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Bioabsorbable Stents (BAS) - Medical Devices Pipeline Assessment, 2016
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Published by Global Data: 01 Nov 2016 | 27460 | In Stock
Related Topics: Medical , Medical Devices , Stent

Introduction

Bioabsorbable Stents (BAS) - Medical Devices Pipeline Assessment, 2016

Summary

GlobalData's Medical Devices sector report, “Bioabsorbable Stents (BAS) - Medical Devices Pipeline Assessment, 2016" provides an overview of Bioabsorbable Stents (BAS) 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 Bioabsorbable Stents (BAS) 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 Bioabsorbable Stents (BAS) 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 Bioabsorbable Stents (BAS) 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 Bioabsorbable Stents (BAS) 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

Table of Contents
for Bioabsorbable Stents (BAS) - Medical Devices Pipeline Assessment, 2016

  • 1 Table of Contents

    1 Table of Contents 2

    1.1 List of Tables 5

    1.2 List of Figures 10

    2 Introduction 11

    2.1 Bioabsorbable Stents (BAS) Overview 11

    3 Products under Development 12

    3.1 Bioabsorbable Stents (BAS) - Pipeline Products by Stage of Development 12

    3.2 Bioabsorbable Stents (BAS) - Pipeline Products by Territory 13

    3.3 Bioabsorbable Stents (BAS) - Pipeline Products by Regulatory Path 14

    3.4 Bioabsorbable Stents (BAS) - Pipeline Products by Estimated Approval Date 15

    3.5 Bioabsorbable Stents (BAS) - Ongoing Clinical Trials 16

    4 Bioabsorbable Stents (BAS) - Pipeline Products under Development by Companies 17

    4.1 Bioabsorbable Stents (BAS) Companies - Pipeline Products by Stage of Development 17

    4.2 Bioabsorbable Stents (BAS) - Pipeline Products by Stage of Development 19

    5 Bioabsorbable Stents (BAS) Companies and Product Overview 21

    5.1 Abbott Vascular Inc. Company Overview 21

    5.1.1 Abbott Vascular Inc. Pipeline Products & Ongoing Clinical Trials Overview 21

    5.2 Amaranth Medical, Inc. Company Overview 45

    5.2.1 Amaranth Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 45

    5.3 Arterius Ltd Company Overview 54

    5.3.1 Arterius Ltd Pipeline Products & Ongoing Clinical Trials Overview 54

    5.4 Biosten, LLC Company Overview 55

    5.4.1 Biosten, LLC Pipeline Products & Ongoing Clinical Trials Overview 55

    5.5 Biotronik SE & Co. KG Company Overview 56

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

    5.6 Boston Scientific Corporation Company Overview 62

    5.6.1 Boston Scientific Corporation Pipeline Products & Ongoing Clinical Trials Overview 62

    5.7 Cardionovum GmbH Company Overview 67

    5.7.1 Cardionovum GmbH Pipeline Products & Ongoing Clinical Trials Overview 67

    5.8 HangZhou HuaAn Biotechnology Co., Ltd. Company Overview 70

    5.8.1 HangZhou HuaAn Biotechnology Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 70

    5.9 Icon Interventional Systems, Inc. Company Overview 71

    5.9.1 Icon Interventional Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 71

    5.10 Japan Stent Technology Co., Ltd. Company Overview 72

    5.10.1 Japan Stent Technology Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 72

    5.11 Kyoto Medical Planning Co., Ltd. Company Overview 73

    5.11.1 Kyoto Medical Planning Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 73

    5.12 Lifetech Scientific (Shenzhen) Co., Ltd. Company Overview 74

    5.12.1 Lifetech Scientific (Shenzhen) Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 74

    5.13 Medlogics Device Corporation Company Overview 75

    5.13.1 Medlogics Device Corporation Pipeline Products & Ongoing Clinical Trials Overview 75

    5.14 Meril Life Sciences Pvt. Ltd. Company Overview 76

    5.14.1 Meril Life Sciences Pvt. Ltd. Pipeline Products & Ongoing Clinical Trials Overview 76

    5.15 MicroPort Scientific Corporation Company Overview 79

    5.15.1 MicroPort Scientific Corporation Pipeline Products & Ongoing Clinical Trials Overview 79

    5.16 NanoCoeur, Inc. Company Overview 81

    5.16.1 NanoCoeur, Inc. Pipeline Products & Ongoing Clinical Trials Overview 81

    5.17 North Carolina State University Company Overview 82

    5.17.1 North Carolina State University Pipeline Products & Ongoing Clinical Trials Overview 82

    5.18 Northwestern University Company Overview 83

    5.18.1 Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 83

    5.19 OrbusNeich Company Overview 85

    5.19.1 OrbusNeich Pipeline Products & Ongoing Clinical Trials Overview 85

    5.20 Pegasus Therapeutics, Llc Company Overview 87

    5.20.1 Pegasus Therapeutics, Llc Pipeline Products & Ongoing Clinical Trials Overview 87

    5.21 REVA Medical, Inc. Company Overview 88

    5.21.1 REVA Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 88

    5.22 S3V Vascular Technologies Company Overview 94

    5.22.1 S3V Vascular Technologies Pipeline Products & Ongoing Clinical Trials Overview 94

    5.23 Shanghai MicroPort Medical Group Co Ltd Company Overview 95

    5.23.1 Shanghai MicroPort Medical Group Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 95

    5.24 Tepha, Inc. Company Overview 97

    5.24.1 Tepha, Inc. Pipeline Products & Ongoing Clinical Trials Overview 97

    5.25 VasoTech Inc. Company Overview 99

    5.25.1 VasoTech Inc. Pipeline Products & Ongoing Clinical Trials Overview 99

    5.26 Xenogenics Corporation Company Overview 101

    5.26.1 Xenogenics Corporation Pipeline Products & Ongoing Clinical Trials Overview 101

    6 Bioabsorbable Stents (BAS)- Recent Developments 105

    6.1 Oct 10, 2016: Professor Ian Meredith To Join Boston Scientific As Executive Vice President And Global Chief Medical Officer 105

    6.2 Sep 28, 2016: Nevada Heart And Vascular Center Announces Partnership With Desert Springs Hospital Offering First-Of-Its-Kind Naturally Dissolving Heart Stent For Patients With Coronary Artery Disease 105

    6.3 Aug 30, 2016: MPSC Announces 2016 Interim Results 106

    6.4 Aug 17, 2016: Fully Dissolving Stent Revolutionizes Heart Disease Treatment 107

    6.5 Aug 08, 2016: DMC Heart Hospital Offers First-Of-Its-Kind Naturally Dissolving Heart Stent To Patients With Coronary Artery Disease 108

    6.6 Aug 02, 2016: REVA Completes Submission of CE Mark Application 108

    6.7 Jul 29, 2016: Sutter Health advances cardiovascular service by offering first-of-its-kind fully dissolving heart stent in Bay Area and Sacramento 109

    6.8 Jul 29, 2016: REVA Medical: Quarter Ended 30 June 2016 109

    6.9 Jul 28, 2016: Boston Scientific Announces Results For Second Quarter 2016 110

    6.10 Jul 27, 2016: St. John Hospital & Medical Center Implants First Dissolving Heart Stent 112

    6.11 Jul 26, 2016: New Heart Device Trialed at Mercy Wins FDA Approval 112

    6.12 Jul 25, 2016: INTEGRIS Heart Hospital Implants First-of-its-kind Naturally Dissolving Heart Stent in Patient with Coronary Artery Disease 113

    6.13 Jul 14, 2016: St. Elizabeth’s Medical Center Becomes First Hospital in New England to Implant Dissolvable Heart Stent 113

    6.14 Jul 14, 2016: Health Canada Approves Abbott's Absorb Bioresorbable Stent, The First Fully Dissolving Heart Stent 114

    6.15 Jul 13, 2016: Boston Scientific Elects Yoshiaki Fujimori to Board of Directors 115

    6.16 Jul 12, 2016: Good Samaritan Hospital First on the West Coast to Offer Naturally Dissolving Heart Stent to Patients with Coronary Artery Disease 115

    6.17 Jul 08, 2016: University Hospitals Case Medical Center cardiologists first to implant Abbott Absorb Stent in Midwest 116

    6.18 Jul 05, 2016: FDA approves first absorbable stent for coronary artery disease 117

    6.19 Jul 05, 2016: Arizona patient will receive first U.S.-approved fully dissolving heart stent 117

    6.20 Jun 08, 2016: Boston Scientific Announces Restructuring Program to Support Long-Term Growth and Innovation 118

    6.21 Jun 06, 2016: Amaranth Medical Completes Enrollment in RENASCENT-II Study of 120-Micron APTITUDE Sirolimus-Eluting Bioresorbable Scaffold 118

    6.22 Jun 06, 2016: Amaranth Medical Completes Enrollment in RENASCENT-II Study of 120-Micron APTITUDE Sirolimus-Eluting Bioresorbable Scaffold 119

    6.23 Jun 03, 2016: LEPUCARE established in India 119

    6.24 May 18, 2016: Amaranth Medical On Track to Complete Enrollment in RENASCENT-II Study of 120-Micron APTITUDE Sirolimus-Eluting Bioresorbable Scaffold in May 119

    6.25 May 18, 2016: REVA Sponsors Symposium at EuroPCR 2016 120

    6.26 May 17, 2016: REVA Releases Positive Clinical Results for Fantom 120

    6.27 May 11, 2016: Elixir Medical to Showcase the Next Generation Bioresorbable Novolimus Eluting Coronary Scaffold System DESolve CX at EuroPCR 2016 121

    6.28 May 11, 2016: Elixir Medical to Showcase the Next Generation Bioresorbable Novolimus Eluting Coronary Scaffold System AMITY at EuroPCR 2016 123

    6.29 May 10, 2016: REVA to Present at EuroPCR 2016 123

    6.30 Apr 01, 2016: MicroPort and Yizheng Municipal Government Establishes "Shanghai-Yizheng Healthcare Cooperation Project" 124

    6.31 Mar 23, 2016: MicroPort Signs Cooperation Agreement with Beijing Weimai Medical Device 124

    6.32 Mar 15, 2016: Abbott's Absorb, the First Fully Dissolving Heart Stent, Earns Positive Review by FDA Advisory Committee 124

    6.33 Feb 23, 2016: REVA Achieves Target Patient Enrollment in FANTOM II Trial 125

    6.34 Feb 10, 2016: REVA Announces Clinical Enrollment Progress and Anticipated .4 Million Cash Receipt 126

    6.35 Jan 19, 2016: REVA Hires Richard Kimes as SVP of Operations 126

    7 Appendix 128

    7.1 Methodology 128

    7.2 About GlobalData 130

    7.3 Contact Us 130

    7.4 Disclaimer 131

List Of Tables
in Bioabsorbable Stents (BAS) - Medical Devices Pipeline Assessment, 2016

1.1 List of Tables

Table 1: Bioabsorbable Stents (BAS) - Pipeline Products by Stage of Development 12

Table 2: Bioabsorbable Stents (BAS) - Pipeline Products by Territory 13

Table 3: Bioabsorbable Stents (BAS) - Pipeline Products by Regulatory Path 14

Table 4: Bioabsorbable Stents (BAS) - Pipeline Products by Estimated Approval Date 15

Table 5: Bioabsorbable Stents (BAS) - Ongoing Clinical Trials 16

Table 6: Bioabsorbable Stents (BAS) Companies - Pipeline Products by Stage of Development 17

Table 7: Bioabsorbable Stents (BAS) - Pipeline Products by Stage of Development 19

Table 8: Abbott Vascular Inc. Pipeline Products & Ongoing Clinical Trials Overview 21

Table 9: Absorb GT1 Bioresorbable Vascular Scaffold - Product Status 21

Table 10: Absorb GT1 Bioresorbable Vascular Scaffold - Product Description 22

Table 11: Second Generation Bioresorbable Vascular Scaffold - Product Status 22

Table 12: Second Generation Bioresorbable Vascular Scaffold - Product Description 23

Table 13: Abbott Vascular Inc. - Ongoing Clinical Trials Overview 24

Table 14: Absorb GT1 Bioresorbable Vascular Scaffold - A Clinical Evaluation of Absorb BVS, the Bioresorbable Vascular Scaffold, in the Treatment of Subjects with de Novo Native Coronary Artery Lesions in Chinese Population 28

Table 15: Absorb GT1 Bioresorbable Vascular Scaffold - A Clinical Evaluation of Absorb BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold In the Treatment of Subjects with De Novo Native Coronary Artery Lesions 28

Table 16: Absorb GT1 Bioresorbable Vascular Scaffold - A Clinical Evaluation of Absorb BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de Novo Native Coronary Artery Lesions 29

Table 17: Absorb GT1 Bioresorbable Vascular Scaffold - A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System (BVS EECSS) in the Treatment of Patients with de Novo Native Coronary Artery Lesions 29

Table 18: Absorb GT1 Bioresorbable Vascular Scaffold - A Clinical Evaluation to Compare the Safety, Efficacy and Performance of ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System Against XIENCE Everolimus Eluting Coronary Stent System in the Treatment of Subjects with Ischemic Heart Disease Caused by de Novo Native Coronary Artery Lesions: ABSORB II Randomized Controlled Trial 30

Table 19: Absorb GT1 Bioresorbable Vascular Scaffold - A Continuation in the Clinical Evaluation of the Abbott Vascular Everolimus-Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de Novo Native Coronary Artery Lesions: ABSORB EXTEND Clinical Investigation 30

Table 20: Absorb GT1 Bioresorbable Vascular Scaffold - A Multicenter Prospective Natural History Study Using Multimodality Imaging in Patients with Acute Coronary Syndromes - PROSPECT II (Natural History Study), Combined with a Randomized, Controlled, Intervention Study - PROSPECT ABSORB (Randomized Trial) 31

Table 21: Absorb GT1 Bioresorbable Vascular Scaffold - A Prospective Evaluation of a Standardized Strategy for the Use of Bioresorbable Vascular Scaffold in ST-segment Elevation Myocardial Infarction -The BVS STEMI STRATEGY-IT Registry 32

Table 22: Absorb GT1 Bioresorbable Vascular Scaffold - A Prospective, Randomized Trial of Synergy Bioresorbable Polymer Coated Stents Versus Absorb Bioresorbable Backbone Stents in Patients Undergoing Coronary Stenting (ISAR-RESORB) 32

Table 23: Absorb GT1 Bioresorbable Vascular Scaffold - A Randomized Comparison of Clinical Outcomes Between Everolimus-eluting Bioresorbable Vascular Scaffold versus Everolimus-eluting Metallic Stent in Long Coronary Lesions 33

Table 24: Absorb GT1 Bioresorbable Vascular Scaffold - A Randomized Controlled Comparison of Optical Coherence Tomography Guidance and Angiography-only Guidance for Percutaneous Coronary Intervention with Bioresorbable Vascular Scaffold 33

Table 25: Absorb GT1 Bioresorbable Vascular Scaffold - Absorb Bioresorbable Scaffold versus Drug Coated Balloon for Treatment of In-Stent- 34

Restenosis 34

Table 26: Absorb GT1 Bioresorbable Vascular Scaffold - ABSORB Bioresorbable Scaffold versus Xience Metallic Stent for Prevention of Restenosis Following Percutaneous Coronary Intervention in Patients at High Risk of Restenosis 34

Table 27: Absorb GT1 Bioresorbable Vascular Scaffold - ABSORB III RCT Pharmacokinetics (PK) Sub-study 35

Table 28: Absorb GT1 Bioresorbable Vascular Scaffold - Amsterdam Investigator-initiated Absorb Strategy All-comers Trial (AIDA Trial) - A Clinical Evaluation Comparing the Efficacy and Performance of ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold Strategy Versus the XIENCE Family (XIENCE PRIME or XIENCE Xpedition) Everolimus Eluting Coronary Stent Strategy in the Treatment of Coronary Lesions in Consecutive All-comers 35

Table 29: Absorb GT1 Bioresorbable Vascular Scaffold - Bifurcation ABSORB OCT Trial 36

Table 30: Absorb GT1 Bioresorbable Vascular Scaffold - Clinical Study on Absorb Polylactic, Reabsorbable Coronary Scaffold (RAI) 36

Table 31: Absorb GT1 Bioresorbable Vascular Scaffold - Comparison Between SYNERGY Versus Bioresorbable Vascular Scaffold (BVS) ABSORB Neointimal Formation Assessed by (Optical Coherence Tomography) OCT and Coronary Angioscopy (CAS) Evaluation (The ENHANCE Study - Endothelial Healing Assessment With Novel Coronary Technology) 37

Table 32: Absorb GT1 Bioresorbable Vascular Scaffold - Comparison of a Paclitaxel-coated Balloon Without Stent Implantation Against an Everolimus-eluting Bioresorbable Scaffold for Treatment of Stable Coronary Artery Disease: A Prospective Randomized Study Using Optical Coherence Tomography 37

Table 33: Absorb GT1 Bioresorbable Vascular Scaffold - Comparison of the Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System with a Drug- Eluting Metal Stent (XienceTM) in Acute ST-Elevation Myocardial Infarction 38

Table 34: Absorb GT1 Bioresorbable Vascular Scaffold - Complex Bifurcation Lesions - A Randomized Comparison Between the AXXESS Device in Combination with Absorb BVS, and Modified T Stenting with Absorb BVS: An OCT Study 38

Table 35: Absorb GT1 Bioresorbable Vascular Scaffold - Comprehensive Imaging and Interventional Therapy Studies for Arteriogenic Erectile Dysfunction and Lower Urinary Tract Symptoms - A Multi-modality, Multi-specialty Collaborative Study (PERFECT Program) 39

Table 36: Absorb GT1 Bioresorbable Vascular Scaffold - Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents for Diffuse Long Coronary Artery Disease 39

Table 37: Absorb GT1 Bioresorbable Vascular Scaffold - Everolimus-eluting Bioresorbable Vascular Scaffold System in the Treatment of Cardiac Allograft Vasculopathy in Heart Transplant Recipients: A Prospective Multicenter Pilot Study 40

Table 38: Absorb GT1 Bioresorbable Vascular Scaffold - Everolimus-eluting Bioresorbable Vascular Scaffolds Versus Everolimus-eluting Stents in Patients with Diabetes Mellitus 40

Table 39: Absorb GT1 Bioresorbable Vascular Scaffold - German-Austrian Register to Evaluate the Short and Long-term Safety and Therapy Outcomes of the ABSORB Everolimus-Eluting Bioresorbable Vascular Scaffold System in Patients with Coronary Artery Stenosis 41

Table 40: Absorb GT1 Bioresorbable Vascular Scaffold - Impact of Vascular Reparative Therapy on Vasomotor Function and Myocardial Perfusion: A Randomized H215O PET/CT Study 41

Table 41: Absorb GT1 Bioresorbable Vascular Scaffold - Intracoronary Scaffold Assessment a Randomized Evaluation of Absorb in Myocardial Infarction (ISAR-Absorb MI): A Prospective, Randomized Trial of BVS Veruss EES in Patients Undergoing Coronary Stenting for Myocardial Infarction 42

Table 42: Absorb GT1 Bioresorbable Vascular Scaffold - Italian Diffuse/Multivessel Disease ABSORB Prospective Registry Under the Auspices of Società Italiana di Cardiologia Invasive-GISE (IT-DISAPPEARS) 42

Table 43: Absorb GT1 Bioresorbable Vascular Scaffold - Optimal Lesion Preparation with Non-compliant Balloons for the Implantation of Bioresorbable Vascular Scaffolds (BVS) (OPRENBIS Study) 43

Table 44: Absorb GT1 Bioresorbable Vascular Scaffold - Performance of Bioresorbable Scaffold in Primary Percutaneous Intervention of ST Elevation Myocardial Infarct (BVS in STEMI) 43

Table 45: Absorb GT1 Bioresorbable Vascular Scaffold - Real World Advanced Experience of Bioresorbable Scaffold by Smart Angioplasty Research Team (SMART REWARD) 44

Table 46: Absorb GT1 Bioresorbable Vascular Scaffold - Safety and Feasibility of Bioabsorbable Everolimus-Eluting Stents for Patients with Internal Pudendal Artery-related Arteriogenic Erectile Dysfunction (PERFECT-ABSORB) 44

Table 47: Absorb GT1 Bioresorbable Vascular Scaffold - Strut Coverage with SYNERGY Stents and Bioresorbable Vascular Scaffold in Acute Myocardial Infarction: An Intracoronary Optical Coherence Tomography Randomized Study 44

Table 48: Amaranth Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 45

Table 49: APTITUDE Bioresorbable Drug-Eluting Coronary Scaffold - Product Status 45

Table 50: APTITUDE Bioresorbable Drug-Eluting Coronary Scaffold - Product Description 46

Table 51: FORTITUDE Scaffold - Product Status 46

Table 52: FORTITUDE Scaffold - Product Description 47

Table 53: MAGNITUDE Scaffold - Product Status 47

Table 54: MAGNITUDE Scaffold - Product Description 47

Table 55: Next Generation FORTITUDE Scaffold - Product Status 48

Table 56: Next Generation FORTITUDE Scaffold - Product Description 48

Table 57: Amaranth Medical, Inc. - Ongoing Clinical Trials Overview 49

Table 58: FORTITUDE Scaffold - Restoring Endoluminal Narrowing Using Bioresorbable Scaffolds - European Trial 50

Table 59: Next Generation FORTITUDE Scaffold - Amaranth Endovascular Study of a Drug-eluting Bioresorbable Coronary Scaffold 51

Table 60: APTITUDE Bioresorbable Drug-Eluting Coronary Scaffold - Restoring Endoluminal Narrowing Using Bioresorbable Scaffolds - Extended Trial II 52

Table 61: MAGNITUDE Scaffold - Clinical Study of Fourth-generation MAGNITUDE Scaffold 53

Table 62: MAGNITUDE Scaffold - Restoring Endoluminal Narrowing Using Bioresorbable Scaffolds - Extended Trial III 53

Table 63: Arterius Ltd Pipeline Products & Ongoing Clinical Trials Overview 54

Table 64: Arteriosorb Absorbable Drug-Eluting Scaffold - Product Status 54

Table 65: Arteriosorb Absorbable Drug-Eluting Scaffold - Product Description 54

Table 66: Biosten, LLC Pipeline Products & Ongoing Clinical Trials Overview 55

Table 67: Biodegradable Endovascular Implant - Product Status 55

Table 68: Biodegradable Endovascular Implant - Product Description 55

Table 69: Biotronik SE & Co. KG Pipeline Products & Ongoing Clinical Trials Overview 56

Table 70: AMS-1 - Product Status 56

Table 71: AMS-1 - Product Description 57

Table 72: AMS-2 - Product Status 57

Table 73: AMS-2 - Product Description 57

Table 74: DREAMS - Product Status 58

Table 75: DREAMS - Product Description 58

Table 76: DREAMS 2G - Product Status 59

Table 77: DREAMS 2G - Product Description 59

Table 78: Biotronik SE & Co. KG - Ongoing Clinical Trials Overview 60

Table 79: DREAMS 2G - 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 61

Table 80: DREAMS 2G - BIOTRONIKS - Acute Performance Of a Drug Eluting Absorbable Metal Scaffold (DREAMS 2G) in Patients with de Novo Lesions in Native Coronary Arteries - BIOSOLVE-III 61

Table 81: Boston Scientific Corporation Pipeline Products & Ongoing Clinical Trials Overview 62

Table 82: Fully Resorbable Drug-Eluting Scaffold System - Product Status 62

Table 83: Fully Resorbable Drug-Eluting Scaffold System - Product Description 63

Table 84: Next Generation SYNERGY - Product Status 63

Table 85: Next Generation SYNERGY - Product Description 63

Table 86: Boston Scientific Corporation - Ongoing Clinical Trials Overview 64

Table 87: Next Generation SYNERGY - Comparison Between SYNERGY Versus Bioresorbable Vascular Scaffold (BVS) ABSORB Neointimal Formation Assessed by (Optical Coherence Tomography) OCT and Coronary Angioscopy (CAS) Evaluation (The ENHANCE Study - Endothelial Healing Assessment With Novel Coronary Technology) 65

Table 88: Fully Resorbable Drug-Eluting Scaffold System - Fully Absorbable Scaffold Feasibility Study 66

Table 89: Cardionovum GmbH Pipeline Products & Ongoing Clinical Trials Overview 67

Table 90: ReNATURAL (M) - Product Status 67

Table 91: ReNATURAL (M) - Product Description 67

Table 92: ReNATURAL (P) - Product Status 68

Table 93: ReNATURAL (P) - Product Description 68

Table 94: RESORB - Product Status 68

Table 95: RESORB - Product Description 69

Table 96: HangZhou HuaAn Biotechnology Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 70

Table 97: Xinsorb BRS - Product Status 70

Table 98: Xinsorb BRS - Product Description 70

Table 99: Icon Interventional Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 71

Table 100: Biosorb Pediatric Dissolving Stent - Product Status 71

Table 101: Biosorb Pediatric Dissolving Stent - Product Description 71

Table 102: Japan Stent Technology Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 72

Table 103: Bioabsorbable Stent - Product Status 72

Table 104: Bioabsorbable Stent - Product Description 72

Table 105: Kyoto Medical Planning Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 73

Table 106: Igaki-Tamai Coronary Stent - Product Status 73

Table 107: Igaki-Tamai Coronary Stent - Product Description 73

Table 108: Lifetech Scientific (Shenzhen) Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 74

Table 109: Absorbable Coronary Stent - Product Status 74

Table 110: Absorbable Coronary Stent - Product Description 74

Table 111: Medlogics Device Corporation Pipeline Products & Ongoing Clinical Trials Overview 75

Table 112: COBRA-P Drug Eluting Stent - Product Status 75

Table 113: COBRA-P Drug Eluting Stent - Product Description 75

Table 114: Meril Life Sciences Pvt. Ltd. Pipeline Products & Ongoing Clinical Trials Overview 76

Table 115: MeRes100 - Product Status 76

Table 116: MeRes100 - Product Description 76

Table 117: Meril Life Sciences Pvt. Ltd. - Ongoing Clinical Trials Overview 77

Table 118: MeRes100 - A Prospective, Multinational, Multicenter, Single Arm, Open Label, Pilot Clinical Study of MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System in the Treatment of De-novo Native Coronary Artery Lesions (MeRes-1 Extend) 78

Table 119: MicroPort Scientific Corporation Pipeline Products & Ongoing Clinical Trials Overview 79

Table 120: Firefalcon Bioresorbable Device - Product Status 79

Table 121: Firefalcon Bioresorbable Device - Product Description 80

Table 122: NanoCoeur, Inc. Pipeline Products & Ongoing Clinical Trials Overview 81

Table 123: Nanocoating Cardiac Stent - Product Status 81

Table 124: Nanocoating Cardiac Stent - Product Description 81

Table 125: North Carolina State University Pipeline Products & Ongoing Clinical Trials Overview 82

Table 126: Biodegradable Metal Stent - Product Status 82

Table 127: Biodegradable Metal Stent - Product Description 82

Table 128: Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 83

Table 129: Liquid Biodegradable Drug Eluting Stent - Product Status 83

Table 130: Liquid Biodegradable Drug Eluting Stent - Product Description 84

Table 131: OrbusNeich Pipeline Products & Ongoing Clinical Trials Overview 85

Table 132: ON-AVS Scaffold - Product Status 85

Table 133: ON-AVS Scaffold - Product Description 86

Table 134: Pegasus Therapeutics, Llc Pipeline Products & Ongoing Clinical Trials Overview 87

Table 135: Bioresorbable Flow Diverter - Product Status 87

Table 136: Bioresorbable Flow Diverter - Product Description 87

Table 137: REVA Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 88

Table 138: Fantom Sirolimus-Eluting Bioresorbable Scaffold - Product Status 88

Table 139: Fantom Sirolimus-Eluting Bioresorbable Scaffold - Product Description 89

Table 140: ReZolve2 - Product Status 89

Table 141: ReZolve2 - Product Description 90

Table 142: REVA Medical, Inc. - Ongoing Clinical Trials Overview 91

Table 143: ReZolve2 - RESTORE II Trial: Safety And Performance Study Of The ReZolve2 Sirolimus-Eluting Bioresorbable Coronary Scaffold 92

Table 144: Fantom Sirolimus-Eluting Bioresorbable Scaffold - FANTOM I Clinical Trial 93

Table 145: Fantom Sirolimus-Eluting Bioresorbable Scaffold - Pilot Study of the REVA Sirolimus-Eluting Bioresorbable Coronary Scaffold 93

Table 146: Fantom Sirolimus-Eluting Bioresorbable Scaffold - Safety & Performance Study of the FANTOM Sirolimus-eluting Bioresorbable Coronary Scaffold 93

Table 147: S3V Vascular Technologies Pipeline Products & Ongoing Clinical Trials Overview 94

Table 148: 3V Avatar - Product Status 94

Table 149: 3V Avatar - Product Description 94

Table 150: Shanghai MicroPort Medical Group Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 95

Table 151: Bioresorbable Scaffold System - Product Status 95

Table 152: Bioresorbable Scaffold System - Product Description 96

Table 153: Tepha, Inc. Pipeline Products & Ongoing Clinical Trials Overview 97

Table 154: TephaFLEX Absorbable Coronary Stent - Product Status 97

Table 155: TephaFLEX Absorbable Coronary Stent - Product Description 98

Table 156: VasoTech Inc. Pipeline Products & Ongoing Clinical Trials Overview 99

Table 157: PowerStent Absorb DES - Product Status 99

Table 158: PowerStent Absorb DES - Product Description 99

Table 159: PowerStent Coro DES - Product Status 100

Table 160: PowerStent Coro DES - Product Description 100

Table 161: Xenogenics Corporation Pipeline Products & Ongoing Clinical Trials Overview 101

Table 162: Ideal BioStent - First Generation - Product Status 101

Table 163: Ideal BioStent - First Generation - Product Description 102

Table 164: Ideal BioStent - Second Generation - Product Status 102

Table 165: Ideal BioStent - Second Generation - Product Description 102

Table 166: IDEAL Stent - Product Status 103

Table 167: IDEAL Stent - Product Description 103

Table 168: Whisper Coronary Stent System - Product Status 103

Table 169: Whisper Coronary Stent System - Product Description 104

Table 170: Glossary 129

List Of Figures, Charts and Diagrams
in Bioabsorbable Stents (BAS) - Medical Devices Pipeline Assessment, 2016

1.2 List of Figures

Figure 1: Bioabsorbable Stents (BAS) - Pipeline Products by Stage of Development 12

Figure 2: Bioabsorbable Stents (BAS) - Pipeline Products by Territory 13

Figure 3: Bioabsorbable Stents (BAS) - Pipeline Products by Regulatory Path 14

Figure 4: Bioabsorbable Stents (BAS) - Pipeline Products by Estimated Approval Date 15

Figure 5: Bioabsorbable Stents (BAS) - Ongoing Clinical Trials 16

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Global Data

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27460 | GDME0235EPD

Number of Pages

131

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PDF

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