Electrophysiology Ablation Catheters Pipeline by Development Stages, Segments, Region and Countries, Regulatory Path and Key Companies

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Electrophysiology Ablation Catheters Pipeline Market Report Overview

Electrophysiology ablation is applicable for a wide variety of arrhythmias and has an extremely high success rate with low rates of complication and recurrence. The electrophysiology ablation 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 Segments ·        Advanced Ablation Catheters

·        Irrigated tip RF Ablation Catheters

·        Conventional Radio Frequency Ablation Catheters

·        Cryoablation Catheters

·        Laser Ablation Catheters

·        Standard Ablation Catheters

Key Territories ·        The US

·        Europe

·        China

·        Australia

·        Japan

Key Regulatory Paths ·        CE

·        510(k)

·        PMA

·        NMPA

·        TGA

Leading Companies ·        Biosense Webster Inc.

·        BioTex Inc.

·        Ablacon Inc

·        Acotec Scientific Co Ltd

·        Adagio Medical Inc.

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Electrophysiology Ablation Catheters Pipeline Market Segmentation by Segments

The key segments for the electrophysiology ablation catheters pipeline market are advanced ablation catheters, irrigated tip RF ablation catheters, conventional radiofrequency ablation catheters, cryoablation catheters, laser ablation catheters, and standard ablation catheters. As of March 2024, advanced ablation catheters accounted for the highest share of pipeline products.

Electrophysiology Ablation Catheters Pipeline Market Analysis by Segments, 2024 (%)

Electrophysiology Ablation Catheters Pipeline Market Analysis by Segments, 2024 (%)

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Electrophysiology Ablation Catheters Pipeline Market Segmentation by Territories

A few of the key territories for the electrophysiology ablation catheters pipeline market are the US, Europe, China, Australia, and Japan. As of March 2024, the US accounted for the highest number of pipeline products.

Electrophysiology Ablation Catheters Pipeline Market Analysis by Territories, 2024 (%)

Electrophysiology Ablation Catheters Pipeline Market Analysis by Territories, 2024 (%)

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Electrophysiology Ablation Catheters Pipeline Market Segmentation by Regulatory Paths

A few of the key regulatory paths in the electrophysiology ablation catheters pipeline products market are CE, 510(k), PMA, NMPA, and TGA. As of March 2024, CE was the most followed pathway for pipeline products in the market.

Electrophysiology Ablation Catheters Pipeline Market Analysis by Regulatory Paths, 2024 (%)

Electrophysiology Ablation Catheters Pipeline Market Analysis by Regulatory Paths, 2024 (%)

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Electrophysiology Ablation Catheters Pipeline Market – Competitive Landscape

A few of the key companies associated with the electrophysiology ablation catheters pipeline market are Biosense Webster Inc., BioTex Inc., Ablacon Inc., Acotec Scientific Co Ltd, and Adagio Medical Inc., among others.

Biosense Webster Inc: Biosense Webster is headquartered in Diamond Bar, California, the US. It is a medical device company that designs, manufactures, and markets cardiac arrhythmias products. Biosense Webster provides onsite training, offsite workshops, online training, EP training, and professional and medical education services. The company offers training and online courses through its education centers in the US, Germany, Belgium, Sweden, and Spain.

BioTex Inc: BioTex is headquartered in Houston, Texas, the US. It operates as a medical device company that designs, develops, manufactures, and distributes electro-mechanical, optical, and software-based devices. The company offers sterile and non-sterile disposable products for surgical, non-surgical, and interventional procedures in the diagnostic, medical device, and life sciences industries.

Electrophysiology Ablation Catheters Pipeline Market Analysis by Companies, 2024

Electrophysiology Ablation Catheters Pipeline Market Analysis by Companies, 2024

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Segments Covered in the Report

Electrophysiology Ablation Catheters Pipeline Market Segments Outlook

  • Advanced Ablation Catheters
  • Irrigated tip RF Ablation Catheters
  • Conventional Radio Frequency Ablation Catheters
  • Cryoablation Catheters
  • Laser Ablation Catheters
  • Standard Ablation Catheters

Electrophysiology Ablation Catheters Pipeline Market Territories Outlook

  • The US
  • Europe
  • China
  • Australia
  • Japan

Electrophysiology Ablation Catheters Pipeline Market Regulatory Paths Outlook

  • CE
  • 510(k)
  • PMA
  • NMPA
  • TGA

Scope

This report provides:

  • Extensive coverage of the electrophysiology ablation 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 electrophysiology ablation 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 electrophysiology ablation 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 an in-depth analysis of the product’s current stage of development, territory, and estimated launch date.

Ablacon Inc
Acotec Scientific Co Ltd
Adagio Medical Inc.
Apama Medical Inc
APT Medical Inc
Biosense Webster Inc
BioTex Inc
Boston Scientific Corp
CardioFocus Inc
CardioNova Ltd
CathEffects LLC
CathRx Ltd
Cibiem, Inc.
Columbia University
Cordis US Corp
CoreMap Inc
Coridea, LLC
CryoTherapeutics SA
Epicardial Technologies Inc (Inactive)
Ethicon US LLC
Farapulse Inc
FocusStart LLC
Galvanize Therapeutics Inc
Hansen Medical Inc (Inactive)
Hyblate Medical
Imricor Medical Systems Inc
Interventional Imaging, Inc.
Iowa Approach Inc.
Japan Lifeline Co Ltd
Maestro Heart SA
Medlumics SL
MedWaves Inc
MicroPort Scientific Corp
Northwestern University
Novasentis Inc
OrbusNeich
SCR, Inc.
Seattle Children's Hospital
Shanghai HeartCare Medical Technology Co Ltd
Shanghai MicroPort EP MedTech Co Ltd
St. Jude Medical LLC
Stereotaxis Inc
University of Arkansas at Little Rock
University of Michigan
University of Rochester
University of Texas Medical Branch at Galveston
Vanderbilt University
Vimecon GmbH
Vivonics Inc
Voyage Medical (Inactive)

Table of Contents

1 Table of Contents 3

1.1 List of Tables 7

1.2 List of Figures 12

2 Introduction 13

2.1 Electrophysiology Ablation Catheters Overview 13

3 Products under Development 14

3.1 Electrophysiology Ablation Catheters – Pipeline Products by Stage of Development 14

3.2 Electrophysiology Ablation Catheters – Pipeline Products by Segment 15

3.3 Electrophysiology Ablation Catheters – Pipeline Products by Territory 16

3.4 Electrophysiology Ablation Catheters – Pipeline Products by Regulatory Path 17

3.5 Electrophysiology Ablation Catheters – Pipeline Products by Estimated Approval Date 18

3.6 Electrophysiology Ablation Catheters – Ongoing Clinical Trials 19

4 Electrophysiology Ablation Catheters – Pipeline Products under Development by Companies 20

4.1 Electrophysiology Ablation Catheters Companies – Pipeline Products by Stage of Development 20

4.2 Electrophysiology Ablation Catheters – Pipeline Products by Stage of Development 22

5 Electrophysiology Ablation Catheters Companies and Product Overview 24

5.1 Ablacon Inc Company Overview 24

5.1.1 Ablacon Inc Pipeline Products & Ongoing Clinical Trials Overview 24

5.2 Acotec Scientific Co Ltd Company Overview 25

5.2.1 Acotec Scientific Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 25

5.3 Adagio Medical Inc. Company Overview 28

5.3.1 Adagio Medical Inc. Pipeline Products & Ongoing Clinical Trials Overview 28

5.4 Apama Medical Inc Company Overview 29

5.4.1 Apama Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 29

5.5 APT Medical Inc Company Overview 30

5.5.1 APT Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 30

5.6 Biosense Webster Inc Company Overview 33

5.6.1 Biosense Webster Inc Pipeline Products & Ongoing Clinical Trials Overview 33

5.7 BioTex Inc Company Overview 40

5.7.1 BioTex Inc Pipeline Products & Ongoing Clinical Trials Overview 40

5.8 Boston Scientific Corp Company Overview 41

5.8.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 41

5.9 CardioFocus Inc Company Overview 44

5.9.1 CardioFocus Inc Pipeline Products & Ongoing Clinical Trials Overview 44

5.10 CardioNova Ltd Company Overview 47

5.10.1 CardioNova Ltd Pipeline Products & Ongoing Clinical Trials Overview 47

5.11 CathEffects LLC Company Overview 48

5.11.1 CathEffects LLC Pipeline Products & Ongoing Clinical Trials Overview 48

5.12 CathRx Ltd Company Overview 49

5.12.1 CathRx Ltd Pipeline Products & Ongoing Clinical Trials Overview 49

5.13 Cibiem, Inc. Company Overview 52

5.13.1 Cibiem, Inc. Pipeline Products & Ongoing Clinical Trials Overview 52

5.14 Columbia University Company Overview 53

5.14.1 Columbia University Pipeline Products & Ongoing Clinical Trials Overview 53

5.15 Cordis US Corp Company Overview 54

5.15.1 Cordis US Corp Pipeline Products & Ongoing Clinical Trials Overview 54

5.16 CoreMap Inc Company Overview 55

5.16.1 CoreMap Inc Pipeline Products & Ongoing Clinical Trials Overview 55

5.17 Coridea, LLC Company Overview 56

5.17.1 Coridea, LLC Pipeline Products & Ongoing Clinical Trials Overview 56

5.18 CryoTherapeutics SA Company Overview 57

5.18.1 CryoTherapeutics SA Pipeline Products & Ongoing Clinical Trials Overview 57

5.19 Epicardial Technologies Inc (Inactive) Company Overview 60

5.19.1 Epicardial Technologies Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 60

5.20 Ethicon US LLC Company Overview 61

5.20.1 Ethicon US LLC Pipeline Products & Ongoing Clinical Trials Overview 61

5.21 Farapulse Inc Company Overview 62

5.21.1 Farapulse Inc Pipeline Products & Ongoing Clinical Trials Overview 62

5.22 FocusStart LLC Company Overview 66

5.22.1 FocusStart LLC Pipeline Products & Ongoing Clinical Trials Overview 66

5.23 Galvanize Therapeutics Inc Company Overview 67

5.23.1 Galvanize Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 67

5.24 Hansen Medical Inc (Inactive) Company Overview 70

5.24.1 Hansen Medical Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 70

5.25 Hyblate Medical Company Overview 71

5.25.1 Hyblate Medical Pipeline Products & Ongoing Clinical Trials Overview 71

5.26 Imricor Medical Systems Inc Company Overview 72

5.26.1 Imricor Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 72

5.27 Interventional Imaging, Inc. Company Overview 76

5.27.1 Interventional Imaging, Inc. Pipeline Products & Ongoing Clinical Trials Overview 76

5.28 Iowa Approach Inc. Company Overview 77

5.28.1 Iowa Approach Inc. Pipeline Products & Ongoing Clinical Trials Overview 77

5.29 Japan Lifeline Co Ltd Company Overview 80

5.29.1 Japan Lifeline Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 80

5.30 Maestro Heart SA Company Overview 81

5.30.1 Maestro Heart SA Pipeline Products & Ongoing Clinical Trials Overview 81

5.31 Medlumics SL Company Overview 82

5.31.1 Medlumics SL Pipeline Products & Ongoing Clinical Trials Overview 82

5.32 MedWaves Inc Company Overview 83

5.32.1 MedWaves Inc Pipeline Products & Ongoing Clinical Trials Overview 83

5.33 MicroPort Scientific Corp Company Overview 84

5.33.1 MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 84

5.34 Northwestern University Company Overview 86

5.34.1 Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 86

5.35 Novasentis Inc Company Overview 87

5.35.1 Novasentis Inc Pipeline Products & Ongoing Clinical Trials Overview 87

5.36 OrbusNeich Company Overview 88

5.36.1 OrbusNeich Pipeline Products & Ongoing Clinical Trials Overview 88

5.37 SCR, Inc. Company Overview 89

5.37.1 SCR, Inc. Pipeline Products & Ongoing Clinical Trials Overview 89

5.38 Seattle Children’s Hospital Company Overview 90

5.38.1 Seattle Children’s Hospital Pipeline Products & Ongoing Clinical Trials Overview 90

5.39 Shanghai HeartCare Medical Technology Co Ltd Company Overview 91

5.39.1 Shanghai HeartCare Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 91

5.40 Shanghai MicroPort EP MedTech Co Ltd Company Overview 92

5.40.1 Shanghai MicroPort EP MedTech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 92

5.41 St. Jude Medical LLC Company Overview 95

5.41.1 St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 95

5.42 Stereotaxis Inc Company Overview 98

5.42.1 Stereotaxis Inc Pipeline Products & Ongoing Clinical Trials Overview 98

5.43 University of Arkansas at Little Rock Company Overview 102

5.43.1 University of Arkansas at Little Rock Pipeline Products & Ongoing Clinical Trials Overview 102

5.44 University of Michigan Company Overview 103

5.44.1 University of Michigan Pipeline Products & Ongoing Clinical Trials Overview 103

5.45 University of Rochester Company Overview 104

5.45.1 University of Rochester Pipeline Products & Ongoing Clinical Trials Overview 104

5.46 University of Texas Medical Branch at Galveston Company Overview 105

5.46.1 University of Texas Medical Branch at Galveston Pipeline Products & Ongoing Clinical Trials Overview 105

5.47 Vanderbilt University Company Overview 106

5.47.1 Vanderbilt University Pipeline Products & Ongoing Clinical Trials Overview 106

5.48 Vimecon GmbH Company Overview 107

5.48.1 Vimecon GmbH Pipeline Products & Ongoing Clinical Trials Overview 107

5.49 Vivonics Inc Company Overview 108

5.49.1 Vivonics Inc Pipeline Products & Ongoing Clinical Trials Overview 108

5.50 Voyage Medical (Inactive) Company Overview 109

5.50.1 Voyage Medical (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 109

6 Electrophysiology Ablation Catheters- Recent Developments 110

6.1 Mar 12, 2024: Medtronic To Present At Barclays Global Healthcare Conference 110

6.2 Mar 04, 2024: Medtronic Receives 510(k) Clearance for OsteoCool

2.0 RF Ablation System 110

6.3 Mar 04, 2024: Stereotaxis Announces Regulatory Submissions of the MAGiC Ablation Catheter in Europe and the United States 110

6.4 Feb 28, 2024: Boston Scientific Raises $2.2B to Support Purchase of California Medical Device Company 111

6.5 Feb 23, 2024: Medical Tech Leader, Boston Scientific (BSX), Announces Notes Offering 111

6.6 Feb 19, 2024: Boston Scientific Appoints Madan Krishnan to Lead India Subcontinent 111

6.7 Feb 16, 2024: Jim Robo, Former Chairman and CEO of NextEra Energy, to Join Mayo Clinic Board of Trustees 111

6.8 Feb 14, 2024: GE HealthCare Management to Present at Upcoming Investor Conferences 111

6.9 Feb 06, 2024: INSERTING and REPLACING GE HealthCare Reports Fourth Quarter and Full Year 2023 Financial Results 112

6.10 Feb 01, 2024: S4 Medical Announces Publication of EASY AF Clinical Study Results Showing Significant Esophageal Injury Reduction in JACC: Electrophysiology 116

6.11 Feb 01, 2024: Japan Lifeline Announces an Appointment of a New Operating Officer 117

6.12 Jan 31, 2024: Boston Scientific Announces Results for Fourth Quarter and Full Year 2023 117

6.13 Jan 18, 2024: GE HealthCare to Announce Fourth Quarter and Full Year 2023 Results on February 6, 2024 119

6.14 Jan 08, 2024: Stereotaxis Announces First Patients Successfully Treated using MAGiC Ablation Catheter 119

6.15 Jan 05, 2024: Boston Scientific Announces Conference Call Discussing Fourth Quarter 2023 Results 119

6.16 Dec 14, 2023: Biosense Webster Begins Enrollment of SmartPulse Study in the U.S. to Evaluate RF and PFA Dual Energy Catheter to Treat Atrial Fibrillation 120

6.17 Dec 11, 2023: MicroPort Scientific : Voluntary Announcement 121

6.18 Dec 01, 2023: Japan Lifeline Announces Changes in Organization and Personnel 121

6.19 Nov 10, 2023: Microport Appointment of Director 122

6.20 Nov 06, 2023: MicroPort EP Participates in LAHRS 2023 122

6.21 Nov 04, 2023: MicroPort EP Participates in 2023 World Congress of Arrhythmias 123

6.22 Oct 31, 2023: GE HealthCare Reports Third Quarter 2023 Financial Results 123

6.23 Oct 26, 2023: Boston Scientific Announces Results for Third Quarter 2023 125

6.24 Oct 04, 2023: Stereotaxis Robotic Technology to be Featured during 7th Annual Meeting of the Society for Cardiac Robotic Navigation 126

6.25 Oct 04, 2023: Medtronic Names Paolo Di Vincenzo President of the Neuromodulation Business 127

6.26 Sep 21, 2023: Microport Scientific Corp. Announces 2023 Interim Report 127

6.27 Sep 19, 2023: Microport EP Receives Approval for Firemagic Trueforce Ablation Catheter in EU and UK 130

6.28 Sep 14, 2023: Adagio announces first procedure with vCLAS catheter system 130

6.29 Sep 14, 2023: Adagio Medical Announces Initiation and First Procedure in FULCRUM-VT Trial, Starting The Process For Bringing Ultra-Low Temperature Cryoablation for Ventricular Arrhythmias to US Market 131

6.30 Sep 01, 2023: Japan Lifeline Announces Changes in Organizations and Personnel 131

6.31 Aug 26, 2023: Medtronic Q2 2024 Earnings Estimates Increased by William Blair 131

6.32 Aug 23, 2023: Boston Scientific Obtains Pre-Market Approval (PMA) for POLARx FIT Cryoablation Balloon Catheter 132

6.33 Aug 17, 2023: Mayo Clinic Reports Strong Finances for 2023 So Far with Q2 Revenue of $4.47 billion 132

6.34 Aug 11, 2023: Kristin Peck, CEO of Zoetis, to join Mayo Clinic Board of Trustees 132

6.35 Aug 08, 2023: Medtronic to Announce Financial Results for its First Quarter of Fiscal Year 2024 132

6.36 Aug 07, 2023: FDA approves J&J’s Afib ablation devices for use without fluoroscopy 133

6.37 Jul 19, 2023: Biosense Webster Completes Enrollment in Pivotal Trial Evaluating PFA and RF Dual Energy Catheter for Patients with Atrial Fibrillation in Europe 133

6.38 Jul 19, 2023: Boston Scientific lays off 52 workers as it closes another Silicon Valley facility 134

6.39 Jul 18, 2023: Imricor Receives US$1 Million Commitment Letter from North Dakota Development Fund 134

6.40 Jul 11, 2023: Microport Scientific Provides Consolidated Earnings Guidance for the Six Months Ended June 30, 2023 135

6.41 Jul 02, 2023: Imricor Signs Landmark Agreement With Leading Distributor In Saudi Arabia 135

6.42 Jun 15, 2023: Stereotaxis to Initiate First-In-Human Trial to Support CE Mark Application of Magic Catheter 135

6.43 Jun 09, 2023: MicroPort EP Exhibiting at the Heart Rhythm Society Annual Meeting 136

6.44 May 18, 2023: MicroPort CRM and MicroPort EP were presented at the 2023 Annual Meeting of the European Heart Rhythm Association 137

6.45 May 15, 2023: New data published on Biosense Webster QDOT MICRO catheter – the latest advancement in Focal RF ablation for treating AFib 137

6.46 May 11, 2023: Medtronic to announce financial results for its fourth quarter and full fiscal year 2023 139

6.47 May 09, 2023: GE HealthCare Names James Saccaro Vice President and Chief Financial Officer 139

6.48 Apr 26, 2023: MicroPort announces annual results for 2022 140

6.49 Apr 25, 2023: Cryofocus Medtech Shanghai Co. Announces 2022 Annual Report 140

6.50 Apr 12, 2023: Medtronic has a layoff in California 141

6.51 Apr 06, 2023: Ablacon receives 510(k) clearance for Ablacath Mapping Catheter 141

7 Appendix 142

7.1 Methodology 142

7.2 About GlobalData 145

7.3 Contact Us 145

7.4 Disclaimer 145

Table

Electrophysiology Ablation Catheters – Pipeline Products by Stage of Development 14

Electrophysiology Ablation Catheters – Pipeline Products by Segment 15

Electrophysiology Ablation Catheters – Pipeline Products by Territory 16

Electrophysiology Ablation Catheters – Pipeline Products by Regulatory Path 17

Electrophysiology Ablation Catheters – Pipeline Products by Estimated Approval Date 18

Electrophysiology Ablation Catheters – Ongoing Clinical Trials 19

Electrophysiology Ablation Catheters Companies – Pipeline Products by Stage of Development 20

Electrophysiology Ablation Catheters – Pipeline Products by Stage of Development 22

Ablacon Inc Pipeline Products & Ongoing Clinical Trials Overview 24

Ablasense – Product Status 24

Ablasense – Product Description 24

Acotec Scientific Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 25

ERA-C30 Endovenous Radiofrequency Closure Catheter – Product Status 25

ERA-C30 Endovenous Radiofrequency Closure Catheter – Product Description 25

ERA-C70 Endovenous Radiofrequency Closure Catheter – Product Status 26

ERA-C70 Endovenous Radiofrequency Closure Catheter – Product Description 26

ERA-G5 Endovenous Radiofrequency Closure Generator – Product Status 26

ERA-G5 Endovenous Radiofrequency Closure Generator – Product Description 27

Adagio Medical Inc. Pipeline Products & Ongoing Clinical Trials Overview 28

vCLAS VT Ablation Catheter – Product Status 28

vCLAS VT Ablation Catheter – Product Description 28

Apama Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 29

LUMINIZE Radiofrequency (RF) Balloon Catheter – Product Status 29

LUMINIZE Radiofrequency (RF) Balloon Catheter – Product Description 29

APT Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 30

Magnetic Positioning Pressure Sensing Radiofrequency Ablation Catheter – Product Status 30

Magnetic Positioning Pressure Sensing Radiofrequency Ablation Catheter – Product Description 30

Pressure Sensing Ablation Catheter – Product Status 31

Pressure Sensing Ablation Catheter – Product Description 31

RF Ablation Device with Pressure Sensing – Product Status 31

RF Ablation Device with Pressure Sensing – Product Description 32

Biosense Webster Inc Pipeline Products & Ongoing Clinical Trials Overview 33

CARTO SMARTTOUCH 5D Catheter – Product Status 33

CARTO SMARTTOUCH 5D Catheter – Product Description 33

Heliostar Multi-Electrode Radiofrequency Balloon Ablation Catheter – Product Status 34

Heliostar Multi-Electrode Radiofrequency Balloon Ablation Catheter – Product Description 34

Thermocool Smarttouch SF Dual Energy Catheter – Product Status 34

Thermocool Smarttouch SF Dual Energy Catheter – Product Description 35

Biosense Webster Inc – Ongoing Clinical Trials Overview 36

Heliostar Multi-Electrode Radiofrequency Balloon Ablation Catheter – Implementation of the HELIOSTAR in Real-world Clinical Practice at a High-volume Center – Operator Learning Curve and Procedural Outcome Parameters 37

CARTO SMARTTOUCH 5D Catheter – Ground-Breaking Electroporation-based Intervention for PERSistent Atrial Fibrillation Treatment (BEAT PERS-AF) 38

Thermocool Smarttouch SF Dual Energy Catheter – Safety and Effectiveness Evaluation of the THERMOCOOL SMARTTOUCH SF Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation (PAF) 39

BioTex Inc Pipeline Products & Ongoing Clinical Trials Overview 40

Cooled Tip Catheter – Product Status 40

Cooled Tip Catheter – Product Description 40

Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 41

Next Generation Blazer Catheter – Product Status 41

Next Generation Blazer Catheter – Product Description 41

Next Generation IntellaTip Catheter – Product Status 42

Next Generation IntellaTip Catheter – Product Description 42

POLARx Next Generation Catheter – Product Status 42

POLARx Next Generation Catheter – Product Description 43

CardioFocus Inc Pipeline Products & Ongoing Clinical Trials Overview 44

HeartLight X3 System – Product Status 44

HeartLight X3 System – Product Description 44

CardioFocus Inc – Ongoing Clinical Trials Overview 45

HeartLight X3 System – A Prospective Multicenter U.S. Comparison of Radiofrequency, Cryoballoon and Laser Balloon Modalities for Pulmonary Vein Isolation Ablation in Patients with Atrial Fibrillation 46

CardioNova Ltd Pipeline Products & Ongoing Clinical Trials Overview 47

CardioNova System – Product Status 47

CardioNova System – Product Description 47

CathEffects LLC Pipeline Products & Ongoing Clinical Trials Overview 48

Desai VectorCathRF1 Mapping And Ablation Catheter – Product Status 48

Desai VectorCathRF1 Mapping And Ablation Catheter – Product Description 48

CathRx Ltd Pipeline Products & Ongoing Clinical Trials Overview 49

CathRx 4mm Therapeutic Catheter – Product Status 49

CathRx 4mm Therapeutic Catheter – Product Description 49

CathRx 8mm Therapeutic Catheter – Product Status 50

CathRx 8mm Therapeutic Catheter – Product Description 50

Khelix Irrigated Ablation EP Catheter – Product Status 50

Khelix Irrigated Ablation EP Catheter – Product Description 51

Khelix Non-Irrigated Ablation EP Catheter – Product Status 51

Khelix Non-Irrigated Ablation EP Catheter – Product Description 51

Cibiem, Inc. Pipeline Products & Ongoing Clinical Trials Overview 52

Catheter-Based Carotid Body Ablation System – Product Status 52

Catheter-Based Carotid Body Ablation System – Product Description 52

Columbia University Pipeline Products & Ongoing Clinical Trials Overview 53

Optically-Integrated RFA Catheter – Product Status 53

Optically-Integrated RFA Catheter – Product Description 53

Cordis US Corp Pipeline Products & Ongoing Clinical Trials Overview 54

EP Contact Force Sensing Catheter Enabled By CARTO 3 – Product Status 54

EP Contact Force Sensing Catheter Enabled By CARTO 3 – Product Description 54

CoreMap Inc Pipeline Products & Ongoing Clinical Trials Overview 55

Electrophysiology Mapping System – Atrial Fibrillation – Product Status 55

Electrophysiology Mapping System – Atrial Fibrillation – Product Description 55

Coridea, LLC Pipeline Products & Ongoing Clinical Trials Overview 56

High Intensity Therapeutic Ultrasound Catheter – Obstructive Hypertrophic Cardiomyopathy – Product Status 56

High Intensity Therapeutic Ultrasound Catheter – Obstructive Hypertrophic Cardiomyopathy – Product Description 56

CryoTherapeutics SA Pipeline Products & Ongoing Clinical Trials Overview 57

Cryotherapy System – Coronary Artery Disease – Product Status 57

Cryotherapy System – Coronary Artery Disease – Product Description 57

CryoTherapeutics SA – Ongoing Clinical Trials Overview 58

Cryotherapy System – Coronary Artery Disease – Clinical Investigation of Intracoronary Cryotherapy Using the CryoTherapy System (CTS) for High-risk Plaque in Patients with Non-ST Segment Elevation Myocardial Infarction (NSTEMI) or Unstable Angina 59

Epicardial Technologies Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 60

Epicardial Access Device – Product Status 60

Epicardial Access Device – Product Description 60

Ethicon US LLC Pipeline Products & Ongoing Clinical Trials Overview 61

Next Generation Ablation Catheter – Product Status 61

Next Generation Ablation Catheter – Product Description 61

Farapulse Inc Pipeline Products & Ongoing Clinical Trials Overview 62

FARAFLEX – Product Status 62

FARAFLEX – Product Description 62

FARAONE – Product Status 63

FARAONE – Product Description 63

FARAPOINT – Product Status 63

FARAPOINT – Product Description 64

FARAWAVE Nav – Product Status 64

FARAWAVE Nav – Product Description 64

Next Gen FARAWAVE Catheter – Product Status 65

Next Gen FARAWAVE Catheter – Product Description 65

FocusStart LLC Pipeline Products & Ongoing Clinical Trials Overview 66

Anti-coagulum Cardiac Ablation Catheter – Product Status 66

Anti-coagulum Cardiac Ablation Catheter – Product Description 66

Galvanize Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 67

QuickShot – Product Status 67

QuickShot – Product Description 67

Galvanize Therapeutics Inc – Ongoing Clinical Trials Overview 68

QuickShot – The First Human Use of QuickShot – A Novel Contact-Sensing, Large Area, Focal Pulsed Electric Field Mapping & Ablation Catheter 69

Hansen Medical Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 70

Sensei X Robotic Catheter System – Atrial Fibrillation – Product Status 70

Sensei X Robotic Catheter System – Atrial Fibrillation – Product Description 70

Hyblate Medical Pipeline Products & Ongoing Clinical Trials Overview 71

Hybrid Ablation Catheter – Product Status 71

Hybrid Ablation Catheter – Product Description 71

Imricor Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 72

Vision-MR Ablation Catheter – Product Status 72

Vision-MR Ablation Catheter – Product Description 72

Vision-MR Ablation Catheter 2.0 – Product Status 73

Vision-MR Ablation Catheter 2.0 – Product Description 73

Imricor Medical Systems Inc – Ongoing Clinical Trials Overview 74

Vision-MR Ablation Catheter 2.0 – Vision-MR Ablation Catheter 2.0 for the Treatment of Ventricular Tachycardia 75

Vision-MR Ablation Catheter 2.0 – Vision-MR Ablation Catheter 2.0 for Treatment of Type I Atrial Flutter 75

Interventional Imaging, Inc. Pipeline Products & Ongoing Clinical Trials Overview 76

Atrial Fibrillation Catheter – Product Status 76

Atrial Fibrillation Catheter – Product Description 76

Iowa Approach Inc. Pipeline Products & Ongoing Clinical Trials Overview 77

MaPP-CS – Product Status 77

MaPP-CS – Product Description 77

ROF-AC – Product Status 78

ROF-AC – Product Description 78

ROF-AS – Product Status 78

ROF-AS – Product Description 79

Japan Lifeline Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 80

ALPHA1 Ablation Catheter – Product Status 80

ALPHA1 Ablation Catheter – Product Description 80

Maestro Heart SA Pipeline Products & Ongoing Clinical Trials Overview 81

Maestro-AF Catheter System – Product Status 81

Maestro-AF Catheter System – Product Description 81

Medlumics SL Pipeline Products & Ongoing Clinical Trials Overview 82

AblaView – Product Status 82

AblaView – Product Description 82

MedWaves Inc Pipeline Products & Ongoing Clinical Trials Overview 83

Arrhythmia Catheters – Product Status 83

Arrhythmia Catheters – Product Description 83

MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 84

Circular Ablation Catheter – Product Status 84

Circular Ablation Catheter – Product Description 84

Voyager Irrigated RF Ablation Catheter – Product Status 85

Voyager Irrigated RF Ablation Catheter – Product Description 85

Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 86

Cardiac Catheter – Product Status 86

Cardiac Catheter – Product Description 86

Novasentis Inc Pipeline Products & Ongoing Clinical Trials Overview 87

Electroactive Polymer Based Steerable Catheter – Product Status 87

Electroactive Polymer Based Steerable Catheter – Product Description 87

OrbusNeich Pipeline Products & Ongoing Clinical Trials Overview 88

Ablation Catheter – Product Status 88

Ablation Catheter – Product Description 88

SCR, Inc. Pipeline Products & Ongoing Clinical Trials Overview 89

Atrial Fibrillation Device – Product Status 89

Atrial Fibrillation Device – Product Description 89

Seattle Children’s Hospital Pipeline Products & Ongoing Clinical Trials Overview 90

Ablation Catheter – Heart Arrhythmia – Product Status 90

Ablation Catheter – Heart Arrhythmia – Product Description 90

Shanghai HeartCare Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 91

Cryoablation Catheter – Product Status 91

Cryoablation Catheter – Product Description 91

Shanghai MicroPort EP MedTech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 92

Contact Force-Sensing RF Ablation Catheter – Product Status 92

Contact Force-Sensing RF Ablation Catheter – Product Description 92

Shanghai MicroPort EP MedTech Co Ltd – Ongoing Clinical Trials Overview 93

Contact Force-Sensing RF Ablation Catheter – A Multicenter Clinical Study of Pulsed Electric Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter for the Treatment of Paroxysmal Supraventricular Tachycardia Under the Guidance of Columbus 3D EP Navigation System 94

St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 95

FlexAbility Irrigated Ablation Catheter Sensor Enabled – Monomorphic Ventricular Tachycardia – Product Status 95

FlexAbility Irrigated Ablation Catheter Sensor Enabled – Monomorphic Ventricular Tachycardia – Product Description 95

St. Jude Medical LLC – Ongoing Clinical Trials Overview 96

FlexAbility Irrigated Ablation Catheter Sensor Enabled – Monomorphic Ventricular Tachycardia – Flexability Sensor Enabled Substrate Targeted Ablation for the Reduction of Ventricular Tachycardia (LESS-VT) Study 97

Stereotaxis Inc Pipeline Products & Ongoing Clinical Trials Overview 98

MAGiC Ablation Catheter – Product Status 98

MAGiC Ablation Catheter – Product Description 98

Next Generation Irrigated Magnetic Catheter – Product Status 99

Next Generation Irrigated Magnetic Catheter – Product Description 99

Stereotaxis Inc – Ongoing Clinical Trials Overview 100

MAGiC Ablation Catheter – The MAGiC Cardiac Ablation Feasibility Study 101

University of Arkansas at Little Rock Pipeline Products & Ongoing Clinical Trials Overview 102

Robotic Catheter – Product Status 102

Robotic Catheter – Product Description 102

University of Michigan Pipeline Products & Ongoing Clinical Trials Overview 103

Non-Contact Mapping Catheter – Product Status 103

Non-Contact Mapping Catheter – Product Description 103

University of Rochester Pipeline Products & Ongoing Clinical Trials Overview 104

RF Ablation Catheter – Product Status 104

RF Ablation Catheter – Product Description 104

University of Texas Medical Branch at Galveston Pipeline Products & Ongoing Clinical Trials Overview 105

Ablation Catheter – Product Status 105

Ablation Catheter – Product Description 105

Vanderbilt University Pipeline Products & Ongoing Clinical Trials Overview 106

Temperature Controlled Catheter – Product Status 106

Temperature Controlled Catheter – Product Description 106

Vimecon GmbH Pipeline Products & Ongoing Clinical Trials Overview 107

Vimecon Laser CAI Catheter – Product Status 107

Vimecon Laser CAI Catheter – Product Description 107

Vivonics Inc Pipeline Products & Ongoing Clinical Trials Overview 108

Catheter Guidance System – Product Status 108

Catheter Guidance System – Product Description 108

Voyage Medical (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 109

IRIS Ablation System – Product Status 109

IRIS Ablation System – Product Description 109

Glossary 144

Figures

Electrophysiology Ablation Catheters – Pipeline Products by Stage of Development 14

Electrophysiology Ablation Catheters – Pipeline Products by Segment 15

Electrophysiology Ablation Catheters – Pipeline Products by Territory 16

Electrophysiology Ablation Catheters – Pipeline Products by Regulatory Path 17

Electrophysiology Ablation Catheters – Pipeline Products by Estimated Approval Date 18

Electrophysiology Ablation Catheters – Ongoing Clinical Trials 19

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