Peripheral Vascular Stents for the Lower Extremity

Transcription

1 Peripheral Vascular Stents for the Lower Extremity Current and Future Players GDME1008FPR / Published April 2013

2 1 Table of Contents 1 Table of Contents List of Tables List of Figures Introduction Catalyst Related Reports Upcoming Related Reports Competitive Assessment Overview Peripheral Vascular Stent Market Products Bare Metal Stents Drug-Eluting Stents Covered Stents Bioabsorbable Stents Pipeline Products Overview Pipeline by Phase of Development Pipeline Product Profiles Peripheral Artery Disease Citation Stent MR-Enhanced Stents ArtiStent Hybrid Dynamic Stent Nipro Corporation Peripheral Stent Yukon icast Page 2 GDME1008FPR / Published APR 2013

3 4.3.8 Peritoneal-Lined Stents LifeJacket Stent Graft Esprit Bioabsorbable Vascular Scaffold (BVS) Magic Explorer Stent Stanza D Biotek Bioresorbable Stent Archer Stent ART Stent Amaranth Bioabsorbable Scaffold TephaFLEX Absorbable Peripheral Stent Zorion Medical Stent Summary Current and Future Players Overview Trends in Corporate Strategy Company Profiles Abbott Vascular Amaranth Medical Arterial Remodeling Technologies Atrium Medical Corporation Bard Peripheral Vascular (C.R. Bard) Biotronik Boston Scientific Corporation D Biotek Biomedical Cook Medical Cordis Corporation (Johnson & Johnson) CorInnova Page 3 GDME1008FPR / Published APR 2013

4 Covidien Cytograft Tissue Engineering Flexible Stenting Solutions IDEV Technologies Kyoto Medical Planning Medtronic Nexeon Stent Nipro Corporation NovoStent Corporation OptiMed PeriTec Biosciences Synergy Flow Tepha Terumo Corporation TissueGen Translumina Vascular Concepts Veryan Medical VueKlar Cardiovascular W.L. Gore & Associates Zorion Medical Appendix Bibliography Abbreviations Report Methodology Overview Coverage Secondary Research Page 4 GDME1008FPR / Published APR 2013

5 6.3.4 Forecasting Methodology Physicians and Specialists Included in this Study Physician Survey About the Authors Analysts Global Head of Healthcare About MediPoint About GlobalData Contact Us Disclaimer Page 5 GDME1008FPR / Published APR 2013

6 1.1 List of Tables Table 1: Global Peripheral Vascular Stent Market ($m) for Each Type of Artery in the Lower Extremity, Table 2: Marketed Bare Metal Stent Products - Self-Expanding Stents Table 3: Marketed Bare Metal Stent Products - Balloon-Expanding Stents Table 4: Absolute Stent Family Product Portfolio Table 5: Absolute Stent SWOT Analysis, Table 6: Astron Stent Product Portfolio Table 7: Astron Stent SWOT Analysis, Table 8: BioMimics 3D Stent Product Portfolio Table 9: BioMimics 3D Stent SWOT Analysis, Table 10: Complete Stent SE Product Portfolio Table 11: Complete SE Stent SWOT Analysis, Table 12: E-Luminexx Stent Product Portfolio Table 13: E-Luminexx Stent SWOT Analysis, Table 14: Epic Stent Product Portfolio Table 15: Epic Stent SWOT Analysis, Table 16: FlexStent Iliac Stent System Product Portfolio Table 17: FlexStent Iliac Stent System SWOT Analysis, Table 18: LifeStent Vascular Stent System Product Portfolio Table 19: LifeStent Vascular Stent System SWOT Analysis, Table 20: Maris Deep Stent Product Portfolio Table 21: Maris Deep Stent SWOT Analysis, Table 22: Maris Plus Stent Product Portfolio Table 23: Maris Plus Stent SWOT Analysis, Table 24: Misago Stent Product Portfolio Table 25: Misago Stent SWOT Analysis, Table 26: NovoStent Samba Stent System Product Portfolio Table 27: NovoStent Samba Stent System SWOT Analysis, Page 6 GDME1008FPR / Published APR 2013

7 Table 28: Protégé Family of Stents Product Portfolio Table 29: Protégé Family of Stents SWOT Analysis, Table 30: Pulsar 18 Stent Product Portfolio Table 31: Pulsar 18 Stent SWOT Analysis, Table 32: SMART Stent Product Portfolio Table 33: SMART Stent SWOT Analysis, Table 34: Sinus Stent Family Product Portfolio Table 35: Sinus Stent Family SWOT Analysis, Table 36: Supera Veritas Stent Product Portfolio Table 37: Supera Veritas Stent SWOT Analysis, Table 38: Wallstent Product Portfolio Table 39: Wallstent SWOT Analysis, Table 40: Xpert Stent Product Portfolio Table 41: Xpert Stent SWOT Analysis, Table 42: Zilver Stent Product Portfolio Table 43: Zilver Stent SWOT Analysis, Table 44: Assurant Cobalt Stent Product Portfolio Table 45: Assurant Cobalt Stent SWOT Analysis, Table 46: Chromis Deep Stent Product Portfolio Table 47: Chromis Deep Stent SWOT Analysis, Table 48: Dynamic Stent Product Portfolio Table 49: Dynamic Stent SWOT Analysis, Table 50: Express LD Product Portfolio Table 51: Express LD SWOT Analysis, Table 52: IntraStent LD Stent Product Portfolio Table 53: IntraStent LD Stent SWOT Analysis, Table 54: Omnilink Elite Stent Product Portfolio Table 55: Omnilink Elite Stent SWOT Analysis, Page 7 GDME1008FPR / Published APR 2013

8 Table 56: ParaMount Mini GPS Product Portfolio Table 57: ParaMount Mini GPS SWOT Analysis, Table 58: ProStar Stent Product Portfolio Table 59: ProStar Stent SWOT Analysis, Table 60: Scuba Stent Product Portfolio Table 61: Scuba Stent SWOT Analysis, Table 62: Visi-Pro Stent Product Portfolio Table 63: Visi-Pro Stent SWOT Analysis, Table 64: Marketed Drug-Eluting Stent Products Table 65: Xience Prime BTK Stent Product Portfolio Table 66: Xience Prime BTK Stent SWOT Analysis, Table 67: Zilver PTX Stent Product Portfolio Table 68: Zilver PTX Stent SWOT Analysis, Table 69: Marketed Covered Stent Products Table 70: Gore Viabahn Stent Product Portfolio Table 71: Gore Viabahn Stent SWOT Analysis, Table 72: Gore Tigris Stent Product Portfolio Table 73: Gore Tigris Stent SWOT Analysis, Table 74: V12 Covered Stents Product Portfolio Table 75: V12 Covered Stents SWOT Analysis, Table 76: Remedy Stent Product Portfolio Table 77: Remedy Stent SWOT Analysis, Table 78: Global Peripheral Vascular Stent Product Pipeline Table 79: Citation Stent SWOT Analysis, Table 80: MR-Enhanced Stents SWOT Analysis, Table 81: Yukon Stent SWOT Analysis, Table 82: icast Stent SWOT Analysis, Table 83: Peritoneal-Lined Stents SWOT Analysis, Page 8 GDME1008FPR / Published APR 2013

9 Table 84: Esprit BVS SWOT Analysis, Table 85: Magic Explorer Stent SWOT Analysis, Table 86: Stanza Stent SWOT Analysis, Table 87: 3D Biotek Bioresorbable Stent SWOT Analysis, Table 88: Archer Stent SWOT Analysis, Table 89: Abbott Vascular Company Profile Table 90: Abbott Vascular, Marketed and Pipeline Vascular Stent Products Table 91: Abbott Vascular SWOT Analysis, Table 92: Amaranth Medical Company Profile Table 93: Amaranth Medical, Pipeline Vascular Stent Products Table 94: Amaranth Medical SWOT Analysis, Table 95: Arterial Remodeling Technologies Company Profile Table 96: Arterial Remodeling Technologies Pipeline Vascular Stent Products Table 97: Arterial Remodeling Technologies SWOT Analysis, Table 98: Atrium Medical Corporation Company Profile Table 99: Atrium Medical Corporation, Marketed and Pipeline Vascular Stent Products Table 100: Atrium Medical Corporation SWOT Analysis, Table 101: Bard Peripheral Vascular (C.R. Bard) Company Profile Table 102: Bard Peripheral Vascular (C.R. Bard), Marketed Stent Products Table 103: Bard Peripheral Vascular (C.R. Bard) SWOT Analysis, Table 104: Biotronik Company Profile Table 105: Marketed and Pipeline Vascular Stent Products by Biotronik Table 106: Biotronik SWOT Analysis, Table 107: Boston Scientific Corporation Company Profile Table 108: Boston Scientific Corporation, Marketed and Pipeline Vascular Stent Products 161 Table 109: Boston Scientific Corporation SWOT Analysis, Table 110: Company Profile 3D Biotek Table 111: 3D Biotek s Pipeline Vascular Stent Products Page 9 GDME1008FPR / Published APR 2013

10 Table 112: 3D Biotek SWOT Analysis, Table 113: 480 Biomedical Company Profile Table 114: 480 Biomedical, Pipeline Vascular Stent Products Table 115: 480 Biomedical SWOT Analysis, Table 116: Cook Medical Company Profile Table 117: Cook Medical, Marketed Vascular Stent Products Table 118: Cook Medical SWOT Analysis, Table 119: Cordis Corporation Company Profile Table 120: Cordis Corporation s Marketed Vascular Stent Products Table 121: Cordis Corporation SWOT Analysis, Table 122: CorInnova Company Profile Table 123: CorInnova, Pipeline Vascular Stent Products Table 124: CorInnova SWOT Analysis, Table 125: Covidien Company Profile Table 126: Covidien s Marketed Vascular Stent Products Table 127: Covidien SWOT Analysis, Table 128: Company Profile Cytograft Tissue Engineering Table 129: Cytograft Tissue Engineering, Pipeline Vascular Stent Products Table 130: Cytograft Tissue Engineering SWOT Analysis, Table 131: Flexible Stenting Solutions Company Profile Table 132: Flexible Stenting Solutions Marketed Vascular Stent Products Table 133: Flexible Stenting Solutions SWOT Analysis, Table 134: IDEV Technologies Company Profile Table 135: IDEV Technologies Marketed Vascular Stent Products Table 136: IDEV Technologies SWOT Analysis, Table 137: Kyoto Medical Planning Company Profile Table 138: Kyoto Medical Planning s Marketed Vascular Stent Product Table 139: Kyoto Medical Planning SWOT Analysis, Page 10 GDME1008FPR / Published APR 2013

11 Table 140: Medtronic Company Profile Table 141: Medtronic s Marketed Vascular Stent Products Table 142: Medtronic SWOT Analysis, Table 143: Nexeon Stent Company Profile Table 144: Nexeon Stent s Pipeline Vascular Stent Product Table 145: Nexeon Stent SWOT Analysis, Table 146: Nipro Corporation Company Profile Table 147: Nipro Corporation s Pipeline Vascular Stent Product Table 148: Nipro Corporation SWOT Analysis, Table 149: NovoStent Corporation Company Profile Table 150: NovoStent Corporation s Marketed Vascular Stent Product Table 151: NovoStent Corporation SWOT Analysis, Table 152: OptiMed Company Profile Table 153: OptiMed s Marketed Vascular Stent Products Table 154: OptiMed SWOT Analysis, Table 155: Company Profile PeriTec Biosciences Table 156: PeriTec Bioscience s Pipeline Vascular Stent Product Table 157: PeriTec Biosciences SWOT Analysis, Table 158: Synergy Flow Company Profile Table 159: Pipeline Vascular Stent Product by Synergy Flow Table 160: Synergy Flow SWOT Analysis, Table 161: Tepha Company Profile Table 162: Tepha Medical Device s Pipeline Vascular Stent Product Table 163: Tepha SWOT Analysis, Table 164: Terumo Corporation Company Profile Table 165: Terumo Corporation s Marketed Vascular Stent Products Table 166: Terumo Corporation SWOT Analysis, Table 167: TissueGen Company Profile Page 11 GDME1008FPR / Published APR 2013

12 Table 168: TissueGen s Pipeline Vascular Stent Product Table 169: TissueGen SWOT Analysis, Table 170: Translumina Company Profile Table 171: Translumina s Pipeline Vascular Stent Product Table 172: Translumina SWOT Analysis, Table 173: Vascular Concepts Company Profile Table 174: Marketed Vascular Stent Products by Vascular Concepts Table 175: Vascular Concepts SWOT Analysis, Table 176: Company Profile Veryan Medical Table 177: Marketed Vascular Stent Products by Veryan Medical Table 178: Veryan Medical SWOT Analysis, Table 179: VueKlar Cardiovascular Company Profile Table 180: VueKlar Cardiovascular s Pipeline Vascular Stent Product Table 181: VueKlar Cardiovascular SWOT Analysis, Table 182: W.L. Gore & Associates Company Profile Table 183: W.L. Gore & Associates Marketed Vascular Stent Products Table 184: W.L. Gore & Associates SWOT Analysis, Table 185: Zorion Medical Company Profile Table 186: Pipeline Vascular Stent Products by Zorion Medical Table 187: Zorion Medical SWOT Analysis, Table 188: Physicians Surveyed, By Country Page 12 GDME1008FPR / Published APR 2013

13 1.2 List of Figures Figure 1: Global Peripheral Vascular Stent Market for Treating Peripheral Artery Disease in the Lower Extremity ($), Figure 2: Global Peripheral Vascular Stent Market ($m) for Each Type of Artery, Figure 3: Remedy Stent for Treating Peripheral Artery Disease Figure 4: Pipeline Peripheral Vascular Stent Products, Figure 5: Global Peripheral Vascular Stent Pipeline by Stage of Clinical Development, Figure 6: Global Peripheral Vascular Stent Market for Treating Peripheral Artery Disease in the Lower Extremity, Company Share (%), Figure 7: Global Peripheral Vascular Stent Market for Each Type of Artery, Company Share (%), Figure 8: Kyoto Medical Planning, Sales Volume ($m), May 2002 May Page 13 GDME1008FPR / Published APR 2013

14 Introduction 2 Introduction Peripheral artery disease (PAD) is a global public health and socioeconomic problem that affect millions of lives each year. Endovascular therapies, such as stenting, have been widely adopted to treat PAD in the lower extremity. Peripheral vascular stents including bare metal, drug-eluting, covered, and bioabsorbable stents, which are associated with improved clinical outcomes compared with balloon angioplasty alone. The peripheral vascular stent market is currently dominated by bare metal stents (BMS) specifically, self-expanding nitinol stents for treating atherosclerotic disease in the iliac, femoropopliteal, and infrapopliteal arteries. Adoption of stents for treating infrapopliteal artery lesions is low, where balloon angioplasty still remains the preferred method of treatment. Given the challenges in treating lesions in the femoropopliteal and infrapopliteal arteries, there is a growing need to develop novel stent platforms that can reduce the risk of restenosis and the need for target lesion revascularization (TLR), and improve long-term vessel patency. As innovative technologies, such as drug-eluting and bioabsorbable stents, enter the market, adoption of these stents will increase over time, especially for femoropopliteal and infrapopliteal applications. Bioabsorbable stents (BAS), which provide transient support to the vessel, are viable alternatives to permanent bare metal, drug-eluting, and covered stent implants. In this report, BAS are defined as fully-biodegradable stents that completely disappear from the vessel over time. This report focuses on the global vascular stents market for treating PAD in the lower extremity. The global peripheral vascular stent market is determined for the 10 countries covered in the report, which are the US, France, Germany, Italy, Spain, UK, Japan, Brazil, China, and India. This report identifies the unmet needs in the market for treating PAD in the lower limb, provides an understanding of physicians perception of different types of peripheral vascular stents, and evaluates their adoption in the future. Through GlobalData s analysis, it is evident that the current peripheral vascular stent market for the lower extremity is saturated with BMS, followed by covered stents. However, increased adoption of innovative stent technologies, such as DES, will decrease the use of bare metal and covered stents specifically for treating the femoropopliteal and infrapopliteal arteries. In the 10 countries covered in the report, widespread adoption of new stent technologies, such as BAS, will be slow. Large-scale, long-term studies need to be conducted to demonstrate clinical efficacy, and new stent technologies need to be integrated appropriately into the existing reimbursement systems. To successfully market peripheral vascular stents, companies need to design novel stent platforms that address the challenges in treating femoropopliteal and infrapopliteal artery lesions and show superior clinical performance to the stents currently in the peripheral vascular stent market. Page 14 GDME1008FPR / Published APR 2013

15 Introduction 2.1 Catalyst Modern developments in endovascular interventions have led to a paradigm shift in the treatment of PAD in the lower extremity towards minimally invasive techniques, such as stenting. Peripheral vascular stents, including bare metal, drug-eluting, covered, and bioabsorbable stents, offer innovative treatment solutions for patients with PAD. Bare metal and covered stents have been widely adopted in clinical practice, where they are associated with maintaining high patency in the iliac arteries. The femoropopliteal and infrapopliteal arteries are challenging to treat, given the diffuse nature of atherosclerotic disease and long and heavily-calcified lesions. In the femoropopliteal arteries, the high plaque burden, slow vascular flow, and exposure to high mechanical forces increase the risk of stent compression and fracture. Effective stent technologies need to be designed to address these unmet needs. Modern developments in endovascular interventions have led to a paradigm shift in the treatment of PAD in the lower extremity towards minimally invasive techniques, such as stenting The peripheral vascular stent market is a large and dynamic one that allows stent manufacturers to develop different types of vascular stent platforms for different types of arteries in the lower extremity. Low-profile stent technologies are being developed to reduce the risk of complications, such as restenosis, thrombosis, and stent fracture, and improve long-term vessel patency. As drugeluting and bioabsorbable stents address the unmet needs of the current peripheral vascular stent market, they will represent the future of stents for treating PAD in the lower extremity. As more long-term clinical data become available demonstrating their superior therapeutic benefits, adoption of drug-eluting and bioabsorbable stents by the medical community will increase in the future. As PAD presents enormous global public health and socioeconomic issues, it is pertinent to find effective treatment modalities that ensure long-term quality results for patients. This report looks at the market breakdown by company, new entrants to the Peripheral Vascular Stent industry and drivers for future growth. 2.2 Related Reports Bioabsorbable Stents Global Market Analysis and Forecasts GDME0164MAR / Published December Upcoming Related Reports Drug-Eluting Balloons Global Market Analysis and Forecasts Expected Publication Date June 2013 Page 15 GDME1008FPR / Published APR 2013

16 Appendix 6.7 About MediPoint MediPoint is the flagship product for GlobalData s Medical team. Each MediPoint report is built from the ground up by our team of healthcare analysts in the US and UK. Each report includes input from experienced physicians and leading Key Opinion Leaders (KOLs). Running throughout each report in the series, What Physicians Think quotes provide a unique insight into how healthcare professionals are reacting to events within the industry, and what their responses could mean for industry strategists. 6.8 About GlobalData GlobalData is a leading global provider of business intelligence in the healthcare industry. GlobalData provides its clients with up-to-date information and analysis on the latest developments in drug research, disease analysis, and clinical research and development. Our integrated business intelligence solutions include a range of interactive online databases, analytical tools, reports, and forecasts. Our analysis is supported by a 24/7 client support and analyst team. GlobalData has offices in New York, Boston, London, India, and Singapore. Page 250 GDME1008FPR / Published APR 2013

17 Appendix 6.10 Disclaimer All Rights Reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, GlobalData. Page 251 GDME1008FPR / Published APR 2013