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MediPoint: Aortic Stent Grafts - EU 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 EU market continues to be the second biggest market for aortic stent grafts at 23% of the global scene. Of this, Germany remains the leader as they are the pioneers of cardiovascular innovations and have a strong local manufacturing base. Similar to the US, the leading companies in the EU aortic stent grafts market are Medtronic, Cook Medical, and Gore Medical, with emerging players such as Endologix.

Scope

- An overview of Aortic Stent Grafts, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
- Annualized the 5EU 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 5EU 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 5EU 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 5EU Aortic Stent Grafts market landscape? Identify, understand and capitalize.

Table Of Contents

MediPoint: Aortic Stent Grafts - EU 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 EU 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 47
3.6.1 Anaconda Back on the Market in March 2014 after a Voluntary Recall of Anaconda by Vascutek 47
3.6.2 Terminated FDA's Class II Recall of TriVascular's Ovation Prime in April 2014 47
3.7 Mergers, Deals, and Acquisitions 47
3.7.1 Medtronic Acquires Covidien 47
3.7.2 TriVascular Launches $100m Initial Public Offering 48
3.7.3 Lombard Medical Pursues US Initial Public Offering 48
3.7.4 TriVascular Raises $40m in Series E Financing 48
3.7.5 LifeTech Scientific Creates Partnership with Medtronic 48
3.7.6 LeMaitre Vascular Terminates Distribution Agreement with Endologix 48
3.7.7 Jotec Enters Licensing Agreement with Hydromer 49
3.7.8 Endologix Public Offering of Notes 49
3.7.9 Aptus Endosystems Secures Financing 49
3.7.10 Altura Medical Secures Financing 49
3.7.11 Endologix Acquires Nellix Endovascular 49
3.8 Economic Impact 50
3.8.1 Economic Impact of Aneurysms 50
3.8.2 Treatment Costs of Aortic Aneurysms 51
4 Unmet Needs 53
4.1 Addressing the Complications 53
4.1.1 Endoleaks 53
4.1.2 Ischemic Complications 54
4.1.3 Limb Thrombosis 55
4.1.4 Infection 55
4.1.5 Paraplegia in Thoracic Aortic Aneurysm 55
4.2 The Seal and Landing Zone 56
4.3 Short Neck 57
4.4 Cost Containment 58
4.5 More Low Profile Systems 59
4.6 Customized Fenestrated Stent Grafts 59
4.7 Multi-Branch Stent Grafts 60
4.8 Thoracic Endovascular Aneurysm Repair Unmet Needs 61
4.9 Long-Term Clinical Data 62
5 Market Opportunity Analysis 63
5.1 Emerging Markets 63
5.2 Thoracic Aortic Disease Market 64
5.3 Addition of Physician Training Programs 65
5.4 Disruptive Technologies 66
5.5 Minimally Invasive Trend 67
6 Market Drivers, Barriers, and Substitutes 68
6.1 Driver: Rising Disease Prevalence 68
6.1.1 Diabetes Mellitus 68
6.1.2 Hypertension 68
6.1.3 Obesity 68
6.1.4 Tobacco Use 69
6.2 Driver: Aging 69
6.3 Driver: Imaging 70
6.4 Driver: Improved Clinical Outcomes with Endovascular Therapy 71
6.5 Driver: Time Savings 71
6.6 Driver: Patient Demand and Awareness 72
6.7 Driver: Technological Developments 73
6.7.1 Custom Branched and Fenestrated Stent Grafts 73
6.7.2 Low Profile Delivery Systems 73
6.8 Driver: Rising Competition and Innovation 75
6.9 Barrier: Availability of Venture Capital 75
6.10 Barrier: Burden of Rising Regulation 76
6.11 Barrier: High Treatment Cost 77
6.12 Barrier: Proving Long-Term Efficacy 78
6.13 Barrier: High Radiation Dosages with Excessive Imaging 79
6.14 Surgical Limitations 79
6.15 Barrier: Medical Device Excise Tax 80
6.16 Substitute: Open Surgery 80
6.17 Substitute: Chimney Technique versus Fenestrated Grafts 81
7 Competitive Assessment 83
7.1 Overview 83
7.2 Key Marketed Products 83
7.2.1 Endovascular Aneurysm Repair and Thoracic Endovascular Aneurysm Repair Products 83
8 Pipeline Assessment 94
8.1 Overview 94
8.2 Product Profiles 94
8.2.1 Altura Medical Endograft 94
8.2.2 Cordis INCRAFT 95
8.2.3 EndoSpan Horizon 96
8.2.4 EndoSpan Nexus 97
8.2.5 MicroPort Scientific Castor Branched Stent Graft System 98
8.2.6 BiFlow Medical Novel Side-Branch Stent 99
8.2.7 Endoluminal Sciences Endograft Mechanism 100
8.2.8 Medtronic Valiant Mona LSA Stent Graft System 101
8.2.9 Endologix Ventana Fenestrated Stent Graft 101
9 Clinical Trials to Watch 103
9.1 Overview 103
9.2 Altura Medical 103
9.3 Cook Medical 104
9.4 Gore Medical 106
9.5 Terumo Corporation 107
9.6 Endologix 108
9.7 TriVascular 109
9.8 Bolton Medical 110
9.9 Medtronic 111
9.10 Cordis Corporation 113
10 Current and Future Players 114
10.1 Overview 114
10.2 Trends in Corporate Strategy 114
10.3 Company Profiles 115
10.3.1 Cook Medical 115
10.3.2 Endologix 118
10.3.3 Gore Medical 121
10.3.4 Medtronic 123
10.3.5 Terumo Corporation 126
10.3.6 Altura Medical 128
10.3.7 Aptus Endosystems 130
10.3.8 Bolton Medical 132
10.3.9 Braile Biomedica 133
10.3.10 B. Braun 136
10.3.11 Cardiatis 137
10.3.12 LeMaitre Vascular 139
10.3.13 Lifetech Scientific 141
10.3.14 Getinge Group 143
10.3.15 Grikin Advanced Materials 146
10.3.16 Johnson and Johnson's Cordis Corporation 147
10.3.17 Jotec 149
10.3.18 Lombard Medical 151
10.3.19 MicroPort Scientific Corporation 152
10.3.20 Nano Endoluminal 155
10.3.21 TriVascular 157
10.3.22 Weike Medical Apparatus and Instrument 160
10.3.23 YTH Biological Material Scitech 160
11 Market Outlook 161
11.1 Company Market Share 161
11.2 By Market Segment 162
11.2.1 Overview 162
11.2.2 Endovascular Aneurysm Repair 164
11.2.3 Thoracic Endovascular Aneurysm Repair 165
11.3 By Geography 166
11.3.1 EU Overview 166
11.3.2 EU 169
12 Appendix 181
12.1 Bibliography 181
12.2 Abbreviations 195
12.3 Research Methodology 198
12.3.1 Overview 198
12.3.2 Coverage 198
12.3.3 Secondary Research 198
12.4 Physicians and Specialists Included in this Study 200
12.4.1 Christopher Abularrage, MD, FACS 200
12.4.2 Gaspar Mestres Alomar, MD 200
12.4.3 Enio Buffolo, MD, PhD 200
12.4.4 Ludovic Canaud, MD, PhD 200
12.4.5 Holger Eggebrecht, MD 200
12.4.6 Daisuke Fukui, MD, PhD 200
12.4.7 Germano Melissano, MD 200
12.4.8 Dr. Raghuram Sekhar MS, FRCS (Edinburgh), FRCS (Glasgow) 200
12.4.9 Ferdinand Serracino-Inglott, MD, MSc, FRCSI, FRCS (Gen Surg), DIC 201
12.4.10 Jiang Xiong, MD, PhD 201
12.5 Primary Research 202
12.5.1 Primary Research - Key Opinion Leader Interviews 202
12.5.2 Primary Research - Physician and Industry Interviews 202
12.5.3 Expert Panel Validation 203
12.6 Forecasting Methodology 204
12.7 About the Authors 205
12.7.1 Analysts 205
12.7.2 Global Head of Healthcare 206
12.8 About MediPoint 207
12.9 About GlobalData 207
12.10 Disclaimer 207

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 EU 39
Table 6: Regulatory Differences between the US and EU 41
Table 7: Direct and Indirect Costs of Open Surgery and Endovascular Repair 51
Table 8: Comparison Costs and Other Variables for Treating AAA By Open Repair and Stent Grafts in 2012 ($US) 52
Table 9: Endoleak Types 53
Table 10: Zenith Family Marketed Products 85
Table 11: Zenith AAA SWOT 85
Table 12: Zenith TAA SWOT 86
Table 13: Endologix's Marketed Products 87
Table 14: AFX Endovascular SWOT 87
Table 15: IntuiTrak Powerlink System SWOT 87
Table 16: Gore Medical's Marketed Products 89
Table 17: Gore AAA Product SWOT 89
Table 18: Gore TAA Product SWOT 90
Table 19: Medtronic's Marketed Products 91
Table 20: Medtronic AAA Product SWOT 92
Table 21: Medtronic TAA Product SWOT 92
Table 22: Terumo Corporation Marketed Products 93
able 23: Terumo Corporation AAA Product SWOT 93
Table 24: SWOT Analysis - Altura Medical Endograft 95
Table 25: SWOT Analysis - Cordis INCRAFT 96
Table 26: SWOT Analysis - EndoSpan Horizon 97
Table 27: SWOT Analysis - EndoSpan Nexus 98
Table 28: SWOT Analysis - MicroPort Scientific Castor Branched Stent Graft System 99
Table 29: SWOT Analysis - BiFlow Medical Novel Side-Branch Stent 100
Table 30: SWOT Analysis - Endoluminal Sciences Endograft Mechanism 100
Table 31: SWOT Analysis - Medtronic Valiant Mona LSA Stent Graft 101
Table 32: SWOT Analysis - Endologix Ventana Fenestrated Stent Graft 102
Table 33: Major Clinical Trials of Altura Medical's Aortic Stent Grafts 104
Table 34: Major Clinical Trials of Cook Medical's Aortic Stent Grafts 105
Table 35: Major Clinical Trials of Gore Medical's Aortic Stent Grafts 106
Table 36: Major Clinical Trials of Terumo's Aortic Stent Grafts 107
Table 37: Major Clinical Trials of Endologix's Aortic Stent Grafts 108
Table 38: Major Clinical Trials of TriVascular's Aortic Stent Grafts 109
Table 39: Major Clinical Trials of Bolton Medical's Aortic Stent Grafts 110
Table 40: Major Clinical Trials of Medtronic's Aortic Stent Grafts 111
Table 41: Major Clinical Trials of Cordis' Aortic Stent Grafts 113
Table 42: Company Profile - Cook Medical 116
Table 43: Cook Medical Marketed Products 117
Table 44: SWOT Analysis - Cook Medical 118
Table 45: Company Profile - Endologix Inc. 119
Table 46: Endologix Marketed Products 120
Table 47: Endologix Pipeline Products 120
Table 48: SWOT Analysis - Endologix Inc. 120
Table 49: Company Profile - Gore Medical 121
Table 50: Gore Medical Marketed Products 122
Table 51: SWOT Analysis - Gore Medical 123
Table 52: Company Profile - Medtronic 124
Table 53: Medtronic Marketed Products 125
Table 54: SWOT Analysis - Medtronic 125
Table 55: Company Profile - Terumo Corporation 126
Table 56:Terumo Corporation Marketed Products 127
Table 57: SWOT Analysis - Terumo Corporation 128
Table 58: Company Profile - Altura Medical Inc. 128
Table 59: Altura Medical Inc. Marketed Products 129
Table 60: SWOT Analysis - Altura Medical Inc. 129
Table 61: Company Profile - Aptus Endosystems, Inc. 130
Table 62: Aptus Endosystems Inc. Marketed Products 131
Table 63: SWOT Analysis - Aptus Endosystems Inc. 131
Table 64: Company Profile - Bolton Medical 132
Table 65: Bolton Medical Marketed Products 133
Table 66: SWOT Analysis - Bolton Medical 133
Table 67: Company Profile - Braile Biomedica 134
Table 68: Braile Biomedica Marketed Products 135
Table 69: SWOT Analysis - Braile Biomedica 135
Table 70: Company Profile - B. Braun 136
Table 71: B. Braun Marketed Products 137
Table 72: SWOT Analysis - B. Braun 137
Table 73: Company Profile - Cardiatis 138
Table 74: Cardiatis Marketed Products 138
Table 75: SWOT Analysis - Cardiatis 139
Table 76: Company Profile - LeMaitre Vascular 140
Table 77: LeMaitre Vascular Medical Marketed Products 140
Table 78: SWOT Analysis - LeMaitre Vascular 141
Table 79: Company Profile - Lifetech Scientific 142
Table 80: Lifetech Scientific Marketed Products 142
Table 81: SWOT Analysis - Lifetech Scientific 143
Table 82: Company Profile - Getinge Group 144
Table 83: Getinge Group Marketed Products 145
Table 84: SWOT Analysis - Getinge Group 145
Table 85: Company Profile - Grikin Advanced Materials 146
Table 86: Grikin Advanced Materials Marketed Products 146
Table 87: SWOT Analysis - Grikin Advanced Materials 147
Table 88: Company Profile - Johnson and Johnson Cordis Corporation 147
Table 89: Cordis Corporation's Pipeline Product 148
Table 90: SWOT Analysis - Cordis Corporation 148
Table 91: Company Profile - Jotec 149
Table 92: Jotec's Marketed Products 150
Table 93: SWOT Analysis - Jotec 150
Table 94: Company Profile - Lombard Medical 151
Table 95: Lombard Medical Marketed Products 152
Table 96: SWOT Analysis - Lombard Medical 152
Table 97: Company Profile - Microport Scientific Corporation 153
Table 98: MicroPort Scientific Marketed Products 154
Table 99: SWOT Analysis - MicroPort Scientific 155
Table 100: Company Profile - Nano Endoluminal 156
Table 101: Nano Endoluminal Medical Marketed Products 156
Table 102: SWOT Analysis - Nano Endoluminal 157
Table 103: Company Profile - TriVascular 158
Table 104: TriVascular Marketed Products 159
Table 105: SWOT Analysis - TriVascular 159
Table 106: 5EU Aortic Stent Grafts Sales ($m) Forecast, by Segment, 2011-2020 163
Table 107: 5EU Aortic Stent Grafts Sales ($m) Forecast, EVAR, 2011-2020 164
Table 108: 5EU Aortic Stent Grafts Sales ($m) Forecast, TEVAR, 2011-2020 165
Table 109: Aortic Stent Grafts Sales ($m) for the 5EU, 2011-2020 166
Table 110: Aortic Stent Grafts Sales ($m) Forecast for the 5EU, 2011-2020 169
Table 111: Aortic Stent Grafts Sales ($m) Forecast for France, 2011-2020 171
Table 112: Aortic Stent Grafts Sales ($m) Forecast for Germany, 2011-2020 173
Table 113: Aortic Stent Grafts Sales ($m) Forecast for Italy, 2011-2020 176
Table 114: Aortic Stent Grafts ($m) Forecast for Spain, 2011-2020 178
Table 115: Aortic Stent Grafts Sales ($m) Forecast for the UK, 2011-2020 180

1.2 List of Figures
Figure 1: Treatment Methodology Markov Model 28
Figure 2: Aortic Stent Graft Product Image 31
Figure 3: EU Abdominal Aortic Stent Grafts Procedure Volume, 2011-2020 33
Figure 4: EU Thoracic Aortic Stent Grafts Procedure Volume, 2011-2020 34
Figure 5: EU Market Share for EVAR, 2013 161
Figure 6: EU Market Share for TEVAR, 2013 162
Figure 7: 5EU Aortic Stent Grafts Sales ($m) Forecast, by Segment, 2011-2020 163
Figure 8: 5EU Aortic Stent Grafts Sales ($m) Forecast, EVAR, 2011-2020 164
Figure 9: 5EU Aortic Stent Grafts Sales ($m) Forecast, TEVAR, 2011-2020 165
Figure 10: Aortic Stent Grafts Sales ($m) for 5EU, 2011-2020 167
Figure 11: Aortic Stent Grafts by Major Market, 2013 and 2020 168
Figure 12: 5EU Sales ($m) Forecast for Aortic Stent Grafts, 2011-2020 170
Figure 13: France Sales ($m) Forecast for Aortic Stent Grafts, 2011-2020 172
Figure 14: Germany Sales ($m) Forecast for Aortic Stent Grafts, 2011-2020 174
Figure 15: Italy Sales ($m) Forecast for Aortic Stent Grafts, 2011-2020 176
Figure 16: Spain Sales ($m) Forecast for Aortic Stent Grafts, 2011-2020 178
Figure 17: UK Sales ($m) Forecast for Aortic Stent Grafts, 2011-2020 180
Figure 18: Aortic Stent Graft Primary Research, Supply and Demand-Side Interviews 203

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