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  5. > Challenges and Opportunities: in the Renal Denervation Market

Challenges and Opportunities: in the Renal Denervation Market

  • July 2013
  • -
  • Espicom Business Intelligence
  • -
  • 60 pages

Hypertension: Prevalence and Significance
Hypertension is one of the most preventable causes of premature morbidity and mortality globally. It is a major risk factor for stroke, myocardial infarction, heart failure, chronic kidney disease, peripheral vascular disease, cognitive decline, damage to retinal blood vessels and visual impairment, and premature death. Therefore, reducing hypertension is a factor in lowering the incidence of these conditions, helping to improve the health of the population and reducing the high burdens that they place on global healthcare systems.

Renal denervation therapy involves a surgical procedure and is therefore a last resort in the treatment of hypertension. It is only considered when cheaper, simpler and potentially safer alternatives such as lifestyle modifications and the use of pharmaceuticals have failed. These patients are termed as having treatment-resistant hypertension.

Current Trends and Future Opportunities
With renal denervation technology only having been in development since the late 1990s and commercially-available since 2010, the market is in its infancy. The products remain unapproved in the US and Japan, and reimbursement is not yet widely available in other regions. Despite being an emerging market, renal denervation has sparked considerable interest due to the good safety and efficacy results it has achieved so far in helping to reduce treatment-resistant hypertension. The expectation is that renal denervation could become a multi-billion dollar market in the future.

Understand the current trends and future opportunities to invest in, in this essential report, and learn about the products and technologies leading this dynamic market. Challenges and Opportunities in the Renal Denervation Market is the complete guide with all you need to know!

What does this critical business analysis resource provide?
• A detailed understanding of the situation relating to treatment-resistant hypertension and the role of renal denervation
• A thorough understanding of the competitive landscape
• Current trends and future opportunities - reviews of the US and Japan new market access and market prospects
• Understand the benefits and disadvantages of major renal denervation techniques
• In-depth reviews of the products and technologies leading the market - including products currently available and in development
• Company directory - including detailed company profiles - learn who your competitors are and their current market position.

Who is this report for?
Challenges & Opportunities in the Renal Denervation Market is the ideal companion in today's dynamic renal denervation market environment. The need to understand key changes in the marketplace, and be able to quickly answer those questions that arise daily, is essential. That is why this current and comprehensive review of the trends, products and competitive landscape is an invaluable aid for every cardiovascular industry executive.

Table Of Contents

Challenges and Opportunities: in the Renal Denervation Market
EXECUTIVE SUMMARY 1

INTRODUCTION 2

Hypertension: Prevalence and Significance 2
Treatment-Resistant Hypertension and the Role of Renal Denervation 3

COMPETITIVE LANDSCAPE 4
Fig.1: Renal Denervation Market Shares by Competitor, 2012 5

CURRENT TRENDS AND FUTURE OPPORTUNITIES 6
Renal Denervation Market, 2011-2012 (US$ millions) 6
Fig.2: Renal Denervation Market by Region, 2012 6
Regional Perspective and Reimbursement 7
The US and Japan: Access to New Markets 7
Gaining Clinical and Cost-Effectiveness Evidence 7
Cost-Effectiveness Analysis 8
Addressable Market: Resistant Hypertension Prevalence and Patient Selection Criteria 8
Currently-Eligible Patients for Renal Denervation 9
Current Renal Denervation Market Opportunity, Global and US 9
Expanding Clinical Indications 10
Heart Failure and Renal Impairment 10
HF Clinical Studies 11
Rival Technologies for Treatment-Resistant Hypertension 11
Summary: Market Drivers, Restraints and Opportunities 12

MARKET PROSPECTS 13
Fig.3: Renal Denervation Market, 2011-2017E (US$ billion) 14
Fig.4: Renal Denervation Market Growth, 2012-2017E (%) 14
Products and technologies 15

RENAL DENERVATION TECHNIQUES 15
Major Renal Denervation Techniques: Benefits and Disadvantages 16

PRODUCTS AVAILABLE OR IN DEVELOPMENT 17

CURRENTLY-AVAILABLE PRODUCTS 17
Medtronic's Symplicity Renal Denervation System 17
Symplicity Clinical Trials 18
Symplicity HTN-1 18
Symplicity HTN-2 18
Symplicity HTN-3 19
Symplicity HTN-4 19
Symplicity HTN-Japan 19
Global SYMPLICITY Patient Registry 20
SYMPLICITY-HF 20
Symplicity Health-Economic Analysis 20
St Jude Medical's EnligHTN 21
EnligHTN Clinical Studies 21
EnligHTNment Clinical Trial 22
ReCor Medical's PARADISE Systems 22
Clinical Studies 22
Covidien's OneShot Renal Denervation Device 23
Boston Scientific's Vessix Vascular V2 Renal Denervation System 23
Clinical Trials 24
Shanghai AngioCare Medical Technology's Iberis Renal Sympathetic Denervation System 24

PRODUCTS IN DEVELOPMENT 25
In Clinical Development 25
Medtronic's Symplicity Spyral Multi-Electrode RF Renal Denervation System 25
Feasibility Study Results 25
Sound Interventions' Circumferential Therapeutic Ultrasound Technology 25
Pre-Clinical Studies 26
SOUND-ITV Clinical Study 26
Kona Medical's Surround Sound 26
WAVE I Study Results 27
St Jude Medical's Second-Generation EnligHTN System 27
Johnson and Johnson (Cordis)'s Renal Denervation Projects 27
Renal Denervation with the Celsius Thermacool Ablation Catheter 27
RELIEF Clinical Study 28
Celsius ThermoCool RD Multi-electrode Ablation Catheter 28
In Pre-Clinical Development 29
Cardiosonic's TIVUS System 29
Ablative Solutions' PeriVascular Renal Denervation 29
Mercator MedSystems' Micro-Infusion Catheter Technology 29
ApexNano Therapeutics' Nanomagnetic Renal Denervation Technology 30
CryoMend/CryoMedix's Cryoablation Technique 30
CyberHeart 31
Best Medical International's Beta-Cath 3.5F Vascular Brachytherapy Catheter 31
Verve Medical's Non-vascular Renal Denervation Procedure 32

COMPANY DIRECTORY 33

COMPANY PROFILES 35
Ablative Solutions 35
Apex Nano Therapeutics 36
Best Medical International 37
Boston Scientific 38
Vessix Vascular V2 Renal Denervation System 38
Cardiosonic 39
Covidien 40
OneShot Renal Denervation Device 40
Cryo Medix 41
Cyber Heart 42
Johnson and Johnson (Cordis ) 43
Renal Denervation with the Celsius Thermacool Ablation Catheter 43
RELIEF Clinical Study 44
Celsius ThermoCool RD Multi-electrode Ablation Catheter 44
Medtronic 45
Recent Key Events 45
Symplicity Renal Denervation System 46
Symplicity HTN Clinical Trials 46
In Development - Symplicity Spyral Multi-Electrode System 47
Mercator Med Systems 49
ReCor Medical 50
Recent Key Events 50
PARADISE Systems 50
Clinical Studies 50
Shanghai Angio Care Medical Technology 52
Sound Interventions 53
St Jude Medical 54
Recent Key Events 54
EnligHTN System 54
EnligHTN Clinical Studies 54
Second-Generation EnligHTN System 55
Verve Medical 56

APPENDICES 57
APPENDIX 1 - LIST OF ABBREVIATIONS 57
APPENDIX 2 - REPORT METHODOLOGY 58
Sources 58
Government and similar sources: 58
Renal denervation product manufacturers: 58
Professional organisations: 58
Medical Literature: 58
Market forecasts 59

List of Tables

Renal Denervation Market, 2011-2012 (US$ millions) 6
Current Renal Denervation Market Opportunity, Global and US 9
Summary: Market Drivers, Restraints and Opportunities 12
Major Renal Denervation Techniques: Benefits and Disadvantages 16
Recent Key Events 45
Recent Key Events 50
Recent Key Events 54

List of Charts

Fig.1: Renal Denervation Market Shares by Competitor, 2012 5
Fig.2: Renal Denervation Market by Region, 2012 6

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