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Drug Eluting Stents (DES)-Medical Devices Pipeline Assessment, 2016

Drug Eluting Stents (DES)-Medical Devices Pipeline Assessment, 2016


  • Products Id :- GDME0300EPD
  • |
  • Pages: 268
  • |
  • December 2016
  • |
  • |
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Executive Summary

Drug Eluting Stents (DES)-Medical Devices Pipeline Assessment, 2016

Summary

GlobalData's Medical Devices sector report, "Drug Eluting Stents (DES)-Medical Devices Pipeline Assessment, 2016" provides an overview of Drug Eluting Stents (DES) currently in pipeline stage.

The report provides comprehensive information on the pipeline products with comparative analysis of the products at various stages of development. The report reviews major players involved in the pipeline product development. It also provides information about clinical trials in progress, which includes trial phase, trial status, trial start and end dates, and, the number of trials for the key Drug Eluting Stents (DES) pipeline products.

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

*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.

Scope

Extensive coverage of the Drug Eluting Stents (DES) 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 Drug Eluting Stents (DES) 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 Drug Eluting Stents (DES) 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



Contact Us:
Ken Research
Ankur Gupta, Head Marketing & Communications
ankur [@] kenresearch.com
+91-9015378249
www.kenresearch.com

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 8

1.2 List of Figures 17

2 Introduction 18

2.1 Drug Eluting Stents (DES) Overview 18

3 Products under Development 19

3.1 Drug Eluting Stents (DES)-Pipeline Products by Stage of Development 19

3.2 Drug Eluting Stents (DES)-Pipeline Products by Territory 20

3.3 Drug Eluting Stents (DES)-Pipeline Products by Regulatory Path 21

3.4 Drug Eluting Stents (DES)-Pipeline Products by Estimated Approval Date 22

3.5 Drug Eluting Stents (DES)-Ongoing Clinical Trials 23

4 Drug Eluting Stents (DES)-Pipeline Products under Development by Companies 24

4.1 Drug Eluting Stents (DES) Companies-Pipeline Products by Stage of Development 24

4.2 Drug Eluting Stents (DES)-Pipeline Products by Stage of Development 27

5 Drug Eluting Stents (DES) Companies and Product Overview 30

5.1 Aachen Resonance GmbH Company Overview 30

5.1.1 Aachen Resonance GmbH Pipeline Products & Ongoing Clinical Trials Overview 30

5.2 Abbott Vascular Inc. Company Overview 31

5.2.1 Abbott Vascular Inc. Pipeline Products & Ongoing Clinical Trials Overview 31

5.3 Adcomp Technologies Inc. Company Overview 35

5.3.1 Adcomp Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview 35

5.4 Aeon Bioscience Company Overview 36

5.4.1 Aeon Bioscience Pipeline Products & Ongoing Clinical Trials Overview 36

5.5 AlviMedica Medical Technologies Inc. Company Overview 37

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

5.6 Amaranth Medical Inc Company Overview 44

5.6.1 Amaranth Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 44

5.7 Arravasc Ltd Company Overview 46

5.7.1 Arravasc Ltd Pipeline Products & Ongoing Clinical Trials Overview 46

5.8 B. Braun Melsungen AG Company Overview 47

5.8.1 B. Braun Melsungen AG Pipeline Products & Ongoing Clinical Trials Overview 47

5.9 Biosensors International Group Ltd Company Overview 48

5.9.1 Biosensors International Group Ltd Pipeline Products & Ongoing Clinical Trials Overview 48

5.10 Biotronik SE & Co KG Company Overview 56

5.10.1 Biotronik SE & Co KG Pipeline Products & Ongoing Clinical Trials Overview 56

5.11 Boston Scientific Corp Company Overview 72

5.11.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 72

5.12 Cardionovum GmbH Company Overview 76

5.12.1 Cardionovum GmbH Pipeline Products & Ongoing Clinical Trials Overview 76

5.13 CARDIOREV PTE. LTD Company Overview 77

5.13.1 CARDIOREV PTE. LTD Pipeline Products & Ongoing Clinical Trials Overview 77

5.14 Columbia University Company Overview 78

5.14.1 Columbia University Pipeline Products & Ongoing Clinical Trials Overview 78

5.15 Contego Medical, LLC Company Overview 79

5.15.1 Contego Medical, LLC Pipeline Products & Ongoing Clinical Trials Overview 79

5.16 Cordis Corp Company Overview 80

5.16.1 Cordis Corp Pipeline Products & Ongoing Clinical Trials Overview 80

5.17 DISA Vascular (Pty) Ltd. Company Overview 85

5.17.1 DISA Vascular (Pty) Ltd. Pipeline Products & Ongoing Clinical Trials Overview 85

5.18 Divya Laboratories Company Overview 86

5.18.1 Divya Laboratories Pipeline Products & Ongoing Clinical Trials Overview 86

5.19 Elixir Medical Corp Company Overview 87

5.19.1 Elixir Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 87

5.20 Envision Scientific Pvt. Ltd Company Overview 90

5.20.1 Envision Scientific Pvt. Ltd Pipeline Products & Ongoing Clinical Trials Overview 90

5.21 I.B.S. S.p.A. Company Overview 92

5.21.1 I.B.S. S.p.A. Pipeline Products & Ongoing Clinical Trials Overview 92

5.22 InspireMD Inc Company Overview 93

5.22.1 InspireMD Inc Pipeline Products & Ongoing Clinical Trials Overview 93

5.23 Kaneka Corp Company Overview 95

5.23.1 Kaneka Corp Pipeline Products & Ongoing Clinical Trials Overview 95

5.24 Lepu Medical Technology (Beijing) Co Ltd Company Overview 97

5.24.1 Lepu Medical Technology (Beijing) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 97

5.25 Medinol Ltd Company Overview 102

5.25.1 Medinol Ltd Pipeline Products & Ongoing Clinical Trials Overview 102

5.26 Medlogics Device Corp Company Overview 108

5.26.1 Medlogics Device Corp Pipeline Products & Ongoing Clinical Trials Overview 108

5.27 Medtronic plc Company Overview 109

5.27.1 Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 109

5.28 Meril Life Sciences Pvt Ltd Company Overview 117

5.28.1 Meril Life Sciences Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 117

5.29 Micell Technologies Inc Company Overview 123

5.29.1 Micell Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 123

5.30 MicroPort Scientific Corp Company Overview 127

5.30.1 MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 127

5.31 Minvasys Company Overview 131

5.31.1 Minvasys Pipeline Products & Ongoing Clinical Trials Overview 131

5.32 MIV Therapeutics Inc Company Overview 132

5.32.1 MIV Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 132

5.33 Northwestern University Company Overview 136

5.33.1 Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 136

5.34 NuVascular Technologies Inc Company Overview 138

5.34.1 NuVascular Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 138

5.35 OrbusNeich Company Overview 139

5.35.1 OrbusNeich Pipeline Products & Ongoing Clinical Trials Overview 139

5.36 Relisys Medical Devices Ltd Company Overview 146

5.36.1 Relisys Medical Devices Ltd Pipeline Products & Ongoing Clinical Trials Overview 146

5.37 REVA Medical Inc Company Overview 148

5.37.1 REVA Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 148

5.38 Rontis AG Company Overview 150

5.38.1 Rontis AG Pipeline Products & Ongoing Clinical Trials Overview 150

5.39 Sino Medical-Device Technology Co., Ltd. Company Overview 151

5.39.1 Sino Medical-Device Technology Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 151

5.40 Stentys SA Company Overview 155

5.40.1 Stentys SA Pipeline Products & Ongoing Clinical Trials Overview 155

5.41 Svelte Medical Systems, Inc. Company Overview 157

5.41.1 Svelte Medical Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 157

5.42 Terumo Corp Company Overview 161

5.42.1 Terumo Corp Pipeline Products & Ongoing Clinical Trials Overview 161

5.43 Tryton Medical Inc Company Overview 163

5.43.1 Tryton Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 163

5.44 University of Alabama at Birmingham Company Overview 166

5.44.1 University of Alabama at Birmingham Pipeline Products & Ongoing Clinical Trials Overview 166

5.45 University of Florida Company Overview 168

5.45.1 University of Florida Pipeline Products & Ongoing Clinical Trials Overview 168

5.46 University of Strathclyde Company Overview 170

5.46.1 University of Strathclyde Pipeline Products & Ongoing Clinical Trials Overview 170

5.47 Vascular Concepts Ltd Company Overview 172

5.47.1 Vascular Concepts Ltd Pipeline Products & Ongoing Clinical Trials Overview 172

5.48 Zorion Medical Company Overview 175

5.48.1 Zorion Medical Pipeline Products & Ongoing Clinical Trials Overview 175

6 Drug Eluting Stents (DES)- Recent Developments 177

6.1 Nov 28, 2016: Micell Technologies Announces First Patient Enrolled In Landmark Registration Trial Of MiStent In Japan 177

6.2 Nov 22, 2016: Medtronic Reports Second Quarter Financial Results 178

6.3 Nov 21, 2016: OrbusNeich Introduces a New Generation COMBO Plus Dual Therapy Stent for Active Healing 180

6.4 Nov 18, 2016: MicroPort's Firesorb Stars in TCT 2016 181

6.5 Nov 18, 2016: MicroPort's Firehawk Stars in TCT 2016 182

6.6 Nov 16, 2016: Medtronic Releases FY16 Integrated Performance Report 182

6.7 Nov 15, 2016: CEVA to work with Medtronic for distribution facility construction 183

6.8 Nov 14, 2016: InspireMD Reports Financial Results for the Third Quarter Ended September 30, 2016 183

6.9 Nov 07, 2016: Medinol receives approval from the Japanese PMDA to begin clinical study on novel DES 185

6.10 Nov 07, 2016: ARIAD Reports Third Quarter 2016 Financial Results 186

6.11 Nov 01, 2016: TCT 2016: Physicians Share Positive Experiences with Magmaris Resorbable Scaffold at Symposium 188

6.12 Oct 31, 2016: First Clinical Data of Medtronic Drug-Filled Stent Show Positive Outcomes 189

6.13 Oct 31, 2016: TCT 2016: Orsiro Drug-Eluting Stent Proves Non-Inferiority to Resolute Integrity and Synergy Stents 190

6.14 Oct 31, 2016: Positive Five-Year Clinical Data from Micell Technologies' MiStent Presented at TCT 2016 191

6.15 Oct 31, 2016: Svelte Medical Systems Announces Start of DIRECT III Post-Market Registry Study 192

6.16 Oct 30, 2016: Independent Study Finds Biodegradable Polymer Stents Provide No Clinical Benefit Over Resolute Integrity DES 192

6.17 Oct 28, 2016: Tryton Medical Enters Into Strategic Agreement with Cardinal Health 193

6.18 Oct 28, 2016: MicroPort Wins Annual PMO Award of PMI (China) 194

6.19 Oct 28, 2016: REVA Medical: Quarter Ended 30 September 2016 195

6.20 Oct 26, 2016: Boston Scientific Announces Results For Third Quarter 2016 195

6.21 Oct 24, 2016: Svelte Medical Systems Announces CE Mark Certification of DIRECT RX 197

6.22 Oct 19, 2016: Firehawk Receives South Korea KGMP Certification 198

6.23 Oct 19, 2016: Abbott Reports Third-Quarter 2016 Results 198

6.24 Oct 19, 2016: Elixir Medical Announces Schedule of Programs for TCT 2016 200

6.25 Oct 17, 2016: Tryton Medical Announces Clinical Symposium on Treatment of Complex Bifurcation Lesions at TCT 2016 202

6.26 Oct 17, 2016: First Firehawk Implantation in Pakistan Completed 203

6.27 Oct 17, 2016: MicroPort Concludes Enrollment In Randomized, Multicenter, European Study Of Firehawk Coronary Stent System 203

6.28 Oct 10, 2016: Professor Ian Meredith To Join Boston Scientific As Executive Vice President And Global Chief Medical Officer 204

6.29 Sep 29, 2016: BIOTRONIK Begins Manufacturing High-Tech Products in Singapore 205

6.30 Sep 15, 2016: STENTYS Reports 2016 First-Half Results 205

6.31 Sep 15, 2016: Medtronic Names Mark Ploof Senior Vice President of Global Operations and Business Services 207

6.32 Sep 12, 2016: Firehawk Receives Regulatory Approval in Pakistan 207

6.33 Sep 07, 2016: InspireMD Appoints Thomas Kester to Board of Directors 208

6.34 Sep 01, 2016: First Firehawk Implantation in East Europe Completed 208

6.35 Aug 30, 2016: BASKET-SAVAGE trial: Drug-eluting stents more benefit in saphenous vein grafts 209

6.36 Aug 30, 2016: MPSC Announces 2016 Interim Results 209

6.37 Aug 25, 2016: Medtronic Reports First Quarter Financial Results 211

6.38 Aug 24, 2016: Firehawk Granted Market Launch in Vietnam 213

6.39 Aug 24, 2016: Innovation, Translation, and Cooperation: MicroPort Attends CHC 2016 to Present Firehawk 214

6.40 Aug 15, 2016: Firehawk Approved for Market Launch in Argentina 215

6.41 Aug 09, 2016: InspireMD Reports Financial Results for the Second Quarter Ended June 30, 2016 215

6.42 Jul 29, 2016: REVA Medical: Quarter Ended 30 June 2016 217

6.43 Jul 28, 2016: Boston Scientific Announces Results For Second Quarter 2016 218

6.44 Jul 28, 2016: ARIAD Reports Second Quarter and First Half 2016 Financial Results 219

6.45 Jul 21, 2016: Firehawk Granted Market Approval in India 221

6.46 Jul 21, 2016: Svelte Medical Systems Raises USD4 Million in Venture Financing 222

6.47 Jul 20, 2016: Abbott Reports Second-Quarter 2016 Results 222

6.48 Jul 19, 2016: STENTYS Enrolls First Patient in Left Main Clinical Trial 224

6.49 Jul 13, 2016: Boston Scientific Elects Yoshiaki Fujimori to Board of Directors 225

6.50 Jul 12, 2016: STENTYS: 41% Increase in Revenues in the Second Quarter of 2016 225

6.51 Jul 05, 2016: Outcomes from Tryton Medical Pivotal Confirmatory Study Published in JACC Cardiovascular Interventions 225

6.52 Jul 04, 2016: STENTYS: Appointment of Cardiolovascular Device Veteran as New CEO 226

6.53 Jun 30, 2016: NuVasive Agrees to Settle Patent Litigation With Medtronic 227

6.54 Jun 29, 2016: InspireMD Raises USD14.6 Million in Public Offering of Preferred Stock and Warrants 227

6.55 Jun 20, 2016: Micell Technologies Raises USD25.8 Million in Venture Financing 227

6.56 Jun 17, 2016: ARIAD Completes Strategic Review and Announces Plans for Growth 227

6.57 Jun 15, 2016: BIOTRONIK Announces CE Mark for Magmaris, the First Clinically Proven Bioresorbable Magnesium Scaffold 228

6.58 Jun 08, 2016: STENTYS Announces CE Marking Of Its Longest Xposition Stent 229

6.59 Jun 08, 2016: Boston Scientific Announces Restructuring Program to Support Long-Term Growth and Innovation 229

6.60 Jun 06, 2016: Medtronic Outlines Future Growth Vision at Investor Day 230

6.61 Jun 03, 2016: Lepu Medical Releases Updates of Clinical trial results of NeoVas Stent in EuroPCR 2016 230

6.62 Jun 03, 2016: LEPUCARE established in India 231

7 Appendix 265

7.1 Methodology 265

7.2 About GlobalData 268

7.3 Contact Us 268

7.4 Disclaimer 268

1.2 List of Figures

Figure 1: Drug Eluting Stents (DES)-Pipeline Products by Stage of Development 19

Figure 2: Drug Eluting Stents (DES)-Pipeline Products by Territory 20

Figure 3: Drug Eluting Stents (DES)-Pipeline Products by Regulatory Path 21

Figure 4: Drug Eluting Stents (DES)-Pipeline Products by Estimated Approval Date 22

Figure 5: Drug Eluting Stents (DES)-Ongoing Clinical Trials 23

1.1 List of Tables

Table 1: Drug Eluting Stents (DES)-Pipeline Products by Stage of Development 19

Table 2: Drug Eluting Stents (DES)-Pipeline Products by Territory 20

Table 3: Drug Eluting Stents (DES)-Pipeline Products by Regulatory Path 21

Table 4: Drug Eluting Stents (DES)-Pipeline Products by Estimated Approval Date 22

Table 5: Drug Eluting Stents (DES)-Ongoing Clinical Trials 23

Table 6: Drug Eluting Stents (DES) Companies-Pipeline Products by Stage of Development 24

Table 7: Drug Eluting Stents (DES)-Pipeline Products by Stage of Development 27

Table 8: Aachen Resonance GmbH Pipeline Products & Ongoing Clinical Trials Overview 30

Table 9: ARtax Coronary Stent-Product Status 30

Table 10: ARtax Coronary Stent-Product Description 30

Table 11: Abbott Vascular Inc. Pipeline Products & Ongoing Clinical Trials Overview 31

Table 12: AVJ-09-385 Everolimus Eluting Coronary Stent System-Product Status 31

Table 13: AVJ-09-385 Everolimus Eluting Coronary Stent System-Product Description 32

Table 14: Xience SBA Everolimus Eluting Coronary Stent System-Product Status 32

Table 15: Xience SBA Everolimus Eluting Coronary Stent System-Product Description 32

Table 16: XIENCE Thinman DES-Product Status 33

Table 17: XIENCE Thinman DES-Product Description 33

Table 18: ZoMaxx Drug Eluting Coronary Stent System-Product Status 33

Table 19: ZoMaxx Drug Eluting Coronary Stent System-Product Description 34

Table 20: Adcomp Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview 35

Table 21: Dual Drug Eluting Stent-Product Status 35

Table 22: Dual Drug Eluting Stent-Product Description 35

Table 23: Aeon Bioscience Pipeline Products & Ongoing Clinical Trials Overview 36

Table 24: Drug Eluting Stent-Product Status 36

Table 25: Drug Eluting Stent-Product Description 36

Table 26: AlviMedica Medical Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview 37

Table 27: Cre8 DES-Product Status 37

Table 28: Cre8 DES-Product Description 38

Table 29: DES-Coracto-Product Status 38

Table 30: DES-Coracto-Product Description 39

Table 31: Janus Flex-Product Status 39

Table 32: Janus Flex-Product Description 40

Table 33: Optima Jet-Product Status 40

Table 34: Optima Jet-Product Description 41

Table 35: AlviMedica Medical Technologies Inc.-Ongoing Clinical Trials Overview 41

Table 36: 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 42

Table 37: 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 42

Table 38: Cre8 DES-A Prospective, Single 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 43

Table 39: Amaranth Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 44

Table 40: MAGNITUDE Scaffold-Product Status 44

Table 41: MAGNITUDE Scaffold-Product Description 44

Table 42: Amaranth Medical Inc-Ongoing Clinical Trials Overview 45

Table 43: MAGNITUDE Scaffold-Clinical Study of Fourth-generation MAGNITUDE Scaffold 45

Table 44: MAGNITUDE Scaffold-Restoring Endoluminal Narrowing Using Bioresorbable Scaffolds-Extended Trial III 45

Table 45: Arravasc Ltd Pipeline Products & Ongoing Clinical Trials Overview 46

Table 46: Sideguard-Product Status 46

Table 47: Sideguard-Product Description 46

Table 48: B. Braun Melsungen AG Pipeline Products & Ongoing Clinical Trials Overview 47

Table 49: Coroflex DEBlue-Product Status 47

Table 50: Coroflex DEBlue-Product Description 47

Table 51: Biosensors International Group Ltd Pipeline Products & Ongoing Clinical Trials Overview 48

Table 52: BioFreedom Drug Coated Stent-Product Status 48

Table 53: BioFreedom Drug Coated Stent-Product Description 49

Table 54: Excel II DES-Product Status 49

Table 55: Excel II DES-Product Description 49

Table 56: Sparrow Drug Eluting Stent System-Product Status 50

Table 57: Sparrow Drug Eluting Stent System-Product Description 50

Table 58: Biosensors International Group Ltd-Ongoing Clinical Trials Overview 51

Table 59: Sparrow Drug Eluting Stent System-CARE II Clinical Trial 52

Table 60: BioFreedom Drug Coated Stent-A Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug Coated Stent versus the Gazelle Bare Metal Stent in Patients with High Risk of Bleeding 53

Table 61: 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 53

Table 62: BioFreedom Drug Coated Stent-A Randomized Multicentre Trial to Evaluate the Utilization of Revascularization or Optimal Medical Therapy for the Treatment of Chronic Total Coronary Occlusions 53

Table 63: 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 54

Table 64: 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 54

Table 65: 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 54

Table 66: 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) 55

Table 67: Biotronik SE & Co KG Pipeline Products & Ongoing Clinical Trials Overview 56

Table 68: Orsiro Hybrid Drug Eluting Stent-Product Status 56

Table 69: Orsiro Hybrid Drug Eluting Stent-Product Description 57

Table 70: ProGenic Pimecrolimus-eluting Coronary Stent System-Product Status 57

Table 71: ProGenic Pimecrolimus-eluting Coronary Stent System-Product Description 58

Table 72: Biotronik SE & Co KG-Ongoing Clinical Trials Overview 59

Table 73: Orsiro Hybrid Drug Eluting Stent-A Comparison of an Ultrathin Strut Biodegradable Polymer Sirolimus-eluting Stent with a Durable Polymer Everolimus-eluting Stent for Patients with Acute ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention 62

Table 74: Orsiro Hybrid Drug Eluting Stent-Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents (BIONYX): A Randomized Trial with Stent Evaluation in All-comers IV (TWENTE IV) 62

Table 75: Orsiro Hybrid Drug Eluting Stent-BIOTRONIK-A Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro SiroLimus Eluting Coronary Stent System in the Treatment of Subjects with up to Three De Novo or Restenotic Coronary Artery Lesions-V 63

Table 76: Orsiro Hybrid Drug Eluting Stent-Biotronik-Safety and Performance Registry for an All-comers Diabetic Patient Population with the Limus Eluting Orsiro Stent System Within Daily Clinical Practice-III Asia 63

Table 77: Orsiro Hybrid Drug Eluting Stent-Biotronik-Safety and Performance Registry for an All-comers Patient Population with the Limus Eluting Orsiro Stent System Within Daily Clinical Practice-III Belgium 64

Table 78: Orsiro Hybrid Drug Eluting Stent-BIOTRONIK-Safety and Performance Registry for an All-comers Patient Population with the Limus Eluting Orsiro Stent System Within Daily Clinical Practice-III French Satellite 64

Table 79: Orsiro Hybrid Drug Eluting Stent-BIOTRONIK-Safety and Performance Registry for an All-comers Patient Population with the Limus Eluting Orsiro Stent System within Daily Clinical Practice-III Hungary 64

Table 80: Orsiro Hybrid Drug Eluting Stent-BIOTRONIK-Safety and Performance Registry for an All-comers Patient Population with the Limus Eluting Orsiro Stent System within Daily Clinical Practice-III United Kingdom Satellite 65

Table 81: Orsiro Hybrid Drug Eluting Stent-Biotronik- Safety and Performance Registry for an all Comers Patient Population with the Limus Eluting Orsiro Stent System within Daily Clinical Practice III- Eladis 65

Table 82: Orsiro Hybrid Drug Eluting Stent-Biotronik-A Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Stent in the Treatment of Subjects with up to Two de Novo Coronary Artery Lesions-IV 65

Table 83: Orsiro Hybrid Drug Eluting Stent-BIOTRONIK-Safety and Clinical PerFormance of the Drug ELuting Orsiro Stent in the Treatment of Subjects with de Novo Coronary Artery Lesions-VI 66

Table 84: Orsiro Hybrid Drug Eluting Stent-Comparison of Biodegradable Polymer and Durable Polymer Drug-eluting Stents in an All Comers Population: Randomized Multicenter Trial in an All Comers Population Treated within the Netherlands 3 (TWENTE 3) 66

Table 85: Orsiro Hybrid Drug Eluting Stent-Comparison of Biomatrix and Orsiro Drug Eluting Stent in Angiographic Result in Patients with All-comer Patients with Coronary Artery Disease : A Multicenter, Randomized, Open Label Study (BIODEGRADE Study) 67

Table 86: Orsiro Hybrid Drug Eluting Stent-Evaluation of Effectiveness and Safety of Orsiro in Routine Clinical Practice: A Multicenter, Prospective Observational Study 67

Table 87: Orsiro Hybrid Drug Eluting Stent-Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-Coronary Intervention with Next Generation Drug-eluting Stent Platforms and Abbreviated Dual Antiplatelet Therapy (HOST-IDEA) Trial 68

Table 88: Orsiro Hybrid Drug Eluting Stent-Hybrid Sirolimus-eluting Stent With Bioresorbable Polymer Versus Everolimus-eluting Stent With Durable Polymer for Total Coronary Occlusions in Native Coronary Arteries (PRISON-IV) 68

Table 89: Orsiro Hybrid Drug Eluting Stent-Prospective, Single-center, Randomized Trial, Intended to Compare of Intravascular Ultrasound and Optical Coherence Tomography Guided Implantation of Different Drug-eluting Stents and Implantation without Using of Intravascular Visualization 69

Table 90: Orsiro Hybrid Drug Eluting 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 69

Table 91: Orsiro Hybrid Drug Eluting 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 70

Table 92: Orsiro Hybrid Drug Eluting Stent-Safety and Performance Registry for an All Comers Patient Population with the Limus Eluting Orsiro Stent Within Daily Clinical Practice III -Italy 70

Table 93: Orsiro Hybrid Drug Eluting Stent-Safety and Performance Registry for an All-comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice-III Canada 70

Table 94: Orsiro Hybrid Drug Eluting Stent-Safety and Performance Registry for an All-comers Patient Population with the Limus Eluting Orsiro Stent System within Daily Clinical Practice-III Russia 71

Table 95: Orsiro Hybrid Drug Eluting Stent-The Comparison of Strategies to PREPARE Severely CalCified Coronary Lesions Trial (PREPARE-CALC): A Prospective Randomized Controlled Trial of Rotational Atherectomy Versus Cutting/Scoring Balloon in Severely Calcified Coronary Lesions 71

Table 96: Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 72

Table 97: Innova Peripheral Vascular Drug-Eluting Stent System-Product Status 72

Table 98: Innova Peripheral Vascular Drug-Eluting Stent System-Product Description 73

Table 99: JACTAX Drug Eluting Stent-Product Status 73

Table 100: JACTAX Drug Eluting Stent-Product Description 73

Table 101: Odyssey-Product Status 74

Table 102: Odyssey-Product Description 74

Table 103: TAXUS Petal Bifurcation Paclitaxel-Eluting Stent System-Product Status 74

Table 104: TAXUS Petal Bifurcation Paclitaxel-Eluting Stent System-Product Description 75

Table 105: Cardionovum GmbH Pipeline Products & Ongoing Clinical Trials Overview 76

Table 106: PROTECT-Product Status 76

Table 107: PROTECT-Product Description 76

Table 108: CARDIOREV PTE. LTD Pipeline Products & Ongoing Clinical Trials Overview 77

Table 109: Peptide-Eluting Coronary Stent-Product Status 77

Table 110: Peptide-Eluting Coronary Stent-Product Description 77

Table 111: Columbia University Pipeline Products & Ongoing Clinical Trials Overview 78

Table 112: C3 Exoenzyme Coated Stent-Product Status 78

Table 113: C3 Exoenzyme Coated Stent-Product Description 78

Table 114: Contego Medical, LLC Pipeline Products & Ongoing Clinical Trials Overview 79

Table 115: CORGUARD-Product Status 79

Table 116: CORGUARD-Product Description 79

Table 117: Cordis Corp Pipeline Products & Ongoing Clinical Trials Overview 80

Table 118: Corio Pimecrolimus-eluting Stent-Product Status 80

Table 119: Corio Pimecrolimus-eluting Stent-Product Description 81

Table 120: CYPHER ELITE-Product Status 81

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Aachen Resonance GmbH, Abbott Vascular Inc., Adcomp Technologies Inc., Aeon Bioscience, AlviMedica Medical Technologies Inc., Amaranth Medical Inc, Arravasc Ltd, B. Braun Melsungen AG, Biosensors International Group Ltd, Biotronik SE & Co KG, Boston Scientific Corp, Cardionovum GmbH, CARDIOREV PTE. LTD, Columbia University, Contego Medical, LLC, Cordis Corp, DISA Vascular (Pty) Ltd., Divya Laboratories, Elixir Medical Corp, Envision Scientific Pvt. Ltd, I.B.S. S.p.A., InspireMD Inc, Kaneka Corp, Lepu Medical Technology (Beijing) Co Ltd, Medinol Ltd, Medlogics Device Corp, Medtronic plc, Meril Life Sciences Pvt Ltd, Micell Technologies Inc, MicroPort Scientific Corp, Minvasys, MIV Therapeutics Inc, Northwestern University, NuVascular Technologies Inc, OrbusNeich, Relisys Medical Devices Ltd, REVA Medical Inc, Rontis AG, Sino Medical-Device Technology Co., Ltd., Stentys SA, Svelte Medical Systems, Inc., Terumo Corp, Tryton Medical Inc, University of Alabama at Birmingham, University of Florida, University of Strathclyde, Vascular Concepts Ltd, Zorion Medical

Aachen Resonance GmbH, ARtax Coronary Stent; Abbott Vascular Inc., AVJ-09-385 Everolimus Eluting Coronary Stent System; Abbott Vascular Inc., Xience SBA Everolimus Eluting Coronary Stent System; Abbott Vascular Inc., XIENCE Thinman DES; Abbott Vascular Inc., ZoMaxx Drug Eluting Coronary Stent System; Adcomp Technologies Inc., Dual Drug Eluting Stent; Aeon Bioscience, Drug Eluting Stent; AlviMedica Medical Technologies Inc., Cre8 DES; AlviMedica Medical Technologies Inc., DES-Coracto; AlviMedica Medical Technologies Inc., Janus Flex; AlviMedica Medical Technologies Inc., Optima Jet; Amaranth Medical Inc, MAGNITUDE Scaffold; Arravasc Ltd, Sideguard; B. Braun Melsungen AG, Coroflex DEBlue; Biosensors International Group Ltd, BioFreedom Drug Coated Stent; Biosensors International Group Ltd, Excel II DES; Biosensors International Group Ltd, Sparrow Drug Eluting Stent System; Biotronik SE &; Co KG, Orsiro Hybrid Drug Eluting Stent; Biotronik SE &; Co KG, ProGenic Pimecrolimus-eluting Coronary Stent System; Boston Scientific Corp, Innova Peripheral Vascular Drug-Eluting Stent System; Boston Scientific Corp, JACTAX Drug Eluting Stent; Boston Scientific Corp, Odyssey; Boston Scientific Corp, TAXUS Petal Bifurcation Paclitaxel-Eluting Stent System; Cardionovum GmbH, PROTECT; CARDIOREV PTE. LTD, Peptide-Eluting Coronary Stent; Columbia University, C3 Exoenzyme Coated Stent; Contego Medical, LLC, CORGUARD; Cordis Corp, Corio Pimecrolimus-eluting Stent; Cordis Corp, CYPHER ELITE; Cordis Corp, Cypher Neo; Cordis Corp, NEVO Sirolimus-Eluting Coronary Stent; Cordis Corp, Next Generation Coronary Stent; Cordis Corp, SymBio Pimecrolimus/Paclitaxel-eluting Stent; DISA Vascular (Pty) Ltd., Stellium Stent; Divya Laboratories, Stent For Dissolving Blood Clots; Elixir Medical Corp, DESolve Myolimus Eluting Bioresorbable Coronary Scaffold System; Elixir Medical Corp, DESyne Nx Novolimus Eluting Coronary Stent System; Elixir Medical Corp, Myolimus Eluting Coronary Stent-Durable Polymer; Envision Scientific Pvt. Ltd, FOCUS np; Envision Scientific Pvt. Ltd, Paclitaxel Eluting Stent; I.B.S. S.p.A., Drug Eluting Stent; InspireMD Inc, MGuard Drug Eluting Stent; Kaneka Corp, MAHOROBA Stent; Lepu Medical Technology (Beijing) Co Ltd, Nano+ Stent; Lepu Medical Technology (Beijing) Co Ltd, NeoVas Bioresorbable Coronary Scaffold (BCS); Medinol Ltd, BioNIR Ridaforolimus Eluting Coronary Stent; Medinol Ltd, EluNIR elastomer Drug Eluting Stent; Medlogics Device Corp, COBRA-Q Drug Eluting Stent; Medtronic plc, Bifurcated Drug Eluting Stent; Medtronic plc, Drug Filled Stent; Medtronic plc, Next Generation Coronary Stent; Medtronic plc, Resolute Onyx; Meril Life Sciences Pvt Ltd, BioMime; Meril Life Sciences Pvt Ltd, BIOMIME AURA; Micell Technologies Inc, MiStent SES; MicroPort Scientific Corp, Firehawk Extreme; MicroPort Scientific Corp, Firesorb Bioresorbable Rapamycin Target Eluting Coronary Scaffold System; Minvasys, Nile LM SIR Sirolimus Eluting Intracoronary Stent; MIV Therapeutics Inc, Smart-1 DES; MIV Therapeutics Inc, Smart-2 DES; MIV Therapeutics Inc, Smart-3 DES; MIV Therapeutics Inc, Smart-4 DES; MIV Therapeutics Inc, VESTAsync; Northwestern University, NO-Eluting Biodegradable PDC Stent; NuVascular Technologies Inc, Drug-Eluting Stent Jacket; OrbusNeich, COMBO Dual Therapy Stent; OrbusNeich, Cura Stent; Relisys Medical Devices Ltd, Corel + C Drug Eluting Stent; REVA Medical Inc, ReZolve Sirolimus-Eluting Bioresorbable Coronary Scaffold; Rontis AG, Bifurcation Stent System; Sino Medical-Device Technology Co., Ltd., BuMA Supreme DES; Stentys SA, STENTYS Paclitaxel-Eluting Stent; Svelte Medical Systems, Inc., DIRECT Sirolimus-Eluting Coronary Stent Rapid-Exchange System; Svelte Medical Systems, Inc., SLENDER IDS; Terumo Corp, Next Generation Drug Eluting Bioresorbable Scaffold; Tryton Medical Inc, Tryton Side Branch Short Stent; Tryton Medical Inc, Tryton Side Branch Stent System; University of Alabama at Birmingham, Endothelium Nanomatrix Coated Stent; University of Florida, Nanocomposite Drug Eluting Stent; University of Strathclyde, CODE Drug-Eluting Stent; University of Strathclyde, Drug-Eluting Stent; Vascular Concepts Ltd, Prograft Balloon Expandable Covered Stent; Vascular Concepts Ltd, ProNova Sirolimus Eluting Stent; Vascular Concepts Ltd, ProTAXX; Zorion Medical, ZMED Absorbable Drug Eluting Stent


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