Renal Denervation Catheters Pipeline by Development Stages, Segments, Region and Countries, Regulatory Path and Key Companies

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Renal Denervation Catheters Pipeline Market Report Overview

Renal denervation is a minimally invasive catheter-based endovascular procedure that utilizes radiofrequency energy or ultrasound energy to ablate nerves in the walls of the renal artery, causing a reduction in nerve activity which ultimately reduces the blood pressure in patients with resistant hypertension.

The renal denervation catheters pipeline market research report provides a comprehensive understanding of the pipeline products along with their comparative analysis at various stages of development. The report also includes information about the territories wherein the clinical trials are in progress, the regulatory paths followed by the trials, and the companies associated with the trials.

Key Territories ·       China

·       United States

·       Japan

·       Mexico

Key Segments ·       Radiofrequency Catheters

·       Ultrasound Catheters

Key Regulatory Paths ·       NMPA

·       PMA

·       510(k)

·       Ninsho

·       Shonin

Leading Companies ·       Abbott Vascular Inc

·       Ablative Solutions Inc

·       Brattea

·       CryoMedix, LLC.

·       Handok-Kalos Medical

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Renal Denervation Catheters Pipeline Market Segmentation by Territories

A few of the key territories for renal denervation catheter pipeline products are China, the US, Japan, and Mexico among others. As of June 2024, China accounts for the highest number of pipeline products.

Renal Denervation Catheters Pipeline Market Analysis by Territories, 2024 (%)

Renal Denervation Catheters Pipeline Market Analysis by Territories, 2024 (%)

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Renal Denervation Catheters Pipeline Market – Key Segments

A few of the key segments in the renal denervation catheters pipeline market are radiofrequency catheters and ultrasound catheters. As of June 2024, the radiofrequency catheters segment has the highest number of renal denervation catheters pipeline products.

Renal Denervation Catheters Pipeline Market Analysis by Segments, 2024 (%)

Renal Denervation Catheters Pipeline Market Analysis by Segments, 2024 (%)

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Renal Denervation Catheters Pipeline Market Segmentation by Regulatory Paths

A few of the key regulatory paths followed by the renal denervation catheters pipeline market are NMPA, PMA, 510(k), Ninsho, and Shonin among others. As of June 2024, NMPA is the most followed pathway for pipeline products in the market.

Renal Denervation Catheters Pipeline Market Analysis by Regulatory Paths, 2024 (%)

Renal Denervation Catheters Pipeline Market Analysis by Regulatory Paths, 2024 (%)

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Renal Denervation Catheters Pipeline Market – Competitive Landscape

A few of the key companies associated with the renal denervation catheters pipeline market are Abbott Vascular Inc., Ablative Solutions In, Bratte, CryoMedix, LLC, and Handok-Kalos Medical among others.

Abbott Vascular Inc.: It is a medical device company that develops, manufactures, and markets cardiovascular devices. The company offers coronary intervention, peripheral intervention, and structural heart products. Its coronary intervention products include bleed back control valves, coronary dilatation catheters, coronary drug-eluting stents, coronary guide wires, and others. Abbott Vascular’s peripheral intervention products comprise peripheral guide wires, dilatation catheters, guiding catheters, and stent grafts.

Renal Denervation Catheters Pipeline Market Analysis by Companies, 2024

Renal Denervation Catheters Pipeline Market Analysis by Companies, 2024

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Segments Covered in the Report

Renal Denervation Catheters Pipeline Market Territories Outlook

  • China
  • United States
  • Global
  • Japan
  • Mexico

Renal Denervation Catheters Pipeline Market Regulatory Paths Outlook

  • NMPA
  • PMA
  • 510(k)
  • Ninsho
  • Shonin

Scope

This report provides:

  • Extensive coverage of the renal denervation catheters under development.
  • Exhaustive list of major pipeline products and their details, including product description, licensing and collaboration details, and other developmental activities.
  • Reviews of major players involved in the development of renal denervation catheters and lists all their pipeline projects.
  • Coverage of pipeline products based on various stages of development ranging from early development to approved/issued stage.
  • Key clinical trial data of ongoing clinical trials specific to pipeline products.
  • Recent developments in the segment/industry.

Reasons to Buy

  • Formulate significant competitor information, analysis, and insights to improve R&D strategies.
  • Identify emerging players with potentially strong product portfolios and create effective counter strategies to gain a 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.
  • Carry out In-depth analysis of the product’s current stage of development, territory, and estimated launch date.

Abbott Vascular Inc
Ablative Solutions Inc
Brattea
CryoMedix, LLC.
Handok-Kalos Medical
Johns Hopkins University
Kona Medical Inc
Lepu Medical Technology (Beijing) Co Ltd
Lifetech Scientific (Shenzhen) Co Ltd
Mayo Clinic
Medtronic Plc
MicroPort Scientific Corp
Northwind Medical Inc
Rainmed Medical Ltd
ReCor Medical Inc
Renal Dynamics, LLC
Renaly Ltd
Shanghai AngioCare Medical Technology Co Ltd
Shanghai Golden Leaf Medtech Co Ltd
SoniVie Ltd.
Sound Interventions, Inc.
St. Jude Medical LLC
Suzhou Xinmai Medical Equipment Co Ltd
Symple Surgical Inc
Tel Aviv University
Terumo Interventional Systems
University of Sydney
Venus Medtech Hangzhou Inc
Verve Medical, Inc.

Table of Contents

|1 Table of Contents 3

|1.1 List of Tables 6

|1.2 List of Figures 10

2 Introduction 11

2.1 Renal Denervation Catheters Overview 11

3 Products under Development 12

3.1 Renal Denervation Catheters – Pipeline Products by Stage of Development 12

3.2 Renal Denervation Catheters – Pipeline Products by Segment 13

3.3 Renal Denervation Catheters – Pipeline Products by Territory 14

3.4 Renal Denervation Catheters – Pipeline Products by Regulatory Path 16

3.5 Renal Denervation Catheters – Pipeline Products by Estimated Approval Date 17

3.6 Renal Denervation Catheters – Ongoing Clinical Trials 18

4 Renal Denervation Catheters – Pipeline Products under Development by Companies 19

4.1 Renal Denervation Catheters Companies – Pipeline Products by Stage of Development 19

4.2 Renal Denervation Catheters – Pipeline Products by Stage of Development 21

5 Renal Denervation Catheters Companies and Product Overview 22

5.1 Abbott Vascular Inc Company Overview 22

5.1.1 Abbott Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 22

5.2 Ablative Solutions Inc Company Overview 23

5.2.1 Ablative Solutions Inc Pipeline Products & Ongoing Clinical Trials Overview 23

5.3 Brattea Company Overview 26

5.3.1 Brattea Pipeline Products & Ongoing Clinical Trials Overview 26

5.4 CryoMedix, LLC. Company Overview 27

5.4.1 CryoMedix, LLC. Pipeline Products & Ongoing Clinical Trials Overview 27

5.5 Handok-Kalos Medical Company Overview 28

5.5.1 Handok-Kalos Medical Pipeline Products & Ongoing Clinical Trials Overview 28

5.6 Johns Hopkins University Company Overview 31

5.6.1 Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 31

5.7 Kona Medical Inc Company Overview 32

5.7.1 Kona Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 32

5.8 Lepu Medical Technology (Beijing) Co Ltd Company Overview 33

5.8.1 Lepu Medical Technology (Beijing) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 33

5.9 Lifetech Scientific (Shenzhen) Co Ltd Company Overview 37

5.9.1 Lifetech Scientific (Shenzhen) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 37

5.10 Mayo Clinic Company Overview 38

5.10.1 Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 38

5.11 Medtronic Plc Company Overview 39

5.11.1 Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 39

5.12 MicroPort Scientific Corp Company Overview 45

5.12.1 MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 45

5.13 Northwind Medical Inc Company Overview 48

5.13.1 Northwind Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 48

5.14 Rainmed Medical Ltd Company Overview 49

5.14.1 Rainmed Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 49

5.15 ReCor Medical Inc Company Overview 50

5.15.1 ReCor Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 50

5.16 Renal Dynamics, LLC Company Overview 55

5.16.1 Renal Dynamics, LLC Pipeline Products & Ongoing Clinical Trials Overview 55

5.17 Renaly Ltd Company Overview 56

5.17.1 Renaly Ltd Pipeline Products & Ongoing Clinical Trials Overview 56

5.18 Shanghai AngioCare Medical Technology Co Ltd Company Overview 57

5.18.1 Shanghai AngioCare Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 57

5.19 Shanghai Golden Leaf Medtech Co Ltd Company Overview 59

5.19.1 Shanghai Golden Leaf Medtech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 59

5.20 SoniVie Ltd. Company Overview 62

5.20.1 SoniVie Ltd. Pipeline Products & Ongoing Clinical Trials Overview 62

5.21 Sound Interventions, Inc. Company Overview 65

5.21.1 Sound Interventions, Inc. Pipeline Products & Ongoing Clinical Trials Overview 65

5.22 St. Jude Medical LLC Company Overview 66

5.22.1 St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 66

5.23 Suzhou Xinmai Medical Equipment Co Ltd Company Overview 67

5.23.1 Suzhou Xinmai Medical Equipment Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 67

5.24 Symple Surgical Inc Company Overview 70

5.24.1 Symple Surgical Inc Pipeline Products & Ongoing Clinical Trials Overview 70

5.25 Tel Aviv University Company Overview 71

5.25.1 Tel Aviv University Pipeline Products & Ongoing Clinical Trials Overview 71

5.26 Terumo Interventional Systems Company Overview 72

5.26.1 Terumo Interventional Systems Pipeline Products & Ongoing Clinical Trials Overview 72

5.27 University of Sydney Company Overview 73

5.27.1 University of Sydney Pipeline Products & Ongoing Clinical Trials Overview 73

5.28 Venus Medtech Hangzhou Inc Company Overview 74

5.28.1 Venus Medtech Hangzhou Inc Pipeline Products & Ongoing Clinical Trials Overview 74

5.29 Verve Medical, Inc. Company Overview 75

5.29.1 Verve Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 75

6 Renal Denervation Catheters- Recent Developments 78

6.1 Jun 04, 2024: Medtronic Announces Dr. Goran Petrovski to Join Diabetes Medical Affairs Team 78

6.2 Jun 04, 2024: Medtronic Announces Retirement of Rob Ten Hoedt as Executive Vice President and President, Global Regions, Effective as of June 28, 2024 78

6.3 May 07, 2024: Medtronic’s renal denervation system receives approval in China 78

6.4 Apr 24, 2024: Medtronic Names Yarmela Pavlovic as Chief Regulatory Officer 79

6.5 Apr 18, 2024: Recor Medical Announces First Cases of Paradise Ultrasound Renal Denervation Therapy in the United Arab Emirates 79

6.6 Apr 11, 2024: Ablative Solutions’ TARGET BP I Pivotal Trial Results Demonstrate Significant Reduction in 24-Hour Ambulatory Systolic Blood Pressure Compared to Sham, Using Alcohol-Mediated Renal Denervation 79

6.7 Mar 14, 2024: Tampa General Hospital Employs New Ultrasound Therapy Designed to Treat Life-Threatening Hypertension 81

6.8 Mar 12, 2024: Medtronic To Present At Barclays Global Healthcare Conference 81

6.9 Feb 28, 2024: Boston Scientific Raises $2.2B to Support Purchase of California Medical Device Company 82

6.10 Feb 23, 2024: Medical Tech Leader, Boston Scientific (BSX), Announces Notes Offering 82

6.11 Feb 19, 2024: Boston Scientific Appoints Madan Krishnan to Lead India Subcontinent 82

6.12 Feb 16, 2024: Jim Robo, Former Chairman and CEO of NextEra Energy, to Join Mayo Clinic Board of Trustees 82

6.13 Feb 07, 2024: Terumo Announces Change of Executive Officers (PDF

232.27 KB) 82

6.14 Feb 02, 2024: SoniVie completes enrolment in renal denervation study 82

6.15 Jan 31, 2024: Boston Scientific Announces Results for Fourth Quarter and Full Year 2023 83

6.16 Jan 05, 2024: Boston Scientific Announces Conference Call Discussing Fourth Quarter 2023 Results 85

6.17 Dec 22, 2023: Medtronic Launches Symplicity Blood Pressure Procedure – A new Horizon in Managing Patients with Hypertension in India 85

6.18 Dec 19, 2023: Ablative Solutions Announces Primary Endpoint Met in the TARGET BP I Pivotal Trial of the Peregrine System Kit for Patients with Uncontrolled Hypertension 86

6.19 Dec 13, 2023: MarinHealth Interventional Cardiologists Are First on the West Coast to Perform Symplicity Renal Denervation Procedure Outside of a Clinical Trial 86

6.20 Dec 09, 2023: Baylor Scott & White Heart and Vascular Hospital – Dallas Deploys FDA-Approved Hypertension Treatment 87

6.21 Nov 28, 2023: Medtronic Obtains Pre-Market Approval (PMA) For Symplicity Spyral Renal Denervation System 88

6.22 Nov 28, 2023: First Patient Treated With Medtronic Symplicity Spyral Renal Denervation System at Piedmont 88

6.23 Nov 17, 2023: Medtronic Announces FDA Approval of Minimally Invasive Device to Treat Hypertension 89

6.24 Nov 16, 2023: ReCor Medical Obtains Pre-Market Approval (PMA) for Paradise Ultrasound Renal Denervation System 90

6.25 Nov 13, 2023: Recor Medical introduces Paradise uRDN system in US 90

6.26 Nov 08, 2023: Recor Medical receives FDA approval for hypertension treatment system 91

6.27 Oct 27, 2023: Positive six-month follow-up results for Recor’s renal denervation system 91

6.28 Oct 26, 2023: Boston Scientific Announces Results for Third Quarter 2023 92

6.29 Oct 20, 2023: Recor Medical to Present Latest Clinical Data on Paradise Ultrasound Renal Denervation at TCT Annual Meeting 93

6.30 Oct 04, 2023: Medtronic Names Paolo Di Vincenzo President of the Neuromodulation Business 95

6.31 Aug 26, 2023: Medtronic Q2 2024 Earnings Estimates Increased by William Blair 95

6.32 Aug 23, 2023: Medtronic Issues Statement on the FDA Circulatory Systems Devices Advisory Panel Vote for the Symplicity Spyral Renal Denervation System 95

6.33 Aug 22, 2023: Otsuka Medical Devices and Recor Medical Announce Positive Vote from U.S. Food and Drug Administration (FDA) Advisory Committee Meeting on the Paradise Ultrasound Renal Denervation System for the Treatment of Hypertension 96

6.34 Aug 17, 2023: Mayo Clinic Reports Strong Finances for 2023 So Far with Q2 Revenue of $4.47 billion 97

6.35 Aug 11, 2023: Kristin Peck, CEO of Zoetis, to join Mayo Clinic Board of Trustees 97

6.36 Aug 08, 2023: Medtronic to Announce Financial Results for its First Quarter of Fiscal Year 2024 97

6.37 Jul 19, 2023: Boston Scientific lays off 52 workers as it closes another Silicon Valley facility 98

6.38 Jul 14, 2023: ReCor Responds to European Society of Hypertension’s (ESH) Updated Guidelines for Management of Arterial Hypertension 98

6.39 Jul 11, 2023: Verve Medical Announces FDA Approval of IDE for Pivotal Trial of RPD Renal Pelvic Denervation System for Treatment of Uncontrolled Hypertension 99

6.40 Jul 03, 2023: Medtronic Statement on ESH Guidelines for Hypertension and Renal Denervation 99

6.41 Jun 30, 2023: Bioheart Announces Clinical Result for Iberis-HTN at CIT 2023 100

6.42 Jun 27, 2023: Kalos Medical Receives Korean MFDS Innovative Medical Device Designation for DENEX Hypertension Treatment System 100

7 Appendix 101

7.1 Methodology 101

7.2 About GlobalData 104

7.3 Contact Us 104

7.4 Disclaimer 104

Table

Renal Denervation Catheters – Pipeline Products by Stage of Development 12

Renal Denervation Catheters – Pipeline Products by Segment 13

Renal Denervation Catheters – Pipeline Products by Territory 14

Renal Denervation Catheters – Pipeline Products by Regulatory Path 16

Renal Denervation Catheters – Pipeline Products by Estimated Approval Date 17

Renal Denervation Catheters – Ongoing Clinical Trials 18

Renal Denervation Catheters Companies – Pipeline Products by Stage of Development 19

Renal Denervation Catheters – Pipeline Products by Stage of Development 21

Abbott Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 22

Chemical RDN System – Product Status 22

Chemical RDN System – Product Description 22

Ablative Solutions Inc Pipeline Products & Ongoing Clinical Trials Overview 23

Peregrine System Kit – Hypertension – Product Status 23

Peregrine System Kit – Hypertension – Product Description 23

Ablative Solutions Inc – Ongoing Clinical Trials Overview 24

Peregrine System Kit – Hypertension – A Pivotal, Multicenter, Blinded, Sham procedure-Controlled Trial of Renal Denervation by the Peregrine System Kit, in Subjects with Hypertension 25

Brattea Pipeline Products & Ongoing Clinical Trials Overview 26

Netrod System – Product Status 26

Netrod System – Product Description 26

CryoMedix, LLC. Pipeline Products & Ongoing Clinical Trials Overview 27

Catheter Based Cryoablation System – Product Status 27

Catheter Based Cryoablation System – Product Description 27

Handok-Kalos Medical Pipeline Products & Ongoing Clinical Trials Overview 28

DENEX – Product Status 28

DENEX – Product Description 28

Handok-Kalos Medical – Ongoing Clinical Trials Overview 29

DENEX – A Prospective, Multicenter, No-treatment Controlled, Randomized, Open-label, Pivotal Study to Evaluate the Safety and Efficacy of DENEX, Renal Denervation Therapy, in Patients with Hypertension on no or 1-3 Antihypertensive Medications 30

DENEX – A Prospective, Multicenter, Sham-controlled, Single-blinded, Randomized, Pilot Study to Evaluate the Safety and Effectiveness of DENEX Renal Denervation System in Patients With Uncontrolled Hypertension Not Treated With Anti-HTN Medication 30

Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 31

Flexible Renal Denervation Ablation Device – Product Status 31

Flexible Renal Denervation Ablation Device – Product Description 31

Kona Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 32

Surround Sound System – Product Status 32

Surround Sound System – Product Description 32

Lepu Medical Technology (Beijing) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 33

Disposable Intravascular Ultrasound Ablation Catheter – Product Status 33

Disposable Intravascular Ultrasound Ablation Catheter – Product Description 33

Renal Denervation System – Product Status 34

Renal Denervation System – Product Description 34

Lepu Medical Technology (Beijing) Co Ltd – Ongoing Clinical Trials Overview 35

Disposable Intravascular Ultrasound Ablation Catheter – First in Man Study to Evaluate the Safety and Efficacy of Disposable Intravascular Ultrasound Ablation Catheters and Ultrasound Ablation Instrument in the Treatment of Essential Hypertension 36

Lifetech Scientific (Shenzhen) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 37

Renal Denervation Catheter – Product Status 37

Renal Denervation Catheter – Product Description 37

Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 38

Pressure Wire – Product Status 38

Pressure Wire – Product Description 38

Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 39

Symplicity Renal Denervation System – Product Status 39

Symplicity Renal Denervation System – Product Description 40

Symplicity Spyral Renal Denervation System – Product Status 40

Symplicity Spyral Renal Denervation System – Product Description 40

Medtronic Plc – Ongoing Clinical Trials Overview 41

Symplicity Renal Denervation System – Global SYMPLICITY Registry (GSR) Denervation Findings in Real World (DEFINE) 42

Symplicity Renal Denervation System – Renal Denervation in Patients with Recurrent Atrial Fibrillation After Successful Pulmonary Vein Isolation (REDE-AF): A National, Multi-Centre, Prospective, Single-arm, Pre-to-post Treatment, Medical-Device Study 42

Symplicity Renal Denervation System – Study Evaluating the Clinical Evidence of Symplicity Renal Denervation System in Subjects with Uncontrolled Hypertension 42

Symplicity Spyral Renal Denervation System – Cardiac Sympathetic Neuromodulation by Renal Denervation in Hypertrophic Cardiomyopathy (SNYPER Pilot Study) 43

Symplicity Spyral Renal Denervation System – 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) 43

Symplicity Spyral Renal Denervation System – Prairie Renal Denervation Study: Renal Denervation (RDN) for Management of Patients with Loin Pain Hematuria Syndrome (LPHS) 43

Symplicity Spyral Renal Denervation System – Renal Nerve Simulation Guided Renal Sympathetic Denervation with Siymplicity Spyral Radiofrequency Catheter for Resistant Hypertension: a Feasibility Study 44

Symplicity Spyral Renal Denervation System – The SPYRAL AFFIRM Global Clinical Study of Renal Denervation with the Symplicity Spyral Renal Denervation System in Subjects with Uncontrolled Hypertension (SPYRAL AFFIRM) 44

Symplicity Spyral Renal Denervation System – The Systemic Effects of Transcatheter Renal Artery Sympathetic Denervation Using a Second- Generation Radiofrequency Ablation Catheter: A Multicenter Observational Study. 44

MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 45

FlashPoint Renal Artery RF Ablation Catheter – Product Status 45

FlashPoint Renal Artery RF Ablation Catheter – Product Description 45

MicroPort Scientific Corp – Ongoing Clinical Trials Overview 46

FlashPoint Renal Artery RF Ablation Catheter – 3D Cardiac Electrophysiological Mapping System on Renal Artery Radiofrequency Ablation System for Hypertension: a Prospective, Multicenter, Randomized Controlled Trial 47

Northwind Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 48

Guidewire Based Catheter – Product Status 48

Guidewire Based Catheter – Product Description 48

Rainmed Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 49

Flash RDN System – Product Status 49

Flash RDN System – Product Description 49

ReCor Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 50

Paradise Ultrasound Renal Denervation System – Product Status 50

Paradise Ultrasound Renal Denervation System – Product Description 50

ReCor Medical Inc – Ongoing Clinical Trials Overview 51

Paradise Ultrasound Renal Denervation System – A Clinical Study of the Ultrasound Renal Denervation System (PRDS-001) in Patients With Hypertension 52

Paradise Ultrasound Renal Denervation System – Clinical Study of an Ultrasound Renal Denervation System in Patients with Heart Failure 52

Paradise Ultrasound Renal Denervation System – Effect of Renal Denervation in Hypertensive Patients With Autosomal Dominant Polycystic Kidney Disease 52

Paradise Ultrasound Renal Denervation System – Radiance Trio Continued Access Protocol (TRIO CAP): A Study of the ReCor Medical Paradise System in Clinical Hypertension 53

Paradise Ultrasound Renal Denervation System – Reducing Sympathetic Activity Through Ultrasound-based Renal Denervation in Excessive Cardiovascular Risk Populations – the RESURRECT Trial. A Pilot Proof-of-concept and Safety Study With the Paradise Denervation System 53

Paradise Ultrasound Renal Denervation System – Safety and Efficacy of Ultrasound Renal Denervation in Kidney Transplantation Patients with Uncontrolled Hypertension: the RESTART Study 53

Paradise Ultrasound Renal Denervation System – The “Global Paradise System” Registry 54

Paradise Ultrasound Renal Denervation System – The Global Paradise® System US Post Approval Study (US GPS) 54

Paradise Ultrasound Renal Denervation System – Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation – Redo Ablation Procedures: A Pilot Study 54

Renal Dynamics, LLC Pipeline Products & Ongoing Clinical Trials Overview 55

ReDy Renal Denervation System – Product Status 55

ReDy Renal Denervation System – Product Description 55

Renaly Ltd Pipeline Products & Ongoing Clinical Trials Overview 56

Renal Artery Denervation System – Product Status 56

Renal Artery Denervation System – Product Description 56

Shanghai AngioCare Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 57

Allegro Renal Denervation System – Product Status 57

Allegro Renal Denervation System – Product Description 57

Iberis Second-Generation Renal Sympathetic Denervation System – Product Status 58

Iberis Second-Generation Renal Sympathetic Denervation System – Product Description 58

Shanghai Golden Leaf Medtech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 59

Renal Denervation System – Hypertension – Product Status 59

Renal Denervation System – Hypertension – Product Description 59

Shanghai Golden Leaf Medtech Co Ltd – Ongoing Clinical Trials Overview 60

Renal Denervation System – Hypertension – Clinical Mechanism of Endovascular Denervation (EDN) for the Treatment of Type 2 Diabetes 61

SoniVie Ltd. Pipeline Products & Ongoing Clinical Trials Overview 62

Therapeutic Intra-Vascular Ultrasound (TIVUS) System – Renal Artery Denervation – Product Status 62

Therapeutic Intra-Vascular Ultrasound (TIVUS) System – Renal Artery Denervation – Product Description 62

SoniVie Ltd. – Ongoing Clinical Trials Overview 63

Therapeutic Intra-Vascular Ultrasound (TIVUS) System – Renal Artery Denervation – Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS) System for Renal Denervation in Patients with Uncontrolled Stage 2 Hypertension 64

Sound Interventions, Inc. Pipeline Products & Ongoing Clinical Trials Overview 65

Ultrasound Renal Denervation System – Product Status 65

Ultrasound Renal Denervation System – Product Description 65

St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 66

Third Generation EnligHTN Renal Denervation System – Product Status 66

Third Generation EnligHTN Renal Denervation System – Product Description 66

Suzhou Xinmai Medical Equipment Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 67

SyMapCath I Catheter – Product Status 67

SyMapCath I Catheter – Product Description 67

Suzhou Xinmai Medical Equipment Co Ltd – Ongoing Clinical Trials Overview 68

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) 69

SyMapCath I Catheter – A Prospective, Single-center, Open-label, Self Controlled Case Series Trial of Renal Sympathetic Denervation Using SyMapCath I Catheter and SYMPIONEER S1 Stimulator/Generator for the Treatment of Hypertension in Patients on Hemodialysis: SMART-HD Trial 69

Symple Surgical Inc Pipeline Products & Ongoing Clinical Trials Overview 70

DirectAblate Renal Denervation System – Product Status 70

DirectAblate Renal Denervation System – Product Description 70

Tel Aviv University Pipeline Products & Ongoing Clinical Trials Overview 71

Catheter System – Arterial Stiffness – Product Status 71

Catheter System – Arterial Stiffness – Product Description 71

Terumo Interventional Systems Pipeline Products & Ongoing Clinical Trials Overview 72

Renal Sympathetic Denervation System – TRI Technique – Product Status 72

Renal Sympathetic Denervation System – TRI Technique – Product Description 72

University of Sydney Pipeline Products & Ongoing Clinical Trials Overview 73

Mu Catheter – Product Status 73

Mu Catheter – Product Description 73

Venus Medtech Hangzhou Inc Pipeline Products & Ongoing Clinical Trials Overview 74

Echomplish Device – Product Status 74

Echomplish Device – Product Description 74

Verve Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 75

Verve Medical Phoenix System – Product Status 75

Verve Medical Phoenix System – Product Description 75

Verve Medical, Inc. – Ongoing Clinical Trials Overview 76

Verve Medical Phoenix System – Natural Orifice via Renal Pelvis Denervation (Novel- Denervation) Pivotal IDE Trial for the Treatment of Uncontrolled Hypertension to Lower Blood Pressure 77

Glossary 103

Figures

Renal Denervation Catheters – Pipeline Products by Stage of Development 12

Renal Denervation Catheters – Pipeline Products by Segment 13

Renal Denervation Catheters – Pipeline Products by Territory 14

Renal Denervation Catheters – Pipeline Products by Regulatory Path 16

Renal Denervation Catheters – Pipeline Products by Estimated Approval Date 17

Renal Denervation Catheters – Ongoing Clinical Trials 18

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“COVID-19 has caused significant interference to our business and the COVID-19 intelligence from GlobalData has helped us reach better decisions around strategy. These two highlights have helped enormously to understand the projections into the future concerning our business units, we also utilise the project database to source new projects for Liebherr-Werk to use as an additional source to pitch for new business.”

Market Analyst & Management, Liebherr-Werk

Your daily news has saved me a lot of time and keeps me up-to-date with what is happening in the market, I like that you almost always have a link to the source origin. We also use your market data in our Strategic Business Process to support our business decisions. By having everything in one place on the Intelligence Center it has saved me a lot of time versus looking on different sources, the alert function also helps with this.

Head of Key Accounts, Saab AB

Having used several other market research companies, I find that GlobalData manages to provide that ‘difficult-to-get’ market data that others can’t, as well as very diverse and complete consumer surveys.

Marketing Intelligence Manager, Portugal Foods

Our experience with GlobalData has been very good, from the platform itself to the people. I find that the analysts and the account team have a high level of customer focus and responsiveness and therefore I can always rely on. The platform is more holistic than other providers. It is convenient and almost like a one stop shop. The pricing suite is highly competitive and value for our organisation.

I like reports that inform new segments such as the analysis on generation Z, millennials, the impact of COVID 19 to our banking customers and their new channel habits. Secondly the specialist insight on affluent sector significantly increases our understanding about this group of customers. The combination of those give us depth and breadth of the evolving market.

I’m in the business of answering and helping people make decisions so with the intelligence center I can do that, effectively and efficiently. I can share quickly key insights that answer and satisfy our country stakeholders by giving them many quality studies and primary research about competitive landscape beyond the outlook of our bank. It helps me be seen as an advisory partner and that makes a big difference. A big benefit of our subscription is that no one holds the whole data and because it allows so many people, so many different parts of our organisation have access, it enables all teams to have the same level of knowledge and decision support.

Head of Customer Insight and Research, Standard Chartered

“I know that I can always rely on Globaldata’s work when I’m searching for the right consumer and market insights. I use Globaldata insights to understand the changing market & consumer landscape and help create better taste & wellbeing solutions for our customers in food, beverage and healthcare industries.

Globaldata has the right data and the reports are of very high quality compared to your competitors. Globaldata not only has overall market sizes & consumer insights on food & beverages but also provides insights at the ingredient & flavour level. That is key for B2B companies like Givaudan. This way we understand our customers’ business and also gain insight to our unique industry”

Head of Consumer Sensory Insights, Givaudan

GlobalData provides a great range of information and reports on various sectors that is highly relevant, timely, easy to access and utilise.  The reports and data dashboards help engagement with clients; they provide valuable industry and market insights that can enrich client conversations and can help in the shaping of value propositions. Moreover, using GlobalData products has helped increase my knowledge of the finance sector, the players within it, and the general threats and opportunities.

I find the consumer surveys that are carried out to be extremely beneficial and not something I have seen anywhere else. They provided an insightful view of why and which consumers take (or don’t) particular financial products. This can help shape conversations with clients to ensure they make the right strategic decisions for their business.

One of the challenges I have found is that data in the payments space is often piecemeal. With GD all of the data I need is in one place, but it also comes with additional market reports that provide useful extra context and information. Having the ability to set-up alerts on relevant movements in the industry, be it competitors or customers, and have them emailed directly to me, ensures I get early sight of industry activity and don’t have to search for news.

Senior Account Manager, TSYS
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