EKOS system reduces bleeding in PE trial 140

6.18 Oct 09, 2023: Scientia Vascular Receives 510(k) Clearance for Socrates Aspiration System 141

6.19 Oct 04, 2023: Medtronic Names Paolo Di Vincenzo President of the Neuromodulation Business 141

6.20 Sep 29, 2023: Barry Slowey Named Vice President and Chief Sustainability Officer 141

6.21 Sep 26, 2023: Ichor Receives 510(k) Clearance for ICHOR 14F Embolectomy System 142

6.22 Sep 22, 2023: SurModics Receives 510(k) Clearance for Pounce Sheath 142

6.23 Sep 15, 2023: Amber Beauchamp Named Vice President of Global Human Resources 142

6.24 Sep 15, 2023: Nomi New Innovation and Zhuhai Mingxiang Have Reached a Strategic Cooperation to Jointly Promote the Domestic Replacement Process of Electronic Flexible Lenses in Otolaryngology 142

6.25 Aug 26, 2023: Medtronic Q2 2024 Earnings Estimates Increased by William Blair 143

6.26 Aug 10, 2023: Vena Cava Filter System Saexten Approved by NMPA 143

6.27 Aug 08, 2023: Medtronic to Announce Financial Results for its First Quarter of Fiscal Year 2024 143

6.28 Aug 01, 2023: Inari Medical Receives Additional 510(k) Clearance for Triever20 Curve 144

6.29 Jul 31, 2023: Route 92 Medical Announces Publication of a Retrospective Study in the Interventional Neuroradiology Journal 144

6.30 Jul 25, 2023: Inari Medical Receives Additional 510(K) Clearance for FlowSaver Blood Return System 145

6.31 Jul 19, 2023: Boston Scientific lays off 52 workers as it closes another Silicon Valley facility 145

6.32 Jul 18, 2023: Thrombolex Receives Additional 510(k) Clearance for Bashir Endovascular Catheter 145

6.33 Jul 18, 2023: Thrombolex Receives Additional 510(k) Clearance for Bashir S-B Endovascular Catheter 145

6.34 Jul 05, 2023: SurModics Receives Additional 510(k) Clearance for Pounce Thrombus Retrieval System 146

6.35 Jun 07, 2023: Interventional Vascular Specialists at Klinikum Hochsauerland, Clinic for Angiology/Clinic for Vascular Surgery in Germany Save Patient’s Arm in Second Human Compassionate Use of VeinWay’s Traversa for Venous Recanalization 146

6.36 Jun 07, 2023: Inari Medical Announces Commercial Launch of RevCore and Triever16 Curve, Two New Purpose-Built Products for Addressing Venous Stent Thrombosis and Venous Thromboembolism 146

6.37 Jun 07, 2023: Innova Vascular Earns FDA Clearance for Two New Thrombectomy Devices: Laguna Clot Retriever System and Malibu Aspiration Catheter System 147

6.38 Jun 04, 2023: Cook Medical receives additional 510(k) clearance for Gunther Tulip Vena Cava Filter Retrieval Set 148

6.39 Jun 02, 2023: Penumbra introduces new Lightning Bolt7 arterial thrombectomy system 148

6.40 May 23, 2023: Inari Medical announces enrolment for venous thromboembolism study 148

6.41 May 11, 2023: Akura Medical begins human trial of mechanical thrombectomy platform 149

6.42 May 11, 2023: Medtronic to announce financial results for its fourth quarter and full fiscal year 2023 150

6.43 May 10, 2023: Japan Lifeline launches Wallaby Medical’s Esperance Aspiration Catheter 150

6.44 May 06, 2023: Inari Medical receives 510(k) clearance for ClotTriever XL Catheter 150

6.45 Apr 29, 2023: Inari Medical obtains additional 510(k) clearance for ClotTriever BOLD 151

6.46 Apr 27, 2023: Route 92 Medical receives 510(k) clearance for Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set 151

6.47 Apr 26, 2023: Argon Medical Devices receives additional 510(k) clearance for Cleaner Plus Thrombectomy System 151

6.48 Apr 24, 2023: Route 92 Medical receives the first FDA clearance for a complete stroke treatment system 151

6.49 Apr 21, 2023: Surmodics enrols first patents in Pounce Thrombectomy System study 152

6.50 Apr 21, 2023: Hexacath receives 510(k) clearance for RayFlow 152

6.51 Apr 20, 2023: Thrombolex receives 510(k) clearance for treatment of Acute Pulmonary Embolism 153

6.52 Apr 20, 2023: Anaconda Biomed names new chairperson, appoints chief medical officer 153

6.53 Apr 18, 2023: 2MG receives 510(k) clearance for ROVO Mechanical Thrombectomy Device 154

6.54 Apr 14, 2023: CR Bard receives additional 510(k) clearance for Aspirex Thrombectomy System 154

6.55 Apr 12, 2023: Medtronic has a layoff in California 154

6.56 Apr 03, 2023: Inari Medical receives 510(k) clearance for RevCore Thrombectomy Catheter 154

6.57 Apr 02, 2023: Inari Medical receives 510(k) clearance for InThrill Thrombectomy System 154

6.58 Mar 26, 2023: Inari Medical obtains additional 510(k) clearance for Protrieve Sheath 155

6.59 Mar 16, 2023: Inari Medical receives 510(k) clearance for Artix AX Thrombectomy Device 155

6.60 Mar 16, 2023: Medtronic joins in $25M funding round for home monitoring company 155

6.61 Mar 10, 2023: Truvic Medical receives 510(k) clearance for Symphony Thrombectomy System 155

6.62 Mar 06, 2023: FLAME study demonstrates 90% survival improvement in high-risk pulmonary embolism with Inari Medical FlowTriever System 155

6.63 Mar 02, 2023: Interventional Radiologists at the University of Michigan Health Save Patient’s Leg in a First-in-Human Compassionate Use of VeinWay’s Traversa 156

6.64 Feb 28, 2023: Endovascular Engineering receives 510(k) clearance for Cobra Catheter System 156

6.65 Feb 28, 2023: Contego Medical receives 510(k) clearance for Excipio LV Thrombectomy Device 157

6.66 Feb 22, 2023: Penumbra receives an additional 510(k) clearance for Indigo Aspiration System – Lightning Aspiration Tubing 157

6.67 Feb 21, 2023: Inari Medical receives 510(k) clearance for FlowSaver Blood Return System 157

7 Appendix 158

7.1 Methodology 158

7.2 About GlobalData 161

7.3 Contact Us 161

7.4 Disclaimer 161

Table

Clot Management Devices – Pipeline Products by Stage of Development 16

Clot Management Devices – Pipeline Products by Segment 17

Clot Management Devices – Pipeline Products by Territory 18

Clot Management Devices – Pipeline Products by Regulatory Path 19

Clot Management Devices – Pipeline Products by Estimated Approval Date 20

Clot Management Devices – Ongoing Clinical Trials 21

Clot Management Devices Companies – Pipeline Products by Stage of Development 22

Clot Management Devices – Pipeline Products by Stage of Development 24

Acotec Scientific Holdings Ltd Pipeline Products & Ongoing Clinical Trials Overview 27

2nd Gen Peripheral Aspiration System – Product Status 27

2nd Gen Peripheral Aspiration System – Product Description 27

Peripheral Thrombectomy Device – Product Status 28

Peripheral Thrombectomy Device – Product Description 28

Adient Medical Inc. Pipeline Products & Ongoing Clinical Trials Overview 29

Absorbable Vascular Filter – Product Status 29

Absorbable Vascular Filter – Product Description 29

Adient Medical Inc. – Ongoing Clinical Trials Overview 30

Absorbable Vascular Filter – A Prospective, Multicenter, Pivotal Study with Randomized Controlled Prophylactic and Independent Therapeutic Cohorts to Evaluate the Safety and Efficacy of an Absorbable Vena Cava Filter for Pulmonary Embolism Prevention 31

Akura Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 32

Mechanical Thrombectomy Device – Product Status 32

Mechanical Thrombectomy Device – Product Description 32

AngioDynamics Inc Pipeline Products & Ongoing Clinical Trials Overview 33

AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System – Product Status 33

AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System – Product Description 34

Alphavac System – Infective Endocarditis – Product Status 34

Alphavac System – Infective Endocarditis – Product Description 34

Alphavac System – Left Atrial Appendage Thrombus – Product Status 35

Alphavac System – Left Atrial Appendage Thrombus – Product Description 35

AngioVac – Left Heart – Product Status 35

AngioVac – Left Heart – Product Description 36

AngioVac Low Profile Catheter – Product Status 36

AngioVac Low Profile Catheter – Product Description 36

AURYON Atherectomy System – Iliofemoral DVT – Product Status 37

AURYON Atherectomy System – Iliofemoral DVT – Product Description 37

AURYON System – Small Vessel Thrombectomy – Product Status 37

AURYON System – Small Vessel Thrombectomy – Product Description 37

Mechanical Thrombectomy Device – Product Status 38

Mechanical Thrombectomy Device – Product Description 38

Multi-Purpose Mechanical Aspiration – F1885 PE – Product Status 38

Multi-Purpose Mechanical Aspiration – F1885 PE – Product Description 38

Multi-Purpose Mechanical Aspiration Gen 2 – Product Status 39

Multi-Purpose Mechanical Aspiration Gen 2 – Product Description 39

Ultrasound-Assisted Thrombectomy System – Product Status 39

Ultrasound-Assisted Thrombectomy System – Product Description 39

AorticLab Sarl Pipeline Products & Ongoing Clinical Trials Overview 40

GEMINI – Product Status 40

GEMINI – Product Description 40

APT Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 41

Retrievable Inferior Vena Cava Filter – Product Status 41

Retrievable Inferior Vena Cava Filter – Product Description 41

Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 42

AngioJet Clothunter – Product Status 42

AngioJet Clothunter – Product Description 42

Next Gen AngioJet – Product Status 43

Next Gen AngioJet – Product Description 43

Next Gen Ekos – Product Status 43

Next Gen Ekos – Product Description 43

Boston Scientific Corp – Ongoing Clinical Trials Overview 44

Next Gen AngioJet – Study on the Effect of Modified Angiojet Thrombectomy in Subjects with Lower Extremity Deep Venous Thrombosis 45

Caeli Vascular LLC Pipeline Products & Ongoing Clinical Trials Overview 46

Hydra Catheter Thrombectomy System – Product Status 46

Hydra Catheter Thrombectomy System – Product Description 46

Capture Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 47

DVT Device – Product Status 47

DVT Device – Product Description 47

Megavac – BTK – Product Status 48

Megavac – BTK – Product Description 48

Thrombowire Clot Retractor – BTK – Product Status 48

Thrombowire Clot Retractor – BTK – Product Description 49

Contego Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 50

Temporary IVC Filter – Product Status 50

Temporary IVC Filter – Product Description 50

CyndRX LLC Pipeline Products & Ongoing Clinical Trials Overview 51

Inferior Vena Cava (IVC) Filter – Product Status 51

Inferior Vena Cava (IVC) Filter – Product Description 51

Embolx, Inc. Pipeline Products & Ongoing Clinical Trials Overview 52

Soldier High Flow Microcatheter – Product Status 52

Soldier High Flow Microcatheter – Product Description 52

Endovascular Engineering Inc Pipeline Products & Ongoing Clinical Trials Overview 53

Helo G1 Thrombectomy System – Product Status 53

Helo G1 Thrombectomy System – Product Description 53

Flow Medical Solutions Inc Pipeline Products & Ongoing Clinical Trials Overview 54

Thrombolytic Catheter – Acute Pulmonary Embolism – Product Status 54

Thrombolytic Catheter – Acute Pulmonary Embolism – Product Description 54

Inari Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 55

ClotTriever Thrombectomy System – Product Status 55

ClotTriever Thrombectomy System – Product Description 56

FlowSaver Blood Return System – Product Status 56

FlowSaver Blood Return System – Product Description 56

FlowTriever Catheter – Product Status 57

FlowTriever Catheter – Product Description 57

FlowTriever2 Catheter – Product Status 57

FlowTriever2 Catheter – Product Description 58

FlowTriever2 Catheter – Pulmonary Embolism – Product Status 58

FlowTriever2 Catheter – Pulmonary Embolism – Product Description 58

Triever16 Curve – Product Status 59

Triever16 Curve – Product Description 59

Triever20 – Product Status 59

Triever20 – Product Description 60

Triever24 – Product Status 60

Triever24 – Product Description 60

Triever24 Flex Catheter – Product Status 61

Triever24 Flex Catheter – Product Description 61

Inari Medical Inc – Ongoing Clinical Trials Overview 62

ClotTriever Thrombectomy System – ClotTriever Outcomes (CLOUT) Registry 63

ClotTriever Thrombectomy System – DEFIANCE – ClotTriever Thrombectomy System vs. Anticoagulation Alone for Treatment of Deep Vein Thrombosis 63

Triever20 – FlowTriever All-comer Registry for Patient Safety and Hemodynamics: FLASH 64

FlowTriever Catheter – Outcomes of Mechanical Thrombectomy with the FlowTriever Device in Acute Pulmonary Embolism, Results of a Swedish Retrospective Analysis 65

FlowTriever Catheter – The PEERLESS Study 65

FlowTriever Catheter – Treatment of Low-Risk Submassive Pulmonary Embolism With FlowTriever: Efficacy and Safety 65

FlowTriever2 Catheter – Pulmonary Embolism – FlowTriever Pulmonary Embolectomy Clinical Study – FlowTriever2 66

FlowTriever2 Catheter – Pulmonary Embolism – PEERLESS II: RCT of FlowTriever vs. Anticoagulation Alone in Pulmonary Embolism 66

Innova Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 67

Deep Vein Thrombosis Device – Product Status 67

Deep Vein Thrombosis Device – Product Description 67

Mechanical Thrombectomy Device – Product Status 68

Mechanical Thrombectomy Device – Product Description 68

Innova Vascular Inc – Ongoing Clinical Trials Overview 69

Mechanical Thrombectomy Device – Safety and Effectiveness of the ATC System in the Treatment of Acute Pulmonary Embolism 70

Interventional & Surgical Innovations, LLC Pipeline Products & Ongoing Clinical Trials Overview 71

Inferior Vena Cava Filter – Product Status 71

Inferior Vena Cava Filter – Product Description 71

Jiangsu Zhenyi Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 72

Pulmonary Thrombectomy Device – Product Status 72

Pulmonary Thrombectomy Device – Product Description 72

Kaleidoscope Pipeline Products & Ongoing Clinical Trials Overview 73

Reversible IVC Filter – Product Status 73

Reversible IVC Filter – Product Description 73

Koninklijke Philips NV Pipeline Products & Ongoing Clinical Trials Overview 74

LUMIFI with Crux VCF System – Product Status 74

LUMIFI with Crux VCF System – Product Description 74

Lazarus Effect, Inc Pipeline Products & Ongoing Clinical Trials Overview 75

Tempus-10 – Product Status 75

Tempus-10 – Product Description 75

LeMaitre Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 76

LeMaitre OTW Embolectomy Catheter – Product Status 76

LeMaitre OTW Embolectomy Catheter – Product Description 77

NovaSil – Product Status 77

NovaSil – Product Description 77

Syntel RT Embolectomy Catheter – Product Status 78

Syntel RT Embolectomy Catheter – Product Description 78

LeMaitre Vascular Inc – Ongoing Clinical Trials Overview 79

LeMaitre OTW Embolectomy Catheter – A Post-market Clinical Study to Confirm the Performance and Safety of the LeMaitre TufTex Over-the-Wire (OTW) Embolectomy Catheter on Patients Undergoing Surgical Treatment for the Removal of Arterial Emboli and/or Thrombi 80

Liquet Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 81

Versus Catheter – Product Status 81

Versus Catheter – Product Description 81

Lithotech Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 82

Great Aspiration Device – Product Status 82

Great Aspiration Device – Product Description 82

Magneto Thrombectomy Solutions Ltd Pipeline Products & Ongoing Clinical Trials Overview 83

eTrieve – Product Status 83

eTrieve – Product Description 83

Magneto Thrombectomy Solutions Ltd – Ongoing Clinical Trials Overview 84

eTrieve – Evaluation of the Safety and Effectiveness of Magneto eTrieve PE Kit for Endovascular Thrombectomy in Subjects with Acute Pulmonary Embolism 85

Merit Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 86

SPINR Macerator – Product Status 86

SPINR Macerator – Product Description 86

MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 87

Fishhawk Mechanical Thrombectomy Catheter – Product Status 87

Fishhawk Mechanical Thrombectomy Catheter – Product Description 87

Morningside (Nantong) Medical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 88

TwiFlow-Thrombectomy Catheter System – Product Status 88

TwiFlow-Thrombectomy Catheter System – Product Description 88

Morningside (Nantong) Medical Co Ltd – Ongoing Clinical Trials Overview 89

TwiFlow-Thrombectomy Catheter System – A Multicenter Prospective Single-arm Study to Evaluate the Safety and Efficacy of a Novel Transcatheter Pulmonary Thrombectomy System Which Named ‘TwiFlow’ for Acute Pulmonary Embolism 90

NexGen Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 91

XCOIL Shield – Product Status 91

XCOIL Shield – Product Description 91

OrbusNeich Pipeline Products & Ongoing Clinical Trials Overview 92

Aspiration Catheter – Product Status 92

Aspiration Catheter – Product Description 92

OsciFlex LLC Pipeline Products & Ongoing Clinical Trials Overview 93

OsciPulse Device – Product Status 93

OsciPulse Device – Product Description 93

Penumbra Inc Pipeline Products & Ongoing Clinical Trials Overview 94

Indigo Aspiration System – Lightning Aspiration Tubing – Product Status 94

Indigo Aspiration System – Lightning Aspiration Tubing – Product Description 95

Indigo Aspiration System – Separator 12 – Product Status 95

Indigo Aspiration System – Separator 12 – Product Description 95

Indigo System Aspiration Lightning 7 – Product Status 95

Indigo System Aspiration Lightning 7 – Product Description 96

Lightning Bolt 7 – Product Status 96

Lightning Bolt 7 – Product Description 97

Thunderbolt – Product Status 97

Thunderbolt – Product Description 97

Penumbra Inc – Ongoing Clinical Trials Overview 98

Indigo Aspiration System – Separator 12 – STORM-PE: A Prospective, Multicenter, Randomized Controlled Trial Evaluating Anticoagulation Alone vs Anticoagulation Plus Mechanical Aspiration With the Indigo Aspiration System for the Treatment of Intermediate High Risk Acute Pulmonary Embolism 99

Indigo Aspiration System – Lightning Aspiration Tubing – STORM-PE: A Prospective, Multicenter, Randomized Controlled Trial Evaluating Anticoagulation Alone vs Anticoagulation Plus Mechanical Aspiration With the Indigo Aspiration System for the Treatment of Intermediate High Risk Acute Pulmonary Embolism 100

Thunderbolt – THUNDER: Acute Ischemic Stroke Study With the Penumbra System Including Thunderbolt Aspiration Tubing 101

Shanghai Changde Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 102

Cardiac Balloon – Deep Vein Thrombosis – Product Status 102

Cardiac Balloon – Deep Vein Thrombosis – Product Description 102

Cardiac Catheter – Deep Vein Thrombosis – Product Status 103

Cardiac Catheter – Deep Vein Thrombosis – Product Description 103

Shanghai HeartCare Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 104

Thrombectomy Device II – Product Status 104

Thrombectomy Device II – Product Description 104

Shanghai MicroPort Endovascular MedTech Group Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 105

Thrombectomy Catheter – Product Status 105

Thrombectomy Catheter – Product Description 105

Vewatch – Product Status 106

Vewatch – Product Description 106

Shenzhen Tendfo Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 107

Thrombectomy Device – Product Status 107

Thrombectomy Device – Product Description 107

Shenzhen Tengfu Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 108

Tendvia Pulmonary Artery Thrombosis Removal System – Product Status 108

Tendvia Pulmonary Artery Thrombosis Removal System – Product Description 108

Suzhou Tianhong Shengjie Medical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 109

Thrombolysis Catheter – Product Status 109

Thrombolysis Catheter – Product Description 109

Thrombus Aspiration Catheter – Product Status 110

Thrombus Aspiration Catheter – Product Description 110

Thrombus Removal Catheter – Product Status 110

Thrombus Removal Catheter – Product Description 110

Vena Cava Filter – Product Status 111

Vena Cava Filter – Product Description 111

TransMed7 LLC Pipeline Products & Ongoing Clinical Trials Overview 112

Hurricane – Product Status 112

Hurricane – Product Description 112

University of Arizona Pipeline Products & Ongoing Clinical Trials Overview 113

Inferior Vena Cava Filter – Product Status 113

Inferior Vena Cava Filter – Product Description 113

University of California Los Angeles Pipeline Products & Ongoing Clinical Trials Overview 114

Clot Retrieval System – Product Status 114

Clot Retrieval System – Product Description 114

University of Michigan Pipeline Products & Ongoing Clinical Trials Overview 115

V-CaTh System – Product Status 115

V-CaTh System – Product Description 115

University of Toledo Pipeline Products & Ongoing Clinical Trials Overview 116

IVC Filter Retrieval System – Product Status 116

IVC Filter Retrieval System – Product Description 116

Minimally Invasive Thrombectomy Device – Product Status 117

Minimally Invasive Thrombectomy Device – Product Description 117

University of Wolverhampton Pipeline Products & Ongoing Clinical Trials Overview 118

GP Mechanical Thrombectomy Device – Product Status 118

GP Mechanical Thrombectomy Device – Product Description 118

VeinWay Ltd Pipeline Products & Ongoing Clinical Trials Overview 119

Traversa – Product Status 119

Traversa – Product Description 119

Veniti Inc Pipeline Products & Ongoing Clinical Trials Overview 120

VENITI VIDI Vena Cava Filter – Product Status 120

VENITI VIDI Vena Cava Filter – Product Description 120

VueKlar Cardiovascular Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 121

MR-Enhancing Retrievable Vena Cava Filter – Product Status 121

MR-Enhancing Retrievable Vena Cava Filter – Product Description 121

Wallaby Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 122

Esperance Aspiration Catheter System – Product Status 122

Esperance Aspiration Catheter System – Product Description 122

WaveClear Inc Pipeline Products & Ongoing Clinical Trials Overview 123

CaviClear Endovascular System – Product Status 123

CaviClear Endovascular System – Product Description 123

Zylox-Tonbridge Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 124

Implantable Inferior Vena Cava Filter – Product Status 124

Implantable Inferior Vena Cava Filter – Product Description 124

Mechanical Thrombectomy Device – Product Status 125

Mechanical Thrombectomy Device – Product Description 125

Peripheral Thrombectomy System – Product Status 125

Peripheral Thrombectomy System – Product Description 126

Zylox-Tonbridge Medical Technology Co Ltd – Ongoing Clinical Trials Overview 127

Implantable Inferior Vena Cava Filter – Multi-center, Randomized and Non-inferiority Clinical Trial to Investigate the Efficacy and Safety of Retrievable Inferior Vena Cava Filter 128

Glossary 160

Figures

Clot Management Devices – Pipeline Products by Stage of Development 16

Clot Management Devices – Pipeline Products by Segment 17

Clot Management Devices – Pipeline Products by Territory 18

Clot Management Devices – Pipeline Products by Regulatory Path 19

Clot Management Devices – Pipeline Products by Estimated Approval Date 20

Clot Management Devices – Ongoing Clinical Trials 21

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