Bioabsorbable Stents - Medical Devices Pipeline Assessment, 2015

Table Of Contents
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 4
1.2 List of Figures 8
2 Introduction 9
2.1 Bioabsorbable Stents Overview 9
3 Products under Development 10
3.1 Bioabsorbable Stents - Pipeline Products by Stage of Development 10
3.2 Bioabsorbable Stents - Pipeline Products by Territory 11
3.3 Bioabsorbable Stents - Pipeline Products by Regulatory Path 12
3.4 Bioabsorbable Stents - Pipeline Products by Estimated Approval Date 13
3.5 Bioabsorbable Stents - Ongoing Clinical Trials 14
4 Bioabsorbable Stents - Pipeline Products under Development by Companies 15
4.1 Bioabsorbable Stents Companies - Pipeline Products by Stage of Development 15
4.2 Bioabsorbable Stents - Pipeline Products by Stage of Development 17
5 Bioabsorbable Stents Companies and Product Overview 19
5.1 Abbott Vascular Inc. Company Overview 19
5.1.1 Abbott Vascular Inc. Pipeline Products & Ongoing Clinical Trials Overview 19
5.2 AlviMedica Medical Technologies Inc. Company Overview 34
5.2.1 AlviMedica Medical Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview 34
5.3 Amaranth Medical, Inc. Company Overview 36
5.3.1 Amaranth Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 36
5.4 Arterius Ltd Company Overview 44
5.4.1 Arterius Ltd Pipeline Products & Ongoing Clinical Trials Overview 44
5.5 Biosensors International Group, Ltd. Company Overview 45
5.5.1 Biosensors International Group, Ltd. Pipeline Products & Ongoing Clinical Trials Overview 45
5.6 Biotronik SE & Co. KG Company Overview 49
5.6.1 Biotronik SE & Co. KG Pipeline Products & Ongoing Clinical Trials Overview 49
5.7 Boston Scientific Corporation Company Overview 54
5.7.1 Boston Scientific Corporation Pipeline Products & Ongoing Clinical Trials Overview 54
5.8 Cardionovum GmbH Company Overview 59
5.8.1 Cardionovum GmbH Pipeline Products & Ongoing Clinical Trials Overview 59
5.9 Elixir Medical Corporation Company Overview 63
5.9.1 Elixir Medical Corporation Pipeline Products & Ongoing Clinical Trials Overview 63
5.10 HangZhou HuaAn Biotechnology Co., Ltd. Company Overview 69
5.10.1 HangZhou HuaAn Biotechnology Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 69
5.11 Icon Interventional Systems, Inc. Company Overview 70
5.11.1 Icon Interventional Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 70
5.12 Japan Stent Technology Co., Ltd. Company Overview 71
5.12.1 Japan Stent Technology Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 71
5.13 Lepu Medical Technology (Beijing) Co., Ltd. Company Overview 72
5.13.1 Lepu Medical Technology (Beijing) Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 72
5.14 Medlogics Device Corporation Company Overview 76
5.14.1 Medlogics Device Corporation Pipeline Products & Ongoing Clinical Trials Overview 76
5.15 Meril Life Sciences Pvt. Ltd. Company Overview 77
5.15.1 Meril Life Sciences Pvt. Ltd. Pipeline Products & Ongoing Clinical Trials Overview 77
5.16 MicroPort Scientific Corporation Company Overview 80
5.16.1 MicroPort Scientific Corporation Pipeline Products & Ongoing Clinical Trials Overview 80
5.17 NanoCoeur, Inc. Company Overview 82
5.17.1 NanoCoeur, Inc. 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 REVA Medical, Inc. Company Overview 87
5.20.1 REVA Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 87
5.21 S3V Vascular Technologies Company Overview 93
5.21.1 S3V Vascular Technologies Pipeline Products & Ongoing Clinical Trials Overview 93
5.22 Shanghai MicroPort Medical (Group) Co., Ltd. Company Overview 94
5.22.1 Shanghai MicroPort Medical (Group) Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 94
5.23 Tepha, Inc. Company Overview 96
5.23.1 Tepha, Inc. Pipeline Products & Ongoing Clinical Trials Overview 96
5.24 Terumo Corporation Company Overview 98
5.24.1 Terumo Corporation Pipeline Products & Ongoing Clinical Trials Overview 98
5.25 Xenogenics Corporation Company Overview 100
5.25.1 Xenogenics Corporation Pipeline Products & Ongoing Clinical Trials Overview 100
5.26 Zorion Medical Company Overview 104
5.26.1 Zorion Medical Pipeline Products & Ongoing Clinical Trials Overview 104
6 Bioabsorbable Stents- Recent Developments 106
7 Appendix 121
7.1 Methodology 121
7.2 About GlobalData 123
7.3 Contact Us 124
7.4 Disclaimer 124

List Of Tables
1.1 List of Tables
Table 1: Bioabsorbable Stents - Pipeline Products by Stage of Development 10
Table 2: Bioabsorbable Stents - Pipeline Products by Territory 11
Table 3: Bioabsorbable Stents - Pipeline Products by Regulatory Path 12
Table 4: Bioabsorbable Stents - Pipeline Products by Estimated Approval Date 13
Table 5: Bioabsorbable Stents - Ongoing Clinical Trials 14
Table 6: Bioabsorbable Stents Companies - Pipeline Products by Stage of Development 15
Table 7: Bioabsorbable Stents - Pipeline Products by Stage of Development 17
Table 8: Abbott Vascular Inc. Pipeline Products & Ongoing Clinical Trials Overview 19
Table 9: Absorb Bioresorbable Vascular Scaffold - Product Status 20
Table 10: Absorb Bioresorbable Vascular Scaffold - Product Description 20
Table 11: Second Generation Bioresorbable Vascular Scaffold - Product Status 21
Table 12: Second Generation Bioresorbable Vascular Scaffold - Product Description 21
Table 13: Abbott Vascular Inc. - Ongoing Clinical Trials Overview 22
Table 14: Absorb 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 25
Table 15: Absorb 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 25
Table 16: Absorb 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 25
Table 17: Absorb 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 26
Table 18: Absorb 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 26
Table 19: Absorb 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) 27
Table 20: Absorb Bioresorbable Vascular Scaffold - A Post-market Registry of Patients with de Novo Lesions in Previously Untreated Vessels Treated with Absorb BVS 27
Table 21: Absorb 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) 28
Table 22: Absorb Bioresorbable Vascular Scaffold - A Randomized Controlled Comparison of Optical Coherence Tomography Guidance and Angiography-only Guidance for Percutaneous Coronary Intervention with Bioresorbable Vascular Scaffold 28
Table 23: Absorb 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 28
Table 24: Absorb Bioresorbable Vascular Scaffold - Absorb Bioresorbable Scaffold Vs. Drug Coated Balloon for Treatment of In-stent-restenosis 29
Table 25: Absorb 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 29
Table 26: Absorb Bioresorbable Vascular Scaffold - An International Post-market Registry of Patients With de Novo Lesions in Previously Untreated Vessels Treated With Absorb Bioresorbable Vascular Scaffold (Absorb BVS): ABSORB FIRST Registry 30
Table 27: Absorb Bioresorbable Vascular Scaffold - Comparison of the ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System With a Drug- Eluting Metal Stent (Xience) in Acute ST-Elevation Myocardial Infarction 30
Table 28: Absorb 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) 30
Table 29: Absorb 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 31
Table 30: Absorb 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 31
Table 31: Absorb Bioresorbable Vascular Scaffold - Impact of Vascular Reparative Therapy on Vasomotor Function and Myocardial Perfusion: A Randomized H215O PET/CT Study 32
Table 32: Absorb Bioresorbable Vascular Scaffold - Optimal Lesion Preparation with Non-compliant Balloons for the Implantation of Bioresorbable Vascular Scaffolds (BVS) - OPRENBIS Study 32
Table 33: Absorb Bioresorbable Vascular Scaffold - Performance of Bioresorbable Scaffold in Primary Percutaneous Intervention of ST Elevation Myocardial Infarct (BVS in STEMI) 32
Table 34: Absorb Bioresorbable Vascular Scaffold - Safety and Feasibility of Bioabsorbable Everolimus-Eluting Stents for Patients with Internal Pudendal Artery-related Arteriogenic Erectile Dysfunction (PERFECT-ABSORB) 33
Table 35: AlviMedica Medical Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview 34
Table 36: Coracto Rapamycin-Eluting Coronary Stent - Product Status 35
Table 37: Coracto Rapamycin-Eluting Coronary Stent - Product Description 35
Table 38: Amaranth Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 36
Table 39: APTITUDE Bioresorbable Drug-Eluting Coronary Scaffold - Product Status 37
Table 40: APTITUDE Bioresorbable Drug-Eluting Coronary Scaffold - Product Description 37
Table 41: FORTITUDE Scaffold - Product Status 38
Table 42: FORTITUDE Scaffold - Product Description 38
Table 43: Next Generation FORTITUDE Scaffold - Product Status 39
Table 44: Next Generation FORTITUDE Scaffold - Product Description 39
Table 45: Amaranth Medical, Inc. - Ongoing Clinical Trials Overview 40
Table 46: FORTITUDE Scaffold - Restoring Endoluminal Narrowing Using Bioresorbable Scaffolds - European Trial 41
Table 47: Next Generation FORTITUDE Scaffold - Amaranth Endovascular Study of a Drug-eluting Bioresorbable Coronary Scaffold 42
Table 48: APTITUDE Bioresorbable Drug-Eluting Coronary Scaffold - Restoring Endoluminal Narrowing Using Bioresorbable Scaffolds - Extended Trial II 43
Table 49: Arterius Ltd Pipeline Products & Ongoing Clinical Trials Overview 44
Table 50: Arteriosorb Absorbable Drug-Eluting Scaffold - Product Status 44
Table 51: Arteriosorb Absorbable Drug-Eluting Scaffold - Product Description 44
Table 52: Biosensors International Group, Ltd. Pipeline Products & Ongoing Clinical Trials Overview 45
Table 53: Sparrow Drug Eluting Stent System - Product Status 46
Table 54: Sparrow Drug Eluting Stent System - Product Description 46
Table 55: Biosensors International Group, Ltd. - Ongoing Clinical Trials Overview 47
Table 56: Sparrow Drug Eluting Stent System - CARE II Clinical Trial 48
Table 57: Biotronik SE & Co. KG Pipeline Products & Ongoing Clinical Trials Overview 49
Table 58: DREAMS - Product Status 50
Table 59: DREAMS - Product Description 50
Table 60: DREAMS 2 - Product Status 51
Table 61: DREAMS 2 - Product Description 51
Table 62: Biotronik SE & Co. KG - Ongoing Clinical Trials Overview 52
Table 63: DREAMS 2 - 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 53
Table 64: Boston Scientific Corporation Pipeline Products & Ongoing Clinical Trials Overview 54
Table 65: Fully Resorbable Drug-Eluting Scaffold System - Product Status 55
Table 66: Fully Resorbable Drug-Eluting Scaffold System - Product Description 55
Table 67: Next Generation SYNERGY - Product Status 56
Table 68: Next Generation SYNERGY - Product Description 56
Table 69: Boston Scientific Corporation - Ongoing Clinical Trials Overview 57
Table 70: Fully Resorbable Drug-Eluting Scaffold System - Fully Absorbable Scaffold Feasibility Study (FAST) 58
Table 71: Cardionovum GmbH Pipeline Products & Ongoing Clinical Trials Overview 59
Table 72: ReNATURAL (M) - Product Status 60
Table 73: ReNATURAL (M) - Product Description 60
Table 74: ReNATURAL (P) - Product Status 61
Table 75: ReNATURAL (P) - Product Description 61
Table 76: RESORB - Product Status 62
Table 77: RESORB - Product Description 62
Table 78: Elixir Medical Corporation Pipeline Products & Ongoing Clinical Trials Overview 63
Table 79: DESolve 100 Novolimus Eluting Bioresorbable Coronary Scaffold System - Product Status 64
Table 80: DESolve 100 Novolimus Eluting Bioresorbable Coronary Scaffold System - Product Description 64
Table 81: DESolve Myolimus Eluting Bioresorbable Coronary Scaffold System - Product Status 65
Table 82: DESolve Myolimus Eluting Bioresorbable Coronary Scaffold System - Product Description 65
Table 83: DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System - Product Status 66
Table 84: DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System - Product Description 66
Table 85: Elixir Medical Corporation - Ongoing Clinical Trials Overview 67
Table 86: DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System - Post-market Evaluation of Desolve Novolimus Eluting Bioresorbable Coronary Scaffold System in the Treatment of Patients with De Novo Native Coronary Artery Lesions 68
Table 87: DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System - X-Pand is Intended to Use the DESolve Scaffold System in Treatment of CAD Patients, by Including "Real World" Use of the DESolve Scaffold Over a Broad Spectrum of Geographies, A Wide Variety of Practicing Clinicians & A Minimum Degree of Selection Criteria 68
Table 88: HangZhou HuaAn Biotechnology Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 69
Table 89: Xinsorb BRS - Product Status 69
Table 90: Xinsorb BRS - Product Description 69
Table 91: Icon Interventional Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 70
Table 92: Dissolving Stent - Product Status 70
Table 93: Dissolving Stent - Product Description 70
Table 94: Japan Stent Technology Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 71
Table 95: Bioabsorbable Stent - Product Status 71
Table 96: Bioabsorbable Stent - Product Description 71
Table 97: Lepu Medical Technology (Beijing) Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 72
Table 98: NeoVas Bioresorbable Coronary Scaffold (BCS) - Product Status 73
Table 99: NeoVas Bioresorbable Coronary Scaffold (BCS) - Product Description 73
Table 100: Lepu Medical Technology (Beijing) Co., Ltd. - Ongoing Clinical Trials Overview 74
Table 101: NeoVas Bioresorbable Coronary Scaffold (BCS) - Clinical Evaluation of a Bioresorbable Sirolimus-eluting Coronary Scaffold in the Treatment of Patients With de Novo Coronary Artery Lesion (NeoVas): a Single Arm Registry Study 75
Table 102: NeoVas Bioresorbable Coronary Scaffold (BCS) - Clinical Evaluation of a Bioresorbable Sirolimus-eluting Coronary Scaffold in the Treatment of Patients with Denovo Coronary Artery Lesion (NeoVas): Randomized Controlled Trial 75
Table 103: Medlogics Device Corporation Pipeline Products & Ongoing Clinical Trials Overview 76
Table 104: COBRA-P Drug Eluting Stent - Product Status 76
Table 105: COBRA-P Drug Eluting Stent - Product Description 76
Table 106: Meril Life Sciences Pvt. Ltd. Pipeline Products & Ongoing Clinical Trials Overview 77
Table 107: BIOMIME AURA - Product Status 78
Table 108: BIOMIME AURA - Product Description 78
Table 109: MeRes - Product Status 79
Table 110: MeRes - Product Description 79
Table 111: MicroPort Scientific Corporation Pipeline Products & Ongoing Clinical Trials Overview 80
Table 112: Firefalcon Bioresorbable Device - Product Status 81
Table 113: Firefalcon Bioresorbable Device - Product Description 81
Table 114: NanoCoeur, Inc. Pipeline Products & Ongoing Clinical Trials Overview 82
Table 115: Nanocoating Cardiac Stent - Product Status 82
Table 116: Nanocoating Cardiac Stent - Product Description 82
Table 117: Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 83
Table 118: Liquid Biodegradable Drug Eluting Stent - Product Status 84
Table 119: Liquid Biodegradable Drug Eluting Stent - Product Description 84
Table 120: OrbusNeich Pipeline Products & Ongoing Clinical Trials Overview 85
Table 121: Acute BRS - Product Status 85
Table 122: Acute BRS - Product Description 85
Table 123: Cura Stent - Product Status 86
Table 124: Cura Stent - Product Description 86
Table 125: REVA Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 87
Table 126: Fantom Sirolimus-Eluting Bioresorbable Scaffold - Product Status 88
Table 127: Fantom Sirolimus-Eluting Bioresorbable Scaffold - Product Description 88
Table 128: ReZolve Sirolimus-Eluting Bioresorbable Coronary Scaffold - Product Status 89
Table 129: ReZolve Sirolimus-Eluting Bioresorbable Coronary Scaffold - Product Description 89
Table 130: ReZolve2 - Product Status 90
Table 131: ReZolve2 - Product Description 90
Table 132: REVA Medical, Inc. - Ongoing Clinical Trials Overview 91
Table 133: Fantom Sirolimus-Eluting Bioresorbable Scaffold - FANTOM I Clinical Trial 92
Table 134: Fantom Sirolimus-Eluting Bioresorbable Scaffold - Pilot Study of the REVA Sirolimus-Eluting Bioresorbable Coronary Scaffold 92
Table 135: Fantom Sirolimus-Eluting Bioresorbable Scaffold - Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold (FANTOM II) 92
Table 136: S3V Vascular Technologies Pipeline Products & Ongoing Clinical Trials Overview 93
Table 137: 3V Avatar - Product Status 93
Table 138: 3V Avatar - Product Description 93
Table 139: Shanghai MicroPort Medical (Group) Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 94
Table 140: Bioresorbable Scaffold System - Product Status 95
Table 141: Bioresorbable Scaffold System - Product Description 95
Table 142: Tepha, Inc. Pipeline Products & Ongoing Clinical Trials Overview 96
Table 143: TephaFLEX Absorbable Stent - Product Status 97
Table 144: TephaFLEX Absorbable Stent - Product Description 97
Table 145: Terumo Corporation Pipeline Products & Ongoing Clinical Trials Overview 98
Table 146: Bioresorbable Coronary Stent - Product Status 99
Table 147: Bioresorbable Coronary Stent - Product Description 99
Table 148: Xenogenics Corporation Pipeline Products & Ongoing Clinical Trials Overview 100
Table 149: Ideal BioStent - First Generation - Product Status 101
Table 150: Ideal BioStent - First Generation - Product Description 101
Table 151: Ideal BioStent - Second Generation - Product Status 102
Table 152: Ideal BioStent - Second Generation - Product Description 102
Table 153: Whisper Coronary Stent System - Product Status 103
Table 154: Whisper Coronary Stent System - Product Description 103
Table 155: Zorion Medical Pipeline Products & Ongoing Clinical Trials Overview 104
Table 156: ZMED Absorbable Drug Eluting Stent - Product Status 105
Table 157: ZMED Absorbable Drug Eluting Stent - Product Description 105
Table 158: Glossary 122

List Of Figures
1.2 List of Figures
Figure 1: Bioabsorbable Stents - Pipeline Products by Stage of Development 10
Figure 2: Bioabsorbable Stents - Pipeline Products by Territory 11
Figure 3: Bioabsorbable Stents - Pipeline Products by Regulatory Path 12
Figure 4: Bioabsorbable Stents - Pipeline Products by Estimated Approval Date 13
Figure 5: Bioabsorbable Stents - Ongoing Clinical Trials 14

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