MediPoint: Renal Denervation - EU Analysis and Market Forecasts

Summary

Numerous medical device news sources and industry executives have proclaimed renal denervation to be the top medical device breakthrough of the past two years, and for good reason. Hypertension is one of the most prevalent chronic conditions worldwide, with some studies estimating that 50% of the adult population globally will have the disease in the next 20 years. With limited effectiveness from pharmacotherapy, medical device therapy has the potential for significant adoption in the treatment of resistive hypertension and uncontrolled hypertension, once efficacy and cost-effectiveness are proven. Additionally, the degree of blood pressure reduction found in long-term clinical trials from such a well-tolerated procedure has generated notable optimism about the intervention’s application in other conditions where hyperactivity of the sympathetic nervous system plays a significant role, such as congestive heart failure.

This report and forecast focuses on the renal denervation market for these indications in the 5 major European markets, which include France, Germany, Italy, Spain, and the United Kingdom (UK).The EU was the first region where renal denervation was introduced, back in 2010. Since then, there has been very slow adoption of the procedure in the major European markets. The development of a brand new market comes with several hurdles, and these need to be overcome before any spikes in the procedure volumes can occur.

Scope

- An overview of renal denervation, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
- Annualized EU renal denervation market revenue and future forecasts from 2010 to 2019.
- Investigation of current and future market competition for renal denervation
- 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 renal denervation sector through market impact analysis, future market scenario and company analysis.
- Direct quotes from Key Opinion Leaders (KOL) as well as cardiovascular Surgeons

Reasons to buy

- Understand the trends shaping and driving the EU renal denervation Market.
- Realize device preferences of physicians who have performed the tests already.
- Access market sizing, forecasts and quantified growth opportunities in the EU renal denervation 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 EU renal denervation market landscape? Identify, understand and capitalize.

Table Of Contents

Table of Contents

Table of Contents 6
List of Tables 14
List of Figures 18
2 Introduction 21
2.1 Overview 21
2.2 Catalyst 21
3 Disease Overview 23
3.1 Anatomy and Physiology 23
3.2 Pathophysiology 24
3.3 Etiology 25
3.3.1 Causes 25
3.3.2 Risk Factors 28
3.4 Clinical Presentation 31
3.4.1 Symptoms 31
3.4.2 Diagnosis 31
3.4.3 Clinical Outcomes 33
3.5 Epidemiology 38
3.5.1 Resistant Hypertension 38
3.5.2 Uncontrolled Hypertension 41
3.5.3 Heart Failure 43
3.6 Economic Impact 45
3.6.1 Overview 45
3.6.2 European Union 46
4 Marketed Products 48
4.1 Overview 48
4.2 Market Share 50
4.2.1 France Market Share, 2013 and 2016 50
4.2.2 Germany Market Share, 2013 and 2016 51
4.2.3 Italy Market Share, 2013 and 2016 53
4.2.4 Spain Market Share, 2013 and 2016 54
4.2.5 UK Market Share, 2013 and 2016 56
4.3 Allegra Renal Denervation System (Terumo/AngioCare) 58
4.3.1 Overview 58
4.3.2 Safety and Efficacy 59
4.3.3 SWOT Analysis 60
4.4 EnligHTN Renal Denervation System (St. Jude Medical) 61
4.4.1 Overview 61
4.4.2 Safety and Efficacy 62
4.4.3 SWOT Analysis 64
4.5 OneShot Renal Denervation System (Covidien) 65
4.5.1 Overview 65
4.5.2 Safety and Efficacy 66
4.5.3 SWOT Analysis 67
4.6 Paradise Renal Denervation System (ReCor Medical) 68
4.6.1 Overview 68
4.6.2 Safety and Efficacy 69
4.6.3 SWOT Analysis 70
4.7 Symplicity Renal Denervation System (Medtronic) 71
4.7.1 Overview 71
4.7.2 Safety and Efficacy 72
4.7.3 SWOT Analysis 75
4.8 Vessix Renal Denervation System (Boston Scientific Corporation) 76
4.8.1 Overview 76
4.8.2 Safety and Efficacy 77
4.8.3 SWOT Analysis 78
5 Unmet Needs 79
5.1 Overview 79
5.1.1 Intervention to Determine Renal Denervation Efficacy 80
5.1.2 Investigation of Renal Nerve Regeneration 81
5.1.3 Ambulatory Versus Office-Based Blood Pressure Readings 83
5.1.4 Effect of Renal Denervation on Prescription Antihypertensive Medication 88
5.1.5 Expanded Indications for Renal Denervation Systems 90
5.1.6 Effect of Renal Denervation on the Adventitial Layer 93
5.1.7 Repeat Renal Denervation Procedures 96
5.1.8 Long-Term Clinical Trial Data 98
6 Pipeline Products 99
6.1 Overview 99
6.2 Beta-Cath System (Best Medical International) 99
6.2.1 Overview 99
6.2.2 Safety and Efficacy 99
6.2.3 SWOT Analysis 100
6.3 Bullfrog MicroFusion Catheter (Mercator MedSystems) 101
6.3.1 Overview 101
6.3.2 Safety and Efficacy 102
6.3.3 SWOT Analysis 102
6.4 Chemical Denervation System (Kipprokration Hospital) 103
6.4.1 Overview 103
6.4.2 Safety and Efficacy 103
6.4.3 SWOT Analysis 104
6.5 Cryoablation System (Cryomend) 105
6.5.1 Overview 105
6.5.2 Safety and Efficacy 105
6.5.3 SWOT Analysis 105
6.6 Kona Surround Sound System (Kona Medical) 106
6.6.1 Overview 106
6.6.2 Safety and Efficacy 107
6.6.3 SWOT Analysis 108
6.7 Magnetic Nanoparticles (ApexNano) 109
6.7.1 Overview 109
6.7.2 Safety and Efficacy 109
6.7.3 SWOT Analysis 110
6.8 Perivascular Renal Denervation System (Ablative Solutions) 111
6.8.1 Overview 111
6.8.2 Safety and Efficacy 111
6.8.3 SWOT Analysis 112
6.9 Sound 360 Ultrasonic Renal Denervation System (Sound Interventions) 113
6.9.1 Overview 113
6.9.2 Safety and Efficacy 114
6.9.3 SWOT Analysis 115
6.10 Symple Surgical System (Symple Surgical) 116
6.10.1 Overview 116
6.10.2 Safety and Efficacy 116
6.10.3 SWOT Analysis 116
6.11 Tivus System (Cardiosonic) 117
6.11.1 Overview 117
6.11.2 Safety and Efficacy 118
6.11.3 SWOT Analysis 119
6.12 Celsius ThermoCool System (Cordis/Johnson and Johnson) 120
6.12.1 Overview 120
6.12.2 Safety and Efficacy 120
6.12.3 SWOT Analysis 121
6.13 Northwind Medical System (Northwind Medical) 122
6.13.1 Overview 122
6.13.2 Safety and Efficacy 122
6.13.3 SWOT Analysis 122
6.14 Verve Medical System (Verve Medical) 123
6.14.1 Overview 123
6.14.2 Safety and Efficacy 123
6.14.3 SWOT Analysis 124
7 Clinical Trial Analysis 125
7.1 Overview 125
7.2 Clinical Trial Timeline 126
7.3 Clinical Trial Results 136
7.4 Analysis of Trials to Watch 140
7.4.1 Longer Follow-Up 140
7.4.2 Uncontrolled Hypertension 140
7.4.3 Second-Generation Devices 141
7.4.4 Additional Indications 144
8 Industry Overview 145
8.1 Procedure Trends 145
8.1.1 European Union 145
8.2 Market Access 149
8.3 Reimbursement Trends 150
8.3.1 European Union 150
8.4 Regulatory Issues/Recalls 156
8.5 Added Indications 157
8.6 Mergers and Acquisitions/Key Partnerships 160
8.6.1 Overview 160
8.6.2 Boston Scientific Acquires Vessix Vascular 161
8.6.3 Covidien Acquires Maya Medical 161
8.6.4 Medtronic Acquires Ardian 162
8.6.5 Terumo Corporation Partners With AngioCare Medical Technology 162
9 Current and Future Players 163
9.1 Trends in Corporate Strategy 163
9.2 Company Profiles 164
9.2.1 Ablative Solutions 164
9.2.2 ApexNano 167
9.2.3 Best Medical International 170
9.2.4 Boston Scientific Corporation 172
9.2.5 Cardiosonic 175
9.2.6 Covidien 178
9.2.7 Cordis Corporation and Johnson and Johnson 181
9.2.8 Cryomend 184
9.2.9 Kona Medical 187
9.2.10 Medtronic 190
9.2.11 Mercator MedSystems 193
9.2.12 Northwind Medical 196
9.2.13 ReCor Medical 198
9.2.14 Sound Interventions 201
9.2.15 St. Jude Medical 204
9.2.16 Symple Surgical 207
9.2.17 Terumo Corporation 209
9.2.18 Verve Medical 212
10 Market Drivers and Opportunities 215
10.1 Market Drivers 215
10.1.1 Growing Global Prevalence and Cost of Hypertension 215
10.1.2 Significant and Sustained Reductions in Office-Based Blood Pressure 216
10.1.3 Growing Clinical Evidence of Efficacy in Other Indications 217
10.1.4 Potential for Outpatient Procedure 218
10.1.5 Positive Results in Moderate Hypertensive Patients 219
10.2 Market Opportunities 220
10.2.1 Expanding Indications 220
10.2.2 Competitive Cost Structure 222
10.2.3 Low-Profile Catheters 223
10.2.4 Catheters for Radial Access 226
10.2.5 Circumferential Ablation 228
10.2.6 Mapping System 229
10.2.7 Clinical Trials in Key Countries 229
10.2.8 Incorporate Renal Denervation Catheters into Sales of Other Cardiology Products 231
10.3 Market Threats 232
10.3.1 Ambulatory Blood Pressure Readings 232
10.3.2 Results of the Symplicity HTN-3 Trial 233
10.3.3 Extent of Clinical Trial Data 234
10.3.4 Radiofrequency Ablation Thermal Damage 235
10.3.5 Degree of Patient Pain 236
10.3.6 Inpatient Procedure 237
10.3.7 Carotid Baroreceptor Stimulation 238
10.3.8 External Systems 240
10.3.9 Micro-Infusion Systems 241
10.3.10 White-Coat Effect 242
10.3.11 Entrance of Cordis Into the Market 243
10.3.12 New Referral Pattern 244
11 Country Outlooks and Forecasts 245
11.1 European Union 245
11.2 France 247
11.3 Germany 249
11.4 Italy 251
11.5 Spain 253
11.6 United Kingdom 255
12 Appendix 257
12.1 Bibliography 257
12.2 Abbreviations 273
12.3 Report Methodology 276
12.3.1 Overview 276
12.3.2 Coverage 276
12.3.3 Primary Research 277
12.3.4 Secondary Research 278
12.3.5 Forecasting Methodology 278
12.4 Key Opinion Leaders Included in this Study 279
12.5 About the Authors 280
12.5.1 Joseph A. Gregory, Analyst, Surgical Devices 280
12.5.2 Derek Archila, MBA, Director of Research and Analysis, Medical Devices 280
12.6 Global Head of Healthcare 281
12.6.1 Bonnie Bain, Ph.D., Global Head of Healthcare 281
12.7 About MediPoint 281
12.8 About GlobalData 281
12.9 Disclaimer 282



List of Tables

Table 1: Secondary Causes of Resistant Hypertension 25
Table 2: Risk Factors for Resistant Hypertension 28
Table 3: Medications That Can Contribute to Hypertension 29
Table 4: Nonsurgical Techniques for Treating Resistant Hypertension: Lifestyle Modifications 34
Table 5: Classes of Antihypertensive Medications 35
Table 6: Relative Risks of Serious Complications Following Renal Denervation 46
Table 7: Healthcare Costs for CHD and CVD in the EU, 2003 47
Table 8: Classification of the Marketed Renal Denervation Systems 48
Table 9: Product Profile - Allegra Renal Denervation System 59
Table 10: Allegra Renal Denervation System - SWOT Analysis, 2013 60
Table 11: Product Profile - EnligHTN Renal Denervation System 62
Table 12: EnligHTN Renal Denervation System - SWOT Analysis, 2013 64
Table 13: Product Profile - OneShot Renal Denervation System 66
Table 14: OneShot System - SWOT Analysis, 2013 67
Table 15: Product Profile - Paradise Renal Denervation System 69
Table 16: Paradise Renal Denervation System - SWOT Analysis, 2013 70
Table 17: Product Profile - Symplicity Renal Denervation System 72
Table 18: Efficacy Results of the Symplicity HTN-1 Clinical Trial 73
Table 19: Efficacy Results of the Symplicity HTN-2 Clinical Trial 73
Table 20: Symplicity Renal Denervation System - SWOT Analysis, 2013 75
Table 21: Product Portfolio - Vessix Renal Denervation System 77
Table 22: Vessix Renal Denervation System - SWOT Analysis, 2013 78
Table 23: Overall Unmet Needs - Current Level of Attainment and Importance 79
Table 24: Comparison of Office-Based and Ambulatory Blood Pressure Reductions in Resistant Hypertensive Patients Treated with Renal Denervation 84
Table 25: Key Renal Denervation Clinical Trials Measuring Ambulatory Blood Pressure 87
Table 26: Proportion of Patients With Changes to Their Medications in the Symplicity HTN-2 Trial 88
Table 27: Key Clinical Trials Assessing Other Indications for Renal Denervation 91
Table 28: Vascular Adverse Events Reported in the EnligHTN-1 Clinical Trial 94
Table 29: Effects of Renal Denervation on the Renal Artery Wall 95
Table 30: Beta-Cath System - SWOT Analysis, 2013 100
Table 31: Bullfrog MicroFusion Catheter - SWOT Analysis, 2013 102
Table 32: Chemical Denervation System - SWOT Analysis, 2013 104
Table 33: Cryoablation System - SWOT Analysis, 2013 105
Table 34: Surround Sound Renal Denervation System - SWOT Analysis, 2013 108
Table 35: Magnetic Nanoparticles System - SWOT Analysis, 2013 110
Table 36: Perivascular Renal Denervation System - SWOT Analysis, 2013 112
Table 37: Sound 360 Ultrasonic Renal Denervation System - SWOT Analysis, 2013 115
Table 38: Symple Surgical Renal Denervation System - SWOT Analysis, 2013 116
Table 39: Tivus Renal Denervation System - SWOT Analysis, 2013 119
Table 40: Celsius Thermocool Renal Denervation System - SWOT Analysis, 2013 121
Table 41: Northwind Medical Renal Denervation System - SWOT Analysis, 2013 122
Table 42: Verve Medical Renal Denervation System - SWOT Analysis, 2013 124
Table 43: Comparison of Clinical Development Stages: Feasibility and Phase II Trials 126
Table 44: Comparison of Clinical Development Stages: Phase III and Phase IV Trials 131
Table 45: Efficacy Results in Renal Denervation Feasibility Trials 137
Table 46: Efficacy Results in Renal Denervation Phase II Trials 138
Table 47: Efficacy Results in Renal Denervation Company-Sponsored Registries 139
Table 48: Companies with Second-Generation Renal Denervation Systems 141
Table 49: Comparison of the Clinical Development Stages for Second-Generation Devices: Feasibility and Phase II Trials 143
Table 50: Key Indications Being Explored for Renal Denervation 158
Table 51: Aspects of Company Acquisitions in the Renal Denervation Market 160
Table 52: Company Profile - Ablative Solutions 164
Table 53: Ablative Solutions - SWOT Analysis, 2013 166
Table 54: Company Profile - ApexNano 167
Table 55: ApexNano - SWOT Analysis, 2013 169
Table 56: Company Profile - Best Medical International 170
Table 57: Best Medical International - SWOT Analysis, 2013 171
Table 58: Company Profile - Boston Scientific Corporation 172
Table 59: Boston Scientific - SWOT Analysis, 2013 174
Table 60: Company Profile - Cardiosonic 175
Table 61: CardioSonic - SWOT Analysis, 2013 177
Table 62: Company Profile - Covidien 178
Table 63: Covidien - SWOT Analysis, 2013 180
Table 64: Company Profile - Cordis Corporation 181
Table 65: Cordis Corporation - SWOT Analysis, 2013 183
Table 66: Company Profile - Cryomend 184
Table 67: Cryomend - SWOT Analysis, 2013 186
Table 68: Company Profile - Kona Medical 187
Table 69: Kona Medical - SWOT Analysis, 2013 189
Table 70: Company Profile - Medtronic 190
Table 71: Medtronic - SWOT Analysis, 2013 192
Table 72: Company Profile - Mercator MedSystems 193
Table 73: Mercator Medsystems - SWOT Analysis, 2013 195
Table 74: Company Profile - Northwind Medical 196
Table 75: Northwind Medical - SWOT Analysis, 2013 197
Table 76: Company Profile - Recor Medical 198
Table 77: ReCor Medical - SWOT Analysis, 2013 200
Table 78: Company Profile - Sound Interventions 201
Table 79: Sound Interventions - SWOT Analysis, 2013 203
Table 80: Company Portfolio - St. Jude Medical 205
Table 81: St. Jude Medical - SWOT Analysis, 2013 206
Table 82: Company Portfolio - Symple Surgical 207
Table 83: Symple Surgical - SWOT Analysis, 2013 208
Table 84: Company Profile - Terumo Corporation 210
Table 85: Terumo Corporation - SWOT Analysis, 2013 211
Table 86: Company Portfolio - Verve Medical 212
Table 87: Verve Medical - SWOT Analysis, 2013 214
Table 88: Worldwide Prevalence of Hypertension (Millions), 2000 and 2025 216
Table 89: Efficacy of Renal Denervation in Moderate Hypertension Patients 219
Table 90: Additional Indications for Renal Denervation 220
Table 91: Patient Exclusion Criteria for Renal Artery Stenosis in Each of the Major Clinical Investigations, 2013 224
Table 92: Advantages and Disadvantages of Carotid Baroreceptor Stimulation 240
Table 93: Renal Denervation Sales ($m) Forecast, 5EU, 2010-2019 245
Table 94: France Renal Denervation Sales ($m) Forecast, 2010-2019 247
Table 95: Germany Renal Denervation Sales ($m) Forecast, 2010-2019 249
Table 96: Italy Renal Denervation Sales ($m) Forecast, 2010-2019 251
Table 97: Spain Renal Denervation Sales ($m) Forecast, 2010-2019 253
Table 98: United Kingdom Renal Denervation Sales ($m) Forecast, 2010-2019 255

List of Figures
Figure 1: Treatment Paradigm for Resistant Hypertension 33
Figure 2: Composition of the Resistant Hypertension Market, 5EU, 2012 39
Figure 3: Prevalence of the Renal Denervation-Eligible Resistant Hypertension Patient Population, 5EU, 2010-2019 40
Figure 4: Composition of the Uncontrolled Hypertension Market, 5EU, 2012 41
Figure 5: Prevalence of Uncontrolled Hypertension, 5EU, 2010-2019 42
Figure 6: Prevalence of Heart Failure (Class II and III), 5EU, 2010-2019 43
Figure 7: Composition of Heart Failure Patients (Class II and II), 5EU, 2012 44
Figure 8: France Renal Denervation Market Share, 2013 50
Figure 9: France Renal Denervation Market Share, 2016 51
Figure 10: Germany Renal Denervation Market Share, 2013 52
Figure 11: Germany Renal Denervation Market Share, 2016 52
Figure 12: Italy Renal Denervation Market Share, 2013 53
Figure 13: Italy Renal Denervation Market Share, 2016 54
Figure 14: Spain Renal Denervation Market Share, 2013 55
Figure 15: Spain Renal Denervation Market Share, 2016 55
Figure 16: United Kingdom Renal Denervation Market Share, 2013 56
Figure 17: United Kingdom Renal Denervation Market Share, 2016 57
Figure 18: Allegra Renal Denervation System 58
Figure 19: EnligHTN Renal Denervation System 61
Figure 20: OneShot Renal Denervation System Balloon Catheter 65
Figure 21: Paradise Renal Denervation System 68
Figure 22: Symplicity Renal Denervation System 71
Figure 23: Vessix Renal Denervation System Catheter 76
Figure 24: Bullfrog MicroFusion Catheter 101
Figure 25: Chemical Denervation System 103
Figure 26: Kona Surround Sound Renal Denervation System 106
Figure 27: Sound 360 Ultrasonic Renal Denervation System 113
Figure 28: Tivus Renal Denervation System 117
Figure 29: Tivus Renal Denervation System Catheter 118
Figure 30: Timeline of Feasibility Clinical Trials 128
Figure 31: Timeline of Phase II Clinical Trials 130
Figure 32: Timeline of Phase III Clinical Trials 133
Figure 33: Timeline of Post-Market Clinical Trials 135
Figure 34: Renal Denervation Procedure Volumes: Resistant Hypertension, 5EU, 2010-2019 146
Figure 35: Renal Denervation Procedure Volumes: Uncontrolled Hypertension, 5EU, 2010-2019 147
Figure 36: Renal Denervation Procedure Volumes: Heart Failure, 5EU, 2010-2019 148
Figure 37: Physiological Changes Resulting from Carotid Baroreceptor Stimulation 238
Figure 38: Renal Denervation Sales ($m) Forecast, 5EU, 2010-2019 246
Figure 39: France Renal Denervation Sales ($m) Forecast, 2010-2019 248
Figure 40: Germany Renal Denervation Sales ($m) Forecast, 2010-2019 250
Figure 41: Italy Renal Denervation Sales ($m) Forecast, 2010-2019 252
Figure 42: Spain Renal Denervation Sales ($m) Forecast, 2010-2019 254
Figure 43: United Kingdom Renal Denervation Sales ($m) Forecast, 2010-2019 256



Companies Mentioned

Ablative Solutions
ApexNano
Best Medical International
Boston Scientific Corporation
Cardiosonic
Covidien
Cordis Corporation and Johnson and Johnson
Cryomend
Kona Medical
Medtronic
Mercator MedSystems
Northwind Medical
ReCor Medical
Sound Interventions
St. Jude Medical
Symple Surgical
Terumo Corporation
Verve Medical

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