MediPoint: Renal Denervation - US Analysis and Market Forecasts

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MediPoint: Renal Denervation - US Analysis and Market Forecasts

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MediPoint: Renal Denervation - US 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.

The renal denervation market in the United States will grow from essentially nothing in 2012 as the intervention was not approved for any indication in the United States in 2012. That is expected to change by the end of the forecast period in 2019. By then, the intervention is expected to be approved in both uncontrolled hypertension and resistant hypertension patients. The adoption of the procedure will be much higher in the US.

Scope

- An overview of hypertension, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
- Annualized US renal denervation market revenue and future forecasts from 2009 to 2011, forecast for 7 years to 2018.
- 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 cardiologists

Reasons to buy

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

Table of Contents

1 Table of Contents 6
1.1 List of Tables 13
1.2 List of Figures 17
2 Introduction 19
2.1 Overview 19
2.2 Catalyst 19
3 Disease Overview 21
3.1 Anatomy and Physiology 21
3.2 Pathophysiology 22
3.3 Etiology 23
3.3.1 Causes 23
3.3.2 Risk Factors 26
3.4 Clinical Presentation 29
3.4.1 Symptoms 29
3.4.2 Diagnosis 29
3.4.3 Clinical Outcomes 31
3.5 Epidemiology 35
3.5.1 Resistant Hypertension 35
3.5.2 Uncontrolled Hypertension 37
3.5.3 Heart Failure 39
3.6 Economic Impact 40
3.6.1 Overview 40
3.6.2 US 41
4 Marketed Products 43
4.1 Overview 43
4.2 US Market Share, 2013 and 2016 45
4.3 Allegra Renal Denervation System (Terumo/AngioCare) 46
4.3.1 Overview 46
4.3.2 Safety and Efficacy 47
4.3.3 SWOT Analysis 48
4.4 EnligHTN Renal Denervation System (St. Jude Medical) 49
4.4.1 Overview 49
4.4.2 Safety and Efficacy 50
4.4.3 SWOT Analysis 52
4.5 OneShot Renal Denervation System (Covidien) 53
4.5.1 Overview 53
4.5.2 Safety and Efficacy 54
4.5.3 SWOT Analysis 55
4.6 Paradise Renal Denervation System (ReCor Medical) 56
4.6.1 Overview 56
4.6.2 Safety and Efficacy 57
4.6.3 SWOT Analysis 58
4.7 Symplicity Renal Denervation System (Medtronic) 59
4.7.1 Overview 59
4.7.2 Safety and Efficacy 60
4.7.3 SWOT Analysis 64
4.8 Vessix Renal Denervation System (Boston Scientific Corporation) 65
4.8.1 Overview 65
4.8.2 Safety and Efficacy 66
4.8.3 SWOT Analysis 67
5 Unmet Needs 68
5.1 Overview 68
5.1.1 Intervention to Determine Renal Denervation Efficacy 69
5.1.2 Investigation of Renal Nerve Regeneration 71
5.1.3 Ambulatory Versus Office-Based Blood Pressure Readings 72
5.1.4 Effect of Renal Denervation on Prescription Antihypertensive Medication 78
5.1.5 Expanded Indications for Renal Denervation Systems 80
5.1.6 Effect of Renal Denervation on the Adventitial Layer 82
5.1.7 Repeat Renal Denervation Procedures 85
5.1.8 Long-Term Clinical Trial Data 86
6 Pipeline Products 87
6.1 Overview 87
6.2 Beta-Cath System (Best Medical International) 87
6.2.1 Overview 87
6.2.2 Safety and Efficacy 87
6.2.3 SWOT Analysis 88
6.3 Bullfrog MicroFusion Catheter (Mercator MedSystems) 89
6.3.1 Overview 89
6.3.2 Safety and Efficacy 90
6.3.3 SWOT Analysis 90
6.4 Chemical Denervation System (Kipprokration Hospital) 91
6.4.1 Overview 91
6.4.2 Safety and Efficacy 91
6.4.3 SWOT Analysis 92
6.5 Cryoablation System (Cryomend) 93
6.5.1 Overview 93
6.5.2 Safety and Efficacy 93
6.5.3 SWOT Analysis 93
6.6 Kona Surround Sound System (Kona Medical) 94
6.6.1 Overview 94
6.6.2 Safety and Efficacy 94
6.6.3 SWOT Analysis 95
6.7 Magnetic Nanoparticles (ApexNano) 96
6.7.1 Overview 96
6.7.2 Safety and Efficacy 96
6.7.3 SWOT Analysis 97
6.8 Perivascular Renal Denervation System (Ablative Solutions) 98
6.8.1 Overview 98
6.8.2 Safety and Efficacy 98
6.8.3 SWOT Analysis 99
6.9 Sound 360 Ultrasonic Renal Denervation System (Sound Interventions) 100
6.9.1 Overview 100
6.9.2 Safety and Efficacy 101
6.9.3 SWOT Analysis 102
6.10 Symple Surgical System (Symple Surgical) 103
6.10.1 Overview 103
6.10.2 Safety and Efficacy 103
6.10.3 SWOT Analysis 103
6.11 Tivus System (Cardiosonic) 104
6.11.1 Overview 104
6.11.2 Safety and Efficacy 105
6.11.3 SWOT Analysis 106
6.12 Celsius ThermoCool System (Cordis/Johnson & Johnson) 107
6.12.1 Overview 107
6.12.2 Safety and Efficacy 107
6.12.3 SWOT Analysis 108
6.13 Northwind Medical System (Northwind Medical) 109
6.13.1 Overview 109
6.13.2 Safety and Efficacy 109
6.13.3 SWOT Analysis 109
6.14 Verve Medical System (Verve Medical) 110
6.14.1 Overview 110
6.14.2 Safety and Efficacy 110
6.14.3 SWOT Analysis 111
7 Clinical Trial Analysis 112
7.1 Overview 112
7.2 Clinical Trial Timeline 113
7.3 Clinical Trial Results 123
7.4 Analysis of Trials to Watch 127
7.4.1 Longer Follow-Up 127
7.4.2 Uncontrolled Hypertension 127
7.4.3 Second-Generation Devices 128
7.4.4 Additional Indications 131
8 Industry Overview 132
8.1 Procedure Trends 132
8.2 Market Access 133
8.3 Reimbursement Trends 134
8.4 Regulatory Issues/Recalls 135
8.5 Added Indications 136
8.6 Mergers and Acquisitions/Key Partnerships 139
8.6.1 Overview 139
8.6.2 Boston Scientific Acquires Vessix Vascular 140
8.6.3 Covidien Acquires Maya Medical 140
8.6.4 Medtronic Acquires Ardian 141
8.6.5 Terumo Corporation Partners With AngioCare Medical Technology 141
9 Current and Future Players 142
9.1 Trends in Corporate Strategy 142
9.2 Company Profiles 143
9.2.1 Ablative Solutions 143
9.2.2 ApexNano 146
9.2.3 Best Medical International 149
9.2.4 Boston Scientific Corporation 151
9.2.5 Cardiosonic 154
9.2.6 Covidien 157
9.2.7 Cordis Corporation and Johnson & Johnson 160
9.2.8 Cryomend 163
9.2.9 Kona Medical 166
9.2.10 Medtronic 169
9.2.11 Mercator MedSystems 172
9.2.12 Northwind Medical 175
9.2.13 ReCor Medical 177
9.2.14 Sound Interventions 180
9.2.15 St. Jude Medical 183
9.2.16 Symple Surgical 186
9.2.17 Terumo Corporation 188
9.2.18 Verve Medical 191
10 Market Drivers and Opportunities 194
10.1 Market Drivers 194
10.1.1 Growing Global Prevalence and Cost of Hypertension 194
10.1.2 Significant and Sustained Reductions in Office-Based Blood Pressure 195
10.1.3 Growing Clinical Evidence of Efficacy in Other Indications 196
10.1.4 Potential for Outpatient Procedure 197
10.1.5 Positive Results in Moderate Hypertensive Patients 198
10.2 Market Opportunities 199
10.2.1 Expanding Indications 199
10.2.2 Competitive Cost Structure 201
10.2.3 Low-Profile Catheters 203
10.2.4 Catheters for Radial Access 206
10.2.5 Circumferential Ablation 208
10.2.6 Mapping System 209
10.2.7 Clinical Trials in Key Countries 209
10.2.8 Incorporate Renal Denervation Catheters into Sales of Other Cardiology Products 211
10.3 Market Threats 212
10.3.1 Ambulatory Blood Pressure Readings 212
10.3.2 Results of the Symplicity HTN-3 Trial 213
10.3.3 Extent of Clinical Trial Data 214
10.3.4 Radiofrequency Ablation Thermal Damage 215
10.3.5 Degree of Patient Pain 216
10.3.6 Inpatient Procedure 217
10.3.7 Carotid Baroreceptor Stimulation 218
10.3.8 External Systems 220
10.3.9 Micro-Infusion Systems 221
10.3.10 White-Coat Effect 222
10.3.11 Entrance of Cordis Into the Market 223
10.3.12 New Referral Pattern 224
11 Country Outlooks and Forecasts 225
12 Appendix 227
12.1 Bibliography 227
12.2 Abbreviations 243
12.3 Report Methodology 246
12.3.1 Overview 246
12.3.2 Coverage 246
12.3.3 Primary Research 247
12.3.4 Secondary Research 248
12.3.5 Forecasting Methodology 249
12.4 Key Opinion Leaders Included in this Study 249
12.5 About the Authors 250
12.5.1 Joseph A. Gregory, Analyst, Surgical Devices 250
12.5.2 Derek Archila, MBA, Director of Research and Analysis, Medical Devices 250
12.6 Global Head of Healthcare 251
12.6.1 Bonnie Bain, Ph.D., Global Head of Healthcare 251
12.7 About MediPoint 252
12.8 About GlobalData 252
12.9 Disclaimer 252

List of Tables

Table 1: Secondary Causes of Resistant Hypertension 23
Table 2: Risk Factors for Resistant Hypertension 26
Table 3: Medications That Can Contribute to Hypertension 27
Table 4: Nonsurgical Techniques for Treating Resistant Hypertension: Lifestyle Modifications 32
Table 5: Classes of Antihypertensive Medications 33
Table 6: Relative Risks of Serious Complications Following Renal Denervation 41
Table 7: Classification of the Marketed Renal Denervation Systems 43
Table 8: Product Profile - Allegra Renal Denervation System 47
Table 9: Allegra Renal Denervation System - SWOT Analysis, 2013 48
Table 10: Product Profile - EnligHTN Renal Denervation System 50
Table 11: EnligHTN Renal Denervation System - SWOT Analysis, 2013 52
Table 12: Product Profile - OneShot Renal Denervation System 54
Table 13: OneShot System - SWOT Analysis, 2013 55
Table 14: Product Profile - Paradise Renal Denervation System 57
Table 15: Paradise Renal Denervation System - SWOT Analysis, 2013 58
Table 16: Product Profile - Symplicity Renal Denervation System 60
Table 17: Efficacy Results of the Symplicity HTN-1 Clinical Trial 61
Table 18: Efficacy Results of the Symplicity HTN-2 Clinical Trial 62
Table 19: Symplicity Renal Denervation System - SWOT Analysis, 2013 64
Table 20: Product Portfolio - Vessix Renal Denervation System 66
Table 21: Vessix Renal Denervation System - SWOT Analysis, 2013 67
Table 22: Overall Unmet Needs - Current Level of Attainment and Importance 68
Table 23: Comparison of Office-Based and Ambulatory Blood Pressure Reductions in Resistant Hypertensive Patients Treated with Renal Denervation 74
Table 24: Key Renal Denervation Clinical Trials Measuring Ambulatory Blood Pressure 77
Table 25: Proportion of Patients With Changes to Their Medications in the Symplicity HTN-2 Trial 78
Table 26: Key Clinical Trials Assessing Other Indications for Renal Denervation 80
Table 27: Vascular Adverse Events Reported in the EnligHTN-1 Clinical Trial 83
Table 28: Effects of Renal Denervation on the Renal Artery Wall 84
Table 29: Beta-Cath System - SWOT Analysis, 2013 88
Table 30: Bullfrog MicroFusion Catheter - SWOT Analysis, 2013 90
Table 31: Chemical Denervation System - SWOT Analysis, 2013 92
Table 32: Cryoablation System - SWOT Analysis, 2013 93
Table 33: Surround Sound Renal Denervation System - SWOT Analysis, 2013 95
Table 34: Magnetic Nanoparticles System - SWOT Analysis, 2013 97
Table 35: Perivascular Renal Denervation System - SWOT Analysis, 2013 99
Table 36: Sound 360 Ultrasonic Renal Denervation System - SWOT Analysis, 2013 102
Table 37: Symple Surgical Renal Denervation System - SWOT Analysis, 2013 103
Table 38: Tivus Renal Denervation System - SWOT Analysis, 2013 106
Table 39: Celsius Thermocool Renal Denervation System - SWOT Analysis, 2013 108
Table 40: Northwind Medical Renal Denervation System - SWOT Analysis, 2013 109
Table 41: Verve Medical Renal Denervation System - SWOT Analysis, 2013 111
Table 42: Comparison of Clinical Development Stages: Feasibility and Phase II Trials 113
Table 43: Comparison of Clinical Development Stages: Phase III and Phase IV Trials 118
Table 44: Efficacy Results in Renal Denervation Feasibility Trials 124
Table 45: Efficacy Results in Renal Denervation Phase II Trials 125
Table 46: Efficacy Results in Renal Denervation Company-Sponsored Registries 126
Table 47: Companies with Second-Generation Renal Denervation Systems 128
Table 48: Comparison of the Clinical Development Stages for Second-Generation Devices: Feasibility and Phase II Trials 130
Table 49: Key Indications Being Explored for Renal Denervation 136
Table 50: Aspects of Company Acquisitions in the Renal Denervation Market 139
Table 51: Company Profile - Ablative Solutions 143
Table 52: Ablative Solutions - SWOT Analysis, 2013 145
Table 53: Company Profile - ApexNano 146
Table 54: ApexNano - SWOT Analysis, 2013 148
Table 55: Company Profile - Best Medical International 149
Table 56: Best Medical International - SWOT Analysis, 2013 150
Table 57: Company Profile - Boston Scientific Corporation 151
Table 58: Boston Scientific - SWOT Analysis, 2013 153
Table 59: Company Profile - Cardiosonic 154
Table 60: CardioSonic - SWOT Analysis, 2013 156
Table 61: Company Profile - Covidien 157
Table 62: Covidien - SWOT Analysis, 2013 159
Table 63: Company Profile - Cordis Corporation 160
Table 64: Cordis Corporation - SWOT Analysis, 2013 162
Table 65: Company Profile - Cryomend 163
Table 66: Cryomend - SWOT Analysis, 2013 165
Table 67: Company Profile - Kona Medical 166
Table 68: Kona Medical - SWOT Analysis, 2013 168
Table 69: Company Profile - Medtronic 169
Table 70: Medtronic - SWOT Analysis, 2013 171
Table 71: Company Profile - Mercator MedSystems 172
Table 72: Mercator Medsystems - SWOT Analysis, 2013 174
Table 73: Company Profile - Northwind Medical 175
Table 74: Northwind Medical - SWOT Analysis, 2013 176
Table 75: Company Profile - Recor Medical 177
Table 76: ReCor Medical - SWOT Analysis, 2013 179
Table 77: Company Profile - Sound Interventions 180
Table 78: Sound Interventions - SWOT Analysis, 2013 182
Table 79: Company Portfolio - St. Jude Medical 183
Table 80: St. Jude Medical - SWOT Analysis, 2013 185
Table 81: Company Portfolio - Symple Surgical 186
Table 82: Symple Surgical - SWOT Analysis, 2013 187
Table 83: Company Profile - Terumo Corporation 188
Table 84: Terumo Corporation - SWOT Analysis, 2013 190
Table 85: Company Portfolio - Verve Medical 191
Table 86: Verve Medical - SWOT Analysis, 2013 193
Table 87: Worldwide Prevalence of Hypertension (Millions), 2000 and 2025 195
Table 88: Efficacy of Renal Denervation in Moderate Hypertension Patients 198
Table 89: Additional Indications for Renal Denervation 199
Table 90: Patient Exclusion Criteria for Renal Artery Stenosis in Each of the Major Clinical Investigations, 2013 204
Table 91: Advantages and Disadvantages of Carotid Baroreceptor Stimulation 220
Table 92: United States Renal Denervation Sales ($m) Forecast, 2010-2019 225

1.2 List of Figures
Figure 1: Treatment Paradigm for Resistant Hypertension 31
Figure 2: Prevalence of the Renal Denervation-Eligible Resistant Hypertension Patient Population, US, 2010-2019 36
Figure 3: Prevalence of Uncontrolled Hypertension, US, 2010-2019 38
Figure 4: Prevalence of Heart Failure (Class II and III), US, 2010-2019 39
Figure 5: United States Renal Denervation Market Share, 2016 45
Figure 6: Allegra Renal Denervation System 46
Figure 7: EnligHTN Renal Denervation System 49
Figure 8: OneShot Renal Denervation System Balloon Catheter 53
Figure 9: Paradise Renal Denervation System 56
Figure 10: Symplicity Renal Denervation System 59
Figure 11: Vessix Renal Denervation System Catheter 65
Figure 12: Bullfrog MicroFusion Catheter 89
Figure 13: Chemical Denervation System 91
Figure 14: Kona Surround Sound Renal Denervation System 94
Figure 15: Sound 360 Ultrasonic Renal Denervation System 100
Figure 16: Tivus Renal Denervation System 104
Figure 17: Tivus Renal Denervation System Catheter 105
Figure 18: Timeline of Feasibility Clinical Trials 115
Figure 19: Timeline of Phase II Clinical Trials 117
Figure 20: Timeline of Phase III Clinical Trials 120
Figure 21: Timeline of Post-Market Clinical Trials 122
Figure 22: Renal Denervation Procedure Volumes: All Indications, United States, 2010-2019 132
Figure 23: Physiological Changes Resulting from Carotid Baroreceptor Stimulation 218
Figure 24: United States Renal Denervation Sales ($m) Forecast, 2010-2019 226

Companies Mentioned

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