Mechanical Circulatory Support Devices Pipeline Report including Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies,2022 Update

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Mechanical circulatory support devices are devices that replace or assist the pumping function of the ventricles. These devices support the functioning of a weak heart by pumping blood. Moreover, they can be used as a bridge to transplantation, for destination therapy, or as a bridge to recovery postcardiotomy.

The mechanical circulatory support devices pipeline market research report provides comprehensive information about the mechanical circulatory support devices pipeline products with a comparative analysis of the products at various stages of development and information about the clinical trials which are in progress. Moreover, the report provides information about various pipeline products and their estimated approval dates.

Mechanical Circulatory Support Devices Pipeline Products Market Segmentation by Territories

Some of the key territories with products in the pipeline are the US, Europe, China, Japan, the UK, Canada, Taiwan, India, Israel, Singapore, and South Korea. The US is the leading territory in the mechanical circulatory support devices pipeline products market followed by Europe and China.

Mechanical Circulatory Support Devices Pipeline Products Market Analysis by Territories

Mechanical Circulatory Support Devices Pipeline Products Market Analysis by Territories

For more territory insights into the mechanical circulatory support devices pipeline products market, download a free report sample

Mechanical Circulatory Support Devices Pipeline Products Market Segmentation by Regulatory Paths

The mechanical circulatory support devices pipeline report provides detailed insights into the pipeline products by a regulatory path including PMA, CE, NMPA, Shonin, UKCA, HDE Approvals, HSA, ICAC, 510(k), and MDL, among others. PMA was the most followed pathway.

Mechanical Circulatory Support Devices Pipeline Products Market Analysis by Regulatory Paths

Mechanical Circulatory Support Devices Pipeline Products Market Analysis by Regulatory Paths

For more regulatory path insights into the mechanical circulatory support devices pipeline products market, download a free report sample

Mechanical Circulatory Support Devices Pipeline Products Market Segments

The key segments in the mechanical circulatory support devices pipeline products market are left ventricular assist devices, total artificial heart, biventricular assist devices, external/paracorporeal ventricular assist devices, and right ventricular assist devices. Left ventricular assist devices was the leading segment.

Left Ventricular Assist Devices: An implantable left ventricular assist device is a ventricular assist system intended for the treatment of end-stage heart failure. It assists the left ventricle by pumping oxygenated blood to the body. It can also be used to treat the right ventricle in some cases. One unit refers to one left ventricular assist pump or kit.

External/Paracorporeal Ventricular Assist Devices: An external/paracorporeal ventricular assist device is a device that has a pump placed outside the body. The external ventricular assist device helps in assisting either both ventricles or one of them. Most of these devices are short-term devices. One unit refers to one external ventricular assist pump or kit.

Mechanical Circulatory Support Devices Pipeline Products Market Analysis by Segments

Mechanical Circulatory Support Devices Pipeline Products Market Analysis by Segments

For more segment insights into the mechanical circulatory support devices pipeline products market, download a free report sample

Mechanical Circulatory Support Devices Pipeline Products Market: Competitive Landscape

Some of the leading companies in the mechanical circulatory support devices pipeline products market are Abbott Laboratories, Abiomed Inc, AdjuCor GmbH, APK Advanced Medical Technologies Inc., Arrow International Cr, A.S., BioLife4D Corp, BioVentrix Inc, BiVacor Pty Ltd, Braile Biomedica Ltda, and Calon Cardio-Technology Ltd.

Mechanical Circulatory Support Devices Pipeline Products Market Report Overview

Key Territories The US, Europe, China, Japan, The UK, Canada, Taiwan, India, Israel, Singapore, and South Korea
Key Regulatory Paths PMA, CE, NMPA, Shonin, UKCA, HDE Approvals, HSA, ICAC, 510(k), and MDL
Key Segments Left Ventricular Assist Devices, Total Artificial Heart, Biventricular Assist Devices, External/Paracorporeal Ventricular Assist Devices, and Right Ventricular Assist Devices
Leading Companies Abbott Laboratories, Abiomed Inc, AdjuCor GmbH, APK Advanced Medical Technologies Inc., Arrow International Cr, A.S., BioLife4D Corp, BioVentrix Inc, BiVacor Pty Ltd, Braile Biomedica Ltda, and Calon Cardio-Technology Ltd

Scope

  • Extensive coverage of the mechanical circulatory support devices under development
  • The report reviews details of major pipeline products which includes, product description, licensing and collaboration details, and other developmental activities
  • The report reviews the major players involved in the development of mechanical circulatory support devices and lists all their pipeline projects
  • The coverage of pipeline products is based on various stages of development ranging from early development to the approved/issued stage
  • The report provides key clinical trial data of ongoing trials specific to pipeline products
  • Recent developments in the segment/industry

Reasons to Buy

The report enables you to:

  • 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 mechanical circulatory support 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

Abbott Laboratories
Abiomed Inc
AdjuCor GmbH
APK Advanced Medical Technologies, Inc.
Arrow International Cr, A.S.
BioLife4D Corp
BioVentrix Inc
BiVacor Pty Ltd
Braile Biomedica Ltda
Calon Cardio-Technology Ltd
Cardiac Success Ltd
CardiacAssist Inc
CardiacBooster BV
CARDIAnove Inc
Cardiovascular Systems Inc
Carmat SAS
Carnegie Mellon University
Cleveland Clinic Hospital
Cleveland Clinic Lerner College of Medicine
Cleveland Heart Inc
Colorado State University
CorAssist Cardiovascular Ltd
CorInnova, Inc.
CoRISMA MCS Systems Inc
Corvion Inc
CorWave SA
Drexel University
Duke University
Ension, Inc.
Evaheart Inc
FineHeart
Foster-Miller Inc (Inactive)
Fundacion para la Investigacion Biomedica del Hospital Gregorio Maranon
Georgia Institute of Technology
Griffith University
Grupo Vitalmex SA de CV
Hangzhou Shengshi Technology Co Ltd
HeartWare International Inc
I M Sechenov Moscow State Medical University
Indian Institute of Technology, Kanpur
Indiana University
Innova Vascular Inc
Inspired Therapeutics LLC
Jarvik Heart Inc
LaunchPoint Technologies Inc
Lausanne University Hospital
Leviticus Cardio Ltd
Levram Medical Systems Ltd
Magenta Medical Inc
Mayo Clinic
Medtronic Plc
Michigan Critical Care Consultants Inc
MyoCardioCare, Inc.
Myotech, LLC (Inactive)
NeoCardial Technologies, LLC
Nipro Corp
Novapump GmbH
NuPulseCV, Inc.
OregonHeart Inc (Inactive)
Pennsylvania State University
Percassist Inc
Perfusion Solution Inc
PlugMed Heart SAS
Procyrion Inc
PulseCath BV
Purdue University
Puzzle Medical Devices Inc
ReliantHeart, Inc.
RT Cardiac Systems Inc
Rutgers The State University of New Jersey
Saint Louis University
Scandinavian Real Heart AB
Sree Chitra Tirunal Institute for Medical Sciences & Technology
St. Jude Medical LLC
Sunshine Heart Company, Pty. Ltd.
Supira Medical Inc
Suzhou Xinqing Medical Technology Co Ltd
Syncardia Systems LLC
Syntach AB
TEDA International Cardiovascular Hospital
The Artificial Heart Laboratory of Foundation for Cardiac Surgery Development
Thoratec LLC
Tokyo Medical and Dental University
U.S. Stem Cell Inc
University of Florida
University of Louisville
University of Tokyo
University of Virginia
Vadovations Inc
VASCOR Inc
Windmill Cardiovascular Systems, Inc.
W-Z BIOTECH, LLC
Yale University

Table of Contents

1 Table of Contents

2 Introduction 17

2.1 Mechanical Circulatory Support Devices Overview 17

3 Products under Development 18

3.1 Mechanical Circulatory Support Devices – Pipeline Products by Stage of Development 18

3.2 Mechanical Circulatory Support Devices – Pipeline Products by Segment 19

3.3 Mechanical Circulatory Support Devices – Pipeline Products by Territory 20

3.4 Mechanical Circulatory Support Devices – Pipeline Products by Regulatory Path 22

3.5 Mechanical Circulatory Support Devices – Pipeline Products by Estimated Approval Date 23

3.6 Mechanical Circulatory Support Devices – Ongoing Clinical Trials 24

4 Mechanical Circulatory Support Devices – Pipeline Products under Development by Companies 25

4.1 Mechanical Circulatory Support Devices Companies – Pipeline Products by Stage of Development 25

4.2 Mechanical Circulatory Support Devices – Pipeline Products by Stage of Development 29

5 Mechanical Circulatory Support Devices Companies and Product Overview 33

5.1 Abbott Laboratories Company Overview 33

5.1.1 Abbott Laboratories Pipeline Products & Ongoing Clinical Trials Overview 33

5.2 Abiomed Inc Company Overview 34

5.2.1 Abiomed Inc Pipeline Products & Ongoing Clinical Trials Overview 34

5.3 AdjuCor GmbH Company Overview 42

5.3.1 AdjuCor GmbH Pipeline Products & Ongoing Clinical Trials Overview 42

5.4 APK Advanced Medical Technologies, Inc. Company Overview 43

5.4.1 APK Advanced Medical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 43

5.5 Arrow International Cr, A.S. Company Overview 44

5.5.1 Arrow International Cr, A.S. Pipeline Products & Ongoing Clinical Trials Overview 44

5.6 BioLife4D Corp Company Overview 45

5.6.1 BioLife4D Corp Pipeline Products & Ongoing Clinical Trials Overview 45

5.7 BioVentrix Inc Company Overview 46

5.7.1 BioVentrix Inc Pipeline Products & Ongoing Clinical Trials Overview 46

5.8 BiVacor Pty Ltd Company Overview 47

5.8.1 BiVacor Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 47

5.9 Braile Biomedica Ltda Company Overview 48

5.9.1 Braile Biomedica Ltda Pipeline Products & Ongoing Clinical Trials Overview 48

5.10 Calon Cardio-Technology Ltd Company Overview 49

5.10.1 Calon Cardio-Technology Ltd Pipeline Products & Ongoing Clinical Trials Overview 49

5.11 Cardiac Success Ltd Company Overview 52

5.11.1 Cardiac Success Ltd Pipeline Products & Ongoing Clinical Trials Overview 52

5.12 CardiacAssist Inc Company Overview 53

5.12.1 CardiacAssist Inc Pipeline Products & Ongoing Clinical Trials Overview 53

5.13 CardiacBooster BV Company Overview 54

5.13.1 CardiacBooster BV Pipeline Products & Ongoing Clinical Trials Overview 54

5.14 CARDIAnove Inc Company Overview 55

5.14.1 CARDIAnove Inc Pipeline Products & Ongoing Clinical Trials Overview 55

5.15 Cardiovascular Systems Inc Company Overview 56

5.15.1 Cardiovascular Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 56

5.16 Carmat SAS Company Overview 57

5.16.1 Carmat SAS Pipeline Products & Ongoing Clinical Trials Overview 57

5.17 Carnegie Mellon University Company Overview 61

5.17.1 Carnegie Mellon University Pipeline Products & Ongoing Clinical Trials Overview 61

5.18 Cleveland Clinic Hospital Company Overview 63

5.18.1 Cleveland Clinic Hospital Pipeline Products & Ongoing Clinical Trials Overview 63

5.19 Cleveland Clinic Lerner College of Medicine Company Overview 64

5.19.1 Cleveland Clinic Lerner College of Medicine Pipeline Products & Ongoing Clinical Trials Overview 64

5.20 Cleveland Heart Inc Company Overview 66

5.20.1 Cleveland Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 66

5.21 Colorado State University Company Overview 68

5.21.1 Colorado State University Pipeline Products & Ongoing Clinical Trials Overview 68

5.22 CorAssist Cardiovascular Ltd Company Overview 69

5.22.1 CorAssist Cardiovascular Ltd Pipeline Products & Ongoing Clinical Trials Overview 69

5.23 CorInnova, Inc. Company Overview 73

5.23.1 CorInnova, Inc. Pipeline Products & Ongoing Clinical Trials Overview 73

5.24 CoRISMA MCS Systems Inc Company Overview 78

5.24.1 CoRISMA MCS Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 78

5.25 Corvion Inc Company Overview 79

5.25.1 Corvion Inc Pipeline Products & Ongoing Clinical Trials Overview 79

5.26 CorWave SA Company Overview 80

5.26.1 CorWave SA Pipeline Products & Ongoing Clinical Trials Overview 80

5.27 Drexel University Company Overview 82

5.27.1 Drexel University Pipeline Products & Ongoing Clinical Trials Overview 82

5.28 Duke University Company Overview 83

5.28.1 Duke University Pipeline Products & Ongoing Clinical Trials Overview 83

5.29 Ension, Inc. Company Overview 84

5.29.1 Ension, Inc. Pipeline Products & Ongoing Clinical Trials Overview 84

5.30 Evaheart Inc Company Overview 86

5.30.1 Evaheart Inc Pipeline Products & Ongoing Clinical Trials Overview 86

5.31 FineHeart Company Overview 89

5.31.1 FineHeart Pipeline Products & Ongoing Clinical Trials Overview 89

5.32 Foster-Miller Inc (Inactive) Company Overview 90

5.32.1 Foster-Miller Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 90

5.33 Fundacion para la Investigacion Biomedica del Hospital Gregorio Maranon Company Overview 91

5.33.1 Fundacion para la Investigacion Biomedica del Hospital Gregorio Maranon Pipeline Products & Ongoing Clinical Trials Overview 91

5.34 Georgia Institute of Technology Company Overview 92

5.34.1 Georgia Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 92

5.35 Griffith University Company Overview 93

5.35.1 Griffith University Pipeline Products & Ongoing Clinical Trials Overview 93

5.36 Grupo Vitalmex SA de CV Company Overview 94

5.36.1 Grupo Vitalmex SA de CV Pipeline Products & Ongoing Clinical Trials Overview 94

5.37 Hangzhou Shengshi Technology Co Ltd Company Overview 95

5.37.1 Hangzhou Shengshi Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 95

5.38 HeartWare International Inc Company Overview 96

5.38.1 HeartWare International Inc Pipeline Products & Ongoing Clinical Trials Overview 96

5.39 I M Sechenov Moscow State Medical University Company Overview 104

5.39.1 I M Sechenov Moscow State Medical University Pipeline Products & Ongoing Clinical Trials Overview 104

5.40 Indian Institute of Technology, Kanpur Company Overview 105

5.40.1 Indian Institute of Technology, Kanpur Pipeline Products & Ongoing Clinical Trials Overview 105

5.41 Indiana University Company Overview 106

5.41.1 Indiana University Pipeline Products & Ongoing Clinical Trials Overview 106

5.42 Innova Vascular Inc Company Overview 107

5.42.1 Innova Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 107

5.43 Inspired Therapeutics LLC Company Overview 108

5.43.1 Inspired Therapeutics LLC Pipeline Products & Ongoing Clinical Trials Overview 108

5.44 Jarvik Heart Inc Company Overview 109

5.44.1 Jarvik Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 109

5.45 LaunchPoint Technologies Inc Company Overview 115

5.45.1 LaunchPoint Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 115

5.46 Lausanne University Hospital Company Overview 117

5.46.1 Lausanne University Hospital Pipeline Products & Ongoing Clinical Trials Overview 117

5.47 Leviticus Cardio Ltd Company Overview 118

5.47.1 Leviticus Cardio Ltd Pipeline Products & Ongoing Clinical Trials Overview 118

5.48 Levram Medical Systems Ltd Company Overview 120

5.48.1 Levram Medical Systems Ltd Pipeline Products & Ongoing Clinical Trials Overview 120

5.49 Magenta Medical Inc Company Overview 121

5.49.1 Magenta Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 121

5.50 Mayo Clinic Company Overview 122

5.50.1 Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 122

5.51 Medtronic Plc Company Overview 124

5.51.1 Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 124

5.52 Michigan Critical Care Consultants Inc Company Overview 125

5.52.1 Michigan Critical Care Consultants Inc Pipeline Products & Ongoing Clinical Trials Overview 125

5.53 MyoCardioCare, Inc. Company Overview 127

5.53.1 MyoCardioCare, Inc. Pipeline Products & Ongoing Clinical Trials Overview 127

5.54 Myotech, LLC (Inactive) Company Overview 129

5.54.1 Myotech, LLC (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 129

5.55 NeoCardial Technologies, LLC Company Overview 130

5.55.1 NeoCardial Technologies, LLC Pipeline Products & Ongoing Clinical Trials Overview 130

5.56 Nipro Corp Company Overview 131

5.56.1 Nipro Corp Pipeline Products & Ongoing Clinical Trials Overview 131

5.57 Novapump GmbH Company Overview 133

5.57.1 Novapump GmbH Pipeline Products & Ongoing Clinical Trials Overview 133

5.58 NuPulseCV, Inc. Company Overview 135

5.58.1 NuPulseCV, Inc. Pipeline Products & Ongoing Clinical Trials Overview 135

5.59 OregonHeart Inc (Inactive) Company Overview 139

5.59.1 OregonHeart Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 139

5.60 Pennsylvania State University Company Overview 140

5.60.1 Pennsylvania State University Pipeline Products & Ongoing Clinical Trials Overview 140

5.61 Percassist Inc Company Overview 141

5.61.1 Percassist Inc Pipeline Products & Ongoing Clinical Trials Overview 141

5.62 Perfusion Solution Inc Company Overview 142

5.62.1 Perfusion Solution Inc Pipeline Products & Ongoing Clinical Trials Overview 142

5.63 PlugMed Heart SAS Company Overview 145

5.63.1 PlugMed Heart SAS Pipeline Products & Ongoing Clinical Trials Overview 145

5.64 Procyrion Inc Company Overview 146

5.64.1 Procyrion Inc Pipeline Products & Ongoing Clinical Trials Overview 146

5.65 PulseCath BV Company Overview 149

5.65.1 PulseCath BV Pipeline Products & Ongoing Clinical Trials Overview 149

5.66 Purdue University Company Overview 151

5.66.1 Purdue University Pipeline Products & Ongoing Clinical Trials Overview 151

5.67 Puzzle Medical Devices Inc Company Overview 152

5.67.1 Puzzle Medical Devices Inc Pipeline Products & Ongoing Clinical Trials Overview 152

5.68 ReliantHeart, Inc. Company Overview 153

5.68.1 ReliantHeart, Inc. Pipeline Products & Ongoing Clinical Trials Overview 153

5.69 RT Cardiac Systems Inc Company Overview 156

5.69.1 RT Cardiac Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 156

5.70 Rutgers The State University of New Jersey Company Overview 157

5.70.1 Rutgers The State University of New Jersey Pipeline Products & Ongoing Clinical Trials Overview 157

5.71 Saint Louis University Company Overview 158

5.71.1 Saint Louis University Pipeline Products & Ongoing Clinical Trials Overview 158

5.72 Scandinavian Real Heart AB Company Overview 160

5.72.1 Scandinavian Real Heart AB Pipeline Products & Ongoing Clinical Trials Overview 160

5.73 Sree Chitra Tirunal Institute for Medical Sciences & Technology Company Overview 162

5.73.1 Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 162

5.74 St. Jude Medical LLC Company Overview 163

5.74.1 St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 163

5.75 Sunshine Heart Company, Pty. Ltd. Company Overview 165

5.75.1 Sunshine Heart Company, Pty. Ltd. Pipeline Products & Ongoing Clinical Trials Overview 165

5.76 Supira Medical Inc Company Overview 166

5.76.1 Supira Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 166

5.77 Suzhou Xinqing Medical Technology Co Ltd Company Overview 167

5.77.1 Suzhou Xinqing Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 167

5.78 Syncardia Systems LLC Company Overview 168

5.78.1 Syncardia Systems LLC Pipeline Products & Ongoing Clinical Trials Overview 168

5.79 Syntach AB Company Overview 174

5.79.1 Syntach AB Pipeline Products & Ongoing Clinical Trials Overview 174

5.80 TEDA International Cardiovascular Hospital Company Overview 175

5.80.1 TEDA International Cardiovascular Hospital Pipeline Products & Ongoing Clinical Trials Overview 175

5.81 The Artificial Heart Laboratory of Foundation for Cardiac Surgery Development Company Overview 176

5.81.1 The Artificial Heart Laboratory of Foundation for Cardiac Surgery Development Pipeline Products & Ongoing Clinical Trials Overview 176

5.82 Thoratec LLC Company Overview 177

5.82.1 Thoratec LLC Pipeline Products & Ongoing Clinical Trials Overview 177

5.83 Tokyo Medical and Dental University Company Overview 180

5.83.1 Tokyo Medical and Dental University Pipeline Products & Ongoing Clinical Trials Overview 180

5.84 U.S. Stem Cell Inc Company Overview 181

5.84.1 U.S. Stem Cell Inc Pipeline Products & Ongoing Clinical Trials Overview 181

5.85 University of Florida Company Overview 182

5.85.1 University of Florida Pipeline Products & Ongoing Clinical Trials Overview 182

5.86 University of Louisville Company Overview 183

5.86.1 University of Louisville Pipeline Products & Ongoing Clinical Trials Overview 183

5.87 University of Tokyo Company Overview 184

5.87.1 University of Tokyo Pipeline Products & Ongoing Clinical Trials Overview 184

5.88 University of Virginia Company Overview 185

5.88.1 University of Virginia Pipeline Products & Ongoing Clinical Trials Overview 185

5.89 Vadovations Inc Company Overview 186

5.89.1 Vadovations Inc Pipeline Products & Ongoing Clinical Trials Overview 186

5.90 VASCOR Inc Company Overview 187

5.90.1 VASCOR Inc Pipeline Products & Ongoing Clinical Trials Overview 187

5.91 Windmill Cardiovascular Systems, Inc. Company Overview 188

5.91.1 Windmill Cardiovascular Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 188

5.92 W-Z BIOTECH, LLC Company Overview 190

5.92.1 W-Z BIOTECH, LLC Pipeline Products & Ongoing Clinical Trials Overview 190

5.93 Yale University Company Overview 192

5.93.1 Yale University Pipeline Products & Ongoing Clinical Trials Overview 192

6 Mechanical Circulatory Support Devices- Recent Developments 194

6.1 May 02, 2022: Teleflex to Host Analyst & Investor Day on May 20, 2022 194

6.2 Apr 28, 2022: Teleflex Reports First Quarter Financial Results And Full Year Outlook 194

6.3 Apr 28, 2022: Abiomed Announces Fourth Quarter Record Revenue of $270 Million, up 12% Year Over Year 196

6.4 Apr 28, 2022: Improved controller for clinical trials results in six-month delay 197

6.5 Apr 27, 2022: Applied BioMath, LLC to present on machine learning in drug discovery at Bio-IT World Conference and Expo 198

6.6 Apr 20, 2022: Applied BioMath to present on De-risking Bispecifics and gene therapy development at PEGS Boston Summit 198

6.7 Apr 13, 2022: Realheart set to begin animal studies with clinical version 198

6.8 Apr 12, 2022: CARMAT Successfully Raises a Global Total of €40.5 Million via the Issuance of 4,054,282 Shares 199

6.9 Apr 08, 2022: Abiomed Fourth Quarter Fiscal 2022 Earnings and Conference Call Notification 201

6.10 Apr 07, 2022: Realheart initiates collaboration with researchers at KTH 201

6.11 Mar 23, 2022: Realheart to establish Australian subsidiary 202

6.12 Mar 21, 2022: Abiomed to Host Investor Call on Impella ECP, the World’s Smallest Heart Pump at 9 French 203

6.13 Feb 24, 2022: Teleflex Announces Fourth Quarter and Full-Year 2021 Financial Results 203

6.14 Feb 24, 2022: Christer Norström appointed acting chairman of Realheart 204

6.15 Feb 08, 2022: Abiomed to Present at the SVB Leerink 11th Annual Global Healthcare Conference 205

6.16 Jan 14, 2022: Abiomed Third Quarter Fiscal 2022 Earnings and Conference Call Notification 205

6.17 Nov 19, 2021: First Left Ventricular Assist Device (LVAD) program for adults in Tarrant County launches at Baylor Scott & White All Saints Medical Center – Fort Worth 205

6.18 Nov 18, 2021: Abiomed to Present at Upcoming Investor Conferences 206

6.19 Nov 18, 2021: Teleflex to Participate in the 33rd Annual Virtual Piper Sandler Healthcare Conference 206

6.20 Nov 04, 2021: Terumo Corp Half Yearly Results For the Period 30 September 2021 207

6.21 Oct 28, 2021: Teleflex Reports Third Quarter 2021 Results and Full Year Outlook 207

6.22 Oct 28, 2021: Abiomed Announces Q2 FY 2022 Revenue of $248 Million, Up 18% Year Over Year 211

6.23 Oct 14, 2021: Teleflex Announces Third Quarter 2021 Earnings Conference Call Information 213

6.24 Sep 03, 2021: CARMAT Appoints Ivo Simundic as Sales Manager for the DACH Region to Support the Deployment of the Aeson Artificial Heart in Germany, Austria and Switzerland 213

6.25 Sep 03, 2021: Realheart enters partnership with software experts Codialist 213

6.26 Sep 01, 2021: Teleflex to Present at the Morgan Stanley 19th Annual Global Healthcare Conference 214

6.27 Aug 26, 2021: Teleflex to Present at the Wells Fargo 2021 Virtual Healthcare Conference 214

6.28 Aug 04, 2021: Terumo Revises its Full-Year Financial Guidance for FY2021 214

6.29 Aug 04, 2021: Corvion appoints William Cohn, MD and Sean Morris to Board of Directors 214

6.30 Aug 04, 2021: Terumo Corp. Announces Consolidated Financial Results for the First Quarter Ended June 30, 2021 215

6.31 Jul 21, 2021: BioVentrix Announces Raymond W. Cohen as Chairman of the Board and Newly Appointed Accredited Public Company Directors Rinda K. Sama and Andrew G. Hinson to Its Board of Directors 215

6.32 May 28, 2021: Realheart granted SEK 500,000 for blood research 216

6.33 May 27, 2021: Purdue University hires new chief information officer 216

7 Appendix 218

7.1 Methodology 218

7.2 About GlobalData 221

7.3 Contact Us 221

7.4 Disclaimer 221

Table

Mechanical Circulatory Support Devices – Pipeline Products by Stage of Development 18

Mechanical Circulatory Support Devices – Pipeline Products by Segment 19

Mechanical Circulatory Support Devices – Pipeline Products by Territory 21

Mechanical Circulatory Support Devices – Pipeline Products by Regulatory Path 22

Mechanical Circulatory Support Devices – Pipeline Products by Estimated Approval Date 23

Mechanical Circulatory Support Devices – Ongoing Clinical Trials 24

Mechanical Circulatory Support Devices Companies – Pipeline Products by Stage of Development 25

Mechanical Circulatory Support Devices – Pipeline Products by Stage of Development 29

Abbott Laboratories Pipeline Products & Ongoing Clinical Trials Overview 33

Fully Implantable Left Ventricular Assist System – Product Status 33

Fully Implantable Left Ventricular Assist System – Product Description 33

Abiomed Inc Pipeline Products & Ongoing Clinical Trials Overview 34

AbioCor II – Product Status 34

AbioCor II – Product Description 35

Impella BTR – Product Status 35

Impella BTR – Product Description 35

Impella ECP – Product Status 36

Impella ECP – Product Description 36

Impella RP IJ – Product Status 36

Impella RP IJ – Product Description 37

Next Generation Impella CP – STEMI – Product Status 37

Next Generation Impella CP – STEMI – Product Description 37

Abiomed Inc – Ongoing Clinical Trials Overview 38

Impella ECP – Use of the Impella ECP in Patients Undergoing an Elective High-risk Percutaneous Coronary Intervention: An Early Feasibility Study 39

Impella ECP – Use of the Impella ECP in Patients Undergoing an Elective or Urgent High-Risk Percutaneous Coronary Intervention 39

Next Generation Impella CP – STEMI – Primary Unloading and Delayed Reperfusion in St-elevation Myocardial Infarction: The STEMI-DTU Trial 40

Impella BTR – Use of the Impella BTR in Patients with Heart Failure: An Early Feasibility Study 41

AdjuCor GmbH Pipeline Products & Ongoing Clinical Trials Overview 42

reBEAT – Product Status 42

reBEAT – Product Description 42

APK Advanced Medical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 43

Apical Access System – Product Status 43

Apical Access System – Product Description 43

Arrow International Cr, A.S. Pipeline Products & Ongoing Clinical Trials Overview 44

CorAide Left Ventricular Assist System – Product Status 44

CorAide Left Ventricular Assist System – Product Description 44

BioLife4D Corp Pipeline Products & Ongoing Clinical Trials Overview 45

Mini-Heart – Product Status 45

Mini-Heart – Product Description 45

BioVentrix Inc Pipeline Products & Ongoing Clinical Trials Overview 46

PliCath HF – Product Status 46

PliCath HF – Product Description 46

BiVacor Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 47

BiVACOR Device – Product Status 47

BiVACOR Device – Product Description 47

Braile Biomedica Ltda Pipeline Products & Ongoing Clinical Trials Overview 48

Blood Pump – Product Status 48

Blood Pump – Product Description 48

Calon Cardio-Technology Ltd Pipeline Products & Ongoing Clinical Trials Overview 49

Calon MiniVAD – Product Status 49

Calon MiniVAD – Product Description 49

CathVAD – Product Status 50

CathVAD – Product Description 50

MicroVAD – Product Status 50

MicroVAD – Product Description 51

Cardiac Success Ltd Pipeline Products & Ongoing Clinical Trials Overview 52

V-Sling Device – Product Status 52

V-Sling Device – Product Description 52

CardiacAssist Inc Pipeline Products & Ongoing Clinical Trials Overview 53

Pediatric pVAD – Product Status 53

Pediatric pVAD – Product Description 53

CardiacBooster BV Pipeline Products & Ongoing Clinical Trials Overview 54

Percutaneous Ventricular Assist Device – Product Status 54

Percutaneous Ventricular Assist Device – Product Description 54

CARDIAnove Inc Pipeline Products & Ongoing Clinical Trials Overview 55

CARDIAnove Pump – Product Status 55

CARDIAnove Pump – Product Description 55

Cardiovascular Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 56

MCS System – Product Status 56

MCS System – Product Description 56

Carmat SAS Pipeline Products & Ongoing Clinical Trials Overview 57

Aeson – Product Status 57

Aeson – Product Description 58

Carmat SAS – Ongoing Clinical Trials Overview 59

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 60

Carnegie Mellon University Pipeline Products & Ongoing Clinical Trials Overview 61

Non-Blood Contacting Muscle Powered VAD – Product Status 61

Non-Blood Contacting Muscle Powered VAD – Product Description 61

tVAD – Heart Failure – Product Status 62

tVAD – Heart Failure – Product Description 62

Cleveland Clinic Hospital Pipeline Products & Ongoing Clinical Trials Overview 63

PediPump – Product Status 63

PediPump – Product Description 63

Cleveland Clinic Lerner College of Medicine Pipeline Products & Ongoing Clinical Trials Overview 64

Continuous-Flow Total Artificial Heart – Product Status 64

Continuous-Flow Total Artificial Heart – Product Description 64

Pediatric Continuous-Flow Total Artificial Heart – Product Status 65

Pediatric Continuous-Flow Total Artificial Heart – Product Description 65

Cleveland Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 66

SmartHeart LVAD – Product Status 66

SmartHeart LVAD – Product Description 66

SmartHeart TAH – Product Status 67

SmartHeart TAH – Product Description 67

Colorado State University Pipeline Products & Ongoing Clinical Trials Overview 68

Flexible Multilayered Pump – Product Status 68

Flexible Multilayered Pump – Product Description 68

CorAssist Cardiovascular Ltd Pipeline Products & Ongoing Clinical Trials Overview 69

CORolla – Product Status 69

CORolla – Product Description 69

ImCardia – Product Status 70

ImCardia – Product Description 70

CorAssist Cardiovascular Ltd – Ongoing Clinical Trials Overview 71

CORolla – CORolla TAA for Heart Failure with Preserved Ejection Fraction (HFpEF) and Diastolic Dysfunction (DD) Safety and Feasibility 72

CorInnova, Inc. Pipeline Products & Ongoing Clinical Trials Overview 73

Cardiacstar – Bridge To Decision – Product Status 73

Cardiacstar – Bridge To Decision – Product Description 73

Cardiacstar – Bridge To Recovery – Product Status 74

Cardiacstar – Bridge To Recovery – Product Description 74

Cardiacstar – Bridge To Transplant – Product Status 74

Cardiacstar – Bridge To Transplant – Product Description 75

Cardiacstar – Destination Therapy – Product Status 75

Cardiacstar – Destination Therapy – Product Description 75

Cardiacstar – Heart Rehabilitation – Product Status 76

Cardiacstar – Heart Rehabilitation – Product Description 76

Epicheart – Soft Robotic Heart Device – Product Status 76

Epicheart – Soft Robotic Heart Device – Product Description 77

CoRISMA MCS Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 78

CoRISMA – Product Status 78

CoRISMA – Product Description 78

Corvion Inc Pipeline Products & Ongoing Clinical Trials Overview 79

Nautilus Pump – Product Status 79

Nautilus Pump – Product Description 79

CorWave SA Pipeline Products & Ongoing Clinical Trials Overview 80

CorWave LVAD – Product Status 80

CorWave LVAD – Product Description 80

CorWave Nemo – Product Status 81

CorWave Nemo – Product Description 81

Drexel University Pipeline Products & Ongoing Clinical Trials Overview 82

Intravascular Blood Pump – Product Status 82

Intravascular Blood Pump – Product Description 82

Duke University Pipeline Products & Ongoing Clinical Trials Overview 83

Para-Aortic Blood Pump – Product Status 83

Para-Aortic Blood Pump – Product Description 83

Ension, Inc. Pipeline Products & Ongoing Clinical Trials Overview 84

CardioFlowPQ – Product Status 84

CardioFlowPQ – Product Description 84

Magnetic Levitation Motor – Product Status 85

Magnetic Levitation Motor – Product Description 85

Evaheart Inc Pipeline Products & Ongoing Clinical Trials Overview 86

EVAHEART 2 Left Ventricular Assist System – Product Status 86

EVAHEART 2 Left Ventricular Assist System – Product Description 86

Evaheart Inc – Ongoing Clinical Trials Overview 87

EVAHEART 2 Left Ventricular Assist System – Prospective Multi-Center Randomized Study for Evaluating the EVAHEART2 Left Ventricular Assist System: the COMPETENCE Trial 88

FineHeart Pipeline Products & Ongoing Clinical Trials Overview 89

ICOMS FLOWMAKER – Product Status 89

ICOMS FLOWMAKER – Product Description 89

Foster-Miller Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 90

Magscrew Total Artificial Heart – Product Status 90

Magscrew Total Artificial Heart – Product Description 90

Fundacion para la Investigacion Biomedica del Hospital Gregorio Maranon Pipeline Products & Ongoing Clinical Trials Overview 91

Ventricular Assist Device – Product Status 91

Ventricular Assist Device – Product Description 91

Georgia Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 92

OptiFlo – Product Status 92

OptiFlo – Product Description 92

Griffith University Pipeline Products & Ongoing Clinical Trials Overview 93

Next Generation Artificial Heart – Product Status 93

Next Generation Artificial Heart – Product Description 93

Grupo Vitalmex SA de CV Pipeline Products & Ongoing Clinical Trials Overview 94

Vitacor – UVAD – Product Status 94

Vitacor – UVAD – Product Description 94

Hangzhou Shengshi Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 95

Mechanical Circulation Auxiliary Device – Product Status 95

Mechanical Circulation Auxiliary Device – Product Description 95

HeartWare International Inc Pipeline Products & Ongoing Clinical Trials Overview 96

BiVAD – Product Status 96

BiVAD – Product Description 96

HeartWare IV-VAD – Product Status 97

HeartWare IV-VAD – Product Description 97

HVAD System – Destination Therapy – Product Status 97

HVAD System – Destination Therapy – Product Description 98

Levacor Rotary VAD – Product Status 98

Levacor Rotary VAD – Product Description 98

Longhorn – Product Status 99

Longhorn – Product Description 99

MiFlow VAD – Product Status 99

MiFlow VAD – Product Description 100

Miniaturized Ventricular Assist Device (MVAD) Pump – Product Status 100

Miniaturized Ventricular Assist Device (MVAD) Pump – Product Description 100

VCAN Trans-Mitral – Product Status 101

VCAN Trans-Mitral – Product Description 101

HeartWare International Inc – Ongoing Clinical Trials Overview 102

Miniaturized Ventricular Assist Device (MVAD) Pump – Multi Center, Prospective, Non-randomized, Single-arm Trial Evaluating the Clinical Safety and Performance of the HeartWare MVAD System for the Treatment of Advanced Heart Failure 103

I M Sechenov Moscow State Medical University Pipeline Products & Ongoing Clinical Trials Overview 104

Cardiac Assist Device – Children – Product Status 104

Cardiac Assist Device – Children – Product Description 104

Indian Institute of Technology, Kanpur Pipeline Products & Ongoing Clinical Trials Overview 105

Left Ventricular Assist Device – Product Status 105

Left Ventricular Assist Device – Product Description 105

Indiana University Pipeline Products & Ongoing Clinical Trials Overview 106

Bi-Conical Heart Pump – Product Status 106

Bi-Conical Heart Pump – Product Description 106

Innova Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 107

Mechanical Circulatory Support System – Product Status 107

Mechanical Circulatory Support System – Product Description 107

Inspired Therapeutics LLC Pipeline Products & Ongoing Clinical Trials Overview 108

Neomate System – Product Status 108

Neomate System – Product Description 108

Jarvik Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 109

Jarvik 2000 Heart – Bridge To Transplant – Product Status 109

Jarvik 2000 Heart – Bridge To Transplant – Product Description 109

Jarvik 2000 Heart – Destination Therapy – Product Status 110

Jarvik 2000 Heart – Destination Therapy – Product Description 110

Jarvik 2015 – Product Status 110

Jarvik 2015 – Product Description 111

Jarvik Heart Inc – Ongoing Clinical Trials Overview 112

Jarvik 2000 Heart – Destination Therapy – Evaluation of the Jarvik 2000 Left Ventricular Assist System with Post-auricular Connector–destination Therapy Study 113

Jarvik 2015 – Pumps for Kids, Infants, and Neonates 114

LaunchPoint Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 115

Pediaflow Pediatric VAD – Product Status 115

Pediaflow Pediatric VAD – Product Description 115

Streamliner VAD – Product Status 116

Streamliner VAD – Product Description 116

Lausanne University Hospital Pipeline Products & Ongoing Clinical Trials Overview 117

RollingHeart – Product Status 117

RollingHeart – Product Description 117

Leviticus Cardio Ltd Pipeline Products & Ongoing Clinical Trials Overview 118

FiVAD System – Product Status 118

FiVAD System – Product Description 118

Hybrid FILVAS – Product Status 119

Hybrid FILVAS – Product Description 119

Levram Medical Systems Ltd Pipeline Products & Ongoing Clinical Trials Overview 120

Levram – Ventricular Assist Device – Product Status 120

Levram – Ventricular Assist Device – Product Description 120

Magenta Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 121

Magenta pLVAD – Product Status 121

Magenta pLVAD – Product Description 121

Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 122

Cardiac Device – Diastolic Heart Failure – Product Status 122

Cardiac Device – Diastolic Heart Failure – Product Description 122

Implantable Left Ventricular Assist Device – Product Status 123

Implantable Left Ventricular Assist Device – Product Description 123

Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 124

Fully Implantable Left Ventricular Assist Device – Product Status 124

Fully Implantable Left Ventricular Assist Device – Product Description 124

Michigan Critical Care Consultants Inc Pipeline Products & Ongoing Clinical Trials Overview 125

BioVAD – Product Status 125

BioVAD – Product Description 125

Pediatric Mpulse – Product Status 126

Pediatric Mpulse – Product Description 126

MyoCardioCare, Inc. Pipeline Products & Ongoing Clinical Trials Overview 127

MCC3000 Heart Pump – Product Status 127

MCC3000 Heart Pump – Product Description 127

MCC3000 Heart Pump – Pediatrics – Product Status 128

MCC3000 Heart Pump – Pediatrics – Product Description 128

Myotech, LLC (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 129

Myotech Circulatory Support System – Product Status 129

Myotech Circulatory Support System – Product Description 129

NeoCardial Technologies, LLC Pipeline Products & Ongoing Clinical Trials Overview 130

eHeart Extra Ventricular Assist Device – Product Status 130

eHeart Extra Ventricular Assist Device – Product Description 130

Nipro Corp Pipeline Products & Ongoing Clinical Trials Overview 131

BR16010 – Product Status 131

BR16010 – Product Description 131

Implantable Left Ventricular Assist Device – Product Status 132

Implantable Left Ventricular Assist Device – Product Description 132

Novapump GmbH Pipeline Products & Ongoing Clinical Trials Overview 133

PERKAT Biventricular Heart Pump – Product Status 133

PERKAT Biventricular Heart Pump – Product Description 133

PERKAT RV – Product Status 134

PERKAT RV – Product Description 134

NuPulseCV, Inc. Pipeline Products & Ongoing Clinical Trials Overview 135

NuPulseCV iVAS – Product Status 135

NuPulseCV iVAS – Product Description 135

PediPulse – Product Status 136

PediPulse – Product Description 136

NuPulseCV, Inc. – Ongoing Clinical Trials Overview 137

NuPulseCV iVAS – A Clinical Study to Evaluate Ambulatory Counterpulsation for the Treatment of Advanced Heart Failure: A Feasibility Study 138

OregonHeart Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 139

Next Generation Total Artificial Heart – Product Status 139

Next Generation Total Artificial Heart – Product Description 139

Pennsylvania State University Pipeline Products & Ongoing Clinical Trials Overview 140

Pediatric Heart-Assist Device – Product Status 140

Pediatric Heart-Assist Device – Product Description 140

Percassist Inc Pipeline Products & Ongoing Clinical Trials Overview 141

PercAssist Ventricular Assist Device – Product Status 141

PercAssist Ventricular Assist Device – Product Description 141

Perfusion Solution Inc Pipeline Products & Ongoing Clinical Trials Overview 142

Cavopulmonary Assist System – Product Status 142

Cavopulmonary Assist System – Product Description 142

Right Ventricular Assist Device – Long Term Care – Product Status 143

Right Ventricular Assist Device – Long Term Care – Product Description 143

Transapical LVAD – Product Status 143

Transapical LVAD – Product Description 144

PlugMed Heart SAS Pipeline Products & Ongoing Clinical Trials Overview 145

Implantable Left Ventricular Assist Device – Product Status 145

Implantable Left Ventricular Assist Device – Product Description 145

Procyrion Inc Pipeline Products & Ongoing Clinical Trials Overview 146

Aortix Device – Product Status 146

Aortix Device – Product Description 146

Procyrion Inc – Ongoing Clinical Trials Overview 147

Aortix Device – An Evaluation of the Safety and Performance of the Aortix System for Intra-aortic Mechanical Circulatory Support in Patients with Cardiorenal Syndrome 148

Aortix Device – Aortix Therapy for Perioperative Reduction of Renal Injury 148

PulseCath BV Pipeline Products & Ongoing Clinical Trials Overview 149

iVAC 2L – Product Status 149

iVAC 2L – Product Description 150

Purdue University Pipeline Products & Ongoing Clinical Trials Overview 151

Viscous Impeller Pump – Infants – Product Status 151

Viscous Impeller Pump – Infants – Product Description 151

Puzzle Medical Devices Inc Pipeline Products & Ongoing Clinical Trials Overview 152

ModulHeart – Product Status 152

ModulHeart – Product Description 152

ReliantHeart, Inc. Pipeline Products & Ongoing Clinical Trials Overview 153

aVAD Liberty System – Product Status 153

aVAD Liberty System – Product Description 153

Pulse Less Total Artificial Heart – Product Status 154

Pulse Less Total Artificial Heart – Product Description 154

VAD Maintenance System – Product Status 154

VAD Maintenance System – Product Description 155

RT Cardiac Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 156

Percutaneous Mechanical Circulatory Support System – Product Status 156

Percutaneous Mechanical Circulatory Support System – Product Description 156

Rutgers The State University of New Jersey Pipeline Products & Ongoing Clinical Trials Overview 157

Temporary Percutaneous Ventricular Assist Device – Product Status 157

Temporary Percutaneous Ventricular Assist Device – Product Description 157

Saint Louis University Pipeline Products & Ongoing Clinical Trials Overview 158

Percutaneously Implantable Cardiovascular Support Device – Product Status 158

Percutaneously Implantable Cardiovascular Support Device – Product Description 158

TURBOCARDIA – Product Status 159

TURBOCARDIA – Product Description 159

Scandinavian Real Heart AB Pipeline Products & Ongoing Clinical Trials Overview 160

Total Artificial Heart – Product Status 160

Total Artificial Heart – Product Description 160

Total Artificial Heart – Clinical Version – Product Status 161

Total Artificial Heart – Clinical Version – Product Description 161

Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 162

Paracorporeal Left Ventricle Assist Device – Product Status 162

Paracorporeal Left Ventricle Assist Device – Product Description 162

St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 163

UltraMag Adult Ventricular Assist System – Product Status 163

UltraMag Adult Ventricular Assist System – Product Description 163

UltraMag Pediatric Ventricular Assist System – Product Status 164

UltraMag Pediatric Ventricular Assist System – Product Description 164

Sunshine Heart Company, Pty. Ltd. Pipeline Products & Ongoing Clinical Trials Overview 165

C-Pulse – Wireless Version – Product Status 165

C-Pulse – Wireless Version – Product Description 165

Supira Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 166

Next Generation Percutaneous Ventricular Assist Device – Product Status 166

Next Generation Percutaneous Ventricular Assist Device – Product Description 166

Suzhou Xinqing Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 167

External Magnetic Levitation Artificial Heart – Product Status 167

External Magnetic Levitation Artificial Heart – Product Description 167

Syncardia Systems LLC Pipeline Products & Ongoing Clinical Trials Overview 168

10cc Ventricular Assist Device – Product Status 168

10cc Ventricular Assist Device – Product Description 168

30cc Ventricular Assist Device – Product Status 169

30cc Ventricular Assist Device – Product Description 169

60cc Ventricular Assist Device – Product Status 169

60cc Ventricular Assist Device – Product Description 170

SynCardia 50cc Temporary Total Artificial Heart – Destination Therapy – Product Status 170

SynCardia 50cc Temporary Total Artificial Heart – Destination Therapy – Product Description 170

SynCardia 70cc Temporary Total Artificial Heart – Destination Therapy – Product Status 171

SynCardia 70cc Temporary Total Artificial Heart – Destination Therapy – Product Description 171

Syncardia Systems LLC – Ongoing Clinical Trials Overview 172

SynCardia 70cc Temporary Total Artificial Heart – Destination Therapy – SynCardia 70cc Temporary Total Artificial Heart (TAH-t) for Destination Therapy (DT) 173

Syntach AB Pipeline Products & Ongoing Clinical Trials Overview 174

Syntach CS – Product Status 174

Syntach CS – Product Description 174

TEDA International Cardiovascular Hospital Pipeline Products & Ongoing Clinical Trials Overview 175

Heartcon – Product Status 175

Heartcon – Product Description 175

The Artificial Heart Laboratory of Foundation for Cardiac Surgery Development Pipeline Products & Ongoing Clinical Trials Overview 176

ReligaHeart EXT – Product Status 176

ReligaHeart EXT – Product Description 176

Thoratec LLC Pipeline Products & Ongoing Clinical Trials Overview 177

DuraHeart II – Product Status 177

DuraHeart II – Product Description 177

Fully Implantable Ventricular Assist System – Product Status 178

Fully Implantable Ventricular Assist System – Product Description 178

HeartMate X – Product Status 178

HeartMate X – Product Description 179

Tokyo Medical and Dental University Pipeline Products & Ongoing Clinical Trials Overview 180

TinyPump – Product Status 180

TinyPump – Product Description 180

U.S. Stem Cell Inc Pipeline Products & Ongoing Clinical Trials Overview 181

SVAD – Product Status 181

SVAD – Product Description 181

University of Florida Pipeline Products & Ongoing Clinical Trials Overview 182

Ventricular Assist Device Monitor – Product Status 182

Ventricular Assist Device Monitor – Product Description 182

University of Louisville Pipeline Products & Ongoing Clinical Trials Overview 183

Paediatric Heart Pump – Product Status 183

Paediatric Heart Pump – Product Description 183

University of Tokyo Pipeline Products & Ongoing Clinical Trials Overview 184

Helical Flow Total Artificial Heart – Product Status 184

Helical Flow Total Artificial Heart – Product Description 184

University of Virginia Pipeline Products & Ongoing Clinical Trials Overview 185

VADStent – Product Status 185

VADStent – Product Description 185

Vadovations Inc Pipeline Products & Ongoing Clinical Trials Overview 186

REVOLUTION – Product Status 186

REVOLUTION – Product Description 186

VASCOR Inc Pipeline Products & Ongoing Clinical Trials Overview 187

Vascor LVAD – Product Status 187

Vascor LVAD – Product Description 187

Windmill Cardiovascular Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 188

Pediatric TORVAD – Product Status 188

Pediatric TORVAD – Product Description 188

TORVAD – Product Status 189

TORVAD – Product Description 189

W-Z BIOTECH, LLC Pipeline Products & Ongoing Clinical Trials Overview 190

Double Lumen Cannula-Based Left Ventricular Assist Device – Product Status 190

Double Lumen Cannula-Based Left Ventricular Assist Device – Product Description 190

SppVAD – Product Status 191

SppVAD – Product Description 191

Yale University Pipeline Products & Ongoing Clinical Trials Overview 192

BoLetz Pump – Product Status 192

BoLetz Pump – Product Description 192

CAP RVAD Pump – Product Status 193

CAP RVAD Pump – Product Description 193

Glossary 220

Figures

Mechanical Circulatory Support Devices – Pipeline Products by Stage of Development 18

Mechanical Circulatory Support Devices – Pipeline Products by Segment 19

Mechanical Circulatory Support Devices – Pipeline Products by Territory 20

Mechanical Circulatory Support Devices – Pipeline Products by Regulatory Path 22

Mechanical Circulatory Support Devices – Pipeline Products by Estimated Approval Date 23

Mechanical Circulatory Support Devices – Ongoing Clinical Trials 24

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