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

Transcription

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

2 Bioabsorbable Stents (BAS) - Medical Devices Pipeline Assessment, 2016 BioPortfolio has been marketing business and market research reports from selected publishers for over fifteen years. BioPortfolio offers a personal service to our customers with dedicated research managers who will work with you to source the best report for your needs. Based in the UK, BioPortfolio is well positioned to coordinate our customers' orders sourced from over 50 global report publishers. We are pleased to present details of this report to assist your buying decision and administrative process. You will find easy-to-use How To Buy information on the last page of this document. We look forward to being of service to you. If you have bulk and/or recurring requirements, please get in touch - we can liaise with publishers to obtain sample pages and negotiate discounts on your behalf. Phone: +44 (0) or reportstore@bioportfolio.com 2

3 Bioabsorbable Stents (BAS) - Medical Devices Pipeline Assessment, 2016 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 3

4 - 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 Additional Details Publisher : Global Data Reference : GDME0235EPD Number of Pages : 131 Report Format : PDF Publisher Information : 4

5 Table Of Contents for Bioabsorbable Stents (BAS) - Medical Devices Pipeline Assessment, Table of Contents1 Table of Contents 21.1 List of Tables 51.2 List of Figures 102 Introduction Bioabsorbable Stents (BAS) Overview 113 Products under Development Bioabsorbable Stents (BAS) - Pipeline Products by Stage of Development Bioabsorbable Stents (BAS) - Pipeline Products by Territory Bioabsorbable Stents (BAS) - Pipeline Products by Regulatory Path Bioabsorbable Stents (BAS) - Pipeline Products by Estimated Approval Date Bioabsorbable Stents (BAS) - Ongoing Clinical Trials 164 Bioabsorbable Stents (BAS) - Pipeline Products under Development by Companies Bioabsorbable Stents (BAS) Companies - Pipeline Products by Stage of Development Bioabsorbable Stents (BAS) - Pipeline Products by Stage of Development 195 Bioabsorbable Stents (BAS) Companies and Product Overview Abbott Vascular Inc. Company Overview Abbott Vascular Inc. Pipeline Products & Ongoing Clinical Trials Overview Amaranth Medical, Inc. Company Overview Amaranth Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview Arterius Ltd Company Overview Arterius Ltd Pipeline Products & Ongoing Clinical Trials Overview Biosten, LLC Company Overview Biosten, LLC Pipeline Products & Ongoing Clinical Trials Overview Biotronik SE & Co. KG Company Overview Biotronik SE & Co. KG Pipeline Products & Ongoing Clinical Trials Overview Boston Scientific Corporation Company Overview Boston Scientific Corporation Pipeline Products & Ongoing Clinical Trials Overview Cardionovum GmbH Company Overview Cardionovum GmbH Pipeline Products & Ongoing Clinical Trials Overview HangZhou HuaAn Biotechnology Co., Ltd. Company Overview HangZhou HuaAn Biotechnology Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview Icon Interventional Systems, Inc. Company Overview Icon Interventional Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview Japan Stent Technology Co., Ltd. Company Overview Japan Stent Technology Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview Kyoto Medical Planning Co., Ltd. Company Overview Kyoto Medical Planning Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview Lifetech Scientific (Shenzhen) Co., Ltd. Company Overview Lifetech Scientific (Shenzhen) Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview Medlogics Device Corporation Company Overview Medlogics Device Corporation Pipeline Products & Ongoing Clinical Trials Overview Meril Life Sciences Pvt. Ltd. Company Overview Meril Life Sciences Pvt. Ltd. Pipeline Products & Ongoing Clinical Trials Overview MicroPort Scientific Corporation Company Overview MicroPort Scientific Corporation Pipeline Products & Ongoing Clinical Trials Overview NanoCoeur, Inc. Company Overview NanoCoeur, Inc. Pipeline Products & Ongoing Clinical Trials Overview North Carolina State University Company Overview North Carolina State University Pipeline Products & Ongoing Clinical Trials Overview Northwestern University Company Overview Northwestern University Pipeline Products & Ongoing Clinical Trials Overview OrbusNeich Company Overview OrbusNeich Pipeline Products & Ongoing Clinical Trials Overview Pegasus Therapeutics, Llc Company Overview Pegasus Therapeutics, Llc Pipeline Products & Ongoing Clinical Trials Overview REVA Medical, Inc. Company Overview REVA Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview S3V Vascular Technologies Company Overview S3V Vascular Technologies Pipeline Products & Ongoing Clinical Trials Overview Shanghai MicroPort Medical Group Co Ltd Company Overview Shanghai MicroPort Medical Group Co Ltd Pipeline Products & Ongoing Clinical Trials Overview Tepha, Inc. Company Overview Tepha, Inc. Pipeline Products & Ongoing Clinical Trials Overview VasoTech Inc. Company Overview VasoTech Inc. Pipeline Products & Ongoing Clinical Trials Overview Xenogenics Corporation Company Overview Xenogenics Corporation Pipeline Products & Ongoing Clinical Trials Overview 1016 Bioabsorbable Stents (BAS)- Recent Developments Oct 10, 2016: Professor Ian Meredith To Join Boston Scientific As Executive Vice President And Global Chief Medical Officer 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 Aug 30, 2016: MPSC Announces 2016 Interim Results Aug 17, 2016: Fully Dissolving Stent Revolutionizes Heart Disease Treatment Aug 08, 2016: DMC Heart Hospital Offers First-Of-Its-Kind Naturally Dissolving Heart Stent To Patients With Coronary Artery Disease Aug 02, 2016: REVA Completes Submission of CE Mark Application Jul 29, 2016: Sutter Health advances cardiovascular service by offering first-of-its-kind fully dissolving heart stent in Bay Area and Sacramento Jul 29, 2016: REVA Medical: Quarter Ended 30 June Jul 28, 2016: Boston 5

6 Scientific Announces Results For Second Quarter Jul 27, 2016: St. John Hospital & Medical Center Implants First Dissolving Heart Stent Jul 26, 2016: New Heart Device Trialed at Mercy Wins FDA Approval Jul 25, 2016: INTEGRIS Heart Hospital Implants First-of-its-kind Naturally Dissolving Heart Stent in Patient with Coronary Artery Disease Jul 14, 2016: St. Elizabeth s Medical Center Becomes First Hospital in New England to Implant Dissolvable Heart Stent Jul 14, 2016: Health Canada Approves Abbott's Absorb Bioresorbable Stent, The First Fully Dissolving Heart Stent Jul 13, 2016: Boston Scientific Elects Yoshiaki Fujimori to Board of Directors Jul 12, 2016: Good Samaritan Hospital First on the West Coast to Offer Naturally Dissolving Heart Stent to Patients with Coronary Artery Disease Jul 08, 2016: University Hospitals Case Medical Center cardiologists first to implant Abbott Absorb Stent in Midwest Jul 05, 2016: FDA approves first absorbable stent for coronary artery disease Jul 05, 2016: Arizona patient will receive first U.S.-approved fully dissolving heart stent Jun 08, 2016: Boston Scientific Announces Restructuring Program to Support Long-Term Growth and Innovation Jun 06, 2016: Amaranth Medical Completes Enrollment in RENASCENT-II Study of 120-Micron APTITUDE Sirolimus-Eluting Bioresorbable Scaffold Jun 06, 2016: Amaranth Medical Completes Enrollment in RENASCENT-II Study of 120-Micron APTITUDE Sirolimus-Eluting Bioresorbable Scaffold Jun 03, 2016: LEPUCARE established in India May 18, 2016: Amaranth Medical On Track to Complete Enrollment in RENASCENT-II Study of 120-Micron APTITUDE Sirolimus-Eluting Bioresorbable Scaffold in May May 18, 2016: REVA Sponsors Symposium at EuroPCR May 17, 2016: REVA Releases Positive Clinical Results for Fantom May 11, 2016: Elixir Medical to Showcase the Next Generation Bioresorbable Novolimus Eluting Coronary Scaffold System DESolve CX at EuroPCR May 11, 2016: Elixir Medical to Showcase the Next Generation Bioresorbable Novolimus Eluting Coronary Scaffold System AMITY at EuroPCR May 10, 2016: REVA to Present at EuroPCR Apr 01, 2016: MicroPort and Yizheng Municipal Government Establishes "Shanghai-Yizheng Healthcare Cooperation Project" Mar 23, 2016: MicroPort Signs Cooperation Agreement with Beijing Weimai Medical Device Mar 15, 2016: Abbott's Absorb, the First Fully Dissolving Heart Stent, Earns Positive Review by FDA Advisory Committee Feb 23, 2016: REVA Achieves Target Patient Enrollment in FANTOM II Trial Feb 10, 2016: REVA Announces Clinical Enrollment Progress and Anticipated $11.4 Million Cash Receipt Jan 19, 2016: REVA Hires Richard Kimes as SVP of Operations 1267 Appendix Methodology About GlobalData Contact Us Disclaimer 131 6

7 List Of Tables in Bioabsorbable Stents (BAS) - Medical Devices Pipeline Assessment, 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), 7

8 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 Allcomers 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, Multispecialty Collaborative Study (PERFECT Program) 39 8

9 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 9

10 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 10

11 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 11

12 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 12

13 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

14 List Of Figures, Charts and Diagrams in Bioabsorbable Stents (BAS) - Medical Devices Pipeline Assessment, 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 14

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