Cardiovascular Surgery Devices – Medical Devices Pipeline Assessment, 2020

Cardiovascular surgery devices include devices used in cardiovascular surgeries such as coronary artery bypass surgery. GlobalData's Medical Devices sector report, “Cardiovascular Surgery Devices -Medical Devices Pipeline Assessment, 2020" provides comprehensive information about the Cardiovascular Surgery Devices pipeline products with comparative analysis of the products at various stages of development and information about the clinical trials which are in progress.

The Cardiovascular Surgery Devices Pipeline Assessment report provides key information and data related to:

Extensive coverage of the Cardiovascular Surgery Devices under development

Review details of major pipeline products which include product description, licensing and collaboration details and other developmental activities including pipeline territories, regulatory paths and estimated approval dates

Reviews of major players involved in the pipeline product development.

Provides key clinical trial data related to ongoing clinical trials such as trial phase, trial status, trial start and end dates, and, the number of trials of the major Cardiovascular Surgery Devices pipeline products.

Review of Recent Developments in the segment / industry

The Cardiovascular Surgery Devices Pipeline Assessment report enables you to:

Access significant competitor information, analysis, and insights to improve your R&D strategies

Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

Identify and understand important and diverse types of Cardiovascular Surgery Devices under development

Formulate market-entry and market expansion strategies

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

The major companies covered in the “Cardiovascular Surgery Devices- Medical Devices Pipeline Assessment, 2020” report:

Note: Certain sections in the report may be removed or altered based on the availability and relevance of data in relation to the equipment type.

The GlobalData Differentiation

This report is prepared using data sourced from in-house databases, secondary and primary research by GlobalData's team of industry experts.

The data and analysis within this report are driven by GlobalData Medical Intelligence Center (GDMIC) database. GDMIC gives you the key information required to drive sales, investment and deal-making activity in your business. It includes the following:

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• 47,000+ clinical trials

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Scope

– Extensive coverage of the Cardiovascular Surgery 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 Cardiovascular Surgery Devices and list all their pipeline projects

– The coverage of pipeline products based on various stages of development ranging from Early Development to 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 portfolio and create effective counter-strategies to gain competitive advantage

– Identify and understand important and diverse types of Cardiovascular Surgery 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

Companies mentioned

3DT Holdings LLC

510 Kardiac Devices Inc

Abiomed Inc

AblaCor Medical Corporation

Adagio Medical Inc.

Advanced Catheter Therapies Inc

AdvanSource Biomaterials Corporation

AFreeze GmbH

AngioDynamics Inc

Apaxis Medical Inc

APK Advanced Medical Technologies, Inc.

Applied Medical Resources Corporation

Atrian Medical Ltd

AtriCure Inc

Axcelon Biopolymers Corp.

Baylis Medical Company Inc

Beth Israel Deaconess Medical Center

Bioretec Ltd

Boston Children's Hospital

Boston University

CardioPolymers Inc

CardioPrecision Ltd

CardioScout, LLC

Cardious Inc

Centre Hospitalier Universitaire de Nice

Cincinnati Children's Hospital Medical Center

Circulatory Technology Inc.

Cleveland Clinic Hospital

Corazon Technologies, Inc.

Corfigo Inc

Coridea, LLC

Coromedic Ltd.

CPSI Biotech

CVD Equipment Corp

Cytograft Tissue Engineering Inc (Inactive)

Daidalos Solutions BV

Edwards Lifesciences Corp

Elana bv

Elsius Biomedical Inc

Emory University

Ension, Inc.

EpiEP, Inc.

Ethicon US LLC

Getinge AB

Graft-Loc Inc.

H. Lee Moffitt Cancer Center & Research Institute Inc

Hadassah Medical Center

Haemair Ltd

Hancock Jaffe Laboratories Inc

Harpoon Medical, Inc.

HeartLander Surgical, Inc.

HeartStitch Inc.

Helical Solutions, Inc. (Inactive)

Hemovent GmbH

iiTech BV

Imricor Medical Systems Inc

Johns Hopkins University

Kardium Inc

LaunchPoint Technologies Inc

LeMaitre Vascular Inc

LivaNova PLC

LuxCath, LLC

Mayo Clinic

MC3 Inc

McGill University

McGowan Institute for Regenerative Medicine

MedArray Inc.

Medical 21 Inc

Medtronic Plc

Microsurgical Innovations Inc

Monash University

Myocardial Assist Systems and Technology LLC

Neograft Technologies Inc

Nido Surgical LLC

Nikkiso Co Ltd

Nipro Corp

Northwestern University

Peca Labs Inc

PeriCor LLC

PetVivo Holdings Inc

Prekubator TTO

Quest Medical Inc

Rafael Medical Technologies, Inc.

RegenMedTX LLC

Replication Medical Inc

RWTH Aachen University

SeamVad Ltd.

Shandong University

Sheba Medical Center

Sichuan Jinjiang Electronic Science and Technology Co., Ltd.

Southern Research Institute

Spectranetics Corp

Sree Chitra Tirunal Institute for Medical Sciences & Technology

Stanford University

Sunnybrook Health Sciences Centre

Surg Solutions SL

Synovis Micro Companies Alliance Inc

Terumo Cardiovascular Systems Corp

The Charles Stark Draper Laboratory Inc

Thermedical Inc

Thoratec LLC

Tissue Regeneration Technologies LLC

TransMed7 LLC

Transmural systems LLC

Tufts Medical Center

University College London

University Hospital Basel

University of Arizona

University of California Los Angeles

University of California San Francisco

University of Chicago

University of Iowa

University of Michigan

University of Montreal

University of Nebraska

University of Nebraska Medical Center

University of Pittsburgh

University of Strathclyde

Vascular Graft Solutions Ltd

VentriFlo Inc

Vigor Medical Technologies Ltd.

Vivonics Inc

VytronUS Inc

W-Z BIOTECH, LLC

Xenios AG

Table of Contents

1 Table of Contents 2

1.1 List of Tables 10

1.2 List of Figures 19

2 Introduction 20

2.1 Cardiovascular Surgery Devices Overview 20

3 Products under Development 21

3.1 Cardiovascular Surgery Devices – Pipeline Products by Stage of Development 21

3.2 Cardiovascular Surgery Devices – Pipeline Products by Segment 22

3.3 Cardiovascular Surgery Devices – Pipeline Products by Territory 23

3.4 Cardiovascular Surgery Devices – Pipeline Products by Regulatory Path 24

3.5 Cardiovascular Surgery Devices – Pipeline Products by Estimated Approval Date 25

3.6 Cardiovascular Surgery Devices – Ongoing Clinical Trials 26

4 Cardiovascular Surgery Devices – Pipeline Products under Development by Companies 27

4.1 Cardiovascular Surgery Devices Companies – Pipeline Products by Stage of Development 27

4.2 Cardiovascular Surgery Devices – Pipeline Products by Stage of Development 32

5 Cardiovascular Surgery Devices Companies and Product Overview 37

5.1 3DT Holdings LLC Company Overview 37

5.1.1 3DT Holdings LLC Pipeline Products & Ongoing Clinical Trials Overview 37

5.2 510 Kardiac Devices Inc Company Overview 38

5.2.1 510 Kardiac Devices Inc Pipeline Products & Ongoing Clinical Trials Overview 38

5.3 Abiomed Inc Company Overview 39

5.3.1 Abiomed Inc Pipeline Products & Ongoing Clinical Trials Overview 39

5.4 AblaCor Medical Corporation Company Overview 40

5.4.1 AblaCor Medical Corporation Pipeline Products & Ongoing Clinical Trials Overview 40

5.5 Adagio Medical Inc. Company Overview 42

5.5.1 Adagio Medical Inc. Pipeline Products & Ongoing Clinical Trials Overview 42

5.6 Advanced Catheter Therapies Inc Company Overview 45

5.6.1 Advanced Catheter Therapies Inc Pipeline Products & Ongoing Clinical Trials Overview 45

5.7 AdvanSource Biomaterials Corporation Company Overview 47

5.7.1 AdvanSource Biomaterials Corporation Pipeline Products & Ongoing Clinical Trials Overview 47

5.8 AFreeze GmbH Company Overview 48

5.8.1 AFreeze GmbH Pipeline Products & Ongoing Clinical Trials Overview 48

5.9 AngioDynamics Inc Company Overview 52

5.9.1 AngioDynamics Inc Pipeline Products & Ongoing Clinical Trials Overview 52

5.10 Apaxis Medical Inc Company Overview 55

5.10.1 Apaxis Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 55

5.11 APK Advanced Medical Technologies, Inc. Company Overview 58

5.11.1 APK Advanced Medical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 58

5.12 Applied Medical Resources Corporation Company Overview 59

5.12.1 Applied Medical Resources Corporation Pipeline Products & Ongoing Clinical Trials Overview 59

5.13 Atrian Medical Ltd Company Overview 60

5.13.1 Atrian Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 60

5.14 AtriCure Inc Company Overview 61

5.14.1 AtriCure Inc Pipeline Products & Ongoing Clinical Trials Overview 61

5.15 Axcelon Biopolymers Corp. Company Overview 67

5.15.1 Axcelon Biopolymers Corp. Pipeline Products & Ongoing Clinical Trials Overview 67

5.16 Baylis Medical Company Inc Company Overview 68

5.16.1 Baylis Medical Company Inc Pipeline Products & Ongoing Clinical Trials Overview 68

5.17 Beth Israel Deaconess Medical Center Company Overview 69

5.17.1 Beth Israel Deaconess Medical Center Pipeline Products & Ongoing Clinical Trials Overview 69

5.18 Bioretec Ltd Company Overview 71

5.18.1 Bioretec Ltd Pipeline Products & Ongoing Clinical Trials Overview 71

5.19 Boston Children's Hospital Company Overview 72

5.19.1 Boston Children's Hospital Pipeline Products & Ongoing Clinical Trials Overview 72

5.20 Boston University Company Overview 75

5.20.1 Boston University Pipeline Products & Ongoing Clinical Trials Overview 75

5.21 CardioPolymers Inc Company Overview 76

5.21.1 CardioPolymers Inc Pipeline Products & Ongoing Clinical Trials Overview 76

5.22 CardioPrecision Ltd Company Overview 77

5.22.1 CardioPrecision Ltd Pipeline Products & Ongoing Clinical Trials Overview 77

5.23 CardioScout, LLC Company Overview 78

5.23.1 CardioScout, LLC Pipeline Products & Ongoing Clinical Trials Overview 78

5.24 Cardious Inc Company Overview 79

5.24.1 Cardious Inc Pipeline Products & Ongoing Clinical Trials Overview 79

5.25 Centre Hospitalier Universitaire de Nice Company Overview 80

5.25.1 Centre Hospitalier Universitaire de Nice Pipeline Products & Ongoing Clinical Trials Overview 80

5.26 Cincinnati Children's Hospital Medical Center Company Overview 81

5.26.1 Cincinnati Children's Hospital Medical Center Pipeline Products & Ongoing Clinical Trials Overview 81

5.27 Circulatory Technology Inc. Company Overview 82

5.27.1 Circulatory Technology Inc. Pipeline Products & Ongoing Clinical Trials Overview 82

5.28 Cleveland Clinic Hospital Company Overview 83

5.28.1 Cleveland Clinic Hospital Pipeline Products & Ongoing Clinical Trials Overview 83

5.29 Corazon Technologies, Inc. Company Overview 84

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

5.30 Corfigo Inc Company Overview 85

5.30.1 Corfigo Inc Pipeline Products & Ongoing Clinical Trials Overview 85

5.31 Coridea, LLC Company Overview 86

5.31.1 Coridea, LLC Pipeline Products & Ongoing Clinical Trials Overview 86

5.32 Coromedic Ltd. Company Overview 87

5.32.1 Coromedic Ltd. Pipeline Products & Ongoing Clinical Trials Overview 87

5.33 CPSI Biotech Company Overview 89

5.33.1 CPSI Biotech Pipeline Products & Ongoing Clinical Trials Overview 89

5.34 CVD Equipment Corp Company Overview 93

5.34.1 CVD Equipment Corp Pipeline Products & Ongoing Clinical Trials Overview 93

5.35 Cytograft Tissue Engineering Inc (Inactive) Company Overview 94

5.35.1 Cytograft Tissue Engineering Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 94

5.36 Daidalos Solutions BV Company Overview 96

5.36.1 Daidalos Solutions BV Pipeline Products & Ongoing Clinical Trials Overview 96

5.37 Edwards Lifesciences Corp Company Overview 100

5.37.1 Edwards Lifesciences Corp Pipeline Products & Ongoing Clinical Trials Overview 100

5.38 Elana bv Company Overview 103

5.38.1 Elana bv Pipeline Products & Ongoing Clinical Trials Overview 103

5.39 Elsius Biomedical Inc Company Overview 104

5.39.1 Elsius Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 104

5.40 Emory University Company Overview 105

5.40.1 Emory University Pipeline Products & Ongoing Clinical Trials Overview 105

5.41 Ension, Inc. Company Overview 106

5.41.1 Ension, Inc. Pipeline Products & Ongoing Clinical Trials Overview 106

5.42 EpiEP, Inc. Company Overview 107

5.42.1 EpiEP, Inc. Pipeline Products & Ongoing Clinical Trials Overview 107

5.43 Ethicon US LLC Company Overview 108

5.43.1 Ethicon US LLC Pipeline Products & Ongoing Clinical Trials Overview 108

5.44 Getinge AB Company Overview 109

5.44.1 Getinge AB Pipeline Products & Ongoing Clinical Trials Overview 109

5.45 Graft-Loc Inc. Company Overview 110

5.45.1 Graft-Loc Inc. Pipeline Products & Ongoing Clinical Trials Overview 110

5.46 H. Lee Moffitt Cancer Center & Research Institute Inc Company Overview 111

5.46.1 H. Lee Moffitt Cancer Center & Research Institute Inc Pipeline Products & Ongoing Clinical Trials Overview 111

5.47 Hadassah Medical Center Company Overview 112

5.47.1 Hadassah Medical Center Pipeline Products & Ongoing Clinical Trials Overview 112

5.48 Haemair Ltd Company Overview 114

5.48.1 Haemair Ltd Pipeline Products & Ongoing Clinical Trials Overview 114

5.49 Hancock Jaffe Laboratories Inc Company Overview 115

5.49.1 Hancock Jaffe Laboratories Inc Pipeline Products & Ongoing Clinical Trials Overview 115

5.50 Harpoon Medical, Inc. Company Overview 118

5.50.1 Harpoon Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 118

5.51 HeartLander Surgical, Inc. Company Overview 122

5.51.1 HeartLander Surgical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 122

5.52 HeartStitch Inc. Company Overview 123

5.52.1 HeartStitch Inc. Pipeline Products & Ongoing Clinical Trials Overview 123

5.53 Helical Solutions, Inc. (Inactive) Company Overview 124

5.53.1 Helical Solutions, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 124

5.54 Hemovent GmbH Company Overview 125

5.54.1 Hemovent GmbH Pipeline Products & Ongoing Clinical Trials Overview 125

5.55 iiTech BV Company Overview 128

5.55.1 iiTech BV Pipeline Products & Ongoing Clinical Trials Overview 128

5.56 Imricor Medical Systems Inc Company Overview 130

5.56.1 Imricor Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 130

5.57 Johns Hopkins University Company Overview 131

5.57.1 Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 131

5.58 Kardium Inc Company Overview 133

5.58.1 Kardium Inc Pipeline Products & Ongoing Clinical Trials Overview 133

5.59 LaunchPoint Technologies Inc Company Overview 137

5.59.1 LaunchPoint Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 137

5.60 LeMaitre Vascular Inc Company Overview 138

5.60.1 LeMaitre Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 138

5.61 LivaNova PLC Company Overview 141

5.61.1 LivaNova PLC Pipeline Products & Ongoing Clinical Trials Overview 141

5.62 LuxCath, LLC Company Overview 147

5.62.1 LuxCath, LLC Pipeline Products & Ongoing Clinical Trials Overview 147

5.63 Mayo Clinic Company Overview 148

5.63.1 Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 148

5.64 MC3 Inc Company Overview 149

5.64.1 MC3 Inc Pipeline Products & Ongoing Clinical Trials Overview 149

5.65 McGill University Company Overview 150

5.65.1 McGill University Pipeline Products & Ongoing Clinical Trials Overview 150

5.66 McGowan Institute for Regenerative Medicine Company Overview 151

5.66.1 McGowan Institute for Regenerative Medicine Pipeline Products & Ongoing Clinical Trials Overview 151

5.67 MedArray Inc. Company Overview 152

5.67.1 MedArray Inc. Pipeline Products & Ongoing Clinical Trials Overview 152

5.68 Medical 21 Inc Company Overview 155

5.68.1 Medical 21 Inc Pipeline Products & Ongoing Clinical Trials Overview 155

5.69 Medtronic Plc Company Overview 156

5.69.1 Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 156

5.70 Microsurgical Innovations Inc Company Overview 162

5.70.1 Microsurgical Innovations Inc Pipeline Products & Ongoing Clinical Trials Overview 162

5.71 Monash University Company Overview 163

5.71.1 Monash University Pipeline Products & Ongoing Clinical Trials Overview 163

5.72 Myocardial Assist Systems and Technology LLC Company Overview 164

5.72.1 Myocardial Assist Systems and Technology LLC Pipeline Products & Ongoing Clinical Trials Overview 164

5.73 Neograft Technologies Inc Company Overview 165

5.73.1 Neograft Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 165

5.74 Nido Surgical LLC Company Overview 166

5.74.1 Nido Surgical LLC Pipeline Products & Ongoing Clinical Trials Overview 166

5.75 Nikkiso Co Ltd Company Overview 167

5.75.1 Nikkiso Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 167

5.76 Nipro Corp Company Overview 168

5.76.1 Nipro Corp Pipeline Products & Ongoing Clinical Trials Overview 168

5.77 Northwestern University Company Overview 170

5.77.1 Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 170

5.78 Peca Labs Inc Company Overview 171

5.78.1 Peca Labs Inc Pipeline Products & Ongoing Clinical Trials Overview 171

5.79 PeriCor LLC Company Overview 172

5.79.1 PeriCor LLC Pipeline Products & Ongoing Clinical Trials Overview 172

5.80 PetVivo Holdings Inc Company Overview 173

5.80.1 PetVivo Holdings Inc Pipeline Products & Ongoing Clinical Trials Overview 173

5.81 Prekubator TTO Company Overview 174

5.81.1 Prekubator TTO Pipeline Products & Ongoing Clinical Trials Overview 174

5.82 Quest Medical Inc Company Overview 175

5.82.1 Quest Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 175

5.83 Rafael Medical Technologies, Inc. Company Overview 176

5.83.1 Rafael Medical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 176

5.84 RegenMedTX LLC Company Overview 177

5.84.1 RegenMedTX LLC Pipeline Products & Ongoing Clinical Trials Overview 177

5.85 Replication Medical Inc Company Overview 178

5.85.1 Replication Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 178

5.86 RWTH Aachen University Company Overview 179

5.86.1 RWTH Aachen University Pipeline Products & Ongoing Clinical Trials Overview 179

5.87 SeamVad Ltd. Company Overview 180

5.87.1 SeamVad Ltd. Pipeline Products & Ongoing Clinical Trials Overview 180

5.88 Shandong University Company Overview 181

5.88.1 Shandong University Pipeline Products & Ongoing Clinical Trials Overview 181

5.89 Sheba Medical Center Company Overview 182

5.89.1 Sheba Medical Center Pipeline Products & Ongoing Clinical Trials Overview 182

5.90 Sichuan Jinjiang Electronic Science and Technology Co., Ltd. Company Overview 183

5.90.1 Sichuan Jinjiang Electronic Science and Technology Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 183

5.91 Southern Research Institute Company Overview 184

5.91.1 Southern Research Institute Pipeline Products & Ongoing Clinical Trials Overview 184

5.92 Spectranetics Corp Company Overview 185

5.92.1 Spectranetics Corp Pipeline Products & Ongoing Clinical Trials Overview 185

5.93 Sree Chitra Tirunal Institute for Medical Sciences & Technology Company Overview 186

5.93.1 Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 186

5.94 Stanford University Company Overview 188

5.94.1 Stanford University Pipeline Products & Ongoing Clinical Trials Overview 188

5.95 Sunnybrook Health Sciences Centre Company Overview 190

5.95.1 Sunnybrook Health Sciences Centre Pipeline Products & Ongoing Clinical Trials Overview 190

5.96 Surg Solutions SL Company Overview 191

5.96.1 Surg Solutions SL Pipeline Products & Ongoing Clinical Trials Overview 191

5.97 Synovis Micro Companies Alliance Inc Company Overview 192

5.97.1 Synovis Micro Companies Alliance Inc Pipeline Products & Ongoing Clinical Trials Overview 192

5.98 Terumo Cardiovascular Systems Corp Company Overview 193

5.98.1 Terumo Cardiovascular Systems Corp Pipeline Products & Ongoing Clinical Trials Overview 193

5.99 The Charles Stark Draper Laboratory Inc Company Overview 195

5.99.1 The Charles Stark Draper Laboratory Inc Pipeline Products & Ongoing Clinical Trials Overview 195

5.100 Thermedical Inc Company Overview 196

5.100.1 Thermedical Inc Pipeline Products & Ongoing Clinical Trials Overview 196

5.101 Thoratec LLC Company Overview 199

5.101.1 Thoratec LLC Pipeline Products & Ongoing Clinical Trials Overview 199

5.102 Tissue Regeneration Technologies LLC Company Overview 201

5.102.1 Tissue Regeneration Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 201

5.103 TransMed7 LLC Company Overview 202

5.103.1 TransMed7 LLC Pipeline Products & Ongoing Clinical Trials Overview 202

5.104 Transmural systems LLC Company Overview 203

5.104.1 Transmural systems LLC Pipeline Products & Ongoing Clinical Trials Overview 203

5.105 Tufts Medical Center Company Overview 205

5.105.1 Tufts Medical Center Pipeline Products & Ongoing Clinical Trials Overview 205

5.106 University College London Company Overview 206

5.106.1 University College London Pipeline Products & Ongoing Clinical Trials Overview 206

5.107 University Hospital Basel Company Overview 207

5.107.1 University Hospital Basel Pipeline Products & Ongoing Clinical Trials Overview 207

5.108 University of Arizona Company Overview 208

5.108.1 University of Arizona Pipeline Products & Ongoing Clinical Trials Overview 208

5.109 University of California Los Angeles Company Overview 209

5.109.1 University of California Los Angeles Pipeline Products & Ongoing Clinical Trials Overview 209

5.110 University of California San Francisco Company Overview 211

5.110.1 University of California San Francisco Pipeline Products & Ongoing Clinical Trials Overview 211

5.111 University of Chicago Company Overview 212

5.111.1 University of Chicago Pipeline Products & Ongoing Clinical Trials Overview 212

5.112 University of Iowa Company Overview 213

5.112.1 University of Iowa Pipeline Products & Ongoing Clinical Trials Overview 213

5.113 University of Michigan Company Overview 214

5.113.1 University of Michigan Pipeline Products & Ongoing Clinical Trials Overview 214

5.114 University of Montreal Company Overview 215

5.114.1 University of Montreal Pipeline Products & Ongoing Clinical Trials Overview 215

5.115 University of Nebraska Company Overview 216

5.115.1 University of Nebraska Pipeline Products & Ongoing Clinical Trials Overview 216

5.116 University of Nebraska Medical Center Company Overview 217

5.116.1 University of Nebraska Medical Center Pipeline Products & Ongoing Clinical Trials Overview 217

5.117 University of Pittsburgh Company Overview 218

5.117.1 University of Pittsburgh Pipeline Products & Ongoing Clinical Trials Overview 218

5.118 University of Strathclyde Company Overview 219

5.118.1 University of Strathclyde Pipeline Products & Ongoing Clinical Trials Overview 219

5.119 Vascular Graft Solutions Ltd Company Overview 220

5.119.1 Vascular Graft Solutions Ltd Pipeline Products & Ongoing Clinical Trials Overview 220

5.120 VentriFlo Inc Company Overview 221

5.120.1 VentriFlo Inc Pipeline Products & Ongoing Clinical Trials Overview 221

5.121 Vigor Medical Technologies Ltd. Company Overview 222

5.121.1 Vigor Medical Technologies Ltd. Pipeline Products & Ongoing Clinical Trials Overview 222

5.122 Vivonics Inc Company Overview 223

5.122.1 Vivonics Inc Pipeline Products & Ongoing Clinical Trials Overview 223

5.123 VytronUS Inc Company Overview 224

5.123.1 VytronUS Inc Pipeline Products & Ongoing Clinical Trials Overview 224

5.124 W-Z BIOTECH, LLC Company Overview 228

5.124.1 W-Z BIOTECH, LLC Pipeline Products & Ongoing Clinical Trials Overview 228

5.125 Xenios AG Company Overview 229

5.125.1 Xenios AG Pipeline Products & Ongoing Clinical Trials Overview 229

6 Cardiovascular Surgery Devices- Recent Developments 231

6.1 Aug 13, 2020: Medline joins NPPGov as an approved vendor offering top-notch medical supplies 231

6.2 Jul 24, 2020: Breaking Ground for preeminent surgical Services at Robert Wood Johnson University Hospital 231

6.3 Jul 13, 2020: Abbott agrees to global Transcatheter Litigation Settlement with Edwards Lifesciences 231

6.4 Jun 15, 2020: MicroPort announces strategic investment and forms joint venture with Indian medical device company purple medical 232

6.5 May 15, 2020: Microport orthopedics group brings in new strategic investors 233

6.6 Apr 14, 2020: BioCardia announces litigation financing in the case captioned Boston Scientific 234

6.7 Apr 06, 2020: MiMedx Group agrees to pay $6.5 million to resolve false claims act allegations of false commercial pricing disclosures 235

6.8 Apr 02, 2020: SI-BONE provides business update in response to covid-19 pandemic 235

6.9 Mar 04, 2020: Sanofi's Board of Directors proposes the appointment of Rachel Duan and Lise Kingo as independent directors 236

6.10 Feb 28, 2020: Long Beach Medical Center only Southern California site participating in AFib clinical trial 237

6.11 Feb 26, 2020: First patient in U.S. treated for atrial fibrillation using new device to restore normal heart rhythm 238

6.12 Feb 26, 2020: LivaNova reports fourth quarter and full-year 2019 results 238

6.13 Feb 26, 2020: Mayo Clinic reports 'remarkable growth' in 2019 241

6.14 Feb 25, 2020: LivaNova receives FDA clearance for 3T Heater-Cooler Device Modification 241

6.15 Feb 25, 2020: Mallinckrodt reports strong fourth quarter and 2019 results 241

6.16 Feb 25, 2020: Sanofi announces resignation of Director 243

6.17 Feb 24, 2020: 2020 Catalyst award winner Medtronic hires Chief Inclusion and Diversity Officer 244

6.18 Feb 24, 2020: Merit Medical reports earnings for fourth quarter and year ended December 31, 2019, gives FY 2020 Guidance 244

6.19 Feb 24, 2020: 2020 Catalyst Award Winner Medtronic hires Chief Inclusion and Diversity Officer 245

6.20 Feb 19, 2020: Integra LifeSciences reports fourth quarter and full-year 2019 financial results and provides 2020 financial guidance 246

6.21 Feb 18, 2020: Medtronic reports third quarter financial results 2020 247

6.22 Feb 18, 2020: Elos Medtech – Year-end report, 1 January – 31 December, 2019 250

6.23 Feb 18, 2020: Getinge announces first manufacturing site and products to be EU MDR certified 251

6.24 Feb 13, 2020: CryoLife reports fourth quarter and full year 2019 financial results 251

6.25 Feb 11, 2020: Celerion expands clinical research to Nebraska Innovation Campus 252

6.26 Feb 06, 2020: AngioDynamics appoints Stephen Trowbridge Executive Vice President and Chief Financial Officer 253

6.27 Feb 06, 2020: Sanofi delivers strong 2019 business EPS growth of

6.8% at CER 253

6.28 Feb 06, 2020: LeMaitre Vascular Announces Q4 2019 Financial Results 263

6.29 Feb 05, 2020: Boston Scientific announces results for fourth quarter and full year 2019 264

6.30 Feb 05, 2020: Surmodics reports first quarter Fiscal 2020 results 266

6.31 Feb 03, 2020: Surmodics names Nusrath Sultana, MD, as Vice President, Clinical Affairs 266

6.32 Jan 31, 2020: Emboline completes $5m bridge round of financing 267

6.33 Jan 30, 2020: Getinge full year report 2019: continued growth, higher margins and strengthened cash flow 267

6.34 Jan 27, 2020: Merit Medical issues statement regarding director nominations from starboard 268

6.35 Jan 24, 2020: Medtronic secures FDA approval for PulseSelect PFA system trial 269

6.36 Jan 22, 2020: Teleflex receives FDA clearance for Wattson Temporary Pacing Guidewire 270

6.37 Jan 15, 2020: Merit milestones: facilities in Galway and Tijuana reach 1,000 employees 270

6.38 Jan 14, 2020: Boston Scientific announces preliminary unaudited sales for the fourth quarter and full year 2019 271

6.39 Jan 09, 2020: SI-BONE reports preliminary unaudited revenue for fourth quarter and full year 2019 and provides full year 2020 revenue guidance 272

6.40 Jan 07, 2020: AtriCure announces successful completion of patient enrollment of aMAZE clinical trial and FDA approval of continued access protocol 272

6.41 Jan 07, 2020: AngioDynamics reports fiscal 2020 second quarter financial results 273

6.42 Jan 03, 2020: Former Kroger Exec Christopher Hjelm joins CPSI board of directors 275

6.43 Jan 02, 2020: Pfizer, Sanofi and GlaxoSmithKline plan to increase US drug prices in 2020 275

6.44 Dec 23, 2019: Mayo Clinic names chief digital officer to lead transformative digital strategy, create Center for Digital Health 275

6.45 Dec 19, 2019: The Children's Heart Foundation funds new research into congenital heart defects 275

6.46 Dec 18, 2019: Getinge is announcing a medical device recall/field action related to packaging of QUADROX-iD Pediatric Oxygenators 276

6.47 Dec 16, 2019: Adagio Medical announces first patient enrollment in its iCLAS U.S. IDE clinical trial evaluating ultra-low temperature cryoablation for persistent atrial fibrillation 277

6.48 Dec 16, 2019: MiMedx Announces addition of Peter M. Carlson 277

6.49 Dec 10, 2019: Mallinckrodt announces plans to update its Incentive Compensation Clawback Policy and create Opioid Report 278

6.50 Dec 06, 2019: Gilero opens new design center in Southern California 278

6.51 Dec 04, 2019: Getinge is announcing a voluntary recall of the ROTAFLOW drive unit 278

6.52 Dec 04, 2019: SI-BONE names Jeryl Hilleman to Board of Directors 279

6.53 Dec 04, 2019: AtriCure names two industry veterans to Board of Directors 279

6.54 Dec 04, 2019: Lumeon and Medtronic partner to deliver new models of care in Europe 280

6.55 Dec 03, 2019: Dr. John Halamka named president of Mayo Clinic Platform 280

6.56 Nov 26, 2019: MiMedx announces Securities and Exchange Commission Settlement 281

6.57 Nov 26, 2019: MiMedx names William "Butch" Hulse as General Counsel and Secretary 282

6.58 Nov 26, 2019: SEC charges biotech company and executives with accounting fraud 283

6.59 Nov 20, 2019: First cryoballoon ablation procedures performed using the VersaCross Transseptal Solution 283

6.60 Nov 19, 2019: Hancock Jaffe Medical Team to make presentations at 46th Annual VEITH Vascular Symposium 284

6.61 Nov 19, 2019: Medtronic reports second quarter financial results for the year 2019 285

6.62 Nov 18, 2019: CE Approval for Quantum Centrifugal Pump Drive systems 287

6.63 Nov 18, 2019: Biosense Webster launches a two-pronged initiative to tackle the new millennium epidemic of Atrial Fibrillation 287

6.64 Nov 14, 2019: First Canadian cardiac procedure performed using the All-in-One VersaCross Transseptal Solution 288

6.65 Nov 14, 2019: Stereotaxis reports 2019 third quarter financial results 289

6.66 Nov 14, 2019: Medtronic highlights leadership in inclusion, diversity, and equity in 2019 integrated performance report 290

6.67 Nov 12, 2019: Cardiovascular Systems announces Stephen Stenbeck joins Board of Directors 291

6.68 Nov 11, 2019: SI-BONE reports third quarter 2019 financial results and updates full-year 2019 revenue guidance 292

6.69 Nov 08, 2019: Stereotaxis and Catheter Precision combine robotic navigation and preoperative arrhythmia localization to treat cardiac arrhythmias 293

6.70 Nov 05, 2019: Mallinckrodt reports earnings and pipeline advancements for the third quarter 2019 and raises adjusted diluted earnings per share guidance range for 2019 293

6.71 Nov 04, 2019: Ernie Green Industries and Gilero announce business realignment 295

6.72 Oct 31, 2019: Surmodics reports fourth quarter fiscal 2019 results and issues fiscal 2020 revenue and EPS Guidance 296

6.73 Oct 31, 2019: Sanofi Q3 well on track 297

6.74 Oct 30, 2019: LivaNova reports third quarter 2019 results 300

6.75 Oct 30, 2019: CryoLife reports third quarter 2019 financial results 301

6.76 Oct 30, 2019: Merit Medical reports earnings for third quarter of 2019 302

6.77 Oct 30, 2019: AtriCure reports third quarter 2019 financial results 305

6.78 Oct 29, 2019: Cardiovascular Systems reports fiscal 2020 first-quarter financial results 306

6.79 Oct 24, 2019: Integra LifeSciences reports third quarter 2019 financial results 308

6.80 Oct 24, 2019: Elos Medtech interim report January 1 – September 30, 2019 309

6.81 Oct 24, 2019: Strong demand for life science – Elos Medtech expanding in Sweden 310

6.82 Oct 23, 2019: Boston Scientific announces results for third quarter 2019 311

6.83 Oct 23, 2019: Edwards Lifesciences reports third quarter results 313

6.84 Oct 23, 2019: LeMaitre Vascular announces Q3 2019 financial results 315

6.85 Oct 22, 2019: AngioDynamics announces departure of CFO and appointment of interim CFO 316

6.86 Oct 21, 2019: Sean Salmon named executive vice president and group president of Medtronic Diabetes 316

6.87 Oct 18, 2019: Getinge Q3 2019 result: Continued growth and improved margins 317

6.88 Oct 15, 2019: Sanofi opens digital manufacturing facility in the US 318

6.89 Oct 10, 2019: CINDE announces Edwards Lifesciences invests $100 million to expand its operations in Costa Rica 319

6.90 Oct 08, 2019: Kardium announces successful results from the GLOBAL-AF study 320

7 Appendix 321

7.1 Methodology 321

7.2 About GlobalData 325

7.3 Contact Us 325

List of Tables

Table 1: Cardiovascular Surgery Devices – Pipeline Products by Stage of Development 21

Table 2: Cardiovascular Surgery Devices – Pipeline Products by Segment 22

Table 3: Cardiovascular Surgery Devices – Pipeline Products by Territory 23

Table 4: Cardiovascular Surgery Devices – Pipeline Products by Regulatory Path 24

Table 5: Cardiovascular Surgery Devices – Pipeline Products by Estimated Approval Date 25

Table 6: Cardiovascular Surgery Devices – Ongoing Clinical Trials 26

Table 7: Cardiovascular Surgery Devices Companies – Pipeline Products by Stage of Development 27

Table 8: Cardiovascular Surgery Devices – Pipeline Products by Stage of Development 32

Table 9: 3DT Holdings LLC Pipeline Products & Ongoing Clinical Trials Overview 37

Table 10: Venous Pressure Preconditioning Device – Product Status 37

Table 11: Venous Pressure Preconditioning Device – Product Description 37

Table 12: 510 Kardiac Devices Inc Pipeline Products & Ongoing Clinical Trials Overview 38

Table 13: Lim Transseptal System – Product Status 38

Table 14: Lim Transseptal System – Product Description 38

Table 15: Abiomed Inc Pipeline Products & Ongoing Clinical Trials Overview 39

Table 16: Expandable Sheath – Heart Failure – Product Status 39

Table 17: Expandable Sheath – Heart Failure – Product Description 39

Table 18: AblaCor Medical Corporation Pipeline Products & Ongoing Clinical Trials Overview 40

Table 19: AutoBlator – Product Status 40

Table 20: AutoBlator – Product Description 40

Table 21: CircumBlator AF Catheter Ablation System – Product Status 41

Table 22: CircumBlator AF Catheter Ablation System – Product Description 41

Table 23: Adagio Medical Inc. Pipeline Products & Ongoing Clinical Trials Overview 42

Table 24: iCLAS System – Product Status 42

Table 25: iCLAS System – Product Description 42

Table 26: Adagio Medical Inc. – Ongoing Clinical Trials Overview 43

Table 27: iCLAS System – A Prospective, Multicenter Investigation of the Adagio Cryoablation System in Patients with Atrial Fibrillation 44

Table 28: iCLAS System – iCLAS for Persistent Atrial Fibrillation 44

Table 29: Advanced Catheter Therapies Inc Pipeline Products & Ongoing Clinical Trials Overview 45

Table 30: Atherectomy Device – Product Status 45

Table 31: Atherectomy Device – Product Description 45

Table 32: Thrombectomy Device – Product Status 46

Table 33: Thrombectomy Device – Product Description 46

Table 34: AdvanSource Biomaterials Corporation Pipeline Products & Ongoing Clinical Trials Overview 47

Table 35: CardioPass – Product Status 47

Table 36: CardioPass – Product Description 47

Table 37: AFreeze GmbH Pipeline Products & Ongoing Clinical Trials Overview 48

Table 38: CoolLoop – Product Status 48

Table 39: CoolLoop – Product Description 48

Table 40: Tip-Catheter – Product Status 49

Table 41: Tip-Catheter – Product Description 49

Table 42: AFreeze GmbH – Ongoing Clinical Trials Overview 50

Table 43: CoolLoop – Treatment Success with the CoolLoop Cryoablation System – Post-Market Surveillance 51

Table 44: AngioDynamics Inc Pipeline Products & Ongoing Clinical Trials Overview 52

Table 45: AngioVac – Generation 4 – Product Status 52

Table 46: AngioVac – Generation 4 – Product Description 53

Table 47: Multi-Purpose Mechanical Aspirator – Product Status 53

Table 48: Multi-Purpose Mechanical Aspirator – Product Description 53

Table 49: Non-Thermal Vein Ablation Device – Product Status 54

Table 50: Non-Thermal Vein Ablation Device – Product Description 54

Table 51: Apaxis Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 55

Table 52: Anastomotic Suturing Connector – Product Status 55

Table 53: Anastomotic Suturing Connector – Product Description 55

Table 54: ApiCor – Product Status 56

Table 55: ApiCor – Product Description 56

Table 56: EasyApex CV – Product Status 56

Table 57: EasyApex CV – Product Description 57

Table 58: Endo LV – Product Status 57

Table 59: Endo LV – Product Description 57

Table 60: APK Advanced Medical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 58

Table 61: Apical Access System – Product Status 58

Table 62: Apical Access System – Product Description 58

Table 63: Applied Medical Resources Corporation Pipeline Products & Ongoing Clinical Trials Overview 59

Table 64: Next Generation Cardiac Surgical Device – Product Status 59

Table 65: Next Generation Cardiac Surgical Device – Product Description 59

Table 66: Atrian Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 60

Table 67: mPEF Device – Atrial Fibrillation – Product Status 60

Table 68: mPEF Device – Atrial Fibrillation – Product Description 60

Table 69: AtriCure Inc Pipeline Products & Ongoing Clinical Trials Overview 61

Table 70: AtriClip System – Stroke – Product Status 61

Table 71: AtriClip System – Stroke – Product Description 61

Table 72: AtriCure Bipolar System – Product Status 62

Table 73: AtriCure Bipolar System – Product Description 62

Table 74: Isolator Synergy Encompass Clamp – Product Status 62

Table 75: Isolator Synergy Encompass Clamp – Product Description 63

Table 76: AtriCure Inc – Ongoing Clinical Trials Overview 64

Table 77: AtriClip System – Stroke – Stand-alone Thoracoscopic Epicardial Left Atrial Appendage Occlusion with AtriClip Device for Thromboembolism Prevention in Nonvalvular Atrial Fibrillation – the Polish Nationwide Registry 65

Table 78: AtriCure Bipolar System – Combined Endoscopic Epicardial and Percutaneous Endocardial Ablation Versus Repeated Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation 66

Table 79: Axcelon Biopolymers Corp. Pipeline Products & Ongoing Clinical Trials Overview 67

Table 80: BNC – PVA Based Vascular Graft – Product Status 67

Table 81: BNC – PVA Based Vascular Graft – Product Description 67

Table 82: Baylis Medical Company Inc Pipeline Products & Ongoing Clinical Trials Overview 68

Table 83: Cardiac Ablation Mitigating Device – Product Status 68

Table 84: Cardiac Ablation Mitigating Device – Product Description 68

Table 85: Beth Israel Deaconess Medical Center Pipeline Products & Ongoing Clinical Trials Overview 69

Table 86: Pericardial Reinforcement Device – Product Status 69

Table 87: Pericardial Reinforcement Device – Product Description 69

Table 88: Tissue Transplant And Regeneration Device – Product Status 70

Table 89: Tissue Transplant And Regeneration Device – Product Description 70

Table 90: Bioretec Ltd Pipeline Products & Ongoing Clinical Trials Overview 71

Table 91: Bioabsorbable Sternotomy Fixation Device – Product Status 71

Table 92: Bioabsorbable Sternotomy Fixation Device – Product Description 71

Table 93: Boston Children's Hospital Pipeline Products & Ongoing Clinical Trials Overview 72

Table 94: Heart Patch Deployment System – Product Status 72

Table 95: Heart Patch Deployment System – Product Description 72

Table 96: Millimeter-Scale Device – Product Status 73

Table 97: Millimeter-Scale Device – Product Description 73

Table 98: Mitral Valve Repair Clip Delivery Device – Product Status 73

Table 99: Mitral Valve Repair Clip Delivery Device – Product Description 74

Table 100: Boston University Pipeline Products & Ongoing Clinical Trials Overview 75

Table 101: Sternal Approximation Device – Product Status 75

Table 102: Sternal Approximation Device – Product Description 75

Table 103: CardioPolymers Inc Pipeline Products & Ongoing Clinical Trials Overview 76

Table 104: Plexisyl-AF – Product Status 76

Table 105: Plexisyl-AF – Product Description 76

Table 106: CardioPrecision Ltd Pipeline Products & Ongoing Clinical Trials Overview 77

Table 107: CardioPrecision Device – Product Status 77

Table 108: CardioPrecision Device – Product Description 77

Table 109: CardioScout, LLC Pipeline Products & Ongoing Clinical Trials Overview 78

Table 110: Minimally Invasive Surgical Device – Product Status 78

Table 111: Minimally Invasive Surgical Device – Product Description 78

Table 112: Cardious Inc Pipeline Products & Ongoing Clinical Trials Overview 79

Table 113: AvA Aortic Valve Bypass Graft System – Product Status 79

Table 114: AvA Aortic Valve Bypass Graft System – Product Description 79

Table 115: Centre Hospitalier Universitaire de Nice Pipeline Products & Ongoing Clinical Trials Overview 80

Table 116: Shark Anastomosis Connector – Product Status 80

Table 117: Shark Anastomosis Connector – Product Description 80

Table 118: Cincinnati Children's Hospital Medical Center Pipeline Products & Ongoing Clinical Trials Overview 81

Table 119: Right Angle Cannula – Product Status 81

Table 120: Right Angle Cannula – Product Description 81

Table 121: Circulatory Technology Inc. Pipeline Products & Ongoing Clinical Trials Overview 82

Table 122: Heart Lung Machine – Product Status 82

Table 123: Heart Lung Machine – Product Description 82

Table 124: Cleveland Clinic Hospital Pipeline Products & Ongoing Clinical Trials Overview 83

Table 125: Flexible Fiberoptic Cardioscope – Product Status 83

Table 126: Flexible Fiberoptic Cardioscope – Product Description 83

Table 127: Corazon Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 84

Table 128: Beating Heart Aortic Valve Repair Demineralization System – Product Status 84

Table 129: Beating Heart Aortic Valve Repair Demineralization System – Product Description 84

Table 130: Corfigo Inc Pipeline Products & Ongoing Clinical Trials Overview 85

Table 131: HeArTPAD – Product Status 85

Table 132: HeArTPAD – Product Description 85

Table 133: Coridea, LLC Pipeline Products & Ongoing Clinical Trials Overview 86

Table 134: Cardiac Sympathetic Denervation Device – Product Status 86

Table 135: Cardiac Sympathetic Denervation Device – Product Description 86

Table 136: Coromedic Ltd. Pipeline Products & Ongoing Clinical Trials Overview 87

Table 137: Distal Anastomosis Device – Product Status 87

Table 138: Distal Anastomosis Device – Product Description 87

Table 139: Proximal Anastomosis Device – Product Status 88

Table 140: Proximal Anastomosis Device – Product Description 88

Table 141: CPSI Biotech Pipeline Products & Ongoing Clinical Trials Overview 89

Table 142: ICEolate Catheter – Product Status 89

Table 143: ICEolate Catheter – Product Description 90

Table 144: ICEolate Catheter With Spot Ablation Tip – Product Status 90

Table 145: ICEolate Catheter With Spot Ablation Tip – Product Description 90

Table 146: ICEolate Surgical Probe With Control Handle – Product Status 91

Table 147: ICEolate Surgical Probe With Control Handle – Product Description 91

Table 148: ICEolate Surgical Probe With Flexible Ablation Tip – Product Status 91

Table 149: ICEolate Surgical Probe With Flexible Ablation Tip – Product Description 92

Table 150: CVD Equipment Corp Pipeline Products & Ongoing Clinical Trials Overview 93

Table 151: Extracorporeal Membrane Oxygenation Device – Product Status 93

Table 152: Extracorporeal Membrane Oxygenation Device – Product Description 93

Table 153: Cytograft Tissue Engineering Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 94

Table 154: Cytograft Device – Percutaneous Bypass – Product Status 94

Table 155: Cytograft Device – Percutaneous Bypass – Product Description 94

Table 156: LifeLine TEBV – CABG – Product Status 95

Table 157: LifeLine TEBV – CABG – Product Description 95

Table 158: Daidalos Solutions BV Pipeline Products & Ongoing Clinical Trials Overview 96

Table 159: Heart Valve Prostheses Applicator – Product Status 96

Table 160: Heart Valve Prostheses Applicator – Product Description 96

Table 161: Loading Device – Sutureless Heart Valve Prostheses – Product Status 97

Table 162: Loading Device – Sutureless Heart Valve Prostheses – Product Description 97

Table 163: Repair Rings Applicator – Product Status 97

Table 164: Repair Rings Applicator – Product Description 97

Table 165: Sutureless Cannula – Product Status 98

Table 166: Sutureless Cannula – Product Description 98

Table 167: Sutureless Natural Vascular Connector – Product Status 98

Table 168: Sutureless Natural Vascular Connector – Product Description 99

Table 169: Sutureless Vascular Synthetic Graft Connector – Product Status 99

Table 170: Sutureless Vascular Synthetic Graft Connector – Product Description 99

Table 171: Edwards Lifesciences Corp Pipeline Products & Ongoing Clinical Trials Overview 100

Table 172: MultiShot – Product Status 100

Table 173: MultiShot – Product Description 100

Table 174: Next-Gen EndoVent With Pacing – Product Status 101

Table 175: Next-Gen EndoVent With Pacing – Product Description 101

Table 176: Next-Gen QuickDraw Cannula – Product Status 101

Table 177: Next-Gen QuickDraw Cannula – Product Description 101

Table 178: Sutrafix – Product Status 102

Table 179: Sutrafix – Product Description 102

Table 180: Elana bv Pipeline Products & Ongoing Clinical Trials Overview 103

Table 181: ELANA CLIP 3.0 – Product Status 103

Table 182: ELANA CLIP 3.0 – Product Description 103

Table 183: Elsius Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 104

Table 184: ECMO Portable Device – Product Status 104

Table 185: ECMO Portable Device – Product Description 104

Table 186: Emory University Pipeline Products & Ongoing Clinical Trials Overview 105

Table 187: CorAccess – Product Status 105

Table 188: CorAccess – Product Description 105

Table 189: Ension, Inc. Pipeline Products & Ongoing Clinical Trials Overview 106

Table 190: pCAS – Product Status 106

Table 191: pCAS – Product Description 106

Table 192: EpiEP, Inc. Pipeline Products & Ongoing Clinical Trials Overview 107

Table 193: Epicardial Access Trocar – Product Status 107

Table 194: Epicardial Access Trocar – Product Description 107

Table 195: Ethicon US LLC Pipeline Products & Ongoing Clinical Trials Overview 108

Table 196: Next Generation Ablation Catheter – Product Status 108

Table 197: Next Generation Ablation Catheter – Product Description 108

Table 198: Getinge AB Pipeline Products & Ongoing Clinical Trials Overview 109

Table 199: Heart-Lung Machine HL 40 – Product Status 109

Table 200: Heart-Lung Machine HL 40 – Product Description 109

Table 201: Graft-Loc Inc. Pipeline Products & Ongoing Clinical Trials Overview 110

Table 202: Graft-Loc Device – Product Status 110

Table 203: Graft-Loc Device – Product Description 110

Table 204: H. Lee Moffitt Cancer Center & Research Institute Inc Pipeline Products & Ongoing Clinical Trials Overview 111

Table 205: Vascular Stent – Product Status 111

Table 206: Vascular Stent – Product Description 111

Table 207: Hadassah Medical Center Pipeline Products & Ongoing Clinical Trials Overview 112

Table 208: Cardio Safex – Product Status 112

Table 209: Cardio Safex – Product Description 112

Table 210: Qualiblate – Product Status 113

Table 211: Qualiblate – Product Description 113

Table 212: Haemair Ltd Pipeline Products & Ongoing Clinical Trials Overview 114

Table 213: Extracorporeal Membrane Oxygenation (ECMO) Device – Product Status 114

Table 214: Extracorporeal Membrane Oxygenation (ECMO) Device – Product Description 114

Table 215: Hancock Jaffe Laboratories Inc Pipeline Products & Ongoing Clinical Trials Overview 115

Table 216: CoreoGraft – Product Status 115

Table 217: CoreoGraft – Product Description 115

Table 218: Hancock Jaffe Laboratories Inc – Ongoing Clinical Trials Overview 116

Table 219: CoreoGraft – First-in-human Trial Evaluating the Efficacy of CoreoGraft in the Coronary Artery Bypass Graft (CABG) Surgery 117

Table 220: Harpoon Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 118

Table 221: HARPOON – Product Status 118

Table 222: HARPOON – Product Description 118

Table 223: Harpoon Medical, Inc. – Ongoing Clinical Trials Overview 119

Table 224: HARPOON – Assessment of the Safety and Performance of the HARPOON Beating Heart Mitral Valve Repair System; A Multi-center Post-market Study: ASCEND 120

Table 225: HARPOON – Beating Heart Mitral Valve Repair with the HARPOON System: Real World Outcomes from a Multicenter Observational European Registry 120

Table 226: HARPOON – Mitral Trans-apical Neochordal Echo-guided Repair: TRACER Trial 120

Table 227: HARPOON – Safety and Performance Study of the Harpoon Medical Transapical Suturing Device (TSD-5) in Subjects with Degenerative Mitral Regurgitation – CE Mark Study for the Harpoon Medical Device in Poland 121

Table 228: HARPOON – Safety and Performance Study of the Harpoon Medical Transapical Suturing Device (TSD-5) in Subjects with Degenerative Mitral Regurgitation – EFS/CE Mark Study for the Harpoon Medical Device in Poland 121

Table 229: HeartLander Surgical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 122

Table 230: HeartLander – Product Status 122

Table 231: HeartLander – Product Description 122

Table 232: HeartStitch Inc. Pipeline Products & Ongoing Clinical Trials Overview 123

Table 233: HeartStitch – Remo Pro – Product Status 123

Table 234: HeartStitch – Remo Pro – Product Description 123

Table 235: Helical Solutions, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 124

Table 236: Catheter-Based Ablation Device – Product Status 124

Table 237: Catheter-Based Ablation Device – Product Description 124

Table 238: Hemovent GmbH Pipeline Products & Ongoing Clinical Trials Overview 125

Table 239: Mobybox – Product Status 125

Table 240: Mobybox – Product Description 125

Table 241: Hemovent GmbH – Ongoing Clinical Trials Overview 126

Table 242: Mobybox – A Post Market Surveillance Study of the Hemovent Extracorporeal Cardiopulmonary Support System for Cardiac and Respiratory Support: The MOBYBOX Trial 127

Table 243: iiTech BV Pipeline Products & Ongoing Clinical Trials Overview 128

Table 244: S² Distal Anastomotic System – Product Status 128

Table 245: S² Distal Anastomotic System – Product Description 128

Table 246: S² Proximal Anastomotic System – Product Status 129

Table 247: S² Proximal Anastomotic System – Product Description 129

Table 248: Imricor Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 130

Table 249: Vision-MR Dispersive Electrode – Product Status 130

Table 250: Vision-MR Dispersive Electrode – Product Description 130

Table 251: Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 131

Table 252: Catheter Guiding Computational Modeling Tool – Product Status 131

Table 253: Catheter Guiding Computational Modeling Tool – Product Description 131

Table 254: Oscillatory Atherectomy Device – Product Status 132

Table 255: Oscillatory Atherectomy Device – Product Description 132

Table 256: Kardium Inc Pipeline Products & Ongoing Clinical Trials Overview 133

Table 257: CHS – Coated Globe Mapping And Ablation System – Product Status 133

Table 258: CHS – Coated Globe Mapping And Ablation System – Product Description 133

Table 259: Globe Mapping And Ablation System – Product Status 134

Table 260: Globe Mapping And Ablation System – Product Description 134

Table 261: Kardium Inc – Ongoing Clinical Trials Overview 135

Table 262: Globe Mapping And Ablation System – A Prospective, Non-randomized Clinical Study to Assess the Performance of the Globe Positioning System for Left Atrial Mapping During Cardiac Ablation for the Treatment of Atrial Fibrillation 136

Table 263: LaunchPoint Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 137

Table 264: Quintessential Ventricular Cannula – Product Status 137

Table 265: Quintessential Ventricular Cannula – Product Description 137

Table 266: LeMaitre Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 138

Table 267: XenoSure Biologic Vascular Patch – Product Status 138

Table 268: XenoSure Biologic Vascular Patch – Product Description 138

Table 269: LeMaitre Vascular Inc – Ongoing Clinical Trials Overview 139

Table 270: XenoSure Biologic Vascular Patch – Random, Controlled, Single-blinded, Multi-center and Non-inferiority Clinical Study to Evaluate Safety and Effectiveness of XenoSure Biological Patch in the Application of Cardiac Repair 140

Table 271: XenoSure Biologic Vascular Patch – Random, Controlled, Single-blinded, Multi-center and Non-inferiority Clinical Study to Evaluate Safety and Effectiveness of XenoSure Biological Patch in the Application of Peripheral Vascular Repair 140

Table 272: LivaNova PLC Pipeline Products & Ongoing Clinical Trials Overview 141

Table 273: Bi-Flow – Product Status 141

Table 274: Bi-Flow – Product Description 142

Table 275: LBATS – Product Status 142

Table 276: LBATS – Product Description 142

Table 277: New Oxy Apex HP Oxygenator – Product Status 143

Table 278: New Oxy Apex HP Oxygenator – Product Description 143

Table 279: Next Generation ECMO System – Product Status 143

Table 280: Next Generation ECMO System – Product Description 144

Table 281: NINO – Product Status 144

Table 282: NINO – Product Description 144

Table 283: LivaNova PLC – Ongoing Clinical Trials Overview 145

Table 284: Bi-Flow – Comparative Clinical Efficacy of Novel Bidirectional Peripheral Artery Cannula in Minimally Invasive Aortic Valve Surgery 146

Table 285: LuxCath, LLC Pipeline Products & Ongoing Clinical Trials Overview 147

Table 286: OmniView Light-Guided Ablation Catheter – Product Status 147

Table 287: OmniView Light-Guided Ablation Catheter – Product Description 147

Table 288: Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 148

Table 289: Heart-Lung Machine Reservoir Sensor – Product Status 148

Table 290: Heart-Lung Machine Reservoir Sensor – Product Description 148

Table 291: MC3 Inc Pipeline Products & Ongoing Clinical Trials Overview 149

Table 292: PedOxy – Product Status 149

Table 293: PedOxy – Product Description 149

Table 294: McGill University Pipeline Products & Ongoing Clinical Trials Overview 150

Table 295: Transcatheter Aorta Pulmonary Shunt – Product Status 150

Table 296: Transcatheter Aorta Pulmonary Shunt – Product Description 150

Table 297: McGowan Institute for Regenerative Medicine Pipeline Products & Ongoing Clinical Trials Overview 151

Table 298: Biohybrid Artificial Lung – Product Status 151

Table 299: Biohybrid Artificial Lung – Product Description 151

Table 300: MedArray Inc. Pipeline Products & Ongoing Clinical Trials Overview 152

Table 301: ECMO Oxygenator – Adult – Product Status 152

Table 302: ECMO Oxygenator – Adult – Product Description 152

Table 303: ECMO Oxygenator – Neonatal – Product Status 153

Table 304: ECMO Oxygenator – Neonatal – Product Description 153

Table 305: ECMO Oxygenator – Pediatric – Product Status 153

Table 306: ECMO Oxygenator – Pediatric – Product Description 154

Table 307: Medical 21 Inc Pipeline Products & Ongoing Clinical Trials Overview 155

Table 308: Artificial Blood Vessel – Product Status 155

Table 309: Artificial Blood Vessel – Product Description 155

Table 310: Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 156

Table 311: Cardioblate Irrigated RF (IRF) System – Non-Paroxysmal Atrial Fibrillation – Product Status 156

Table 312: Cardioblate Irrigated RF (IRF) System – Non-Paroxysmal Atrial Fibrillation – Product Description 157

Table 313: Confida Expandable Sheath – Product Status 157

Table 314: Confida Expandable Sheath – Product Description 157

Table 315: CryoFlex Surgical Ablation System – Non-Paroxysmal Atrial Fibrillation – Product Status 158

Table 316: CryoFlex Surgical Ablation System – Non-Paroxysmal Atrial Fibrillation – Product Description 158

Table 317: PulseSelect PFA System – Product Status 158

Table 318: PulseSelect PFA System – Product Description 159

Table 319: Medtronic Plc – Ongoing Clinical Trials Overview 160

Table 320: PulseSelect PFA System – Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF 161

Table 321: Microsurgical Innovations Inc Pipeline Products & Ongoing Clinical Trials Overview 162

Table 322: Vascular Coupling Device – Product Status 162

Table 323: Vascular Coupling Device – Product Description 162

Table 324: Monash University Pipeline Products & Ongoing Clinical Trials Overview 163

Table 325: Cardio By-Pass Machine – Product Status 163

Table 326: Cardio By-Pass Machine – Product Description 163

Table 327: Myocardial Assist Systems and Technology LLC Pipeline Products & Ongoing Clinical Trials Overview 164

Table 328: Sutureless Anastomotic Graft Connection Device – Product Status 164

Table 329: Sutureless Anastomotic Graft Connection Device – Product Description 164

Table 330: Neograft Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 165

Table 331: Neovaso – Product Status 165

Table 332: Neovaso – Product Description 165

Table 333: Nido Surgical LLC Pipeline Products & Ongoing Clinical Trials Overview 166

Table 334: Cardioport – Product Status 166

Table 335: Cardioport – Product Description 166

Table 336: Nikkiso Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 167

Table 337: Cardiopulmonary Bypass Pump – Product Status 167

Table 338: Cardiopulmonary Bypass Pump – Product Description 167

Table 339: Nipro Corp Pipeline Products & Ongoing Clinical Trials Overview 168

Table 340: Extracorporeal Membrane Oxygenator – Product Status 168

Table 341: Extracorporeal Membrane Oxygenator – Product Description 168

Table 342: Venous And Arterial Cannula – Product Status 169

Table 343: Venous And Arterial Cannula – Product Description 169

Table 344: Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 170

Table 345: Cardiac Tissue Ablation Device – Product Status 170

Table 346: Cardiac Tissue Ablation Device – Product Description 170

Table 347: Peca Labs Inc Pipeline Products & Ongoing Clinical Trials Overview 171

Table 348: RV-PA Shunt – Product Status 171

Table 349: RV-PA Shunt – Product Description 171

Table 350: PeriCor LLC Pipeline Products & Ongoing Clinical Trials Overview 172

Table 351: PeriPath – Product Status 172

Table 352: PeriPath – Product Description 172

Table 353: PetVivo Holdings Inc Pipeline Products & Ongoing Clinical Trials Overview 173

Table 354: Coronary Artery Bypass Graft – Product Status 173

Table 355: Coronary Artery Bypass Graft – Product Description 173

Table 356: Prekubator TTO Pipeline Products & Ongoing Clinical Trials Overview 174

Table 357: Snapcon – Product Status 174

Table 358: Snapcon – Product Description 174

Table 359: Quest Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 175

Table 360: MPS 3 – Product Status 175

Table 361: MPS 3 – Product Description 175

Table 362: Rafael Medical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 176

Table 363: Space Station – Product Status 176

Table 364: Space Station – Product Description 176

Table 365: RegenMedTX LLC Pipeline Products & Ongoing Clinical Trials Overview 177

Table 366: Neo-Vessel Replacement – Coronary Artery Bypass – Product Status 177

Table 367: Neo-Vessel Replacement – Coronary Artery Bypass – Product Description 177

Table 368: Replication Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 178

Table 369: Hydrogel Implant- Vascular Surgery – Product Status 178

Table 370: Hydrogel Implant- Vascular Surgery – Product Description 178

Table 371: RWTH Aachen University Pipeline Products & Ongoing Clinical Trials Overview 179

Table 372: StentEx – Product Status 179

Table 373: StentEx – Product Description 179

Table 374: SeamVad Ltd. Pipeline Products & Ongoing Clinical Trials Overview 180

Table 375: MySide – Product Status 180

Table 376: MySide – Product Description 180

Table 377: Shandong University Pipeline Products & Ongoing Clinical Trials Overview 181

Table 378: ECMO Device – Product Status 181

Table 379: ECMO Device – Product Description 181

Table 380: Sheba Medical Center Pipeline Products & Ongoing Clinical Trials Overview 182

Table 381: Transcatheter Septal Myectomy Device – Product Status 182

Table 382: Transcatheter Septal Myectomy Device – Product Description 182

Table 383: Sichuan Jinjiang Electronic Science and Technology Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 183

Table 384: New Energy Management Device – Product Status 183

Table 385: New Energy Management Device – Product Description 183

Table 386: Southern Research Institute Pipeline Products & Ongoing Clinical Trials Overview 184

Table 387: Cardiac Implant – Product Status 184

Table 388: Cardiac Implant – Product Description 184

Table 389: Spectranetics Corp Pipeline Products & Ongoing Clinical Trials Overview 185

Table 390: Nexcimer – Product Status 185

Table 391: Nexcimer – Product Description 185

Table 392: Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 186

Table 393: Paediatric And Neonatal Arterial Filter – Product Status 186

Table 394: Paediatric And Neonatal Arterial Filter – Product Description 186

Table 395: Pediatric And Neonatal Membrane Oxygenator – Product Status 187

Table 396: Pediatric And Neonatal Membrane Oxygenator – Product Description 187

Table 397: Stanford University Pipeline Products & Ongoing Clinical Trials Overview 188

Table 398: Perivascular Electroporation Device – Product Status 188

Table 399: Perivascular Electroporation Device – Product Description 188

Table 400: Wirelessly Powered Cardiac Device – Product Status 189

Table 401: Wirelessly Powered Cardiac Device – Product Description 189

Table 402: Sunnybrook Health Sciences Centre Pipeline Products & Ongoing Clinical Trials Overview 190

Table 403: Ultrasound Phased Array System – Tachyarrhythmia – Product Status 190

Table 404: Ultrasound Phased Array System – Tachyarrhythmia – Product Description 190

Table 405: Surg Solutions SL Pipeline Products & Ongoing Clinical Trials Overview 191

Table 406: VessConnect – Product Status 191

Table 407: VessConnect – Product Description 191

Table 408: Synovis Micro Companies Alliance Inc Pipeline Products & Ongoing Clinical Trials Overview 192

Table 409: Arterial Everter – Product Status 192

Table 410: Arterial Everter – Product Description 192

Table 411: Terumo Cardiovascular Systems Corp Pipeline Products & Ongoing Clinical Trials Overview 193

Table 412: CAPIOX NX19 Oxygenator – Product Status 193

Table 413: CAPIOX NX19 Oxygenator – Product Description 193

Table 414: Next Generation Oxygenator NX – Product Status 194

Table 415: Next Generation Oxygenator NX – Product Description 194

Table 416: The Charles Stark Draper Laboratory Inc Pipeline Products & Ongoing Clinical Trials Overview 195

Table 417: Lung Assist – Product Status 195

Table 418: Lung Assist – Product Description 195

Table 419: Thermedical Inc Pipeline Products & Ongoing Clinical Trials Overview 196

Table 420: Durablate Ablation Catheter – Product Status 196

Table 421: Durablate Ablation Catheter – Product Description 196

Table 422: Thermedical Inc – Ongoing Clinical Trials Overview 197

Table 423: Durablate Ablation Catheter – Saline Enhanced Radiofrequency (SERF) VT Ablation Early Feasibility Study (EFS) 198

Table 424: Durablate Ablation Catheter – Saline-enhanced Radiofrequency (SERF) Catheter Ablation for the Treatment of Ventricular Tachycardia 198

Table 425: Thoratec LLC Pipeline Products & Ongoing Clinical Trials Overview 199

Table 426: Automated Anastomosis Device – Product Status 199

Table 427: Automated Anastomosis Device – Product Description 199

Table 428: PediPL System – Product Status 200

Table 429: PediPL System – Product Description 200

Table 430: Tissue Regeneration Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 201

Table 431: Cardiogold – Product Status 201

Table 432: Cardiogold – Product Description 201

Table 433: TransMed7 LLC Pipeline Products & Ongoing Clinical Trials Overview 202

Table 434: Warhawk – Product Status 202

Table 435: Warhawk – Product Description 202

Table 436: Transmural systems LLC Pipeline Products & Ongoing Clinical Trials Overview 203

Table 437: Transcatheter Glenn Shunt and Fontan Device – Product Status 203

Table 438: Transcatheter Glenn Shunt and Fontan Device – Product Description 203

Table 439: Transcaval Closure Device – Product Status 204

Table 440: Transcaval Closure Device – Product D

List of Figures

Figure 1: Cardiovascular Surgery Devices – Pipeline Products by Stage of Development 21

Figure 2: Cardiovascular Surgery Devices – Pipeline Products by Segment 22

Figure 3: Cardiovascular Surgery Devices – Pipeline Products by Territory 23

Figure 4: Cardiovascular Surgery Devices – Pipeline Products by Regulatory Path 24

Figure 5: Cardiovascular Surgery Devices – Pipeline Products by Estimated Approval Date 25

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