Coronary Stents – Medical Devices Pipeline Assessment, 2020

A stent is an expandable perforated tube that is inserted into a natural conduit of the body to prevent or counteract a disease-induced localized flow constriction. GlobalData's Medical Devices sector report, “Coronary Stents-Medical Devices Pipeline Assessment, 2020" provides comprehensive information about the Coronary Stents pipeline products with comparative analysis of the products at various stages of development and information about the clinical trials which are in progress.

The Coronary Stents Pipeline Assessment report provides key information and data related to:

Extensive coverage of the Coronary Stents 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 Coronary Stents pipeline products.

Review of Recent Developments in the segment / industry

The Coronary Stents 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 Coronary Stents 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 “Coronary Stents- 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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• 1,600+ quarterly and annual medical equipment company financials

• 850+ medical equipment company SWOTs

• 28,000+ pipeline product profiles

• 56,400+ marketed product profiles

• 47,000+ clinical trials

• 41,500+ trial investigators

• 7,000+ reports on companies with products in development

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Scope

– Extensive coverage of the Coronary Stents 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 Coronary Stents 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 Coronary Stents 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

Abbott Vascular Inc

Adcomp Technologies Inc.

Advanced Bifurcation Systems Inc

Aeon Bioscience

AlviMedica Medical Technologies Inc

Amaranth Medical Inc

Arterius Ltd

Atrium Medical Corp

Axordia Ltd (Inactive)

B. Braun Melsungen AG

Bactiguard Holding AB

Bionext Biotech Products Ltd.

Biosensors International Group Ltd

Biosten, LLC

Biotronik AG

Biotronik SE & Co KG

Boston Scientific Corp

Cardionovum GmbH

Cardiorev Pte Ltd (Inactive)

Columbia University

Concept Medical Inc

Contego Medical LLC

Cordis Corp

Cytograft Tissue Engineering Inc (Inactive)

DISA Vascular (Pty) Ltd

Elixir Medical Corp

Envision Scientific Pvt Ltd

HangZhou HuaAn Biotechnology Co., Ltd.

I.B.S. S.p.A.

Icon Interventional Systems, Inc.

ID Nest Medical SAS

InspireMD Inc

Japan Stent Technology Co., Ltd.

JW Medical Systems Ltd

Kaneka Corp

Kyoto Medical Planning Co Ltd

Liaoning Biomedical Materials R&D Center Co Ltd

Lifetech Scientific (Shenzhen) Co Ltd

MangoGen Pharma Inc

Manli Cardiology Ltd

Medinol Ltd

Medlogics Device Corp (Inactive)

Medtronic Plc

Miami Cardiovascular Innovations

Micell Technologies Inc

Michigan Technological University

MicroPort Scientific Corp

Minvasys SAS

MIV Therapeutics Inc

NanoCoeur, Inc.

Nanova, Inc

National University of Ireland Galway

Nesstent Ltd.

Nexeon MedSystems Inc

North Carolina State University

Northwestern University

NuVascular Technologies Inc

OrbusNeich

Palmaz Scientific Inc (Inactive)

Pediastent LLC

QualiMed Innovative Medizinprodukte GmbH

Qvanteq AG

Relisys Medical Devices Ltd

REVA Medical Inc

Rontis AG

S3V Vascular Technologies

Sahajanand Medical Technologies Pvt Ltd

Shanghai Bio-heart Biological Technology Co Ltd

Sino Medical Sciences Technology Inc

Sree Chitra Tirunal Institute for Medical Sciences & Technology

Stentys SA

Svelte Medical Systems Inc

Tepha Inc

Terumo Corp

TissueGen Inc

TrendyMED Inc.

University of Alabama at Birmingham

University of Colorado

University of Florida

University of Michigan

University of Strathclyde

University of Utah

VasoTech Inc.

Viller Scientific LLC

Vornia Biomaterials Ltd

Xenogenics Corporation

Table of Contents

1 Table of Contents 2

1.1 List of Tables 7

1.2 List of Figures 17

2 Introduction 19

2.1 Coronary Stents Overview 19

3 Products under Development 20

3.1 Coronary Stents – Pipeline Products by Stage of Development 20

3.2 Coronary Stents – Pipeline Products by Segment 21

3.3 Coronary Stents – Pipeline Products by Territory 22

3.4 Coronary Stents – Pipeline Products by Regulatory Path 24

3.5 Coronary Stents – Pipeline Products by Estimated Approval Date 25

3.6 Coronary Stents – Ongoing Clinical Trials 26

4 Coronary Stents – Pipeline Products under Development by Companies 27

4.1 Coronary Stents Companies – Pipeline Products by Stage of Development 27

4.2 Coronary Stents – Pipeline Products by Stage of Development 31

5 Coronary Stents Companies and Product Overview 35

5.1 Abbott Vascular Inc Company Overview 35

5.1.1 Abbott Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 35

5.2 Adcomp Technologies Inc. Company Overview 42

5.2.1 Adcomp Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview 42

5.3 Advanced Bifurcation Systems Inc Company Overview 43

5.3.1 Advanced Bifurcation Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 43

5.4 Aeon Bioscience Company Overview 45

5.4.1 Aeon Bioscience Pipeline Products & Ongoing Clinical Trials Overview 45

5.5 AlviMedica Medical Technologies Inc Company Overview 46

5.5.1 AlviMedica Medical Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 46

5.6 Amaranth Medical Inc Company Overview 57

5.6.1 Amaranth Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 57

5.7 Arterius Ltd Company Overview 66

5.7.1 Arterius Ltd Pipeline Products & Ongoing Clinical Trials Overview 66

5.8 Atrium Medical Corp Company Overview 67

5.8.1 Atrium Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 67

5.9 Axordia Ltd (Inactive) Company Overview 68

5.9.1 Axordia Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 68

5.10 B. Braun Melsungen AG Company Overview 69

5.10.1 B. Braun Melsungen AG Pipeline Products & Ongoing Clinical Trials Overview 69

5.11 Bactiguard Holding AB Company Overview 70

5.11.1 Bactiguard Holding AB Pipeline Products & Ongoing Clinical Trials Overview 70

5.12 Bionext Biotech Products Ltd. Company Overview 71

5.12.1 Bionext Biotech Products Ltd. Pipeline Products & Ongoing Clinical Trials Overview 71

5.13 Biosensors International Group Ltd Company Overview 72

5.13.1 Biosensors International Group Ltd Pipeline Products & Ongoing Clinical Trials Overview 72

5.14 Biosten, LLC Company Overview 79

5.14.1 Biosten, LLC Pipeline Products & Ongoing Clinical Trials Overview 79

5.15 Biotronik AG Company Overview 80

5.15.1 Biotronik AG Pipeline Products & Ongoing Clinical Trials Overview 80

5.16 Biotronik SE & Co KG Company Overview 88

5.16.1 Biotronik SE & Co KG Pipeline Products & Ongoing Clinical Trials Overview 88

5.17 Boston Scientific Corp Company Overview 90

5.17.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 90

5.18 Cardionovum GmbH Company Overview 98

5.18.1 Cardionovum GmbH Pipeline Products & Ongoing Clinical Trials Overview 98

5.19 Cardiorev Pte Ltd (Inactive) Company Overview 102

5.19.1 Cardiorev Pte Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 102

5.20 Columbia University Company Overview 103

5.20.1 Columbia University Pipeline Products & Ongoing Clinical Trials Overview 103

5.21 Concept Medical Inc Company Overview 104

5.21.1 Concept Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 104

5.22 Contego Medical LLC Company Overview 108

5.22.1 Contego Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 108

5.23 Cordis Corp Company Overview 109

5.23.1 Cordis Corp Pipeline Products & Ongoing Clinical Trials Overview 109

5.24 Cytograft Tissue Engineering Inc (Inactive) Company Overview 113

5.24.1 Cytograft Tissue Engineering Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 113

5.25 DISA Vascular (Pty) Ltd Company Overview 114

5.25.1 DISA Vascular (Pty) Ltd Pipeline Products & Ongoing Clinical Trials Overview 114

5.26 Elixir Medical Corp Company Overview 115

5.26.1 Elixir Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 115

5.27 Envision Scientific Pvt Ltd Company Overview 117

5.27.1 Envision Scientific Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 117

5.28 HangZhou HuaAn Biotechnology Co., Ltd. Company Overview 119

5.28.1 HangZhou HuaAn Biotechnology Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 119

5.29 I.B.S. S.p.A. Company Overview 120

5.29.1 I.B.S. S.p.A. Pipeline Products & Ongoing Clinical Trials Overview 120

5.30 Icon Interventional Systems, Inc. Company Overview 121

5.30.1 Icon Interventional Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 121

5.31 ID Nest Medical SAS Company Overview 122

5.31.1 ID Nest Medical SAS Pipeline Products & Ongoing Clinical Trials Overview 122

5.32 InspireMD Inc Company Overview 123

5.32.1 InspireMD Inc Pipeline Products & Ongoing Clinical Trials Overview 123

5.33 Japan Stent Technology Co., Ltd. Company Overview 124

5.33.1 Japan Stent Technology Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 124

5.34 JW Medical Systems Ltd Company Overview 125

5.34.1 JW Medical Systems Ltd Pipeline Products & Ongoing Clinical Trials Overview 125

5.35 Kaneka Corp Company Overview 128

5.35.1 Kaneka Corp Pipeline Products & Ongoing Clinical Trials Overview 128

5.36 Kyoto Medical Planning Co Ltd Company Overview 129

5.36.1 Kyoto Medical Planning Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 129

5.37 Liaoning Biomedical Materials R&D Center Co Ltd Company Overview 130

5.37.1 Liaoning Biomedical Materials R&D Center Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 130

5.38 Lifetech Scientific (Shenzhen) Co Ltd Company Overview 131

5.38.1 Lifetech Scientific (Shenzhen) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 131

5.39 MangoGen Pharma Inc Company Overview 134

5.39.1 MangoGen Pharma Inc Pipeline Products & Ongoing Clinical Trials Overview 134

5.40 Manli Cardiology Ltd Company Overview 135

5.40.1 Manli Cardiology Ltd Pipeline Products & Ongoing Clinical Trials Overview 135

5.41 Medinol Ltd Company Overview 136

5.41.1 Medinol Ltd Pipeline Products & Ongoing Clinical Trials Overview 136

5.42 Medlogics Device Corp (Inactive) Company Overview 143

5.42.1 Medlogics Device Corp (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 143

5.43 Medtronic Plc Company Overview 144

5.43.1 Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 144

5.44 Miami Cardiovascular Innovations Company Overview 151

5.44.1 Miami Cardiovascular Innovations Pipeline Products & Ongoing Clinical Trials Overview 151

5.45 Micell Technologies Inc Company Overview 152

5.45.1 Micell Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 152

5.46 Michigan Technological University Company Overview 157

5.46.1 Michigan Technological University Pipeline Products & Ongoing Clinical Trials Overview 157

5.47 MicroPort Scientific Corp Company Overview 158

5.47.1 MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 158

5.48 Minvasys SAS Company Overview 164

5.48.1 Minvasys SAS Pipeline Products & Ongoing Clinical Trials Overview 164

5.49 MIV Therapeutics Inc Company Overview 165

5.49.1 MIV Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 165

5.50 NanoCoeur, Inc. Company Overview 170

5.50.1 NanoCoeur, Inc. Pipeline Products & Ongoing Clinical Trials Overview 170

5.51 Nanova, Inc Company Overview 171

5.51.1 Nanova, Inc Pipeline Products & Ongoing Clinical Trials Overview 171

5.52 National University of Ireland Galway Company Overview 172

5.52.1 National University of Ireland Galway Pipeline Products & Ongoing Clinical Trials Overview 172

5.53 Nesstent Ltd. Company Overview 173

5.53.1 Nesstent Ltd. Pipeline Products & Ongoing Clinical Trials Overview 173

5.54 Nexeon MedSystems Inc Company Overview 174

5.54.1 Nexeon MedSystems Inc Pipeline Products & Ongoing Clinical Trials Overview 174

5.55 North Carolina State University Company Overview 175

5.55.1 North Carolina State University Pipeline Products & Ongoing Clinical Trials Overview 175

5.56 Northwestern University Company Overview 176

5.56.1 Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 176

5.57 NuVascular Technologies Inc Company Overview 177

5.57.1 NuVascular Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 177

5.58 OrbusNeich Company Overview 178

5.58.1 OrbusNeich Pipeline Products & Ongoing Clinical Trials Overview 178

5.59 Palmaz Scientific Inc (Inactive) Company Overview 180

5.59.1 Palmaz Scientific Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 180

5.60 Pediastent LLC Company Overview 181

5.60.1 Pediastent LLC Pipeline Products & Ongoing Clinical Trials Overview 181

5.61 QualiMed Innovative Medizinprodukte GmbH Company Overview 182

5.61.1 QualiMed Innovative Medizinprodukte GmbH Pipeline Products & Ongoing Clinical Trials Overview 182

5.62 Qvanteq AG Company Overview 183

5.62.1 Qvanteq AG Pipeline Products & Ongoing Clinical Trials Overview 183

5.63 Relisys Medical Devices Ltd Company Overview 184

5.63.1 Relisys Medical Devices Ltd Pipeline Products & Ongoing Clinical Trials Overview 184

5.64 REVA Medical Inc Company Overview 185

5.64.1 REVA Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 185

5.65 Rontis AG Company Overview 193

5.65.1 Rontis AG Pipeline Products & Ongoing Clinical Trials Overview 193

5.66 S3V Vascular Technologies Company Overview 194

5.66.1 S3V Vascular Technologies Pipeline Products & Ongoing Clinical Trials Overview 194

5.67 Sahajanand Medical Technologies Pvt Ltd Company Overview 195

5.67.1 Sahajanand Medical Technologies Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 195

5.68 Shanghai Bio-heart Biological Technology Co Ltd Company Overview 196

5.68.1 Shanghai Bio-heart Biological Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 196

5.69 Sino Medical Sciences Technology Inc Company Overview 199

5.69.1 Sino Medical Sciences Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 199

5.70 Sree Chitra Tirunal Institute for Medical Sciences & Technology Company Overview 204

5.70.1 Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 204

5.71 Stentys SA Company Overview 206

5.71.1 Stentys SA Pipeline Products & Ongoing Clinical Trials Overview 206

5.72 Svelte Medical Systems Inc Company Overview 207

5.72.1 Svelte Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 207

5.73 Tepha Inc Company Overview 213

5.73.1 Tepha Inc Pipeline Products & Ongoing Clinical Trials Overview 213

5.74 Terumo Corp Company Overview 214

5.74.1 Terumo Corp Pipeline Products & Ongoing Clinical Trials Overview 214

5.75 TissueGen Inc Company Overview 220

5.75.1 TissueGen Inc Pipeline Products & Ongoing Clinical Trials Overview 220

5.76 TrendyMED Inc. Company Overview 221

5.76.1 TrendyMED Inc. Pipeline Products & Ongoing Clinical Trials Overview 221

5.77 University of Alabama at Birmingham Company Overview 222

5.77.1 University of Alabama at Birmingham Pipeline Products & Ongoing Clinical Trials Overview 222

5.78 University of Colorado Company Overview 223

5.78.1 University of Colorado Pipeline Products & Ongoing Clinical Trials Overview 223

5.79 University of Florida Company Overview 224

5.79.1 University of Florida Pipeline Products & Ongoing Clinical Trials Overview 224

5.80 University of Michigan Company Overview 225

5.80.1 University of Michigan Pipeline Products & Ongoing Clinical Trials Overview 225

5.81 University of Strathclyde Company Overview 226

5.81.1 University of Strathclyde Pipeline Products & Ongoing Clinical Trials Overview 226

5.82 University of Utah Company Overview 228

5.82.1 University of Utah Pipeline Products & Ongoing Clinical Trials Overview 228

5.83 VasoTech Inc. Company Overview 229

5.83.1 VasoTech Inc. Pipeline Products & Ongoing Clinical Trials Overview 229

5.84 Viller Scientific LLC Company Overview 231

5.84.1 Viller Scientific LLC Pipeline Products & Ongoing Clinical Trials Overview 231

5.85 Vornia Biomaterials Ltd Company Overview 232

5.85.1 Vornia Biomaterials Ltd Pipeline Products & Ongoing Clinical Trials Overview 232

5.86 Xenogenics Corporation Company Overview 233

5.86.1 Xenogenics Corporation Pipeline Products & Ongoing Clinical Trials Overview 233

6 Coronary Stents- Recent Developments 236

6.1 Sep 17, 2020: CIRSE 2020: New clinical data support use of 4-french devices for ambulatory pad treatment 236

6.2 Jul 28, 2020: Impressio and MedShape awarded competitive grant from the National Science Foundation to develop joint replacement device 236

6.3 Jun 15, 2020: MicroPort announces strategic investment and forms joint venture with Indian medical device company purple medical 237

6.4 May 15, 2020: Microport orthopedics group brings in new strategic investors 238

6.5 May 14, 2020: Study examines the safety of bioabsorbable polymer against durable polymer drug-eluting stents in high-risk patients undergoing percutaneous coronary intervention 239

6.6 May 13, 2020: Truleaf Medical's successful mitral valve replacement large animals clinical trial proves the accurate deployment and long-term functioning of the implants in the heart 240

6.7 Apr 16, 2020: Abbott reports first-quarter 2020 results 241

6.8 Apr 14, 2020: BioCardia announces litigation financing in the case captioned Boston Scientific 243

6.9 Feb 24, 2020: BIOTRONIK's Ultrathin Strut Orsiro Coronary Drug-Eluting Stent continues to deliver excellent results after three years 244

6.10 Feb 24, 2020: 2020 Catalyst award winner Medtronic hires Chief Inclusion and Diversity Officer 245

6.11 Feb 24, 2020: Merit Medical reports earnings for fourth quarter and year ended December 31, 2019, gives FY 2020 Guidance 245

6.12 Feb 24, 2020: 2020 Catalyst Award Winner Medtronic hires Chief Inclusion and Diversity Officer 246

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

6.14 Feb 14, 2020: Vascular Perspectives and Asahi Intecc form strategic alliance. 249

6.15 Feb 12, 2020: BIOTRONIK introduces next generation Drug-Eluting Stent System in the CE region 250

6.16 Feb 11, 2020: Abbott Laboratories: Departure of directors or certain officers; election of directors; appointment of certain officers; compensatory arrangements of certain officer 250

6.17 Feb 05, 2020: Boston Scientific announces results for fourth quarter and full year 2019 251

6.18 Feb 05, 2020: Surmodics reports first quarter Fiscal 2020 results 252

6.19 Feb 03, 2020: Surmodics names Nusrath Sultana, MD, as Vice President, Clinical Affairs 253

6.20 Jan 27, 2020: Merit Medical issues statement regarding director nominations from starboard 254

6.21 Jan 22, 2020: ANGIOLITE trial 2 years outcomes have been published at EuroIntervention 254

6.22 Jan 22, 2020: Abbott reports fourth-quarter 2019 results; announces strong forecast for 2020 255

6.23 Jan 15, 2020: Merit milestones: facilities in Galway and Tijuana reach 1,000 employees 257

6.24 Jan 14, 2020: Boston Scientific announces preliminary unaudited sales for the fourth quarter and full year 2019 257

6.25 Jan 14, 2020: ICON issues financial guidance for full year 2020 259

6.26 Jan 08, 2020: ABBOTT LABORATORIES: Departure of directors or certain officers; election of directors; appointment of certain officers; compensatory arrangements of certain officers. 259

6.27 Dec 20, 2019: Cook Medical applauds congressional action to repeal the medical device excise tax 259

6.28 Dec 20, 2019: Osprey Medical: Fourth Quarter Update 260

6.29 Dec 12, 2019: Notice regarding establishment of Overseas Sales Subsidiary Asahi Intecc CIS 261

6.30 Dec 04, 2019: Lumeon and Medtronic partner to deliver new models of care in Europe 261

6.31 Nov 27, 2019: Enrolment completed for MASTER DAPT, a landmark trial investigating abbreviated DAPT post-implantation of Terumo's Ultimaster DES in high bleeding risk patients 262

6.32 Nov 27, 2019: Indian stent-maker SMT acquires majority stake in Zarek 263

6.33 Nov 19, 2019: Medtronic reports second quarter financial results for the year 2019 263

6.34 Nov 14, 2019: Medtronic highlights leadership in inclusion, diversity, and equity in 2019 integrated performance report 266

6.35 Nov 13, 2019: Abbott announces Robert B. Ford to Succeed Miles D. White as Chief Executive Officer on March 31, 2020 267

6.36 Nov 12, 2019: Cook Medical’s leadership updates in Asia-pacific reinforce focus on growth and physician relationships 268

6.37 Nov 06, 2019: Final five unpublished late-breaking clinical trial results announced at VIVA19 268

6.38 Oct 31, 2019: Surmodics reports fourth quarter fiscal 2019 results and issues fiscal 2020 revenue and EPS Guidance 271

6.39 Oct 30, 2019: Orsiro Coronary Drug-Eluting Stent receives market approval in China 272

6.40 Oct 30, 2019: Merit Medical reports earnings for third quarter of 2019 273

6.41 Oct 29, 2019: Osprey Medical: 48% increase in DyeVert third quarter unit sales 275

6.42 Oct 28, 2019: PolyNovo: Appointment non-executive director – Dr Robyn Elliott 277

6.43 Oct 23, 2019: ICON reports third quarter 2019 results 277

6.44 Oct 23, 2019: Boston Scientific announces results for third quarter 2019 278

6.45 Oct 23, 2019: Edwards Lifesciences reports third quarter results 280

6.46 Oct 21, 2019: Sean Salmon named executive vice president and group president of Medtronic Diabetes 283

6.47 Oct 16, 2019: Abbott reports third-quarter 2019 results 284

6.48 Oct 14, 2019: STENTYS: 2019 half-year results 287

6.49 Oct 10, 2019: CINDE announces Edwards Lifesciences invests $100 million to expand its operations in Costa Rica 290

6.50 Oct 09, 2019: ASAHI INTECC announces opening of medical components website of EU branch 291

6.51 Oct 08, 2019: Paclitaxel-coated devices are safe for unblocking arteries in lower limbs 291

7 Appendix 293

7.1 Methodology 293

7.2 About GlobalData 297

7.3 Contact Us 297

List of Tables

Table 1: Coronary Stents – Pipeline Products by Stage of Development 20

Table 2: Coronary Stents – Pipeline Products by Segment 21

Table 3: Coronary Stents – Pipeline Products by Territory 22

Table 4: Coronary Stents – Pipeline Products by Regulatory Path 24

Table 5: Coronary Stents – Pipeline Products by Estimated Approval Date 25

Table 6: Coronary Stents – Ongoing Clinical Trials 26

Table 7: Coronary Stents Companies – Pipeline Products by Stage of Development 27

Table 8: Coronary Stents – Pipeline Products by Stage of Development 31

Table 9: Abbott Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 35

Table 10: Second Generation Bioresorbable Vascular Scaffold – Product Status 35

Table 11: Second Generation Bioresorbable Vascular Scaffold – Product Description 36

Table 12: Xience SBA Everolimus Eluting Coronary Stent System – Product Status 36

Table 13: Xience SBA Everolimus Eluting Coronary Stent System – Product Description 36

Table 14: XIENCE Thin man DES – Product Status 37

Table 15: XIENCE Thin man DES – Product Description 37

Table 16: ZoMaxx Drug Eluting Coronary Stent System – Product Status 37

Table 17: ZoMaxx Drug Eluting Coronary Stent System – Product Description 38

Table 18: Abbott Vascular Inc – Ongoing Clinical Trials Overview 39

Table 19: Xience SBA Everolimus Eluting Coronary Stent System – A Multi-center, Randomized, Controlled Trial to Demonstrate the Safety and Effectiveness of the MiStent II for the Revascularization of Coronary Arteries: CRYSTAL Study 40

Table 20: Xience SBA Everolimus Eluting Coronary Stent System – A Prospective Global Randomized Trial Assessing the Safety and Efficacy of the BuMA Supreme Biodegradable Drug Coated Coronary Stent System for Coronary Revascularization in Patients with Stable Coronary Artery Disease or Non-ST Segment Elevation Acute Coronary Syndromes 40

Table 21: Xience SBA Everolimus Eluting Coronary Stent System – A Prospective Multicenter Randomized Post Market All-comer Trial to Assess the Safety and Effectiveness of the Supraflex Sirolimus-eluting Coronary Stent System for the Treatment of Atherosclerotic Lesion(s) 41

Table 22: Xience SBA Everolimus Eluting Coronary Stent System – Polish Bifurcation Optimal Treatment Strategy Study for Left Main Bifurcation Percutaneous Coronary Intervention (PCI) 41

Table 23: Adcomp Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview 42

Table 24: Dual Drug Eluting Stent – Product Status 42

Table 25: Dual Drug Eluting Stent – Product Description 42

Table 26: Advanced Bifurcation Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 43

Table 27: Stenting System – Bare Metal Stent – Product Status 43

Table 28: Stenting System – Bare Metal Stent – Product Description 43

Table 29: Stenting System – Drug Eluting Stent – Product Status 44

Table 30: Stenting System – Drug Eluting Stent – Product Description 44

Table 31: Aeon Bioscience Pipeline Products & Ongoing Clinical Trials Overview 45

Table 32: Drug Eluting Stent – Product Status 45

Table 33: Drug Eluting Stent – Product Description 45

Table 34: AlviMedica Medical Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 46

Table 35: BMS – Avantgarde – Product Status 46

Table 36: BMS – Avantgarde – Product Description 47

Table 37: Commander – Product Status 47

Table 38: Commander – Product Description 47

Table 39: Cre8 DES – Product Status 48

Table 40: Cre8 DES – Product Description 48

Table 41: Cre8 EVO DES – Product Status 48

Table 42: Cre8 EVO DES – Product Description 49

Table 43: DES – Coracto – Product Status 49

Table 44: DES – Coracto – Product Description 49

Table 45: Ephesos II – Product Status 50

Table 46: Ephesos II – Product Description 50

Table 47: Inperia Advance – Product Status 50

Table 48: Inperia Advance – Product Description 51

Table 49: AlviMedica Medical Technologies Inc – Ongoing Clinical Trials Overview 52

Table 50: Cre8 DES – A Prospective, Multi-center, Open Label, Randomized Controlled, Two Arm Study Evaluating Safety and Efficacy of the Permanent Polymer Zotarolimus Eluting Stent Resolute Integrity Compared to the Polymer Free Amphilimus Eluting Stent Cre8 53

Table 51: Cre8 DES – A Prospective, Multi-center, Randomized Controlled Trial Evaluating the Safety and Efficacy of the CRE8 Sirolimus-Eluting Stent Versus the RESOLUTE Zotarolimus-eluting Stent in the Treatment of Patients with De Novo Coronary Artery Lesions 53

Table 52: Cre8 DES – A Prospective, Multi-center, Single-arm Observational Registry Trial Evaluating the Safety and Efficacy of CRE8 Sirolimus-Eluting Stent in the Treatment of Patients With De Novo Coronary Artery Lesions 54

Table 53: Cre8 DES – Prove ART (Abluminal Reservoir Technology) Clinical Benefit in Alla Comers Patients 54

Table 54: Cre8 DES – Safety and Performance Assessment of Coronary Drug-eluting Stent CRE8: Post-market Observational Study 54

Table 55: Cre8 DES – Second-generation Drug-eluting Stents in Diabetes: A Randomized Trial: The SUGAR Trial 55

Table 56: Cre8 EVO DES – Randomized 2×2 Factorial Trial Comparing the Cre8 Amphilimus-sirolimus Eluting Stent versus the Synergy Everolimus-eluting Stent and a Personalized versus Standard Duration of Dual Antiplatelet Therapy in All-comers Patients Undergoing Percutaneous Coronary Intervention 56

Table 57: Amaranth Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 57

Table 58: 80-micron MAGNITUDE Bioresorbable Scaffold – Product Status 57

Table 59: 80-micron MAGNITUDE Bioresorbable Scaffold – Product Description 57

Table 60: APTITUDE Sirolimus-Eluting Bioresorbable Scaffold – Product Status 58

Table 61: APTITUDE Sirolimus-Eluting Bioresorbable Scaffold – Product Description 58

Table 62: DEFIANCE Scaffold – Product Status 58

Table 63: DEFIANCE Scaffold – Product Description 59

Table 64: FORTITUDE Scaffold – Product Status 59

Table 65: FORTITUDE Scaffold – Product Description 59

Table 66: MAGNITUDE Sirolimus-Eluting Bioresorbable Scaffold – Product Status 60

Table 67: MAGNITUDE Sirolimus-Eluting Bioresorbable Scaffold – Product Description 60

Table 68: Second Generation FORTITUDE Scaffold – Product Status 60

Table 69: Second Generation FORTITUDE Scaffold – Product Description 61

Table 70: Amaranth Medical Inc – Ongoing Clinical Trials Overview 62

Table 71: FORTITUDE Scaffold – Amaranth Endovascular Study of a Drug-eluting Bioresorbable Coronary Scaffold 63

Table 72: FORTITUDE Scaffold – Restoring Endoluminal Narrowing Using Bioresorbable Scaffolds – European Trial 63

Table 73: APTITUDE Sirolimus-Eluting Bioresorbable Scaffold – Restoring Endoluminal Narrowing Using Bioresorbable Scaffolds – Extended Trial II 64

Table 74: MAGNITUDE Sirolimus-Eluting Bioresorbable Scaffold – Restoring Endoluminal Narrowing Using Bioresorbable Scaffolds – Extended Trial III 65

Table 75: Arterius Ltd Pipeline Products & Ongoing Clinical Trials Overview 66

Table 76: Arteriosorb Absorbable Drug-Eluting Scaffold – Product Status 66

Table 77: Arteriosorb Absorbable Drug-Eluting Scaffold – Product Description 66

Table 78: Atrium Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 67

Table 79: Next Generation Super Flexible Cobalt Chromium Coronary Stent – Product Status 67

Table 80: Next Generation Super Flexible Cobalt Chromium Coronary Stent – Product Description 67

Table 81: Axordia Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 68

Table 82: Regenerative Stent – Product Status 68

Table 83: Regenerative Stent – Product Description 68

Table 84: B. Braun Melsungen AG Pipeline Products & Ongoing Clinical Trials Overview 69

Table 85: Coroflex DEBlue – Product Status 69

Table 86: Coroflex DEBlue – Product Description 69

Table 87: Bactiguard Holding AB Pipeline Products & Ongoing Clinical Trials Overview 70

Table 88: Metal-Coated Vascular Stent – Product Status 70

Table 89: Metal-Coated Vascular Stent – Product Description 70

Table 90: Bionext Biotech Products Ltd. Pipeline Products & Ongoing Clinical Trials Overview 71

Table 91: Biostent – Product Status 71

Table 92: Biostent – Product Description 71

Table 93: Biosensors International Group Ltd Pipeline Products & Ongoing Clinical Trials Overview 72

Table 94: BioFreedom Drug Coated Stent – Product Status 72

Table 95: BioFreedom Drug Coated Stent – Product Description 72

Table 96: Sparrow Drug Eluting Stent System – Product Status 73

Table 97: Sparrow Drug Eluting Stent System – Product Description 73

Table 98: Biosensors International Group Ltd – Ongoing Clinical Trials Overview 74

Table 99: BioFreedom Drug Coated Stent – A Prospective Study of the BioFreedom Biolimus A9 Drug Coated Stent in Patients at High Risk for Bleeding 75

Table 100: BioFreedom Drug Coated Stent – A Randomized Controlled Comparison Between One Versus More than Six Months of Dual Antiplatelet Therapy after Biolimus A9-eluting Stent Implantation 75

Table 101: BioFreedom Drug Coated Stent – A Study Evaluating the Safety and Efficacy of the BioFreedom Biolimus A9 Coated Cobalt Chromium Coronary Stent System in Patients at High Risk of Bleeding 75

Table 102: BioFreedom Drug Coated Stent – Asian Registry of the BioFreedom BA9 Drug-Coated Coronary Stent for Patients with ST Elevation Myocardial Infarction (STEMI) Undergoing Percutaneous Coronary Intervention (PCI) 76

Table 103: BioFreedom Drug Coated Stent – Evaluation of Effectiveness and Safety of BioFreedom Stent in Routine Clinical Practice: A Multicenter, Prospective Observational Study 76

Table 104: BioFreedom Drug Coated Stent – Evaluation of Effectiveness and Safety of the First, Second, and New Drug-eluting Stents in Routine Clinical Practice 76

Table 105: BioFreedom Drug Coated Stent – Prospective Multicenter Observational Study for Evaluating Efficacy and Safety of Biofreedom Stent in Patients with Coronary Artery Disease: Biofreedom Registry 77

Table 106: BioFreedom Drug Coated Stent – Randomized Comparison of a Polymer-free Biolimus-eluting BioFreedom Stent with a Biodegradable-polymer Sirolimus-eluting Orsiro Stent in Patients Treated with Percutaneous Coronary Intervention 77

Table 107: BioFreedom Drug Coated Stent – Randomized Comparison of Vascular Healing of a Polymer-free Biolimus-eluting BIOFREEDOM Stent with a Biodegradable-polymer Sirolimus-eluting ORSIRO Stent in Patients with ST-segment Elevation Myocardial Infarction 77

Table 108: BioFreedom Drug Coated Stent – Six-month Endothelial and Microvascular Function of the Bioactive Sirolimus-eluting Combo Stent Vs. The Polymer-free Biolimus-eluting Biofreedom Stent in Patients with St-segment Elevation Myocardial Infarction 78

Table 109: BioFreedom Drug Coated Stent – To Collect Additional Safety and Effectiveness Data for the Biosensors BioFreedom BA9 Drug Coated Coronary Stent in Patients with Native, de Novo Coronary Artery Disease 78

Table 110: Biosten, LLC Pipeline Products & Ongoing Clinical Trials Overview 79

Table 111: Biodegradable Endovascular Implant – Product Status 79

Table 112: Biodegradable Endovascular Implant – Product Description 79

Table 113: Biotronik AG Pipeline Products & Ongoing Clinical Trials Overview 80

Table 114: Coronary Stent System – Product Status 80

Table 115: Coronary Stent System – Product Description 80

Table 116: DREAMS 3G System – Product Status 81

Table 117: DREAMS 3G System – Product Description 81

Table 118: Magmaris Bioresorbable Magnesium Scaffold – Product Status 81

Table 119: Magmaris Bioresorbable Magnesium Scaffold – Product Description 82

Table 120: Biotronik AG – Ongoing Clinical Trials Overview 83

Table 121: Magmaris Bioresorbable Magnesium Scaffold – A Sirolimus Eluting Bioresorbable Magnesium Stent for Treatment of Coronary Bifurcation Lesions: The BIFSORB Pilot Study II 84

Table 122: Magmaris Bioresorbable Magnesium Scaffold – BIOTRONIK – Safety and Clinical Performance of the Drug Eluting Absorbable Metal Scaffold (DREAMS 2nd Generation) in the Treatment of Subjects with de Novo Lesions in Native Coronary Arteries: BIOSOLVE-II 84

Table 123: Magmaris Bioresorbable Magnesium Scaffold – Biotroniks – Safety and Performance in de Novo Lesion of Native Coronary Arteries with Magmaris- Registry: BIOSOLVE-IV 84

Table 124: Magmaris Bioresorbable Magnesium Scaffold – BIOTRONIKS-Safety and Performance in de Novo Lesion of Native Coronary Arteries with Magmaris (BIOSOLVE)-IV Magmaris Swiss Satellite Registry 85

Table 125: Magmaris Bioresorbable Magnesium Scaffold – Coronary Artery Healing Process after Bioresorbable Scaffold in Patients with Non-ST-segment Elevation Myocardial Infarction (NSTEMI) 85

Table 126: Magmaris Bioresorbable Magnesium Scaffold – Optical Coherence Guided Treatment of ST-segment Elevation Myocardial Infarction with the Drug-eluting Resorbable Magnesium Scaffold: The BEST- MAG Multicentre Study (Belgian ST-segment Elevation Myocardial Infarction Treatment with Resorbable Magnesium Scaffold) 85

Table 127: Magmaris Bioresorbable Magnesium Scaffold – Prospective Observational Registry of Patients with a Bioabsorbable Magnesium Stent Implant -MAGMARIS- in Usual Clinical Practice 86

Table 128: Magmaris Bioresorbable Magnesium Scaffold – Retrospective, Observational Register to Investigate the Procedural and Post Procedural Implantation of Bioabsorbable Magnesium Scaffolds Magmaris (MAGIC Registry) 86

Table 129: Magmaris Bioresorbable Magnesium Scaffold – Scaffold Implantation in Emilia-Romagna 86

Table 130: DREAMS 3G System – BIOTRONIK – Safety and Clinical Performance of the – Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold System (DREAMS 3G) in the Treatment of Subjects with de Novo Lesions in Native Coronary Arteries 87

Table 131: Biotronik SE & Co KG Pipeline Products & Ongoing Clinical Trials Overview 88

Table 132: AMS-2 – Product Status 88

Table 133: AMS-2 – Product Description 88

Table 134: ProGenic Pimecrolimus-eluting Coronary Stent System – Product Status 89

Table 135: ProGenic Pimecrolimus-eluting Coronary Stent System – Product Description 89

Table 136: Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 90

Table 137: Fully Resorbable Drug-Eluting Scaffold System – Product Status 90

Table 138: Fully Resorbable Drug-Eluting Scaffold System – Product Description 91

Table 139: JACTAX Drug Eluting Stent – Product Status 91

Table 140: JACTAX Drug Eluting Stent – Product Description 91

Table 141: SYNERGY 48 Stent – Product Status 92

Table 142: SYNERGY 48 Stent – Product Description 92

Table 143: Synergy Megatron Bioabsorbable Polymer (BP) Stent – Product Status 92

Table 144: Synergy Megatron Bioabsorbable Polymer (BP) Stent – Product Description 93

Table 145: SYNERGY XD Stent – Product Status 93

Table 146: SYNERGY XD Stent – Product Description 93

Table 147: TAXUS Petal Bifurcation Paclitaxel-Eluting Stent System – Product Status 94

Table 148: TAXUS Petal Bifurcation Paclitaxel-Eluting Stent System – Product Description 94

Table 149: Boston Scientific Corp – Ongoing Clinical Trials Overview 95

Table 150: Fully Resorbable Drug-Eluting Scaffold System – Fully Absorbable Scaffold Feasibility Study 96

Table 151: SYNERGY 48 Stent – A Prospective Multicenter Single Arm Trial to Assess the Safety and Effectiveness of the SYNERGY 48mm Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesion(s): EVOLVE 48 97

Table 152: SYNERGY 48 Stent – Stent Coverage and Neointimal Tissue Characterization after Extra Long Everolimus – Eluting Stent Implantation: Prospective Study using Optical Coherence Tomography 97

Table 153: Cardionovum GmbH Pipeline Products & Ongoing Clinical Trials Overview 98

Table 154: CARDIOSORB – Product Status 98

Table 155: CARDIOSORB – Product Description 98

Table 156: DEBLIMUS – Product Status 99

Table 157: DEBLIMUS – Product Description 99

Table 158: PROTECT – Product Status 99

Table 159: PROTECT – Product Description 100

Table 160: ReNATURAL (M) – Product Status 100

Table 161: ReNATURAL (M) – Product Description 100

Table 162: ReNATURAL (P) – Product Status 101

Table 163: ReNATURAL (P) – Product Description 101

Table 164: Cardiorev Pte Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 102

Table 165: Peptide-Eluting Coronary Stent – Product Status 102

Table 166: Peptide-Eluting Coronary Stent – Product Description 102

Table 167: Columbia University Pipeline Products & Ongoing Clinical Trials Overview 103

Table 168: C3 Exoenzyme Coated Stent – Product Status 103

Table 169: C3 Exoenzyme Coated Stent – Product Description 103

Table 170: Concept Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 104

Table 171: Abluminus DES+ – Product Status 104

Table 172: Abluminus DES+ – Product Description 104

Table 173: Concept Medical Inc – Ongoing Clinical Trials Overview 105

Table 174: Abluminus DES+ – A Multicenter, Prospective, Study to Evaluate the Safety and Effcacy of the Abluminus DES+ in an All-Comers Population 106

Table 175: Abluminus DES+ – A Post Market Registry of Abluminus Sirolimus Eluting Coronary Stent System for Percutaneous Intervention in Patients with Diabetes Mellitus 106

Table 176: Abluminus DES+ – A Randomized Clinical Trial of Abluminus DES+ Sirolimus Eluting Stent Versus Everolimus-eluting DES for Percutaneous Coronary Intervention in Patients with Diabetes Mellitus: an Investigator-initiated Pilot Study 106

Table 177: Abluminus DES+ – ABLUMINUS Below the Knee (BTK) Drug Eluting Stent (DES) Registry (ABLUMINUS BTK) – First in Men 107

Table 178: Abluminus DES+ – Randomized Comparison of Abluminus DES+ Sirolimus-Eluting Stents Versus Everolimus-Eluting Stents in Coronary Artery Disease Patients with Diabetes Mellitus Global – ABILITY Diabetes Global 107

Table 179: Contego Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 108

Table 180: CORGUARD Coronary Stent System – Product Status 108

Table 181: CORGUARD Coronary Stent System – Product Description 108

Table 182: Cordis Corp Pipeline Products & Ongoing Clinical Trials Overview 109

Table 183: Corio Pimecrolimus-eluting Stent – Product Status 109

Table 184: Corio Pimecrolimus-eluting Stent – Product Description 109

Table 185: CYPHER ELITE – Product Status 110

Table 186: CYPHER ELITE – Product Description 110

Table 187: NEVO Sirolimus-Eluting Coronary Stent – Product Status 110

Table 188: NEVO Sirolimus-Eluting Coronary Stent – Product Description 111

Table 189: Next Generation Coronary Stent – Product Status 111

Table 190: Next Generation Coronary Stent – Product Description 111

Table 191: SymBio Pimecrolimus/Paclitaxel-eluting Stent – Product Status 112

Table 192: SymBio Pimecrolimus/Paclitaxel-eluting Stent – Product Description 112

Table 193: Cytograft Tissue Engineering Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 113

Table 194: LifeJacket Stent Graft – Coronary Stenting – Product Status 113

Table 195: LifeJacket Stent Graft – Coronary Stenting – Product Description 113

Table 196: DISA Vascular (Pty) Ltd Pipeline Products & Ongoing Clinical Trials Overview 114

Table 197: Stellium Stent – Product Status 114

Table 198: Stellium Stent – Product Description 114

Table 199: Elixir Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 115

Table 200: DESolve Myolimus Eluting Bioresorbable Coronary Scaffold System – Product Status 115

Table 201: DESolve Myolimus Eluting Bioresorbable Coronary Scaffold System – Product Description 115

Table 202: Myolimus Eluting Coronary Stent – Durable Polymer – Product Status 116

Table 203: Myolimus Eluting Coronary Stent – Durable Polymer – Product Description 116

Table 204: Envision Scientific Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 117

Table 205: Abluminus NP – Product Status 117

Table 206: Abluminus NP – Product Description 117

Table 207: Paclitaxel Eluting Stent – Product Status 118

Table 208: Paclitaxel Eluting Stent – Product Description 118

Table 209: HangZhou HuaAn Biotechnology Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 119

Table 210: Xinsorb BRS – Product Status 119

Table 211: Xinsorb BRS – Product Description 119

Table 212: I.B.S. S.p.A. Pipeline Products & Ongoing Clinical Trials Overview 120

Table 213: Drug Eluting Stent – Product Status 120

Table 214: Drug Eluting Stent – Product Description 120

Table 215: Icon Interventional Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 121

Table 216: Biosorb Pediatric Dissolving Stent – Product Status 121

Table 217: Biosorb Pediatric Dissolving Stent – Product Description 121

Table 218: ID Nest Medical SAS Pipeline Products & Ongoing Clinical Trials Overview 122

Table 219: ID Arterial System – Product Status 122

Table 220: ID Arterial System – Product Description 122

Table 221: InspireMD Inc Pipeline Products & Ongoing Clinical Trials Overview 123

Table 222: MGuard Drug Eluting Stent – Product Status 123

Table 223: MGuard Drug Eluting Stent – Product Description 123

Table 224: Japan Stent Technology Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 124

Table 225: Bioabsorbable Stent – Product Status 124

Table 226: Bioabsorbable Stent – Product Description 124

Table 227: JW Medical Systems Ltd Pipeline Products & Ongoing Clinical Trials Overview 125

Table 228: Excel II DES – Product Status 125

Table 229: Excel II DES – Product Description 125

Table 230: JW Medical Systems Ltd – Ongoing Clinical Trials Overview 126

Table 231: Excel II DES – A Prospective Multicenter Randomized Trial to Assess the Safety and Effectiveness of EXCEL-II Sirolimus Eluting Stent vs. EXCEL Sirolimus Eluting Stent for the Treatment of Patients with de Novo Coronary Artery Lesions (CREDIT II Trial) 127

Table 232: Excel II DES – A Prospective Multicenter Single-Arm Observational Registry Study to Assess the Safety and Efficacy of EXCEL-II with Sirolimus Eluting Stent for the Treatment of Patients with de Novo Coronary Artery (CREDIT-III) 127

Table 233: Kaneka Corp Pipeline Products & Ongoing Clinical Trials Overview 128

Table 234: MAHOROBA Stent – Product Status 128

Table 235: MAHOROBA Stent – Product Description 128

Table 236: Kyoto Medical Planning Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 129

Table 237: Igaki-Tamai Coronary Stent – Product Status 129

Table 238: Igaki-Tamai Coronary Stent – Product Description 129

Table 239: Liaoning Biomedical Materials R&D Center Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 130

Table 240: YINYI Polymer-free Drug-coated (Paclitaxel) Coronary Stent System – Product Status 130

Table 241: YINYI Polymer-free Drug-coated (Paclitaxel) Coronary Stent System – Product Description 130

Table 242: Lifetech Scientific (Shenzhen) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 131

Table 243: IBS Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System – Product Status 131

Table 244: IBS Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System – Product Description 131

Table 245: Lifetech Scientific (Shenzhen) Co Ltd – Ongoing Clinical Trials Overview 132

Table 246: IBS Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System – A First-in-man Study of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System (IBS) 133

Table 247: IBS Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System – A Prospective, Non-randomized, Open-label, Non-comparative, First-in-Man Study to Evaluate the Feasibility and Safety of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System 133

Table 248: MangoGen Pharma Inc Pipeline Products & Ongoing Clinical Trials Overview 134

Table 249: Gene-Delivering Stent – Product Status 134

Table 250: Gene-Delivering Stent – Product Description 134

Table 251: Manli Cardiology Ltd Pipeline Products & Ongoing Clinical Trials Overview 135

Table 252: MIRAGE – Product Status 135

Table 253: MIRAGE – Product Description 135

Table 254: Medinol Ltd Pipeline Products & Ongoing Clinical Trials Overview 136

Table 255: Elunir Elastomer Drug Eluting Stent – Product Status 136

Table 256: Elunir Elastomer Drug Eluting Stent – Product Description 137

Table 257: Elunir Elastomer Drug Eluting Stent – 38mm – Product Status 137

Table 258: Elunir Elastomer Drug Eluting Stent – 38mm – Product Description 138

Table 259: Elunir Elastomer Drug Eluting Stent – 44mm – Product Status 138

Table 260: Elunir Elastomer Drug Eluting Stent – 44mm – Product Description 139

Table 261: Medinol Ltd – Ongoing Clinical Trials Overview 140

Table 262: Elunir Elastomer Drug Eluting Stent – BioNIR Ridaforolimus Eluting Coronary Stent System (BioNIR) EUropean Angiography Study 141

Table 263: Elunir Elastomer Drug Eluting Stent – BioNIR Ridaforolimus Eluting Coronary Stent System (BioNIR) In Coronary Stenosis – PK Study 141

Table 264: Elunir Elastomer Drug Eluting Stent – BioNIR Ridaforolimus Eluting Coronary Stent System (BioNIR) in Coronary Stenosis Trial 141

Table 265: Elunir Elastomer Drug Eluting Stent – Elunir Ridaforolimus Eluting Coronary Stent System in Patients at High Bleeding Risk (HBR)- EluNIR HBR Study 142

Table 266: Elunir Elastomer Drug Eluting Stent – Multi-center Study for Evaluating the Safety and Efficacy of the MedJ-01 Ridaforolimus Eluting Coronary Stent System (MedJ-01) In Coronary Stenosis Trial 142

Table 267: Medlogics Device Corp (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 143

Table 268: COBRA-Q Drug Eluting Stent – Product Status 143

Table 269: COBRA-Q Drug Eluting Stent – Product Description 143

Table 270: Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 144

Table 271: Bifurcated Drug Eluting Stent – Product Status 144

Table 272: Bifurcated Drug Eluting Stent – Product Description 145

Table 273: Drug Filled Stent – Product Status 145

Table 274: Drug Filled Stent – Product Description 145

Table 275: Resolute Onyx DES – Bifurcation Lesions – Product Status 146

Table 276: Resolute Onyx DES – Bifurcation Lesions – Product Description 146

Table 277: Resolute Onyx DES – DAPT – Product Status 146

Table 278: Resolute Onyx DES – DAPT – Product Description 147

Table 279: Twin-Rail – Product Status 147

Table 280: Twin-Rail – Product Description 147

Table 281: Medtronic Plc – Ongoing Clinical Trials Overview 148

Table 282: Resolute Onyx DES – Bifurcation Lesions – A Post-approval Study of the Medtronic Resolute Onyx Zotarolimus-eluting Coronary Stent System 149

Table 283: Resolute Onyx DES – DAPT – A Single Arm Trial with Resolute Onyx in ONE-month DAPT for High-bleeding Risk Patients Who Are Considered One-month Clear: Onyx ONE Clear 150

Table 284: Miami Cardiovascular Innovations Pipeline Products & Ongoing Clinical Trials Overview 151

Table 285: Biologically Engineered Stent – Product Status 151

Table 286: Biologically Engineered Stent – Product Description 151

Table 287: Micell Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 152

Table 288: Bioresorbable Scaffold (BRS) – Product Status 152

Table 289: Bioresorbable Scaffold (BRS) – Product Description 152

Table 290: MiStent SES – Product Status 153

Table 291: MiStent SES – Product Description 153

Table 292: Micell Technologies Inc – Ongoing Clinical Trials Overview 154

Table 293: MiStent SES – A Prospective, Single-blinded, Multi-center, Randomized, Controlled, Registered Clinical Trial on the Efficacy and Safety of Sirolimus-eluting Stent (MiStent System) in the Treatment of Patients with Coronary Heart Disease 155

Table 294: MiStent SES – MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES) Optical Coherence Tomography (OCT) 155

Table 295: MiStent SES – Multicenter Randomized Study of the MiStent Sirolimus Eluting Absorbable Polymer Stent System (MiStent SES) for Revascularization of Coronary Arteries 156

Table 296: MiStent SES – Multicenter Randomized Study of the Mistent Sirolimus Eluting Absorbable Polymer Stent System (MT005) for Revascularization of Coronary Arteries 156

Table 297: Michigan Technological University Pipeline Products & Ongoing Clinical Trials Overview 157

Table 298: Bioabsorbable Stent – Product Status 157

Table 299: Bioabsorbable Stent – Product Description 157

Table 300: MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 158

Table 301: Fantasy Drug-Eluting Stent – Product Status 158

Table 302: Fantasy Drug-Eluting Stent – Product Description 159

Table 303: Firebird2 Nova – Product Status 159

Table 304: Firebird2 Nova – Product Description 159

Table 305: Firefalcon Bioresorbable Device – Product Status 160

Table 306: Firefalcon Bioresorbable Device – Product Description 160

Table 307: Firesorb – Product Status 160

Table 308: Firesorb – Product Description 161

Table 309: MicroPort Scientific Corp – Ongoing Clinical Trials Overview 162

Table 310: Firesorb – A First-in-man Study of the Firesorb Sirolimus Target Eluting Bioresorbable Vascular Scaffold in Patients with Coronary Artery Disease: FUTURE-I 163

Table 311: Firesorb – A Prospective Multicenter Single-arm Clinical Trial Assessing the Safety and Effectiveness of Firesorb Sirolimus Target Eluting Bioresorbable Vascular Scaffold for the Treatment of Coronary Artery Disease: FUTURE III 163

Table 312: Firesorb – A Randomized Trial of the Firesorb Sirolimus Target Eluting Bioresorbable Vascular Scaffold in Patients with Coronary Artery Disease: FUTURE-II 163

Table 313: Minvasys SAS Pipeline Products & Ongoing Clinical Trials Overview 164

Table 314: Nile LM SIR Sirolimus Eluting Intracoronary Stent – Product Status 164

Table 315: Nile LM SIR Sirolimus Eluting Intracoronary Stent – Product Description 164

Table 316: MIV Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 165

Table 317: Smart-1 DES – Product Status 165

Table 318: Smart-1 DES – Product Description 166

Table 319: Smart-2 DES – Product Status 166

Table 320: Smart-2 DES – Product Description 166

Table 321: Smart-3 DES – Product Status 167

Table 322: Smart-3 DES – Product Description 167

Table 323: Smart-4 DES – Product Status 167

Table 324: Smart-4 DES – Product Description 168

Table 325: Vestapor – Product Status 168

Table 326: Vestapor – Product Description 168

Table 327: VESTAsync – Product Status 169

Table 328: VESTAsync – Product Description 169

Table 329: NanoCoeur, Inc. Pipeline Products & Ongoing Clinical Trials Overview 170

Table 330: Nanocoating Cardiac Stent – Product Status 170

Table 331: Nanocoating Cardiac Stent – Product Description 170

Table 332: Nanova, Inc Pipeline Products & Ongoing Clinical Trials Overview 171

Table 333: Coronary Stent – Product Status 171

Table 334: Coronary Stent – Product Description 171

Table 335: National University of Ireland Galway Pipeline Products & Ongoing Clinical Trials Overview 172

Table 336: Cardiovascular Stent – Product Status 172

Table 337: Cardiovascular Stent – Product Description 172

Table 338: Nesstent Ltd. Pipeline Products & Ongoing Clinical Trials Overview 173

Table 339: NesStent's Stent – Coronary Bifurcations – Product Status 173

Table 340: NesStent's Stent – Coronary Bifurcations – Product Description 173

Table 341: Nexeon MedSystems Inc Pipeline Products & Ongoing Clinical Trials Overview 174

Table 342: PROTEX Coronary Stent System – Product Status 174

Table 343: PROTEX Coronary Stent System – Product Description 174

Table 344: North Carolina State University Pipeline Products & Ongoing Clinical Trials Overview 175

Table 345: Biodegradable Metal Stent – Product Status 175

Table 346: Biodegradable Metal Stent – Product Description 175

Table 347: Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 176

Table 348: Liquid Cast Drug-Eluting Biodegradable Stent – Product Status 176

Table 349: Liquid Cast Drug-Eluting Biodegradable Stent – Product Description 176

Table 350: NuVascular Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 177

Table 351: NuSpun DE Stent Sheath – Product Status 177

Table 352: NuSpun DE Stent Sheath – Product Description 177

Table 353: OrbusNeich Pipeline Products & Ongoing Clinical Trials Overview 178

Table 354: Cura Stent – Product Status 178

Table 355: Cura Stent – Product Description 178

Table 356: Sirolimus-Eluting Absorbable Vascular

List of Figures

Figure 1: Coronary Stents – Pipeline Products by Stage of Development 20

Figure 2: Coronary Stents – Pipeline Products by Segment 21

Figure 3: Coronary Stents – Pipeline Products by Territory 22

Figure 4: Coronary Stents – Pipeline Products by Regulatory Path 24

Figure 5: Coronary Stents – Pipeline Products by Estimated Approval Date 25

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