MediPoint: Renal Denervation - South American 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.

GlobalData estimates that the renal denervation market in Brazil will grow to $6.7m in 2019 from nothing in 2012. The entire market will be driven by the adoption of the intervention by resistant hypertension patients.

Scope

- An overview of hypertension, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
- Annualized South American 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 South American renal denervation market.
- Realize device preferences of physicians who have performed the tests already.
- Access market sizing, forecasts and quantified growth opportunities in the South American 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 South American renal denervation market landscape? Identify, understand and capitalize.

Table Of Contents

Table of Contents

1 Table of Contents 5
1.1 List of Tables 12
1.2 List of Figures 16
2 Introduction 18
2.1 Overview 18
2.2 Catalyst 19
3 Disease Overview 20
3.1 Anatomy and Physiology 20
3.2 Pathophysiology 21
3.3 Etiology 22
3.3.1 Causes 22
3.3.2 Risk Factors 25
3.4 Clinical Presentation 28
3.4.1 Symptoms 28
3.4.2 Diagnosis 28
3.4.3 Clinical Outcomes 30
3.5 Epidemiology 34
3.5.1 Resistant Hypertension 34
3.5.2 Uncontrolled Hypertension 36
3.5.3 Heart Failure 38
3.6 Economic Impact 39
3.6.1 Overview 39
3.6.2 South America 40
4 Marketed Products 42
4.1 Overview 42
4.2 Market Share, 2013 and 2016 44
4.3 Allegra Renal Denervation System (Terumo/AngioCare) 45
4.3.1 Overview 45
4.3.2 Safety and Efficacy 46
4.3.3 SWOT Analysis 47
4.4 EnligHTN Renal Denervation System (St. Jude Medical) 48
4.4.1 Overview 48
4.4.2 Safety and Efficacy 49
4.4.3 SWOT Analysis 51
4.5 OneShot Renal Denervation System (Covidien) 52
4.5.1 Overview 52
4.5.2 Safety and Efficacy 53
4.5.3 SWOT Analysis 54
4.6 Paradise Renal Denervation System (ReCor Medical) 55
4.6.1 Overview 55
4.6.2 Safety and Efficacy 56
4.6.3 SWOT Analysis 57
4.7 Symplicity Renal Denervation System (Medtronic) 58
4.7.1 Overview 58
4.7.2 Safety and Efficacy 59
4.7.3 SWOT Analysis 63
4.8 Vessix Renal Denervation System (Boston Scientific Corporation) 64
4.8.1 Overview 64
4.8.2 Safety and Efficacy 65
4.8.3 SWOT Analysis 66
5 Unmet Needs 67
5.1 Overview 67
5.1.1 Intervention to Determine Renal Denervation Efficacy 68
5.1.2 Investigation of Renal Nerve Regeneration 70
5.1.3 Ambulatory Versus Office-Based Blood Pressure Readings 71
5.1.4 Effect of Renal Denervation on Prescription Antihypertensive Medication 77
5.1.5 Expanded Indications for Renal Denervation Systems 79
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 95
6.6.3 SWOT Analysis 96
6.7 Magnetic Nanoparticles (ApexNano) 97
6.7.1 Overview 97
6.7.2 Safety and Efficacy 97
6.7.3 SWOT Analysis 98
6.8 Perivascular Renal Denervation System (Ablative Solutions) 99
6.8.1 Overview 99
6.8.2 Safety and Efficacy 99
6.8.3 SWOT Analysis 100
6.9 Sound 360 Ultrasonic Renal Denervation System (Sound Interventions) 101
6.9.1 Overview 101
6.9.2 Safety and Efficacy 102
6.9.3 SWOT Analysis 103
6.10 Symple Surgical System (Symple Surgical) 104
6.10.1 Overview 104
6.10.2 Safety and Efficacy 104
6.10.3 SWOT Analysis 104
6.11 Tivus System (Cardiosonic) 105
6.11.1 Overview 105
6.11.2 Safety and Efficacy 106
6.11.3 SWOT Analysis 107
6.12 Celsius ThermoCool System (Cordis/Johnson and Johnson) 108
6.12.1 Overview 108
6.12.2 Safety and Efficacy 108
6.12.3 SWOT Analysis 109
6.13 Northwind Medical System (Northwind Medical) 110
6.13.1 Overview 110
6.13.2 Safety and Efficacy 110
6.13.3 SWOT Analysis 110
6.14 Verve Medical System (Verve Medical) 111
6.14.1 Overview 111
6.14.2 Safety and Efficacy 111
6.14.3 SWOT Analysis 112
7 Clinical Trial Analysis 113
7.1 Overview 113
7.2 Clinical Trial Timeline 114
7.3 Clinical Trial Results 124
7.4 Analysis of Trials to Watch 128
7.4.1 Longer Follow-Up 128
7.4.2 Uncontrolled Hypertension 128
7.4.3 Second-Generation Devices 129
7.4.4 Additional Indications 132
8 Industry Overview 133
8.1 Procedure Trends 133
8.2 Market Access 134
8.3 Reimbursement Trends 135
8.4 Regulatory Issues/Recalls 135
8.5 Added Indications 136
8.6 Mergers and Acquisitions/Key Partnerships 138
8.6.1 Overview 138
8.6.2 Boston Scientific Acquires Vessix Vascular 139
8.6.3 Covidien Acquires Maya Medical 139
8.6.4 Medtronic Acquires Ardian 140
8.6.5 Terumo Corporation Partners With AngioCare Medical Technology 140
9 Current and Future Players 141
9.1 Trends in Corporate Strategy 141
9.2 Company Profiles 142
9.2.1 Ablative Solutions 142
9.2.2 ApexNano 145
9.2.3 Best Medical International 148
9.2.4 Boston Scientific Corporation 150
9.2.5 Cardiosonic 153
9.2.6 Covidien 156
9.2.7 Cordis Corporation and Johnson and Johnson 159
9.2.8 Cryomend 162
9.2.9 Kona Medical 165
9.2.10 Medtronic 168
9.2.11 Mercator MedSystems 171
9.2.12 Northwind Medical 174
9.2.13 ReCor Medical 176
9.2.14 Sound Interventions 179
9.2.15 St. Jude Medical 182
9.2.16 Symple Surgical 185
9.2.17 Terumo Corporation 187
9.2.18 Verve Medical 190
10 Market Drivers and Opportunities 193
10.1 Market Drivers 193
10.1.1 Growing Global Prevalence and Cost of Hypertension 193
10.1.2 Significant and Sustained Reductions in Office-Based Blood Pressure 194
10.1.3 Growing Clinical Evidence of Efficacy in Other Indications 195
10.1.4 Potential for Outpatient Procedure 196
10.1.5 Positive Results in Moderate Hypertensive Patients 197
10.2 Market Opportunities 198
10.2.1 Expanding Indications 198
10.2.2 Competitive Cost Structure 200
10.2.3 Low-Profile Catheters 202
10.2.4 Catheters for Radial Access 204
10.2.5 Circumferential Ablation 206
10.2.6 Mapping System 207
10.2.7 Clinical Trials in Key Countries 207
10.2.8 Incorporate Renal Denervation Catheters into Sales of Other Cardiology Products 209
10.3 Market Threats 210
10.3.1 Ambulatory Blood Pressure Readings 210
10.3.2 Results of the Symplicity HTN-3 Trial 211
10.3.3 Extent of Clinical Trial Data 212
10.3.4 Radiofrequency Ablation Thermal Damage 213
10.3.5 Degree of Patient Pain 214
10.3.6 Inpatient Procedure 215
10.3.7 Carotid Baroreceptor Stimulation 216
10.3.8 External Systems 219
10.3.9 Micro-Infusion Systems 219
10.3.10 White-Coat Effect 220
10.3.11 Entrance of Cordis Into the Market 221
10.3.12 New Referral Pattern 222
11 Country Outlooks and Forecasts 223
12 Appendix 225
12.1 Bibliography 225
12.2 Abbreviations 241
12.3 Report Methodology 244
12.3.1 Overview 244
12.3.2 Coverage 244
12.3.3 Primary Research 245
12.3.4 Secondary Research 245
12.3.5 Forecasting Methodology 246
12.4 Key Opinion Leaders Included in this Study 247
12.5 About the Authors 248
12.5.1 Joseph A. Gregory, Analyst, Surgical Devices 248
12.5.2 Derek Archila, MBA, Director of Research and Analysis, Medical Devices 248
12.6 Global Head of Healthcare 249
12.6.1 Bonnie Bain, Ph.D., Global Head of Healthcare 249
12.7 About MediPoint 250
12.8 About GlobalData 250
12.9 Disclaimer 250



List of Tables

Table 1: Secondary Causes of Resistant Hypertension 22
Table 2: Risk Factors for Resistant Hypertension 25
Table 3: Medications That Can Contribute to Hypertension 26
Table 4: Nonsurgical Techniques for Treating Resistant Hypertension: Lifestyle Modifications 31
Table 5: Classes of Antihypertensive Medications 32
Table 6: Relative Risks of Serious Complications Following Renal Denervation 40
Table 7: Classification of the Marketed Renal Denervation Systems 42
Table 8: Product Profile - Allegra Renal Denervation System 46
Table 9: Allegra Renal Denervation System - SWOT Analysis, 2013 47
Table 10: Product Profile - EnligHTN Renal Denervation System 49
Table 11: EnligHTN Renal Denervation System - SWOT Analysis, 2013 51
Table 12: Product Profile - OneShot Renal Denervation System 53
Table 13: OneShot System - SWOT Analysis, 2013 54
Table 14: Product Profile - Paradise Renal Denervation System 56
Table 15: Paradise Renal Denervation System - SWOT Analysis, 2013 57
Table 16: Product Profile - Symplicity Renal Denervation System 59
Table 17: Efficacy Results of the Symplicity HTN-1 Clinical Trial 60
Table 18: Efficacy Results of the Symplicity HTN-2 Clinical Trial 61
Table 19: Symplicity Renal Denervation System - SWOT Analysis, 2013 63
Table 20: Product Portfolio - Vessix Renal Denervation System 65
Table 21: Vessix Renal Denervation System - SWOT Analysis, 2013 66
Table 22: Overall Unmet Needs - Current Level of Attainment and Importance 67
Table 23: Comparison of Office-Based and Ambulatory Blood Pressure Reductions in Resistant Hypertensive Patients Treated with Renal Denervation 73
Table 24: Key Renal Denervation Clinical Trials Measuring Ambulatory Blood Pressure 76
Table 25: Proportion of Patients With Changes to Their Medications in the Symplicity HTN-2 Trial 77
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 96
Table 34: Magnetic Nanoparticles System - SWOT Analysis, 2013 98
Table 35: Perivascular Renal Denervation System - SWOT Analysis, 2013 100
Table 36: Sound 360 Ultrasonic Renal Denervation System - SWOT Analysis, 2013 103
Table 37: Symple Surgical Renal Denervation System - SWOT Analysis, 2013 104
Table 38: Tivus Renal Denervation System - SWOT Analysis, 2013 107
Table 39: Celsius Thermocool Renal Denervation System - SWOT Analysis, 2013 109
Table 40: Northwind Medical Renal Denervation System - SWOT Analysis, 2013 110
Table 41: Verve Medical Renal Denervation System - SWOT Analysis, 2013 112
Table 42: Comparison of Clinical Development Stages: Feasibility and Phase II Trials 114
Table 43: Comparison of Clinical Development Stages: Phase III and Phase IV Trials 119
Table 44: Efficacy Results in Renal Denervation Feasibility Trials 125
Table 45: Efficacy Results in Renal Denervation Phase II Trials 126
Table 46: Efficacy Results in Renal Denervation Company-Sponsored Registries 127
Table 47: Companies with Second-Generation Renal Denervation Systems 129
Table 48: Comparison of the Clinical Development Stages for Second-Generation Devices: Feasibility and Phase II Trials 131
Table 49: Key Indications Being Explored for Renal Denervation 136
Table 50: Aspects of Company Acquisitions in the Renal Denervation Market 138
Table 51: Company Profile - Ablative Solutions 142
Table 52: Ablative Solutions - SWOT Analysis, 2013 144
Table 53: Company Profile - ApexNano 145
Table 54: ApexNano - SWOT Analysis, 2013 147
Table 55: Company Profile - Best Medical International 148
Table 56: Best Medical International - SWOT Analysis, 2013 149
Table 57: Company Profile - Boston Scientific Corporation 150
Table 58: Boston Scientific - SWOT Analysis, 2013 152
Table 59: Company Profile - Cardiosonic 153
Table 60: CardioSonic - SWOT Analysis, 2013 155
Table 61: Company Profile - Covidien 156
Table 62: Covidien - SWOT Analysis, 2013 158
Table 63: Company Profile - Cordis Corporation 159
Table 64: Cordis Corporation - SWOT Analysis, 2013 161
Table 65: Company Profile - Cryomend 162
Table 66: Cryomend - SWOT Analysis, 2013 164
Table 67: Company Profile - Kona Medical 165
Table 68: Kona Medical - SWOT Analysis, 2013 167
Table 69: Company Profile - Medtronic 168
Table 70: Medtronic - SWOT Analysis, 2013 170
Table 71: Company Profile - Mercator MedSystems 171
Table 72: Mercator Medsystems - SWOT Analysis, 2013 173
Table 73: Company Profile - Northwind Medical 174
Table 74: Northwind Medical - SWOT Analysis, 2013 175
Table 75: Company Profile - Recor Medical 176
Table 76: ReCor Medical - SWOT Analysis, 2013 178
Table 77: Company Profile - Sound Interventions 179
Table 78: Sound Interventions - SWOT Analysis, 2013 181
Table 79: Company Portfolio - St. Jude Medical 182
Table 80: St. Jude Medical - SWOT Analysis, 2013 184
Table 81: Company Portfolio - Symple Surgical 185
Table 82: Symple Surgical - SWOT Analysis, 2013 186
Table 83: Company Profile - Terumo Corporation 187
Table 84: Terumo Corporation - SWOT Analysis, 2013 189
Table 85: Company Portfolio - Verve Medical 190
Table 86: Verve Medical - SWOT Analysis, 2013 192
Table 87: Worldwide Prevalence of Hypertension (Millions), 2000 and 2025 194
Table 88: Efficacy of Renal Denervation in Moderate Hypertension Patients 197
Table 89: Additional Indications for Renal Denervation 198
Table 90: Patient Exclusion Criteria for Renal Artery Stenosis in Each of the Major Clinical Investigations, 2013 202
Table 91: Advantages and Disadvantages of Carotid Baroreceptor Stimulation 218
Table 92: Brazil Renal Denervation Sales ($m) Forecast, 2010-2019 22

1.2 List of Figures
Figure 1: Treatment Paradigm for Resistant Hypertension 30
Figure 2: Prevalence of the Renal Denervation-Eligible Resistant Hypertension Patient Population, Brazil, 2010-2019 35
Figure 3: Prevalence of Uncontrolled Hypertension, Brazil, 2010-2019 37
Figure 4: Prevalence of Heart Failure (Class II and III), Brazil, 2010-2019 38
Figure 5: Brazil Renal Denervation Market Share, 2016 44
Figure 6: Allegra Renal Denervation System 45
Figure 7: EnligHTN Renal Denervation System 48
Figure 8: OneShot Renal Denervation System Balloon Catheter 52
Figure 9: Paradise Renal Denervation System 55
Figure 10: Symplicity Renal Denervation System 58
Figure 11: Vessix Renal Denervation System Catheter 64
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 101
Figure 16: Tivus Renal Denervation System 105
Figure 17: Tivus Renal Denervation System Catheter 106
Figure 18: Timeline of Feasibility Clinical Trials 116
Figure 19: Timeline of Phase II Clinical Trials 118
Figure 20: Timeline of Phase III Clinical Trials 121
Figure 21: Timeline of Post-Market Clinical Trials 123
Figure 22: Renal Denervation Procedure Volumes: Resistant Hypertension, Brazil, 2010-2019 133
Figure 23: Physiological Changes Resulting from Carotid Baroreceptor Stimulation 217
Figure 24: Brazil Renal Denervation Sales ($m) Forecast, 2010-2019 224



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

View This Report »

Find all the market research you need - instantly, in one place.

+1.2 Million Research Documents & Statistics +200,000 Trusted Public Sources 350 Industries With Global Coverage

24/7 Customer Support

Talk to Amrita

+1 718 303 2019

Purchase Reports From Reputable Market Research Publishers

Enabling Technological Platforms for Lab-on-Chip Applications  (Technical Insights)

Enabling Technological Platforms for Lab-on-Chip Applications (Technical Insights)

  • $ 6 500
  • Industry report
  • June 2014
  • by Frost & Sullivan

6 Dimensional Assessment of Lab on a Chip Innovation Landscape A growing trend towards miniaturizing laboratory practices has been a major driving force behind the steady increase of innovations in the ...

Global Proteomics Market

Global Proteomics Market

  • $ 4 950
  • Industry report
  • May 2014
  • by Global Industry Analysts

This report analyzes the worldwide markets for Proteomics in US$ Million. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of ...

Label-Free Detection Market by Technology (Bio-layer interferometry, Optical waveguide grating technology, Surface Plasmon resonance), Consumables & Instruments, Applications (Lead Generation, Binding Kinetics), End user - Global Forecasts & Trends to 201

Label-Free Detection Market by Technology (Bio-layer interferometry, Optical waveguide grating technology, Surface Plasmon resonance), Consumables & Instruments, Applications (Lead Generation, Binding Kinetics), End user - Global Forecasts & Trends to 201

  • $ 4 650
  • Industry report
  • April 2014
  • by MarketsandMarkets

Label-free technology is rapidly gaining widespread acceptance as a drug discovery and life science research tool. Currently, the drug discovery process is based on target identification and screening ...


ReportLinker is an award-winning market research solution that finds, filters and organizes the latest industry data so you get all the market research you need - quickly, in one place.