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Renal Denervation Catheters - Medical Devices Pipeline Assessment, 2018

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Renal Denervation Catheters-Medical Devices Pipeline Assessment, 2018

Summary

GlobalData's Medical Devices sector report, Renal Denervation Catheters-Medical Devices Pipeline Assessment, 2018 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

- 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

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Table Of Content

Scope

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 5

1.2 List of Figures 8

2 Introduction 9

2.1 Renal Denervation Catheters Overview 9

3 Products under Development 10

3.1 Renal Denervation Catheters-Pipeline Products by Stage of Development 10

3.2 Renal Denervation Catheters-Pipeline Products by Segment 11

3.3 Renal Denervation Catheters-Pipeline Products by Territory 12

3.4 Renal Denervation Catheters-Pipeline Products by Regulatory Path 13

3.5 Renal Denervation Catheters-Pipeline Products by Estimated Approval Date 14

3.6 Renal Denervation Catheters-Ongoing Clinical Trials 15

4 Renal Denervation Catheters-Pipeline Products under Development by Companies 16

4.1 Renal Denervation Catheters Companies-Pipeline Products by Stage of Development 16

4.2 Renal Denervation Catheters-Pipeline Products by Stage of Development 17

5 Renal Denervation Catheters Companies and Product Overview 18

5.1 Abbott Vascular Inc Company Overview 18

5.1.1 Abbott Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 18

5.2 Boston Scientific Corp Company Overview 19

5.2.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 19

5.3 CardioSonic Ltd. Company Overview 23

5.3.1 CardioSonic Ltd. Pipeline Products & Ongoing Clinical Trials Overview 23

5.4 CryoMedix, LLC. Company Overview 24

5.4.1 CryoMedix, LLC. Pipeline Products & Ongoing Clinical Trials Overview 24

5.5 Handok Inc Company Overview 25

5.5.1 Handok Inc Pipeline Products & Ongoing Clinical Trials Overview 25

5.6 Handok-Kalos Medical Company Overview 27

5.6.1 Handok-Kalos Medical Pipeline Products & Ongoing Clinical Trials Overview 27

5.7 Johns Hopkins University Company Overview 28

5.7.1 Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 28

5.8 Kona Medical Inc Company Overview 29

5.8.1 Kona Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 29

5.9 Lepu Medical Technology (Beijing) Co Ltd Company Overview 32

5.9.1 Lepu Medical Technology (Beijing) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 32

5.10 Lifetech Scientific (Shenzhen) Co Ltd Company Overview 33

5.10.1 Lifetech Scientific (Shenzhen) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 33

5.11 Medtronic plc Company Overview 34

5.11.1 Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 34

5.12 MicroPort Scientific Corp Company Overview 42

5.12.1 MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 42

5.13 Northwind Medical Inc Company Overview 43

5.13.1 Northwind Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 43

5.14 Pavmed Inc Company Overview 44

5.14.1 Pavmed Inc Pipeline Products & Ongoing Clinical Trials Overview 44

5.15 ReCor Medical Inc Company Overview 45

5.15.1 ReCor Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 45

5.16 Renal Dynamics, LLC Company Overview 49

5.16.1 Renal Dynamics, LLC Pipeline Products & Ongoing Clinical Trials Overview 49

5.17 Sound Interventions, Inc. Company Overview 52

5.17.1 Sound Interventions, Inc. Pipeline Products & Ongoing Clinical Trials Overview 52

5.18 St. Jude Medical LLC Company Overview 53

5.18.1 St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 53

5.19 Suzhou SyMap Medical Ltd Company Overview 57

5.19.1 Suzhou SyMap Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 57

5.20 Symple Surgical Inc. Company Overview 60

5.20.1 Symple Surgical Inc. Pipeline Products & Ongoing Clinical Trials Overview 60

5.21 Terumo Corp Company Overview 61

5.21.1 Terumo Corp Pipeline Products & Ongoing Clinical Trials Overview 61

5.22 Trinity College Dublin Company Overview 62

5.22.1 Trinity College Dublin Pipeline Products & Ongoing Clinical Trials Overview 62

5.23 University of Sydney Company Overview 63

5.23.1 University of Sydney Pipeline Products & Ongoing Clinical Trials Overview 63

5.24 Verve Medical, Inc. Company Overview 64

5.24.1 Verve Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 64

6 Renal Denervation Catheters- Recent Developments 65

6.1 May 24, 2018: Medtronic Reports Fourth Quarter And Fiscal Year 2018 Financial Results 65

6.2 May 23, 2018: New Medtronic Data Show Significant Blood Pressure Lowering Effect of Renal Denervation in Patients Taking Anti-Hypertensive Medication 67

6.3 May 23, 2018: ReCor Medical Announces RADIANCE-HTN SOLO Hypertension Study Meets Primary Efficacy Endpoint, Pivotal Study Submission, and New Principal Investigator 68

6.4 May 18, 2018: ReCor Medical To Release of Clinical Trial Results 23 May at EuroPCR in Paris 69

6.5 May 11, 2018: Terumo Appoints its U.S.-based Subsidiary's Associate as the Fifth Terumo Fellow 70

6.6 May 09, 2018: Upmc Pinnacle Participating In Groundbreaking Trial To Help Lower Blood Pressure 70

6.7 May 07, 2018: Medtronic Appoints Mike Weinstein As Senior Vice President Of Strategy 71

6.8 Apr 25, 2018: Boston Scientific Reports Financial Results For First Quarter 2018 71

6.9 Apr 25, 2018: Xianjian Technology Receives the Most Attention from Institutional Investors 73

6.10 Apr 09, 2018: Medtronic Announces Renal Denervation Pivotal Trial for the Treatment of Hypertension 74

6.11 Apr 05, 2018: Dr. Laura Mauri to Join Medtronic as Vice President, Global Clinical Research & Analytics 75

6.12 Feb 08, 2018: Terumo Revises the Full-Year Results Forecast for FY 2017 76

6.13 Feb 01, 2018: Boston Scientific Announces Results for Fourth Quarter and Full Year 2017 76

6.14 Jan 30, 2018: Alex Gu Named Senior Vice President and President of Medtronic's Greater China Region 78

6.15 Jan 25, 2018: Terumo Announces Change of Directors and Executive Officers 78

6.16 Jan 09, 2018: Boston Scientific Announces Preliminary Unaudited Sales For The Fourth Quarter And Full Year Ended December 31, 2017 80

6.17 Jan 07, 2018: LifeTech Scientific and Ally Bridge Group Form China-Global Medtech Investment and Operating Partnership 81

6.18 Jan 05, 2018: ReCor Medical Announces Completion of RADIANCE-HTN SOLO Hypertension Study 81

6.19 Dec 19, 2017: Bob White Named Executive Vice President and President of Medtronic's Minimally Invasive Therapies Group; Chris Lee to Assume Leadership of Medtronic's Asia Pacific Region 82

6.20 Dec 13, 2017: Terumo Constructs a New Building in Yamaguchi, Japan To Strengthen Production Operations in Interventional Systems 83

6.21 Nov 24, 2017: MicroPort EP's Contact Force Sensing RF Ablation Catheter Gains CFDA Green-Path 83

6.22 Nov 21, 2017: Medtronic Reports Second Quarter Financial Results 84

6.23 Nov 15, 2017: PAVmed Reports Third Quarter 2017 Financial Results 87

6.24 Nov 08, 2017: Medtronic Announces Preliminary Second Quarter Revenue 89

6.25 Nov 02, 2017: Medtronic Releases Fiscal Year 2017 Integrated Performance Report 90

6.26 Oct 30, 2017: ReCor Medical Announces 1000th Enrollment and 150th Randomization in RADIANCE-HTN Hypertension Study 90

6.27 Oct 26, 2017: Boston Scientific Announces Results For Third Quarter 2017 91

6.28 Oct 16, 2017: The Essex Cardiothoracic Centre team trial novel high blood pressure treatment that could revolutionize care 93

6.29 Oct 06, 2017: Medtronic Provides Update on Impact from Hurricane Maria 93

6.30 Oct 04, 2017: Boston Scientific Appoints Desiree Ralls-Morrison General Counsel and Corporate Secretary 95

6.31 Sep 26, 2017: MicroVention Celebrates Grand Opening of New Worldwide Innovation Center in Aliso Viejo, California 95

6.32 Aug 31, 2017: Westmead inventors win USD1.39m to bankroll novel medical device 96

6.33 Aug 30, 2017: Our inventors win USD3m to bankroll novel medical devices 97

6.34 Aug 28, 2017: Medtronic Plans for Renal Denervation Pivotal Trial After New Study Shows Significant Blood Pressure Reductions 99

6.35 Aug 22, 2017: Medtronic Reports First Quarter Financial Results 100

6.36 Aug 14, 2017: PAVmed Reports Second Quarter 2017 Financial Results 103

6.37 Jul 27, 2017: Boston Scientific Announces Results for Second Quarter 2017 104

6.38 Jun 27, 2017: Boston Scientific Outlines Strategy for Sustained Growth at 2017 Investor Day 106

7 Appendix 109

7.1 Methodology 109

7.2 About GlobalData 112

7.3 Contact Us 112

7.4 Disclaimer 112


List Of Figure

1.2 List of Figures

Figure 1: Renal Denervation Catheters-Pipeline Products by Stage of Development 10

Figure 2: Renal Denervation Catheters-Pipeline Products by Segment 11

Figure 3: Renal Denervation Catheters-Pipeline Products by Territory 12

Figure 4: Renal Denervation Catheters-Pipeline Products by Regulatory Path 13

Figure 5: Renal Denervation Catheters-Pipeline Products by Estimated Approval Date 14

Figure 6: Renal Denervation Catheters-Ongoing Clinical Trials 15


List Of Table

1.1 List of Tables

Table 1: Renal Denervation Catheters-Pipeline Products by Stage of Development 10

Table 2: Renal Denervation Catheters-Pipeline Products by Segment 11

Table 3: Renal Denervation Catheters-Pipeline Products by Territory 12

Table 4: Renal Denervation Catheters-Pipeline Products by Regulatory Path 13

Table 5: Renal Denervation Catheters-Pipeline Products by Estimated Approval Date 14

Table 6: Renal Denervation Catheters-Ongoing Clinical Trials 15

Table 7: Renal Denervation Catheters Companies-Pipeline Products by Stage of Development 16

Table 8: Renal Denervation Catheters-Pipeline Products by Stage of Development 17

Table 9: Abbott Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 18

Table 10: Chemical RDN System-Product Status 18

Table 11: Chemical RDN System-Product Description 18

Table 12: Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 19

Table 13: Vessix Renal Denervation System-Product Status 19

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-Endovascular Renal Sympathetic Denervation Using the Boston Scientific Vessix V2 renal Denervation System to Improve Heart Failure 21

Table 19: Vessix Renal Denervation System-Renal Sympathetic Denervation to Suppress Tachyarrhythmias in ICD Recipients 22

Table 20: 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 21: CardioSonic Ltd. Pipeline Products & Ongoing Clinical Trials Overview 23

Table 22: Next Generation TIVUS System-Product Status 23

Table 23: Next Generation TIVUS System-Product Description 23

Table 24: CryoMedix, LLC. Pipeline Products & Ongoing Clinical Trials Overview 24

Table 25: Catheter Based Cryoablation System-Product Status 24

Table 26: Catheter Based Cryoablation System-Product Description 24

Table 27: Handok Inc Pipeline Products & Ongoing Clinical Trials Overview 25

Table 28: 2nd Gen Renal Denervation System-Product Status 25

Table 29: 2nd Gen Renal Denervation System-Product Description 25

Table 30: 3rd Gen Renal Denervation System-Product Status 26

Table 31: 3rd Gen Renal Denervation System-Product Description 26

Table 32: Handok-Kalos Medical Pipeline Products & Ongoing Clinical Trials Overview 27

Table 33: DENEX-Product Status 27

Table 34: DENEX-Product Description 27

Table 35: Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 28

Table 36: Flexible Renal Denervation Ablation Device-Product Status 28

Table 37: Flexible Renal Denervation Ablation Device-Product Description 28

Table 38: Kona Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 29

Table 39: Surround Sound System-Product Status 29

Table 40: Surround Sound System-Product Description 29

Table 41: Kona Medical Inc-Ongoing Clinical Trials Overview 30

Table 42: 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 43: Lepu Medical Technology (Beijing) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 32

Table 44: Renal Denervation System-Product Status 32

Table 45: Renal Denervation System-Product Description 32

Table 46: Lifetech Scientific (Shenzhen) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 33

Table 47: Renal Denervation Catheter-Product Status 33

Table 48: Renal Denervation Catheter-Product Description 33

Table 49: Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 34

Table 50: Symplicity Renal Denervation System-Product Status 34

Table 51: Symplicity Renal Denervation System-Product Description 34

Table 52: Symplicity Spyral Renal Denervation Catheter-Product Status 35

Table 53: Symplicity Spyral Renal Denervation Catheter-Product Description 35

Table 54: Medtronic plc-Ongoing Clinical Trials Overview 36

Table 55: 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 56: Symplicity Renal Denervation System-Effects of Catheter Based Renal Sympathetic Denervation on Resistant Hypertension in End Stage Renal Disease in Korea 37

Table 57: Symplicity Renal Denervation System-Global Prospective Registry for Sympathetic Renal Denervation in Selected Indications Through 3 Years Registry 37

Table 58: Symplicity Renal Denervation System-Impact of Renal Artery Denervation in Patients with Chronic Heart Failure Compared with Sham Procedure 38

Table 59: Symplicity Renal Denervation System-Prairie Renal Denervation Study 38

Table 60: Symplicity Renal Denervation System-Renal Denervation in Treatment Resistant Hypertension 38

Table 61: Symplicity Renal Denervation System-Renal Sympathetic Denervation Restores Autonomic Imbalance and Prevents Atrial Fibrillation in Patients with Hypertensive Heart Disease: A Pilot Study 39

Table 62: Symplicity Renal Denervation System-Understanding the Mechanisms of Progressive Decrease In Blood Pressure After Renal Nerve Ablation 39

Table 63: 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 64: Symplicity Spyral Renal Denervation Catheter-Combined Treatment with Percutaneous Coronary Intervention and Renal Denervation in Hypertensive Patients with Acute Coronary Syndromes 40

Table 65: 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 66: 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 67: Symplicity Spyral Renal Denervation Catheter-Pivotal Study for the Assessment of Safety and Efficacy of Symplicity Spyral Renal Denervation System in Subjects with Hypertension 41

Table 68: Symplicity Spyral Renal Denervation Catheter-Renal Nerve Denervation in Patients with Hypertension and Paroxysmal and Persistent Atrial Fibrillation 41

Table 69: MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 42

Table 70: FlashPoint Renal Artery RF Ablation Catheter-Product Status 42

Table 71: FlashPoint Renal Artery RF Ablation Catheter-Product Description 42

Table 72: Northwind Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 43

Table 73: Guidewire Based Catheter-Product Status 43

Table 74: Guidewire Based Catheter-Product Description 43

Table 75: Pavmed Inc Pipeline Products & Ongoing Clinical Trials Overview 44

Table 76: Caldus-Renal Denervation-Product Status 44

Table 77: Caldus-Renal Denervation-Product Description 44

Table 78: ReCor Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 45

Table 79: PARADISE Renal Denervation System-Product Status 45

Table 80: PARADISE Renal Denervation System-Product Description 45

Table 81: ReCor Medical Inc-Ongoing Clinical Trials Overview 46

Table 82: PARADISE Renal Denervation System-A Clinical Study of the Ultrasound Renal Denervation System in Patients with Resistant Hypertension 47

Table 83: 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 47

Table 84: PARADISE Renal Denervation System-Renal Denervation by UltraSound Transcatheter Emission 47

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Products and Companies

Products

Abbott Vascular Inc, Chemical RDN System; Boston Scientific Corp, Vessix Renal Denervation System; CardioSonic Ltd., Next Generation TIVUS System; CryoMedix, LLC., Catheter Based Cryoablation System; Handok Inc, 2nd Gen Renal Denervation System; Handok Inc, 3rd Gen Renal Denervation System; Handok-Kalos Medical, DENEX; Johns Hopkins University, Flexible Renal Denervation Ablation Device; Kona Medical Inc, Surround Sound System; Lepu Medical Technology (Beijing) Co Ltd, Renal Denervation System; Lifetech Scientific (Shenzhen) Co Ltd, Renal Denervation Catheter; Medtronic plc, Symplicity Renal Denervation System; Medtronic plc, Symplicity Spyral Renal Denervation Catheter; MicroPort Scientific Corp, FlashPoint Renal Artery RF Ablation Catheter; Northwind Medical Inc, Guidewire Based Catheter; Pavmed Inc, Caldus - Renal Denervation; ReCor Medical Inc, PARADISE Renal Denervation System; Renal Dynamics, LLC, ReDy Renal Denervation System; Sound Interventions, Inc., Ultrasound Renal Denervation System; St. Jude Medical LLC, EnligHTN Multi-Electrode Renal Denervation System; St. Jude Medical LLC, Third Generation EnligHTN Renal Denervation System; Suzhou SyMap Medical Ltd, SyMapCath I Catheter; Symple Surgical Inc., DirectAblate Renal Denervation System; Terumo Corp, Renal Sympathetic Denervation System - TRI Technique; Trinity College Dublin, Crescent System; University of Sydney, Mu Catheter; Verve Medical, Inc., Verve Medical System


Companies

Abbott Vascular Inc

Boston Scientific Corp

CardioSonic Ltd.

CryoMedix, LLC.

Handok Inc

Handok-Kalos Medical

Johns Hopkins University

Kona Medical Inc

Lepu Medical Technology (Beijing) Co Ltd

Lifetech Scientific (Shenzhen) Co Ltd

Medtronic plc

MicroPort Scientific Corp

Northwind Medical Inc

Pavmed Inc

ReCor Medical Inc

Renal Dynamics, LLC

Sound Interventions, Inc.

St. Jude Medical LLC

Suzhou SyMap Medical Ltd

Symple Surgical Inc.

Terumo Corp

Trinity College Dublin

University of Sydney

Verve Medical, Inc.