Renal Denervation Catheters - Medical Devices Pipeline Assessment, 2017

Published : Sep-2017

No. of Pages : 102

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1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 4
1.2 List of Figures 6
2 Introduction 7
2.1 Renal Denervation Catheters Overview 7
3 Products under Development 8
3.1 Renal Denervation Catheters - Pipeline Products by Stage of Development 8
3.2 Renal Denervation Catheters - Pipeline Products by Segment 9
3.3 Renal Denervation Catheters - Pipeline Products by Territory 10
3.4 Renal Denervation Catheters - Pipeline Products by Regulatory Path 11
3.5 Renal Denervation Catheters - Pipeline Products by Estimated Approval Date 12
3.6 Renal Denervation Catheters - Ongoing Clinical Trials 13
4 Renal Denervation Catheters - Pipeline Products under Development by Companies 14
4.1 Renal Denervation Catheters Companies - Pipeline Products by Stage of Development 14
4.2 Renal Denervation Catheters - Pipeline Products by Stage of Development 16
5 Renal Denervation Catheters Companies and Product Overview 17
5.1 Abbott Vascular Inc Company Overview 17
5.1.1 Abbott Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 17
5.2 Boston Scientific Corp Company Overview 18
5.2.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 18
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 Denervx, LLC Company Overview 25
5.5.1 Denervx, LLC Pipeline Products & Ongoing Clinical Trials Overview 25
5.6 Handok Inc Company Overview 26
5.6.1 Handok Inc Pipeline Products & Ongoing Clinical Trials Overview 26
5.7 Handok-Kalos Medical Company Overview 28
5.7.1 Handok-Kalos Medical 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 Perseus Biomed Ltd. Company Overview 45
5.15.1 Perseus Biomed Ltd. Pipeline Products & Ongoing Clinical Trials Overview 45
5.16 ReCor Medical Inc Company Overview 46
5.16.1 ReCor Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 46
5.17 Renal Dynamics, LLC Company Overview 50
5.17.1 Renal Dynamics, LLC Pipeline Products & Ongoing Clinical Trials Overview 50
5.18 Sound Interventions, Inc. Company Overview 53
5.18.1 Sound Interventions, Inc. Pipeline Products & Ongoing Clinical Trials Overview 53
5.19 St. Jude Medical LLC Company Overview 54
5.19.1 St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 54
5.20 Suzhou SyMap Medical Ltd Company Overview 59
5.20.1 Suzhou SyMap Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 59
5.21 Symple Surgical Inc. Company Overview 62
5.21.1 Symple Surgical Inc. Pipeline Products & Ongoing Clinical Trials Overview 62
5.22 Terumo Corp Company Overview 63
5.22.1 Terumo Corp Pipeline Products & Ongoing Clinical Trials Overview 63
5.23 Trinity College Dublin Company Overview 64
5.23.1 Trinity College Dublin Pipeline Products & Ongoing Clinical Trials Overview 64
5.24 Verve Medical, Inc. Company Overview 65
5.24.1 Verve Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 65
6 Renal Denervation Catheters- Recent Developments 66
6.1 Aug 28, 2017: Medtronic Plans for Renal Denervation Pivotal Trial After New Study Shows Significant Blood Pressure Reductions 66
6.2 Aug 22, 2017: Medtronic Reports First Quarter Financial Results 67
6.3 Aug 14, 2017: PAVmed Reports Second Quarter 2017 Financial Results 70
6.4 Jul 27, 2017: Boston Scientific Announces Results for Second Quarter 2017 71
6.5 Jun 27, 2017: Boston Scientific Outlines Strategy for Sustained Growth at 2017 Investor Day 73
6.6 May 25, 2017: Medtronic Reports Fourth Quarter and Fiscal Year 2017 Financial Results 75
6.7 May 22, 2017: PAVmed Reports First Quarter 2017 Financial Results and Provides Business Update 78
6.8 Apr 27, 2017: Boston Scientific Announces Results For First Quarter 2017 78
6.9 Apr 10, 2017: MicroPort Flashpoint Renal Artery RF Ablation Catheter Gains CFDA Green-Path 80
6.10 Mar 24, 2017: LifeTech Announces 2016 Annual Results 80
6.11 Mar 21, 2017: PAVmed Names Medical Device Industry Veteran Dennis M. McGrath as Chief Financial Officer 82
6.12 Feb 21, 2017: Medtronic Reports Third Quarter Financial Results 83
6.13 Feb 09, 2017: Terumo Announces Change of Executive Officers 86
6.14 Feb 06, 2017: Medtronic Awarded U.S. Department of Veterans Affairs National Contracts for Home Telehealth Technologies, with Three Other Vendors 87
6.15 Feb 02, 2017: Boston Scientific Announces Results For Fourth Quarter And Full Year Ended December 31, 2016 87
6.16 Jan 31, 2017: Terumo Opens a Branch in Yangon 89
6.17 Jan 12, 2017: DENEX', a renal-denervating device for the treatment of difficult cases of hypertension by Handok-Kalos Medical', acquires CE qualification 89
6.18 Dec 12, 2016: Terumo Formulates 5-Year Mid- to Long-term Growth Strategy 90
6.19 Nov 22, 2016: Medtronic Reports Second Quarter Financial Results 90
6.20 Nov 16, 2016: Medtronic Releases FY16 Integrated Performance Report 93
6.21 Nov 15, 2016: CEVA to work with Medtronic for distribution facility construction 94
6.22 Oct 31, 2016: ReCor Medical Announces Key Milestones in RADIANCE-HTN Hypertension Clinical Study 94
6.23 Oct 26, 2016: Boston Scientific Announces Results For Third Quarter 2016 95
6.24 Oct 10, 2016: Professor Ian Meredith To Join Boston Scientific As Executive Vice President And Global Chief Medical Officer 97
6.25 Sep 15, 2016: Medtronic Names Mark Ploof Senior Vice President of Global Operations and Business Services 97
7 Appendix 99
7.1 Methodology 99
7.2 About GlobalData 102
7.3 Contact Us 102
7.4 Disclaimer 102

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
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
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
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
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 101

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

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Endoscope Reprocessing Market by Product (HLD and Test Strips, Detergents & Wipes, Automated Endoscope Reprocessors (AER), Endoscope Drying, Storage, & Transport Systems, Tracking Solutions), End User (Hospitals, ASCs & Clinics) (2022 – 2027)

Polymethyl Methacrylate (PMMA) Market by Grade (General Purpose, Optical), Form(Extruded Sheet, Cast Acrylic Sheet, Pellets, Beads),End-Use Industry(Signs & Displays, Construction, Automotive, Lighting Fixtures, Electronics, Marine, Healthcare) & Region – Global Forecast to 2027

Microtome Market by Product (Instruments, (Rotary), Accessories (Microtome Blades), Application (Disease Diagnosis, Medical Research), Technology (Fully Automated, Semi-automated, Manual), End User (Hospital, Clinical Labs) – Global Forecast to 2027