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MediPoint: Aortic Stent Grafts - US Analysis and Market Forecasts

Summary

Aortic stent grafts are most commonly used to reinforce a weak spot in an artery, which is known as an aneurysm. The stent grafts are designed to seal tightly with the patient’s native artery above and below the aneurysm, and are used to treat abdominal aortic aneurysms as well as thoracic aortic aneurysms. Aortic aneurysms, as opposed to aneurysms found elsewhere in the body, are potentially very serious, as a burst aorta results in massive internal bleeding that can be fatal unless treated rapidly by an experienced emergency medical team. Since their introduction in patients in 1991, aortic stent graft devices have gained wide acceptance and availability, with their adoption fueled in great part by advances in stent-graft design and by a variety of devices for various anatomic features. Over time, these devices have gained traction for use in patients with ruptured aneurysms because they are minimally invasive and have shorter recovery times.

The US market is the largest market for aortic stent grafts, accounting for more than 40% of the global market. The US market is very similar to that of the global market with regard to the trends in market share. Gore Medical remains the leader in the US for both the EVAR and TEVAR markets. These three companies also offer market leading products for treating AAA and TAA, ensuring long-term, effective solutions to patients.

Scope

- An overview of Aortic Stent Grafts, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
- Annualized the US Aortic Stent Grafts market revenue and future forecasts from 2011 to 2013, forecast for 7 years to 2020.
- Investigation of current and future market competition for Aortic Stent Grafts.
- Insightful review of the key industry drivers, restraints and challenges as well as predicted impact of key events.
- Competitor assessment including device approval analysis and device sales forecasts.
- Marketed and pipeline product profiles covering efficiency, safety, clinical study details, device approvals, product positioning and device sales forecast.
- Analysis of unmet needs within the market and opportunities for future players.
- Technology trends evaluation to assess strength of pipeline.
- An overview of all devices in development including clinical study details, design and material selection considerations, efficacy reports, and device approval timelines.
- Company profiles including business description, financial overview and SWOT analysis.
- Coverage of key market players.
- Strategic assessment of the Aortic Stent Grafts sector through market impact analysis, future market scenario and company analysis.
- Direct quotes from Key Opinion Leaders (KOL) as well as doctors

Reasons to buy

- Understand the trends shaping and driving the US Aortic Stent Grafts market.
- Realize device preferences of physicians who have performed the tests already.
- Access market sizing, forecasts and quantified growth opportunities in the US Aortic Stent Grafts market through 2018.
- Quantify candidate patient populations to better design product pricing & launch plans.
- Drive revenues, formulate effective sales and marketing strategies and gain in-depth understanding of the competitive landscape.
- Perform benchmarking analysis of growth opportunities against currently marketed products.
- Assess competitiveness of products in market by understanding the strengths and weaknesses of current competition.
- Take a comprehensive look at the market’s device pipeline and identify promising, paradigm-shifting products.
- Create an effective counter-strategy to gain a competitive advantage against those currently in the market.
- Organize your sales and marketing efforts by identifying the market categories and segments that present the best opportunities for growth.
- What’s the next big thing in the US Aortic Stent Grafts market landscape? Identify, understand and capitalize.

Table Of Contents

MediPoint: Aortic Stent Grafts - US Analysis and Market Forecasts
1 Table of Contents

2 Introduction 20
2.1 Catalyst 21
2.2 Related Reports 22
2.3 Upcoming Related Reports 22
3 Industry Overview 23
3.1 Overview 23
3.2 Indications 25
3.2.1 Aortic Abdominal Aneurysm 25
3.2.2 Thoracic Aortic Aneurysm 25
3.2.3 Aortic Dissection 26
3.3 Clinical Outcomes 27
3.3.1 Lifestyle Changes 28
3.3.2 Medication 29
3.3.3 Open Surgery 29
3.3.4 Endovascular Repair 30
3.4 Procedure Trends 32
3.4.1 US 32
3.5 Market Access 34
3.5.1 Adoption 35
3.5.2 Regulation 40
3.5.3 Reimbursement 41
3.6 Regulatory Issues/Recalls 44
3.6.1 Anaconda Back on the Market in March 2014 after a Voluntary Recall of Anaconda by Vascutek 44
3.6.2 Terminated FDA's Class II Recall of TriVascular's Ovation Prime in April 2014 44
3.7 Mergers, Deals, and Acquisitions 44
3.7.1 Medtronic Acquires Covidien 44
3.7.2 TriVascular Launches $100m Initial Public Offering 44
3.7.3 Lombard Medical Pursues US Initial Public Offering 45
3.7.4 TriVascular Raises $40m in Series E Financing 45
3.7.5 LifeTech Scientific Creates Partnership with Medtronic 45
3.7.6 LeMaitre Vascular Terminates Distribution Agreement with Endologix 45
3.7.7 Jotec Enters Licensing Agreement with Hydromer 46
3.7.8 Endologix Public Offering of Notes 46
3.7.9 Aptus Endosystems Secures Financing 46
3.7.10 Altura Medical Secures Financing 46
3.7.11 Endologix Acquires Nellix Endovascular 46
3.8 Economic Impact 47
3.8.1 Economic Impact of Aneurysms 47
3.8.2 Treatment Costs of Aortic Aneurysms 48
4 Unmet Needs 50
4.1 Addressing the Complications 50
4.1.1 Endoleaks 50
4.1.2 Ischemic Complications 51
4.1.3 Limb Thrombosis 52
4.1.4 Infection 52
4.1.5 Paraplegia in Thoracic Aortic Aneurysm 52
4.2 The Seal and Landing Zone 53
4.3 Short Neck 54
4.4 Cost Containment 55
4.5 More Low Profile Systems 56
4.6 Customized Fenestrated Stent Grafts 56
4.7 Multi-Branch Stent Grafts 57
4.8 Thoracic Endovascular Aneurysm Repair Unmet Needs 58
4.9 Long-Term Clinical Data 59
5 Market Opportunity Analysis 60
5.1 Thoracic Aortic Disease Market 60
5.2 Addition of Physician Training Programs 60
5.3 Disruptive Technologies 61
5.4 Minimally Invasive Trend 62
6 Market Drivers, Barriers, and Substitutes 63
6.1 Driver: Rising Disease Prevalence 63
6.1.1 Diabetes Mellitus 63
6.1.2 Hypertension 63
6.1.3 Obesity 64
6.1.4 Tobacco Use 64
6.2 Driver: Aging 64
6.3 Driver: Imaging 65
6.4 Key Opinion LeaderDriver: Improved Clinical Outcomes with Endovascular Therapy 66
6.5 Driver: Time Savings 67
6.6 Driver: Patient Demand and Awareness 67
6.7 Driver: Technological Developments 68
6.7.1 Custom Branched and Fenestrated Stent Grafts 68
6.7.2 Low Profile Delivery Systems 68
6.8 Driver: Rising Competition and Innovation 70
6.9 Barrier: Availability of Venture Capital 70
6.10 Barrier: Burden of Rising Regulation 71
6.11 Barrier: High Treatment Cost 72
6.12 Barrier: Proving Long-Term Efficacy 72
6.13 Barrier: High Radiation Dosages with Excessive Imaging 73
6.14 Surgical Limitations 73
6.15 Barrier: Medical Device Excise Tax 74
6.16 Substitute: Open Surgery 74
6.17 Substitute: Chimney Technique versus Fenestrated Grafts 76
7 Competitive Assessment 77
7.1 Overview 77
7.2 Key Marketed Products 77
7.2.1 Endovascular Aneurysm Repair and Thoracic Endovascular Aneurysm Repair Products 77
8 Pipeline Assessment 88
8.1 Overview 88
8.2 Product Profiles 88
8.2.1 Altura Medical Endograft 88
8.2.2 Cordis INCRAFT 89
8.2.3 EndoSpan Horizon 90
8.2.4 EndoSpan Nexus 91
8.2.5 MicroPort Scientific Castor Branched Stent Graft System 92
8.2.6 BiFlow Medical Novel Side-Branch Stent 93
8.2.7 Endoluminal Sciences Endograft Mechanism 94
8.2.8 Medtronic Valiant Mona LSA Stent Graft System 95
8.2.9 Endologix Ventana Fenestrated Stent Graft 95
9 Clinical Trials to Watch 97
9.1 Overview 97
9.2 Altura Medical 97
9.3 Cook Medical 98
9.4 Gore Medical 100
9.5 Terumo Corporation 101
9.6 Endologix 101
9.7 TriVascular 103
9.8 Bolton Medical 104
9.9 Medtronic 105
9.10 Cordis Corporation 107
10 Current and Future Players 108
10.1 Overview 108
10.2 Trends in Corporate Strategy 108
10.3 Company Profiles 109
10.3.1 Cook Medical 109
10.3.2 Endologix 112
10.3.3 Gore Medical 115
10.3.4 Medtronic 117
10.3.5 Terumo Corporation 120
10.3.6 Altura Medical 122
10.3.7 Aptus Endosystems 123
10.3.8 Bolton Medical 125
10.3.9 Braile Biomedica 127
10.3.10 B. Braun 130
10.3.11 Cardiatis 131
10.3.12 LeMaitre Vascular 133
10.3.13 Lifetech Scientific 135
10.3.14 Getinge Group 137
10.3.15 Grikin Advanced Materials 140
10.3.16 Johnson and Johnson's Cordis Corporation 141
10.3.17 Jotec 143
10.3.18 Lombard Medical 145
10.3.19 MicroPort Scientific Corporation 146
10.3.20 Nano Endoluminal 149
10.3.21 TriVascular 151
10.3.22 Weike Medical Apparatus and Instrument 154
10.3.23 YTH Biological Material Scitech 154
11 Market Outlook 155
11.1 Company Market Share 155
11.1.1 US Market Share 155
11.2 By Market Segment 157
11.2.1 Overview 157
11.2.2 Endovascular Aneurysm Repair 158
11.2.3 Thoracic Endovascular Aneurysm Repair 159
11.3 By Geography 161
11.3.1 US 161
12 Appendix 164
12.1 Bibliography 164
12.2 Abbreviations 177
12.3 Research Methodology 180
12.3.1 Overview 180
12.3.2 Coverage 180
12.3.3 Secondary Research 180
12.4 Physicians and Specialists Included in this Study 182
12.4.1 Christopher Abularrage, MD, FACS 182
12.4.2 Gaspar Mestres Alomar, MD 182
12.4.3 Enio Buffolo, MD, PhD 182
12.4.4 Ludovic Canaud, MD, PhD 182
12.4.5 Holger Eggebrecht, MD 182
12.4.6 Daisuke Fukui, MD, PhD 182
12.4.7 Germano Melissano, MD 182
12.4.8 Dr. Raghuram Sekhar MS, FRCS (Edinburgh), FRCS (Glasgow) 182
12.4.9 Ferdinand Serracino-Inglott, MD, MSc, FRCSI, FRCS (Gen Surg), DIC 183
12.4.10 Jiang Xiong, MD, PhD 183
12.5 Primary Research 184
12.5.1 Primary Research - Key Opinion Leader Interviews 184
12.5.2 Primary Research - Physician and Industry Interviews 184
12.5.3 Expert Panel Validation 185
12.6 Forecasting Methodology 186
12.7 About the Authors 187
12.7.1 Analysts 187
12.7.2 Global Head of Healthcare 188
12.8 About MediPoint 189
12.9 About GlobalData 189
12.10 Disclaimer 189

1.1 List of Tables

Table 1: Summary of Indications, Symptoms, and Treatments 24
Table 2: Thoracic Aortic Aneurysm Types 26
Table 3: Medications for Reducing Risk of Aneurysm Growth and Rupture 29
Table 4: Advantages and Disadvantages of Open Repair versus Endovascular Repair 31
Table 5: Group Purchasing Organizations in the US 39
Table 6: Medicare National Average of Inpatient Hospital Payment for EVAR and TEVAR, 2013-2014 43
Table 7: Medicare Coding Guide for EVAR and TEVAR, 2014 43
Table 8: Direct and Indirect Costs of Open Surgery and Endovascular Repair 48
Table 9: Comparison Costs and Other Variables for Treating AAA By Open Repair and Stent Grafts in 2012 ($US) 49
Table 10: Endoleak Types 50
Table 11: Zenith Family Marketed Products 79
Table 12: Zenith AAA SWOT 79
Table 13: Zenith TAA SWOT 80
Table 14: Endologix's Marketed Products 81
Table 15: AFX Endovascular SWOT 81
Table 16: IntuiTrak Powerlink System SWOT 81
Table 17: Gore Medical's Marketed Products 83
Table 18: Gore AAA Product SWOT 83
Table 19: Gore TAA Product SWOT 84
Table 20: Medtronic's Marketed Products 85
Table 21: Medtronic AAA Product SWOT 86
Table 22: Medtronic TAA Product SWOT 86
Table 23: Terumo Corporation Marketed Products 87
Table 24: Terumo Corporation AAA Product SWOT 87
Table 25: SWOT Analysis - Altura Medical Endograft 89
Table 26: SWOT Analysis - Cordis INCRAFT 90
Table 27: SWOT Analysis - EndoSpan Horizon 91
Table 28: SWOT Analysis - EndoSpan Nexus 92
Table 29: SWOT Analysis - MicroPort Scientific Castor Branched Stent Graft System 93
Table 30: SWOT Analysis - BiFlow Medical Novel Side-Branch Stent 94
Table 31: SWOT Analysis - Endoluminal Sciences Endograft Mechanism 94
Table 32: SWOT Analysis - Medtronic Valiant Mona LSA Stent Graft 95
Table 33: SWOT Analysis - Endologix Ventana Fenestrated Stent Graft 96
Table 34: Major Clinical Trials of Altura Medical's Aortic Stent Grafts 98
Table 35: Major Clinical Trials of Cook Medical's Aortic Stent Grafts 99
Table 36: Major Clinical Trials of Gore Medical's Aortic Stent Grafts 100
Table 37: Major Clinical Trials of Terumo's Aortic Stent Grafts 101
Table 38: Major Clinical Trials of Endologix's Aortic Stent Grafts 102
Table 39: Major Clinical Trials of TriVascular's Aortic Stent Grafts 103
Table 40: Major Clinical Trials of Bolton Medical's Aortic Stent Grafts 104
Table 41: Major Clinical Trials of Medtronic's Aortic Stent Grafts 105
Table 42: Major Clinical Trials of Cordis' Aortic Stent Grafts 107
Table 43: Company Profile - Cook Medical 110
Table 44: Cook Medical Marketed Products 111
Table 45: SWOT Analysis - Cook Medical 112
Table 46: Company Profile - Endologix Inc. 113
Table 47: Endologix Marketed Products 114
Table 48: Endologix Pipeline Products 114
Table 49: SWOT Analysis - Endologix Inc. 114
Table 50: Company Profile - Gore Medical 115
Table 51: Gore Medical Marketed Products 116
Table 52: SWOT Analysis - Gore Medical 117
Table 53: Company Profile - Medtronic 118
Table 54: Medtronic Marketed Products 119
Table 55: SWOT Analysis - Medtronic 119
Table 56: Company Profile - Terumo Corporation 120
Table 57:Terumo Corporation Marketed Products 121
Table 58: SWOT Analysis - Terumo Corporation 122
Table 59: Company Profile - Altura Medical Inc. 122
Table 60: Altura Medical Inc. Marketed Products 123
Table 61: SWOT Analysis - Altura Medical Inc. 123
Table 62: Company Profile - Aptus Endosystems, Inc. 124
Table 63: Aptus Endosystems Inc. Marketed Products 125
Table 64: SWOT Analysis - Aptus Endosystems Inc. 125
Table 65: Company Profile - Bolton Medical 126
Table 66: Bolton Medical Marketed Products 127
Table 67: SWOT Analysis - Bolton Medical 127
Table 68: Company Profile - Braile Biomedica 128
Table 69: Braile Biomedica Marketed Products 129
Table 70: SWOT Analysis - Braile Biomedica 129
Table 71: Company Profile - B. Braun 130
Table 72: B. Braun Marketed Products 131
Table 73: SWOT Analysis - B. Braun 131
Table 74: Company Profile - Cardiatis 132
Table 75: Cardiatis Marketed Products 132
Table 76: SWOT Analysis - Cardiatis 133
Table 77: Company Profile - LeMaitre Vascular 134
Table 78: LeMaitre Vascular Medical Marketed Products 134
Table 79: SWOT Analysis - LeMaitre Vascular 135
Table 80: Company Profile - Lifetech Scientific 136
Table 81: Lifetech Scientific Marketed Products 136
Table 82: SWOT Analysis - Lifetech Scientific 137
Table 83: Company Profile - Getinge Group 138
Table 84: Getinge Group Marketed Products 139
Table 85: SWOT Analysis - Getinge Group 139
Table 86: Company Profile - Grikin Advanced Materials 140
Table 87: Grikin Advanced Materials Marketed Products 140
Table 88: SWOT Analysis - Grikin Advanced Materials 141
Table 89: Company Profile - Johnson and Johnson Cordis Corporation 141
Table 90: Cordis Corporation's Pipeline Product 142
Table 91: SWOT Analysis - Cordis Corporation 142
Table 92: Company Profile - Jotec 143
Table 93: Jotec's Marketed Products 144
Table 94: SWOT Analysis - Jotec 144
Table 95: Company Profile - Lombard Medical 145
Table 96: Lombard Medical Marketed Products 146
Table 97: SWOT Analysis - Lombard Medical 146
Table 98: Company Profile - Microport Scientific Corporation 147
Table 99: MicroPort Scientific Marketed Products 148
Table 100: SWOT Analysis - MicroPort Scientific 149
Table 101: Company Profile - Nano Endoluminal 150
Table 102: Nano Endoluminal Medical Marketed Products 150
Table 103: SWOT Analysis - Nano Endoluminal 151
Table 104: Company Profile - TriVascular 152
Table 105: TriVascular Marketed Products 153
Table 106: SWOT Analysis - TriVascular 153
Table 107:US Aortic Stent Grafts Sales ($m) Forecast, by Segment, 2011-2020 157
Table 108:US Aortic Stent Grafts Sales ($m) Forecast, EVAR, 2011-2020 159
Table 109: US Aortic Stent Grafts Sales ($m) Forecast, TEVAR, 2011-2020 160
Table 110: Aortic Stent Grafts Sales ($m) for the US, 2011-2020 161

1.2 List of Figures
Figure 1: Treatment Methodology Markov Model 28
Figure 2: Aortic Stent Graft Product Image 31
Figure 3: US Abdominal Aortic Stent Grafts Procedure Volume, 2011-2020 33
Figure 4: US Thoracic Aortic Stent Grafts Procedure Volume, 2011-2020 34
Figure 5: US Market Share for EVAR, 2013 156
Figure 6: US Market Share for TEVAR, 2013 157
Figure 7: US Aortic Stent Grafts Sales ($m) Forecast, by Segment, 2011-2020 158
Figure 8: US Aortic Stent Grafts Sales ($m) Forecast, EVAR, 2011-2020 159
Figure 9: US Aortic Stent Grafts Sales ($m) Forecast, TEVAR, 2011-2020 160
Figure 10: US Sales ($m) Forecast for Aortic Stent Grafts, 2011-2020 162
Figure 11: Aortic Stent Graft Primary Research, Supply and Demand-Side Interviews 185

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