Renal Denervation Catheters - Medical Devices Pipeline Assessment, 2017

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1 Renal Denervation Catheters - Medical Devices Pipeline Assessment, 2017

2 Renal Denervation Catheters - Medical Devices Pipeline Assessment, 2017 The Business Research Store is run by Sector Publishing Intelligence Ltd. SPi has been selling professional market research reports and company analyses for over 7 years. Our experienced staff team are on hand to help with any research enquiries you may have, and help you find the right report for your needs. We sell reports to businesses of all sizes across the world who need current market data to plan and develop their business strategies. We are pleased to present details of this report to assist your buying decision and administrative process. You will find easy-to-use How To Buy information on the last page of this document. We look forward to being of service to you. If you have bulk and/or recurring requirements, please get in touch - we can liaise with publishers to obtain sample pages and negotiate discounts on your behalf. Phone: +44 (0) or 2

3 Renal Denervation Catheters - Medical Devices Pipeline Assessment, 2017 Renal Denervation Catheters - Medical Devices Pipeline Assessment, 2017 Summary GlobalData's Medical Devices sector report, Renal Denervation Catheters - Medical Devices Pipeline Assessment, 2017" provides an overview of Renal Denervation Catheters currently in pipeline stage. The report provides comprehensive information on the pipeline products with comparative analysis of the products at various stages of development. The report reviews major players involved in the pipeline product development. It also provides information about clinical trials in progress, which includes trial phase, trial status, trial start and end dates, and, the number of trials for the key Renal Denervation Catheters pipeline products. This report is prepared using data sourced from in-house databases, secondary and primary research by GlobalData's team of industry experts. *Note: Certain sections in the report may be removed or altered based on the availability and relevance of data in relation to the equipment type. Scope - Extensive coverage of the Renal Denervation Catheters under development - The report reviews details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities - The report reviews the major players involved in the development of Renal Denervation Catheters and list all their pipeline projects - The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage - The report provides key clinical trial data of ongoing trials specific to pipeline products - Recent developments in the segment / industry Reasons to buy The report enables you to - - Formulate significant competitor information, analysis, and insights to improve R&D strategies - Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage - Identify and understand important and diverse types of Renal Denervation Catheters under development 3

4 - Develop market-entry and market expansion strategies - Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline - In-depth analysis of the product s current stage of development, territory and estimated launch date Additional Details Publisher : Global Data Reference : GDME0440EPD Number of Pages : 102 Report Format : PDF Publisher Information : 4

5 Table Of Contents for Renal Denervation Catheters - Medical Devices Pipeline Assessment, 2017 [Updated: ] 1 Table of Contents1 Table of Contents 21.1 List of Tables 41.2 List of Figures 62 Introduction 72.1 Renal Denervation Catheters Overview 73 Products under Development 83.1 Renal Denervation Catheters - Pipeline Products by Stage of Development 83.2 Renal Denervation Catheters - Pipeline Products by Segment 93.3 Renal Denervation Catheters - Pipeline Products by Territory Renal Denervation Catheters - Pipeline Products by Regulatory Path Renal Denervation Catheters - Pipeline Products by Estimated Approval Date Renal Denervation Catheters - Ongoing Clinical Trials 134 Renal Denervation Catheters - Pipeline Products under Development by Companies Renal Denervation Catheters Companies - Pipeline Products by Stage of Development Renal Denervation Catheters - Pipeline Products by Stage of Development 165 Renal Denervation Catheters Companies and Product Overview Abbott Vascular Inc Company Overview Abbott Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview Boston Scientific Corp Company Overview Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview CardioSonic Ltd. Company Overview CardioSonic Ltd. Pipeline Products & Ongoing Clinical Trials Overview CryoMedix, LLC. Company Overview CryoMedix, LLC. Pipeline Products & Ongoing Clinical Trials Overview Denervx, LLC Company Overview Denervx, LLC Pipeline Products & Ongoing Clinical Trials Overview Handok Inc Company Overview Handok Inc Pipeline Products & Ongoing Clinical Trials Overview Handok-Kalos Medical Company Overview Handok-Kalos Medical Pipeline Products & Ongoing Clinical Trials Overview Kona Medical Inc Company Overview Kona Medical Inc Pipeline Products & Ongoing Clinical Trials Overview Lepu Medical Technology (Beijing) Co Ltd Company Overview Lepu Medical Technology (Beijing) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview Lifetech Scientific (Shenzhen) Co Ltd Company Overview Lifetech Scientific (Shenzhen) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview Medtronic plc Company Overview Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview MicroPort Scientific Corp Company Overview MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview Northwind Medical Inc Company Overview Northwind Medical Inc Pipeline Products & Ongoing Clinical Trials Overview Pavmed Inc Company Overview Pavmed Inc Pipeline Products & Ongoing Clinical Trials Overview Perseus Biomed Ltd. Company Overview Perseus Biomed Ltd. Pipeline Products & Ongoing Clinical Trials Overview ReCor Medical Inc Company Overview ReCor Medical Inc Pipeline Products & Ongoing Clinical Trials Overview Renal Dynamics, LLC Company Overview Renal Dynamics, LLC Pipeline Products & Ongoing Clinical Trials Overview Sound Interventions, Inc. Company Overview Sound Interventions, Inc. Pipeline Products & Ongoing Clinical Trials Overview St. Jude Medical LLC Company Overview St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview Suzhou SyMap Medical Ltd Company Overview Suzhou SyMap Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview Symple Surgical Inc. Company Overview Symple Surgical Inc. Pipeline Products & Ongoing Clinical Trials Overview Terumo Corp Company Overview Terumo Corp Pipeline Products & Ongoing Clinical Trials Overview Trinity College Dublin Company Overview Trinity College Dublin Pipeline Products & Ongoing Clinical Trials Overview Verve Medical, Inc. Company Overview Verve Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 656 Renal Denervation Catheters- Recent Developments Aug 28, 2017: Medtronic Plans for Renal Denervation Pivotal Trial After New Study Shows Significant Blood Pressure Reductions Aug 22, 2017: Medtronic Reports First Quarter Financial Results Aug 14, 2017: PAVmed Reports Second Quarter 2017 Financial Results Jul 27, 2017: Boston Scientific Announces Results for Second Quarter Jun 27, 2017: Boston Scientific Outlines Strategy for Sustained Growth at 2017 Investor Day May 25, 2017: Medtronic Reports Fourth Quarter and Fiscal Year 2017 Financial Results May 22, 2017: PAVmed Reports First Quarter 2017 Financial Results and Provides Business Update Apr 27, 2017: Boston Scientific Announces Results For First Quarter Apr 10, 2017: MicroPort Flashpoint Renal Artery RF Ablation Catheter Gains CFDA Green-Path Mar 24, 2017: LifeTech Announces 2016 Annual Results Mar 21, 2017: PAVmed Names Medical Device Industry Veteran Dennis M. McGrath as Chief Financial Officer Feb 21, 2017: Medtronic Reports Third Quarter Financial Results Feb 09, 2017: Terumo Announces Change of 5

6 Executive Officers Feb 06, 2017: Medtronic Awarded U.S. Department of Veterans Affairs National Contracts for Home Telehealth Technologies, with Three Other Vendors Feb 02, 2017: Boston Scientific Announces Results For Fourth Quarter And Full Year Ended December 31, Jan 31, 2017: Terumo Opens a Branch in Yangon Jan 12, 2017: DENEX, a renal-denervating device for the treatment of difficult cases of hypertension by Handok-Kalos Medical, acquires CE qualification Dec 12, 2016: Terumo Formulates 5-Year Mid- to Long-term Growth Strategy Nov 22, 2016: Medtronic Reports Second Quarter Financial Results Nov 16, 2016: Medtronic Releases FY16 Integrated Performance Report Nov 15, 2016: CEVA to work with Medtronic for distribution facility construction Oct 31, 2016: ReCor Medical Announces Key Milestones in RADIANCE-HTN Hypertension Clinical Study Oct 26, 2016: Boston Scientific Announces Results For Third Quarter Oct 10, 2016: Professor Ian Meredith To Join Boston Scientific As Executive Vice President And Global Chief Medical Officer Sep 15, 2016: Medtronic Names Mark Ploof Senior Vice President of Global Operations and Business Services 977 Appendix Methodology About GlobalData Contact Us Disclaimer 102 6

7 List Of Tables in Renal Denervation Catheters - Medical Devices Pipeline Assessment, 2017 [Updated: ] 1.1 List of Tables Table 1: Renal Denervation Catheters - Pipeline Products by Stage of Development 8 Table 2: Renal Denervation Catheters - Pipeline Products by Segment 9 Table 3: Renal Denervation Catheters - Pipeline Products by Territory 10 Table 4: Renal Denervation Catheters - Pipeline Products by Regulatory Path 11 Table 5: Renal Denervation Catheters - Pipeline Products by Estimated Approval Date 12 Table 6: Renal Denervation Catheters - Ongoing Clinical Trials 13 Table 7: Renal Denervation Catheters Companies - Pipeline Products by Stage of Development 14 Table 8: Renal Denervation Catheters - Pipeline Products by Stage of Development 16 Table 9: Abbott Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 17 Table 10: Chemical RDN System - Product Status 17 Table 11: Chemical RDN System - Product Description 17 Table 12: Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 18 Table 13: Vessix Renal Denervation System - Product Status 18 Table 14: Vessix Renal Denervation System - Product Description 19 Table 15: Boston Scientific Corp - Ongoing Clinical Trials Overview 20 Table 16: Vessix Renal Denervation System - A Boston Scientific Clinical Trial of Renal Denervation Using the Vessix Reduce Catheter and Vessix Generator for the Treatment of Hypertension (REINFORCE) 21 Table 17: Vessix Renal Denervation System - Adjunctive Renal Denervation to Modify Hypertension and Sympathetic Tone as Upstream Therapy in the Treatment of Atrial Fibrillation 21 Table 18: Vessix Renal Denervation System - Renal Sympathetic Denervation to Suppress Tachyarrhythmias in ICD Recipients 21 Table 19: Vessix Renal Denervation System - The Safety and Efficacy of Catheter-based Renal Denervation Using the Vessix Renal Denervation System in Autosomal Dominant Polycystic Kidney Disease (ADPKD) Patients with Severe Debilitating Pain 22 Table 20: CardioSonic Ltd. Pipeline Products & Ongoing Clinical Trials Overview 23 Table 21: Next Generation TIVUS System - Product Status 23 Table 22: Next Generation TIVUS System - Product Description 23 Table 23: CryoMedix, LLC. Pipeline Products & Ongoing Clinical Trials Overview 24 7

8 Table 24: Catheter Based Cryoablation System - Product Status 24 Table 25: Catheter Based Cryoablation System - Product Description 24 Table 26: Denervx, LLC Pipeline Products & Ongoing Clinical Trials Overview 25 Table 27: Denervx Device - Product Status 25 Table 28: Denervx Device - Product Description 25 Table 29: Handok Inc Pipeline Products & Ongoing Clinical Trials Overview 26 Table 30: 2nd Gen Renal Denervation System - Product Status 26 Table 31: 2nd Gen Renal Denervation System - Product Description 26 Table 32: 3rd Gen Renal Denervation System - Product Status 27 Table 33: 3rd Gen Renal Denervation System - Product Description 27 Table 34: Handok-Kalos Medical Pipeline Products & Ongoing Clinical Trials Overview 28 Table 35: DENEX - Product Status 28 Table 36: DENEX - Product Description 28 Table 37: Kona Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 29 Table 38: Surround Sound System - Product Status 29 Table 39: Surround Sound System - Product Description 29 Table 40: Kona Medical Inc - Ongoing Clinical Trials Overview 30 Table 41: Surround Sound System - Phase II Randomized Sham Controlled Study of Renal Denervation for Untreated Stage I and II Hypertension: Wave VI Feasibility Study 31 Table 42: Lepu Medical Technology (Beijing) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 32 Table 43: Renal Denervation System - Product Status 32 Table 44: Renal Denervation System - Product Description 32 Table 45: Lifetech Scientific (Shenzhen) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 33 Table 46: Renal Denervation Catheter - Product Status 33 Table 47: Renal Denervation Catheter - Product Description 33 Table 48: Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 34 Table 49: Symplicity Renal Denervation System - Product Status 34 Table 50: Symplicity Renal Denervation System - Product Description 35 Table 51: Symplicity Spyral Renal Denervation Catheter - Product Status 35 Table 52: Symplicity Spyral Renal Denervation Catheter - Product Description 35 Table 53: Medtronic plc - Ongoing Clinical Trials Overview 36 8

9 Table 54: Symplicity Renal Denervation System - A Prospective, Multicenter, Randomized, Open-label, Feasibility, Safety and Efficacy Study of Renal Denervation in Patients With Chronic Heart Failure (CHF) 37 Table 55: Symplicity Renal Denervation System - Effects of Catheter Based Renal Sympathetic Denervation on Resistant Hypertension in End Stage Renal Disease in Korea 37 Table 56: Symplicity Renal Denervation System - Global Prospective Registry for Sympathetic Renal Denervation in Selected Indications Through 3 Years Registry 37 Table 57: Symplicity Renal Denervation System - Impact of Renal Artery Denervation in Patients with Chronic Heart Failure Compared with Sham Procedure 38 Table 58: Symplicity Renal Denervation System - Renal Denervation in Treatment Resistant Hypertension 38 Table 59: Symplicity Renal Denervation System - Renal Sympathetic Denervation Restores Autonomic Imbalance and Prevents Atrial Fibrillation in Patients With Hypertensive Heart Disease: A Pilot Study 38 Table 60: Symplicity Renal Denervation System - Understanding the Mechanisms of Progressive Decrease In Blood Pressure After Renal Nerve Ablation 39 Table 61: Symplicity Spyral Renal Denervation Catheter - A Randomized Comparison of Ultrasound Based Versus Radiofrequency Based Catheter Ablation Techniques in Patients with Therapy Resistant Arterial Hypertension With Large Renal Arteries 40 Table 62: Symplicity Spyral Renal Denervation Catheter - Combined Treatment with Percutaneous Coronary Intervention and Renal Denervation in Hypertensive Patients with Acute Coronary Syndromes 40 Table 63: Symplicity Spyral Renal Denervation Catheter - Global Clinical Study of Renal Denervation with the Symplicity Spyral Multi-electrode Renal Denervation System in Patients with Uncontrolled Hypertension in the Absence of Antihypertensive Medications: SPYRAL HTN-OFF MED 40 Table 64: Symplicity Spyral Renal Denervation Catheter - Global Clinical Study of Renal Denervation with the Symplicity Spyral Multi-electrode Renal Denervation System in Patients with Uncontrolled Hypertension on Standard Medical Therapy: SPYRAL HTN-ON MED 41 Table 65: Symplicity Spyral Renal Denervation Catheter - New SPYRAL HTN Global Clinical Trial Program for Renal Denervation: (SPYRAL HTN-ON MED) 41 Table 66: Symplicity Spyral Renal Denervation Catheter - Renal Nerve Denervation in Patients with Hypertension and Paroxysmal and Persistent Atrial Fibrillation 41 Table 67: MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 42 Table 68: FlashPoint Renal Artery RF Ablation Catheter - Product Status 42 Table 69: FlashPoint Renal Artery RF Ablation Catheter - Product Description 42 Table 70: Northwind Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 43 Table 71: Guidewire Based Catheter - Product Status 43 Table 72: Guidewire Based Catheter - Product Description 43 Table 73: Pavmed Inc Pipeline Products & Ongoing Clinical Trials Overview 44 Table 74: Caldus - Renal Denervation - Product Status 44 Table 75: Caldus - Renal Denervation - Product Description 44 Table 76: Perseus Biomed Ltd. Pipeline Products & Ongoing Clinical Trials Overview 45 9

10 Table 77: Renal Denervation Device - Product Status 45 Table 78: Renal Denervation Device - Product Description 45 Table 79: ReCor Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 46 Table 80: PARADISE Renal Denervation System - Product Status 46 Table 81: PARADISE Renal Denervation System - Product Description 46 Table 82: ReCor Medical Inc - Ongoing Clinical Trials Overview 47 Table 83: PARADISE Renal Denervation System - A Clinical Study of the Ultrasound Renal Denervation System in Patients with Resistant Hypertension 48 Table 84: PARADISE Renal Denervation System - A Randomized Comparison of Ultrasound Based Versus Radiofrequency Based Catheter Ablation Techniques in Patients with Therapy Resistant Arterial Hypertension With Large Renal Arteries 48 Table 85: PARADISE Renal Denervation System - A Study of the ReCor Medical Paradise System in Clinical Hypertension: The RADIANCE-HTN Study 48 Table 86: PARADISE Renal Denervation System - Renal DenervatIon by UltraSound Transcatheter Emission 49 Table 87: PARADISE Renal Denervation System - Transcatheter Intravascular Ultrasound Energy Delivery for Renal Denervation 49 Table 88: Renal Dynamics, LLC Pipeline Products & Ongoing Clinical Trials Overview 50 Table 89: ReDy Renal Denervation System - Product Status 50 Table 90: ReDy Renal Denervation System - Product Description 50 Table 91: Renal Dynamics, LLC - Ongoing Clinical Trials Overview 51 Table 92: ReDy Renal Denervation System - A Prospective, Post-marketing, Single-arm, Open Label, Multi-center Clinical Study to Evaluate the Safety and Efficacy of the ReDy Renal Denervation System in the Treatment of Patients with Uncontrolled Hypertension 52 Table 93: Sound Interventions, Inc. Pipeline Products & Ongoing Clinical Trials Overview 53 Table 94: Ultrasound Renal Denervation System - Product Status 53 Table 95: Ultrasound Renal Denervation System - Product Description 53 Table 96: St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 54 Table 97: EnligHTN Multi-Electrode Renal Denervation System - Product Status 54 Table 98: EnligHTN Multi-Electrode Renal Denervation System - Product Description 54 Table 99: Third Generation EnligHTN Renal Denervation System - Product Status 55 Table 100: Third Generation EnligHTN Renal Denervation System - Product Description 55 Table 101: St. Jude Medical LLC - Ongoing Clinical Trials Overview 56 Table 102: EnligHTN Multi-Electrode Renal Denervation System - A Feasibility Study to Evaluate the Effect of Concomitant Renal Denervation and Cardiac Ablation on AF Recurrence 57 Table 103: EnligHTN Multi-Electrode Renal Denervation System - EnligHTN European Observational Study 57 10

11 Table 104: EnligHTN Multi-Electrode Renal Denervation System - International Non-randomized, Single-arm, Long-term Follow-up Study of Patients with Uncontrolled Hypertension 57 Table 105: EnligHTN Multi-Electrode Renal Denervation System - Multi-center, Randomized, Single-blind, Sham Controlled Clinical Investigation of Renal Denervation for Uncontrolled Hypertension 58 Table 106: EnligHTN Multi-Electrode Renal Denervation System - Six-month Evaluation of the Renal Denervation System in Patients with Heart Failure 58 Table 107: Suzhou SyMap Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 59 Table 108: SyMapCath I Catheter - Product Status 59 Table 109: SyMapCath I Catheter - Product Description 59 Table 110: Suzhou SyMap Medical Ltd - Ongoing Clinical Trials Overview 60 Table 111: SyMapCath I Catheter - A Prospective, Multicenter, Single Blind, Randomized and Controlled Trial of Renal Sympathetic Denervation Using SyMapCath I Catheter and SYMPIONEER S1 Stimulator/Generator for the Treatment of Hypertension (SMART Trial) 61 Table 112: Symple Surgical Inc. Pipeline Products & Ongoing Clinical Trials Overview 62 Table 113: DirectAblate Renal Denervation System - Product Status 62 Table 114: DirectAblate Renal Denervation System - Product Description 62 Table 115: Terumo Corp Pipeline Products & Ongoing Clinical Trials Overview 63 Table 116: Renal Sympathetic Denervation System - TRI Technique - Product Status 63 Table 117: Renal Sympathetic Denervation System - TRI Technique - Product Description 63 Table 118: Trinity College Dublin Pipeline Products & Ongoing Clinical Trials Overview 64 Table 119: Crescent System - Product Status 64 Table 120: Crescent System - Product Description 64 Table 121: Verve Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 65 Table 122: Verve Medical System - Product Status 65 Table 123: Verve Medical System - Product Description 65 Table 124: Glossary

12 List Of Figures, Charts and Diagrams in Renal Denervation Catheters - Medical Devices Pipeline Assessment, 2017 [Updated: ] 1.2 List of Figures Figure 1: Renal Denervation Catheters - Pipeline Products by Stage of Development 8 Figure 2: Renal Denervation Catheters - Pipeline Products by Segment 9 Figure 3: Renal Denervation Catheters - Pipeline Products by Territory 10 Figure 4: Renal Denervation Catheters - Pipeline Products by Regulatory Path 11 Figure 5: Renal Denervation Catheters - Pipeline Products by Estimated Approval Date 12 Figure 6: Renal Denervation Catheters - Ongoing Clinical Trials 13 12

13 How to Buy... Renal Denervation Catheters - Medical Devices Pipeline Assessment, 2017 [Updated: ] Option 1 - Online Go to our website and pay online with any major debit or credit card: Option 2 - Request a Proforma Invoice Fill in the details below, and either Scan this page and it to us at or Fax it to us at +44 (0) We will send you a Proforma Invoice and deliver your report on settlement. Your Name: Job Title: Your Your Contact Phone: Company Name: Address: Post/Zip Code: Country: P.O. Number: Any Other Instructions: Pricing Options: (please tick one) $4000 Single User Price $8000 Site License Price $12000 Enterprise License Price Payment Options: (please tick one) Online Credit Card (we will you the invoice with a payment link) Direct Wire Transfer (we will you the invoice with our bank details) Authorising Signature: Option 3 - Phone Us on +44 (0) We will be delighted to give you our personal attention. 13

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