Electrophysiology Devices Pipeline by Stages of Development, Segments, Region, Regulatory Path and Key Companies

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Electrophysiology Devices Pipeline Market Report Overview

Electrophysiology equipment analyzes the electrical activity of the heart. The equipment is used with cardiac catheters and sophisticated computers to generate electrocardiogram (EKG) tracings and electrical measurements with exquisite precision from within the heart chambers. RF generators may be used in conjunction with electrophysiology equipment to treat the abnormal impulse generating areas in the heart.

The Electrophysiology Devices pipeline market research report provides comprehensive information about the Electrophysiology Devices pipeline products with comparative analysis of the products at various stages of development and information about the clinical trials which are in progress.

Electrophysiology Devices Pipeline Market Segments

Some of the key segments in the Electrophysiology Devices pipeline market are Electrophysiology Ablation Catheters, Electrophysiology Diagnostic Catheters, Advanced Ablation Catheters, Electrophysiology Lab Systems, Irrigated tip RF Ablation Catheters, Cryoablation Catheters, Intracardiac Echocardiography (ICE) Systems, 3D Mapping Systems, Conventional Radio Frequency Ablation Catheters, and Radiofrequency Ablation Generators. As of April 2023, Electrophysiology Ablation Catheters has the highest number of pipeline products.

Electrophysiology Devices Pipeline Market Analysis, by Segments, 2023 (%)

Electrophysiology Devices Pipeline Market Analysis, by Segments, 2023 (%)

For more segment insights into the Electrophysiology Devices pipeline market, download a free report sample

Electrophysiology Devices Pipeline Market Segmentation by Territories

Some of the key territories in the Electrophysiology Devices pipeline market are the US, China, Europe, Japan, Australia, Israel, Russia, Canada, Macau, and New Zealand. As of April 2023, the US has the highest number of products.

Electrophysiology Devices Pipeline Market Analysis, by Territories, 2023 (%)

Electrophysiology Devices Pipeline Market Analysis, by Territories, 2023 (%)

For more territory insights into the Electrophysiology Devices pipeline market, download a free report sample

Electrophysiology Devices Pipeline Market Segmentation by Regulatory Paths

The key regulatory paths in the Electrophysiology Devices pipeline market are 510(k), NMPA, CE, PMA, TGA, Shonin, Ninsho, MDL, and MDCO. As of April 2023, 510(k) is the most followed pathway for the pipeline products.

Electrophysiology Devices Pipeline Market Analysis, by Regulatory Paths, 2023 (%)

Electrophysiology Devices Pipeline Market Analysis, by Territories, 2023 (%)

For more regulatory path insights into the Electrophysiology Devices pipeline market, download a free report sample

Electrophysiology Devices Pipeline Market – Competitive Landscape

Some of the key companies in the Electrophysiology Devices pipeline market are Ablacon Inc, AccuPulse Medical Technology Co Ltd, Acotec Scientific Co Ltd, Acutus Medical Inc, Apama Medical Inc, APT Medical Inc, AtriCure Inc, Aust Development, LLC, Baylor College of Medicine, and Ben-Gurion University of the Negev.

Ablacon Inc: Ablacon Inc offers AI based atrial fibrillation therapies that visualizes electrographic flow and monitors heart in real time to qualitatively and quantitatively understand and treat atrial fibrillation (AF).

Acutus Medical Inc: Headquartered in Carlsbad, California, the US, Acutus Medical Inc (Acutus Medical) is engaged in providing electrophysiological mapping systems for the treatment of cardiac arrhythmias. It offers various products which include AcQMap system, AcQMap 3D imaging and mapping catheterand AcQGuide steerable sheath. Acutus Medical’s electrofunctional mapping systems provides solutions to diagnose and treat atrial fibrillation. The company products enable physicians to visualize CT-quality scan, map real-time dipole density, and identify infected locations causing arrhythmia.

Electrophysiology Devices Pipeline Market Report Overview

Key Territories The US, China, Europe, Japan, Australia,               Israel, Russia, Canada, Macau, and New Zealand
Key Segments Electrophysiology Ablation Catheters, Electrophysiology Diagnostic Catheters, Advanced Ablation Catheters, Electrophysiology Lab Systems, Irrigated tip RF Ablation Catheters, Cryoablation Catheters, Intracardiac Echocardiography (ICE) Systems, 3D Mapping Systems, Conventional Radio Frequency Ablation Catheters, and Radiofrequency Ablation Generators
Key Regulatory Paths 510(k), NMPA, CE, PMA, TGA, Shonin, Ninsho, MDL, and MDCO

 

Leading Companies Ablacon Inc, AccuPulse Medical Technology Co Ltd, Acotec Scientific Co Ltd, Acutus Medical Inc, Apama Medical Inc, APT Medical Inc, AtriCure Inc, Aust Development, LLC, Baylor College of Medicine, and Ben-Gurion University of the Negev

Segments Covered in the Report

  • Electrophysiology Devices Pipeline Market Segments Outlook
  • Electrophysiology Ablation Catheters
  • Electrophysiology Diagnostic Catheters
  • Advanced Ablation Catheters
  • Electrophysiology Lab Systems
  • Irrigated tip RF Ablation Catheters
  • Cryoablation Catheters
  • Intracardiac Echocardiography (ICE) Systems
  • 3D Mapping Systems
  • Conventional Radio Frequency Ablation Catheters
  • Radiofrequency Ablation Generators
  • Laser Ablation Catheters
  • Steerable Diagnostic Catheters
  • Ultrasound Diagnostic Catheters
  • Standard Ablation Catheters
  • Cardiac Stimulators

Electrophysiology Devices Pipeline Market Territories Outlook

  • The US
  • China
  • Europe
  • Japan
  • Australia
  • Israel
  • Russia
  • Canada
  • Macau
  • New Zealand
  • Hong Kong
  • Thailand

Electrophysiology Devices Pipeline Market Regulatory Paths Outlook

  • 510(k)
  • NMPA
  • CE
  • PMA
  • TGA
  • Shonin
  • Ninsho
  • MDL
  • MDCO

Scope

  • Extensive coverage of the Electrophysiology Devices under development
  • Reviews details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities
  • Reviews the major players involved in the development of Electrophysiology Devices 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
  • 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 Electrophysiology Devices 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

Ablacon Inc
AccuPulse Medical Technology Co Ltd
Acotec Scientific Co Ltd
Acutus Medical Inc
Apama Medical Inc
APT Medical Inc
AtriCure Inc
Aust Development, LLC
Baylor College of Medicine
Ben-Gurion University of the Negev
Berlin Heals GmbH
Biosense Webster Inc
BioSig Technologies Inc
BioTex Inc
Biotronik AG
Biotronik Australia Pty Ltd
Biotronik SE & Co KG
Boston Scientific Corp
Cardima, Inc. (Inactive)
CardioFocus Inc
CardioNova Ltd
CathEffects LLC
catheter precision Inc
CathRx Ltd
CathVision Aps
Cibiem, Inc.
ClearPoint Neuro Inc
Columbia University
Conavi Medical Inc
Cordis Corp
CoreMap Inc
CoRepair, Inc
Corify Care SL
CryoTherapeutics Gmbh
CyberHeart Inc
EPD Solutions Ltd
Epicardial Technologies Inc (Inactive)
EPMap-System GmbH & Co KG
Ethicon US LLC
Eximo Medical Ltd
Farapulse Inc
FocusStart LLC
Fundacion para la Investigacion Biomedica del Hospital Gregorio Maranon
Galvanize Therapeutics Inc
Hansen Medical Inc (Inactive)
Hyblate Medical
Imricor Medical Systems Inc
Interventional Imaging, Inc.
Iowa Approach Inc.
Japan Lifeline Co Ltd
Jiangsu Tingsheng Technology Co Ltd
Johns Hopkins University
King's College London
Koninklijke Philips NV
Lepu Medical Technology (Beijing) Co Ltd
Lepu Scientech Medical Technology (Shanghai) Co Ltd
Maestro Heart SA
MC10 Inc
Medlumics SL
Medtronic Plc
MedWaves Inc
Medyria AG
MicroPort NeuroTech Ltd
MicroPort Scientific Corp
NeuTrace Inc
Northwestern University
Novasentis Inc
OrbusNeich
Philips Healthcare
S4 Medical Corp
SCR, Inc.
Seattle Children's Hospital
Seoul National University Hospital
Shanghai HeartCare Medical Technology Co Ltd
Shanghai MicroPort EP MedTech Co Ltd
ST Cardio Technologies LLC
St. Jude Medical LLC
Stanford University
Stereotaxis Inc
Suzhou Aikemai Medical Technology Co Ltd
Suzhou Bingjing Intelligent Medical Technology Co Ltd
Suzhou Hengruihongyuan Medical Technology Co Ltd
Suzhou Xinmai Medical Equipment Co Ltd
The Cleveland Clinic Foundation
University of Arkansas at Little Rock
University of Auckland
University of Maryland
University of Michigan
University of Rochester
University of Texas Medical Branch at Galveston
University of Utah
Vanderbilt University
Vimecon GmbH
Viscardia Inc
Vivonics Inc
Voyage Medical (Inactive)
Zylox-Tonbridge Medical Technology Co Ltd

Table of Contents

|1 Table of Contents 3

|1.1 List of Tables 8

|1.2 List of Figures 18

2 Introduction 19

2.1 Electrophysiology Devices Overview 19

3 Products under Development 21

3.1 Electrophysiology Devices – Pipeline Products by Stage of Development 21

3.2 Electrophysiology Devices – Pipeline Products by Segment 22

3.3 Electrophysiology Devices – Pipeline Products by Territory 23

3.4 Electrophysiology Devices – Pipeline Products by Regulatory Path 24

3.5 Electrophysiology Devices – Pipeline Products by Estimated Approval Date 25

3.6 Electrophysiology Devices – Ongoing Clinical Trials 26

4 Electrophysiology Devices – Pipeline Products under Development by Companies 27

4.1 Electrophysiology Devices Companies – Pipeline Products by Stage of Development 27

4.2 Electrophysiology Devices – Pipeline Products by Stage of Development 31

5 Electrophysiology Devices Companies and Product Overview 36

5.1 Ablacon Inc Company Overview 36

5.1.1 Ablacon Inc Pipeline Products & Ongoing Clinical Trials Overview 36

5.2 AccuPulse Medical Technology Co Ltd Company Overview 40

5.2.1 AccuPulse Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 40

5.3 Acotec Scientific Co Ltd Company Overview 41

5.3.1 Acotec Scientific Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 41

5.4 Acutus Medical Inc Company Overview 44

5.4.1 Acutus Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 44

5.5 Apama Medical Inc Company Overview 49

5.5.1 Apama Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 49

5.6 APT Medical Inc Company Overview 50

5.6.1 APT Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 50

5.7 AtriCure Inc Company Overview 56

5.7.1 AtriCure Inc Pipeline Products & Ongoing Clinical Trials Overview 56

5.8 Aust Development, LLC Company Overview 57

5.8.1 Aust Development, LLC Pipeline Products & Ongoing Clinical Trials Overview 57

5.9 Baylor College of Medicine Company Overview 58

5.9.1 Baylor College of Medicine Pipeline Products & Ongoing Clinical Trials Overview 58

5.10 Ben-Gurion University of the Negev Company Overview 59

5.10.1 Ben-Gurion University of the Negev Pipeline Products & Ongoing Clinical Trials Overview 59

5.11 Berlin Heals GmbH Company Overview 60

5.11.1 Berlin Heals GmbH Pipeline Products & Ongoing Clinical Trials Overview 60

5.12 Biosense Webster Inc Company Overview 63

5.12.1 Biosense Webster Inc Pipeline Products & Ongoing Clinical Trials Overview 63

5.13 BioSig Technologies Inc Company Overview 73

5.13.1 BioSig Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 73

5.14 BioTex Inc Company Overview 78

5.14.1 BioTex Inc Pipeline Products & Ongoing Clinical Trials Overview 78

5.15 Biotronik AG Company Overview 79

5.15.1 Biotronik AG Pipeline Products & Ongoing Clinical Trials Overview 79

5.16 Biotronik Australia Pty Ltd Company Overview 83

5.16.1 Biotronik Australia Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 83

5.17 Biotronik SE & Co KG Company Overview 86

5.17.1 Biotronik SE & Co KG Pipeline Products & Ongoing Clinical Trials Overview 86

5.18 Boston Scientific Corp Company Overview 87

5.18.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 87

5.19 Cardima, Inc. (Inactive) Company Overview 97

5.19.1 Cardima, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 97

5.20 CardioFocus Inc Company Overview 99

5.20.1 CardioFocus Inc Pipeline Products & Ongoing Clinical Trials Overview 99

5.21 CardioNova Ltd Company Overview 102

5.21.1 CardioNova Ltd Pipeline Products & Ongoing Clinical Trials Overview 102

5.22 CathEffects LLC Company Overview 103

5.22.1 CathEffects LLC Pipeline Products & Ongoing Clinical Trials Overview 103

5.23 catheter precision Inc Company Overview 104

5.23.1 catheter precision Inc Pipeline Products & Ongoing Clinical Trials Overview 104

5.24 CathRx Ltd Company Overview 105

5.24.1 CathRx Ltd Pipeline Products & Ongoing Clinical Trials Overview 105

5.25 CathVision Aps Company Overview 108

5.25.1 CathVision Aps Pipeline Products & Ongoing Clinical Trials Overview 108

5.26 Cibiem, Inc. Company Overview 111

5.26.1 Cibiem, Inc. Pipeline Products & Ongoing Clinical Trials Overview 111

5.27 ClearPoint Neuro Inc Company Overview 112

5.27.1 ClearPoint Neuro Inc Pipeline Products & Ongoing Clinical Trials Overview 112

5.28 Columbia University Company Overview 114

5.28.1 Columbia University Pipeline Products & Ongoing Clinical Trials Overview 114

5.29 Conavi Medical Inc Company Overview 115

5.29.1 Conavi Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 115

5.30 Cordis Corp Company Overview 118

5.30.1 Cordis Corp Pipeline Products & Ongoing Clinical Trials Overview 118

5.31 CoreMap Inc Company Overview 120

5.31.1 CoreMap Inc Pipeline Products & Ongoing Clinical Trials Overview 120

5.32 CoRepair, Inc Company Overview 121

5.32.1 CoRepair, Inc Pipeline Products & Ongoing Clinical Trials Overview 121

5.33 Corify Care SL Company Overview 122

5.33.1 Corify Care SL Pipeline Products & Ongoing Clinical Trials Overview 122

5.34 CryoTherapeutics Gmbh Company Overview 125

5.34.1 CryoTherapeutics Gmbh Pipeline Products & Ongoing Clinical Trials Overview 125

5.35 CyberHeart Inc Company Overview 128

5.35.1 CyberHeart Inc Pipeline Products & Ongoing Clinical Trials Overview 128

5.36 EPD Solutions Ltd Company Overview 131

5.36.1 EPD Solutions Ltd Pipeline Products & Ongoing Clinical Trials Overview 131

5.37 Epicardial Technologies Inc (Inactive) Company Overview 134

5.37.1 Epicardial Technologies Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 134

5.38 EPMap-System GmbH & Co KG Company Overview 135

5.38.1 EPMap-System GmbH & Co KG Pipeline Products & Ongoing Clinical Trials Overview 135

5.39 Ethicon US LLC Company Overview 137

5.39.1 Ethicon US LLC Pipeline Products & Ongoing Clinical Trials Overview 137

5.40 Eximo Medical Ltd Company Overview 138

5.40.1 Eximo Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 138

5.41 Farapulse Inc Company Overview 139

5.41.1 Farapulse Inc Pipeline Products & Ongoing Clinical Trials Overview 139

5.42 FocusStart LLC Company Overview 142

5.42.1 FocusStart LLC Pipeline Products & Ongoing Clinical Trials Overview 142

5.43 Fundacion para la Investigacion Biomedica del Hospital Gregorio Maranon Company Overview 143

5.43.1 Fundacion para la Investigacion Biomedica del Hospital Gregorio Maranon Pipeline Products & Ongoing Clinical Trials Overview 143

5.44 Galvanize Therapeutics Inc Company Overview 144

5.44.1 Galvanize Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 144

5.45 Hansen Medical Inc (Inactive) Company Overview 147

5.45.1 Hansen Medical Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 147

5.46 Hyblate Medical Company Overview 149

5.46.1 Hyblate Medical Pipeline Products & Ongoing Clinical Trials Overview 149

5.47 Imricor Medical Systems Inc Company Overview 150

5.47.1 Imricor Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 150

5.48 Interventional Imaging, Inc. Company Overview 156

5.48.1 Interventional Imaging, Inc. Pipeline Products & Ongoing Clinical Trials Overview 156

5.49 Iowa Approach Inc. Company Overview 157

5.49.1 Iowa Approach Inc. Pipeline Products & Ongoing Clinical Trials Overview 157

5.50 Japan Lifeline Co Ltd Company Overview 160

5.50.1 Japan Lifeline Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 160

5.51 Jiangsu Tingsheng Technology Co Ltd Company Overview 162

5.51.1 Jiangsu Tingsheng Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 162

5.52 Johns Hopkins University Company Overview 165

5.52.1 Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 165

5.53 King’s College London Company Overview 166

5.53.1 King’s College London Pipeline Products & Ongoing Clinical Trials Overview 166

5.54 Koninklijke Philips NV Company Overview 167

5.54.1 Koninklijke Philips NV Pipeline Products & Ongoing Clinical Trials Overview 167

5.55 Lepu Medical Technology (Beijing) Co Ltd Company Overview 168

5.55.1 Lepu Medical Technology (Beijing) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 168

5.56 Lepu Scientech Medical Technology (Shanghai) Co Ltd Company Overview 169

5.56.1 Lepu Scientech Medical Technology (Shanghai) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 169

5.57 Maestro Heart SA Company Overview 170

5.57.1 Maestro Heart SA Pipeline Products & Ongoing Clinical Trials Overview 170

5.58 MC10 Inc Company Overview 171

5.58.1 MC10 Inc Pipeline Products & Ongoing Clinical Trials Overview 171

5.59 Medlumics SL Company Overview 172

5.59.1 Medlumics SL Pipeline Products & Ongoing Clinical Trials Overview 172

5.60 Medtronic Plc Company Overview 173

5.60.1 Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 173

5.61 MedWaves Inc Company Overview 179

5.61.1 MedWaves Inc Pipeline Products & Ongoing Clinical Trials Overview 179

5.62 Medyria AG Company Overview 180

5.62.1 Medyria AG Pipeline Products & Ongoing Clinical Trials Overview 180

5.63 MicroPort NeuroTech Ltd Company Overview 181

5.63.1 MicroPort NeuroTech Ltd Pipeline Products & Ongoing Clinical Trials Overview 181

5.64 MicroPort Scientific Corp Company Overview 182

5.64.1 MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 182

5.65 NeuTrace Inc Company Overview 185

5.65.1 NeuTrace Inc Pipeline Products & Ongoing Clinical Trials Overview 185

5.66 Northwestern University Company Overview 188

5.66.1 Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 188

5.67 Novasentis Inc Company Overview 189

5.67.1 Novasentis Inc Pipeline Products & Ongoing Clinical Trials Overview 189

5.68 OrbusNeich Company Overview 190

5.68.1 OrbusNeich Pipeline Products & Ongoing Clinical Trials Overview 190

5.69 Philips Healthcare Company Overview 192

5.69.1 Philips Healthcare Pipeline Products & Ongoing Clinical Trials Overview 192

5.70 S4 Medical Corp Company Overview 193

5.70.1 S4 Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 193

5.71 SCR, Inc. Company Overview 194

5.71.1 SCR, Inc. Pipeline Products & Ongoing Clinical Trials Overview 194

5.72 Seattle Children’s Hospital Company Overview 195

5.72.1 Seattle Children’s Hospital Pipeline Products & Ongoing Clinical Trials Overview 195

5.73 Seoul National University Hospital Company Overview 196

5.73.1 Seoul National University Hospital Pipeline Products & Ongoing Clinical Trials Overview 196

5.74 Shanghai HeartCare Medical Technology Co Ltd Company Overview 197

5.74.1 Shanghai HeartCare Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 197

5.75 Shanghai MicroPort EP MedTech Co Ltd Company Overview 198

5.75.1 Shanghai MicroPort EP MedTech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 198

5.76 ST Cardio Technologies LLC Company Overview 203

5.76.1 ST Cardio Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 203

5.77 St. Jude Medical LLC Company Overview 204

5.77.1 St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 204

5.78 Stanford University Company Overview 208

5.78.1 Stanford University Pipeline Products & Ongoing Clinical Trials Overview 208

5.79 Stereotaxis Inc Company Overview 209

5.79.1 Stereotaxis Inc Pipeline Products & Ongoing Clinical Trials Overview 209

5.80 Suzhou Aikemai Medical Technology Co Ltd Company Overview 212

5.80.1 Suzhou Aikemai Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 212

5.81 Suzhou Bingjing Intelligent Medical Technology Co Ltd Company Overview 213

5.81.1 Suzhou Bingjing Intelligent Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 213

5.82 Suzhou Hengruihongyuan Medical Technology Co Ltd Company Overview 216

5.82.1 Suzhou Hengruihongyuan Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 216

5.83 Suzhou Xinmai Medical Equipment Co Ltd Company Overview 219

5.83.1 Suzhou Xinmai Medical Equipment Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 219

5.84 The Cleveland Clinic Foundation Company Overview 220

5.84.1 The Cleveland Clinic Foundation Pipeline Products & Ongoing Clinical Trials Overview 220

5.85 University of Arkansas at Little Rock Company Overview 221

5.85.1 University of Arkansas at Little Rock Pipeline Products & Ongoing Clinical Trials Overview 221

5.86 University of Auckland Company Overview 222

5.86.1 University of Auckland Pipeline Products & Ongoing Clinical Trials Overview 222

5.87 University of Maryland Company Overview 223

5.87.1 University of Maryland Pipeline Products & Ongoing Clinical Trials Overview 223

5.88 University of Michigan Company Overview 224

5.88.1 University of Michigan Pipeline Products & Ongoing Clinical Trials Overview 224

5.89 University of Rochester Company Overview 225

5.89.1 University of Rochester Pipeline Products & Ongoing Clinical Trials Overview 225

5.90 University of Texas Medical Branch at Galveston Company Overview 226

5.90.1 University of Texas Medical Branch at Galveston Pipeline Products & Ongoing Clinical Trials Overview 226

5.91 University of Utah Company Overview 227

5.91.1 University of Utah Pipeline Products & Ongoing Clinical Trials Overview 227

5.92 Vanderbilt University Company Overview 228

5.92.1 Vanderbilt University Pipeline Products & Ongoing Clinical Trials Overview 228

5.93 Vimecon GmbH Company Overview 229

5.93.1 Vimecon GmbH Pipeline Products & Ongoing Clinical Trials Overview 229

5.94 Viscardia Inc Company Overview 230

5.94.1 Viscardia Inc Pipeline Products & Ongoing Clinical Trials Overview 230

5.95 Vivonics Inc Company Overview 233

5.95.1 Vivonics Inc Pipeline Products & Ongoing Clinical Trials Overview 233

5.96 Voyage Medical (Inactive) Company Overview 234

5.96.1 Voyage Medical (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 234

5.97 Zylox-Tonbridge Medical Technology Co Ltd Company Overview 235

5.97.1 Zylox-Tonbridge Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 235

6 Electrophysiology Devices- Recent Developments 236

6.1 Apr 12, 2023: Medtronic has a layoff in California 236

6.2 Apr 06, 2023: Merit Medical Systems to Announce First Quarter 2023 Results on April 26, 2023 236

6.3 Mar 30, 2023: Integer Schedules First Quarter 2023 Earnings Release and Conference Call for April 27, 2023 236

6.4 Mar 16, 2023: Medtronic joins in $25M funding round for home monitoring company 237

6.5 Mar 02, 2023: Researchers suggest novel cutpoints for diagnosing cardiac hypertrophy in adolescents and young adults 237

6.6 Feb 23, 2023: Us2.ai to deliver AI-enabled echocardiography decision support to Brigham and Women’s Hospital’s Cardiac Imaging Core Laboratory 238

6.7 Feb 16, 2023: Integer Holdings Reports Results for Fourth Quarter and Full Year 2022 238

6.8 Feb 03, 2023: Merit Medical Systems to Announce Fourth Quarter and Year End 2022 Results and Issue Fiscal Year 2023 Guidance on February 22, 2023 241

6.9 Feb 01, 2023: Japan Lifeline Announces Consolidated Financial Results for the Nine months Ended December 31, 2022 241

6.10 Jan 30, 2023: GE HealthCare Reports Fourth Quarter and Full Year 2022 Financial Results 242

6.11 Jan 17, 2023: GE HealthCare to Announce Fourth Quarter and Full Year 2022 Results on January 30, 2023 245

6.12 Jan 10, 2023: GE HealthCare Announces Preliminary Fourth Quarter and Full Year 2022 Revenue Results; Introduces 2023 Outlook 245

6.13 Jan 05, 2023: GE HealthCare appoints former Amazon exec as first chief technology officer 246

6.14 Dec 20, 2022: AtriCure to Participate in the 41st Annual J.P. Morgan Healthcare Conference 246

6.15 Nov 23, 2022: Medtronic Reports Quarterly Earnings 246

6.16 Nov 22, 2022: Medtronic reports second quarter fiscal 2023 financial results 246

6.17 Nov 22, 2022: Mayo Clinic surgeon takes the wheel as Kwik Trip’s new CEO 252

6.18 Nov 15, 2022: Medtronic Set to Announce Earnings on Tuesday 252

6.19 Nov 07, 2022: OxSonics Therapeutics announces Jerome Marzinski Appointed as Chief Executive Officer 252

6.20 Nov 07, 2022: National study suggests it’s time to rethink how we treat atrial fibrillation 253

6.21 Oct 27, 2022: Integer Holdings Reports Third Quarter 2022 Results 254

6.22 Oct 13, 2022: Merit Medical Systems to Announce Third Quarter Results on October 26, 2022 255

6.23 Oct 11, 2022: AtriCure to Announce Third Quarter 2022 Financial Results 256

6.24 Sep 30, 2022: Natalie Caine named chief administrative officer at Mayo Clinic in Rochester 256

6.25 Sep 27, 2022: Catheter Precision names Fatih Ayoglu as Business Development Manager—EMEA 256

6.26 Sep 23, 2022: Mentice receives an order of USD 620,000 for simulation solutions and development services 257

6.27 Sep 07, 2022: Medtronic to appear at September investor conferences 257

6.28 Aug 23, 2022: Medtronic reports first quarter fiscal 2023 financial results 257

6.29 Aug 23, 2022: Medtronic Announces Quarterly Earnings Results 260

6.30 Aug 16, 2022: AtriCure to Participate in the Morgan Stanley 20th Annual Global Healthcare Conference 263

6.31 Aug 16, 2022: Boston Scientific Announces Upcoming Conference Schedule 263

6.32 Aug 08, 2022: ClearPoint Neuro Announces Appointment of Mary McNamara-Cullinane as Vice President of Regulatory Affairs 263

6.33 Aug 03, 2022: Harvard Bioscience Announces Second Quarter 2022 Financial Results 264

6.34 Aug 02, 2022: AtriCure Reports Second Quarter 2022 Financial Results 264

6.35 Jul 28, 2022: Integer Holdings Reports Second Quarter 2022 Results 265

6.36 Jul 27, 2022: Merit Medical Reports Results for Quarter Ended June 30, 2022 266

6.37 Jul 20, 2022: AtriCure to Participate at Upcoming Investor Conferences 267

6.38 Jul 14, 2022: Merit Medical Systems to Announce Second Quarter Results on July 27, 2022 268

6.39 Jul 12, 2022: AtriCure to Announce Second Quarter 2022 Financial Results 268

6.40 Jul 08, 2022: Cordis Names Bryan Loo President of Asia-pacific Region 268

6.41 Jun 28, 2022: Japan Lifeline Co. Notice of Resolution of the 42nd Annual General Meeting of Shareholders 269

6.42 Jun 27, 2022: Medtronic Board appoints Lidia Fonseca as a new director 270

6.43 Jun 23, 2022: Cleveland Clinic Appoints Alex A. Adjei, M.D., Ph.D., as Chair of Taussig Cancer Institute 270

6.44 Jun 01, 2022: AtriCure Announces the Appointment of Deborah Yount as Chief Human Resources Officer 271

6.45 May 27, 2022: Medtronic reports full year and fourth quarter fiscal year 2022 financial results 272

6.46 May 26, 2022: Medtronic reports full year and fourth quarter fiscal year 2022 financial results announces 8% dividend increase 272

6.47 May 10, 2022: Stereotaxis Reports 2022 First Quarter Financial Results 272

6.48 May 04, 2022: Harvard Bioscience Announces First Quarter 2022 Financial Results 273

7 Appendix 275

7.1 Methodology 275

7.2 About GlobalData 278

7.3 Contact Us 278

7.4 Disclaimer 278

Table

Electrophysiology Devices – Pipeline Products by Stage of Development 21

Electrophysiology Devices – Pipeline Products by Segment 22

Electrophysiology Devices – Pipeline Products by Territory 23

Electrophysiology Devices – Pipeline Products by Regulatory Path 24

Electrophysiology Devices – Pipeline Products by Estimated Approval Date 25

Electrophysiology Devices – Ongoing Clinical Trials 26

Electrophysiology Devices Companies – Pipeline Products by Stage of Development 27

Electrophysiology Devices – Pipeline Products by Stage of Development 31

Ablacon Inc Pipeline Products & Ongoing Clinical Trials Overview 36

Ablamap System – Product Status 36

Ablamap System – Product Description 36

Ablasense – Product Status 37

Ablasense – Product Description 37

Ablacon Inc – Ongoing Clinical Trials Overview 38

Ablamap System – A Randomized Controlled Study to Evaluate the Reliability of the Ablacon Electrographic FLOW (EGF) Algorithm Technology (Ablamap Software) to Identify AF Sources and Guide Ablation Therapy in Patients with Persistent Atrial Fibrillation 39

AccuPulse Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 40

3D Cardiac Electroanatomic Mapping System – Product Status 40

3D Cardiac Electroanatomic Mapping System – Product Description 40

Acotec Scientific Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 41

ERA-C30 Endovenous Radiofrequency Closure Catheter – Product Status 41

ERA-C30 Endovenous Radiofrequency Closure Catheter – Product Description 41

ERA-C70 Endovenous Radiofrequency Closure Catheter – Product Status 42

ERA-C70 Endovenous Radiofrequency Closure Catheter – Product Description 42

ERA-G5 Endovenous Radiofrequency Closure Generator – Product Status 42

ERA-G5 Endovenous Radiofrequency Closure Generator – Product Description 43

Acutus Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 44

AcQBlate Force Sensing Ablation System – Product Status 44

AcQBlate Force Sensing Ablation System – Product Description 45

AcQMap 3.0 Contact Mapping Catheter – Product Status 45

AcQMap 3.0 Contact Mapping Catheter – Product Description 45

VT Mapping Catheter – Product Status 46

VT Mapping Catheter – Product Description 46

Acutus Medical Inc – Ongoing Clinical Trials Overview 47

AcQBlate Force Sensing Ablation System – Acqblate Force Sensing Ablation System EU Study for Atrial Fibrillation (AcQForce AF-EU) 48

AcQBlate Force Sensing Ablation System – AcQBlate Force Sensing Ablation System US IDE Study for Atrial Fibrillation (AcQForce AF) 48

Apama Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 49

LUMINIZE Radiofrequency (RF) Balloon Catheter – Product Status 49

LUMINIZE Radiofrequency (RF) Balloon Catheter – Product Description 49

APT Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 50

3D Cardiac Electrophysiological Mapping System – Product Status 50

3D Cardiac Electrophysiological Mapping System – Product Description 51

High Integration Electrophysiological Recording System – Product Status 51

High Integration Electrophysiological Recording System – Product Description 51

Magnetic Positioning Pressure Sensing Radiofrequency Ablation Catheter – Product Status 52

Magnetic Positioning Pressure Sensing Radiofrequency Ablation Catheter – Product Description 52

Magnetoelectric Positioning High-density Mapping Catheter – Product Status 52

Magnetoelectric Positioning High-density Mapping Catheter – Product Description 52

Magnetoelectric Positioning Ring Mapping Catheter – Product Status 53

Magnetoelectric Positioning Ring Mapping Catheter – Product Description 53

Pressure Sensing Ablation Catheter – Product Status 53

Pressure Sensing Ablation Catheter – Product Description 54

Pressure Sensing Pulse Cancellation Fusion Catheter – Product Status 54

Pressure Sensing Pulse Cancellation Fusion Catheter – Product Description 54

RF Ablation Device with Pressure Sensing – Product Status 55

RF Ablation Device with Pressure Sensing – Product Description 55

AtriCure Inc Pipeline Products & Ongoing Clinical Trials Overview 56

Next Generation RF Generator – Product Status 56

Next Generation RF Generator – Product Description 56

Aust Development, LLC Pipeline Products & Ongoing Clinical Trials Overview 57

Endovascular Cardiac Optical Mapping Device – Product Status 57

Endovascular Cardiac Optical Mapping Device – Product Description 57

Baylor College of Medicine Pipeline Products & Ongoing Clinical Trials Overview 58

Catheter-Based Electrophysiological Imaging System – Product Status 58

Catheter-Based Electrophysiological Imaging System – Product Description 58

Ben-Gurion University of the Negev Pipeline Products & Ongoing Clinical Trials Overview 59

Excitation Wave Cancellation Device – Product Status 59

Excitation Wave Cancellation Device – Product Description 59

Berlin Heals GmbH Pipeline Products & Ongoing Clinical Trials Overview 60

C-MIC Device – Product Status 60

C-MIC Device – Product Description 60

Berlin Heals GmbH – Ongoing Clinical Trials Overview 61

C-MIC Device – Early Feasibility Study of C-MIC Heart Failure Device 62

C-MIC Device – Prospective, Randomized, Open, Comparison Study to Demonstrate the Performance and the Safety of Cardiac Microcurrent Therapy (C-MIC) System 62

C-MIC Device – The C-MIC-II Follow-Up Study 62

Biosense Webster Inc Pipeline Products & Ongoing Clinical Trials Overview 63

CARTO 4 – Product Status 63

CARTO 4 – Product Description 63

CARTO SMARTTOUCH 5D Catheter – Product Status 64

CARTO SMARTTOUCH 5D Catheter – Product Description 64

Heliostar Multi-Electrode Radiofrequency Balloon Ablation Catheter – Product Status 64

Heliostar Multi-Electrode Radiofrequency Balloon Ablation Catheter – Product Description 65

Navigation Guided Deflectable Sheath – Product Status 65

Navigation Guided Deflectable Sheath – Product Description 65

THERMOCOOL SMARTTOUCH SF-5D Catheter – Product Status 66

THERMOCOOL SMARTTOUCH SF-5D Catheter – Product Description 66

TRUPULSE Generator – Product Status 66

TRUPULSE Generator – Product Description 67

Biosense Webster Inc – Ongoing Clinical Trials Overview 68

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 69

CARTO SMARTTOUCH 5D Catheter – Ground-Breaking Electroporation-based Intervention for PERSistent Atrial Fibrillation Treatment (BEAT PERS-AF) 70

THERMOCOOL SMARTTOUCH SF-5D Catheter – Evaluation of the Safety and Performance of the Very High Power-short Duration QDOT Strategy in Patients Referred for Atrial Fibrillation Ablation 71

TRUPULSE Generator – Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System (AdmIRE) 72

TRUPULSE Generator – Pulsed Field Ablation (PFA) System for the Treatment of Paroxysmal Atrial Fibrillation (PAF) by Irreversible Electroporation (IRE) 72

TRUPULSE Generator – Safety and Effectiveness Evaluation of the THERMOCOOL SMARTTOUCH SF Catheter With the TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF) 72

BioSig Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 73

PURE EP System – Product Status 73

PURE EP System – Product Description 74

PURE EP Version 2.0 – Product Status 74

PURE EP Version 2.0 – Product Description 74

PURE EP Version 3.0 – Product Status 75

PURE EP Version 3.0 – Product Description 75

BioSig Technologies Inc – Ongoing Clinical Trials Overview 76

PURE EP System – To Assess the Efficacy Rate of Unipolar Polarity Switch for Lesion Assessment in Pulmonary Vein Isolation 77

PURE EP System – To Assess the Predictive Value of High Frequency Algorithm of PURE EP for Low Amplitude Signal Detection 77

PURE EP System – Validation of Safety and efficacy of the PURE EP System During Mapping and Ablation Procedures in Cardiac EP lab 77

BioTex Inc Pipeline Products & Ongoing Clinical Trials Overview 78

Cooled Tip Catheter – Product Status 78

Cooled Tip Catheter – Product Description 78

Biotronik AG Pipeline Products & Ongoing Clinical Trials Overview 79

Amvia Edge – Product Status 79

Amvia Edge – Product Description 79

Amvia Sky – Product Status 80

Amvia Sky – Product Description 80

Truvia – Product Status 80

Truvia – Product Description 80

Biotronik AG – Ongoing Clinical Trials Overview 81

Amvia Sky – BIO|CONCEPT.Amvia, First in Human Study for the Amvia/Solvia Pacemaker Family 82

Biotronik Australia Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 83

ElePulse System – Product Status 83

ElePulse System – Product Description 83

Biotronik Australia Pty Ltd – Ongoing Clinical Trials Overview 84

ElePulse System – Rapid One-Shot Electroporation Trial For Atrial Fibrillation: Reset-AF: Investigating the Effect of A Novel Intervention on Atrial Fibrillation Recurrence 85

Biotronik SE & Co KG Pipeline Products & Ongoing Clinical Trials Overview 86

SentiCath – Product Status 86

SentiCath – Product Description 86

Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 87

Intellagen – Product Status 87

Intellagen – Product Description 88

Intellanav Stablepoint – Product Status 88

Intellanav Stablepoint – Product Description 88

LabSystem Pro NextGen – Product Status 89

LabSystem Pro NextGen – Product Description 89

Lesion Assessment Device – Product Status 89

Lesion Assessment Device – Product Description 89

Next Generation Blazer Catheter – Product Status 90

Next Generation Blazer Catheter – Product Description 90

Next Generation IntellaTip Catheter – Product Status 90

Next Generation IntellaTip Catheter – Product Description 91

OI System – Product Status 91

OI System – Product Description 91

POLARx Next Generation Catheter – Product Status 92

POLARx Next Generation Catheter – Product Description 92

POLARx Single Shot Cryoballoon – Product Status 92

POLARx Single Shot Cryoballoon – Product Description 93

Rhythmia 5.0 – Product Status 93

Rhythmia 5.0 – Product Description 93

Boston Scientific Corp – Ongoing Clinical Trials Overview 94

Intellanav Stablepoint – Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation 95

POLARx Single Shot Cryoballoon – Comparison of the PolarX and the Arctic Front Cryoballoon for Pulmonary Vein Isolation in Patients with Symptomatic Paroxysmal Atrial Fibrillation – A Multi-center Non-inferiority Design Clinical Trial 96

POLARx Single Shot Cryoballoon – Safety and Effectiveness IDE Trial for Boston Scientific’s Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation 96

Cardima, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 97

Cadence EPL – Product Status 97

Cadence EPL – Product Description 97

EP Ablation System – Product Status 98

EP Ablation System – Product Description 98

CardioFocus Inc Pipeline Products & Ongoing Clinical Trials Overview 99

HeartLight X3 System – Product Status 99

HeartLight X3 System – Product Description 99

CardioFocus Inc – Ongoing Clinical Trials Overview 100

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 101

CardioNova Ltd Pipeline Products & Ongoing Clinical Trials Overview 102

Electrophysiology Catheter – Atrial Fibrillation – Product Status 102

Electrophysiology Catheter – Atrial Fibrillation – Product Description 102

CathEffects LLC Pipeline Products & Ongoing Clinical Trials Overview 103

Desai VectorCathRF1 Mapping And Ablation Catheter – Product Status 103

Desai VectorCathRF1 Mapping And Ablation Catheter – Product Description 103

catheter precision Inc Pipeline Products & Ongoing Clinical Trials Overview 104

Second Generation Amigo – Product Status 104

Second Generation Amigo – Product Description 104

CathRx Ltd Pipeline Products & Ongoing Clinical Trials Overview 105

CathRx 4mm Therapeutic Catheter – Product Status 105

CathRx 4mm Therapeutic Catheter – Product Description 105

CathRx 8mm Therapeutic Catheter – Product Status 106

CathRx 8mm Therapeutic Catheter – Product Description 106

Khelix Irrigated Ablation EP Catheter – Product Status 106

Khelix Irrigated Ablation EP Catheter – Product Description 107

Khelix Non-Irrigated Ablation EP Catheter – Product Status 107

Khelix Non-Irrigated Ablation EP Catheter – Product Description 107

CathVision Aps Pipeline Products & Ongoing Clinical Trials Overview 108

CathVision ECGenius System – Product Status 108

CathVision ECGenius System – Product Description 108

CathVision Aps – Ongoing Clinical Trials Overview 109

CathVision ECGenius System – A Prospective Single Center Pilot Study Using the ECGenius System to Collect Electrogram Data to Test an Ablation Impact Algorithm 110

CathVision ECGenius System – A Prospective, Single-Center, Open-Label, Single-Arm Study to Evaluate the Safety and Technical Performance of the CathVision ECGenius System 110

CathVision ECGenius System – The Automated Calculation of AF Cycle Length and Complexity Using a Novel EP Recording System (The CathVision ECGenius System) 110

Cibiem, Inc. Pipeline Products & Ongoing Clinical Trials Overview 111

Catheter-Based Carotid Body Ablation System – Product Status 111

Catheter-Based Carotid Body Ablation System – Product Description 111

ClearPoint Neuro Inc Pipeline Products & Ongoing Clinical Trials Overview 112

ClearTrace Cardiac Intervention System – Product Status 112

ClearTrace Cardiac Intervention System – Product Description 113

Columbia University Pipeline Products & Ongoing Clinical Trials Overview 114

Optically-Integrated RFA Catheter – Product Status 114

Optically-Integrated RFA Catheter – Product Description 114

Conavi Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 115

Foresight Intracardiac Echocardiograph System – Product Status 115

Foresight Intracardiac Echocardiograph System – Product Description 115

Conavi Medical Inc – Ongoing Clinical Trials Overview 116

Foresight Intracardiac Echocardiograph System – Visualization of Human Cardiovascular Anatomy with Foresight Intracardiac Echocardiography (ICE) System 117

Cordis Corp Pipeline Products & Ongoing Clinical Trials Overview 118

EP Contact Force Sensing Catheter Enabled By CARTO 3 – Product Status 118

EP Contact Force Sensing Catheter Enabled By CARTO 3 – Product Description 118

EP Lesion Assessment Device – Product Status 119

EP Lesion Assessment Device – Product Description 119

CoreMap Inc Pipeline Products & Ongoing Clinical Trials Overview 120

Electrophysiology Mapping System – Atrial Fibrillation – Product Status 120

Electrophysiology Mapping System – Atrial Fibrillation – Product Description 120

CoRepair, Inc Pipeline Products & Ongoing Clinical Trials Overview 121

Radiofrequency Device – Product Status 121

Radiofrequency Device – Product Description 121

Corify Care SL Pipeline Products & Ongoing Clinical Trials Overview 122

Acorys – Product Status 122

Acorys – Product Description 122

Corify Care SL – Ongoing Clinical Trials Overview 123

Acorys – Non-invasive Tool to Assess Electrophysiological Mechanisms in Cardiac Arrhythmias (SAVE-COR) 124

CryoTherapeutics Gmbh Pipeline Products & Ongoing Clinical Trials Overview 125

Cryotherapy System – Coronary Artery Disease – Product Status 125

Cryotherapy System – Coronary Artery Disease – Product Description 125

CryoTherapeutics Gmbh – Ongoing Clinical Trials Overview 126

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 127

CyberHeart Inc Pipeline Products & Ongoing Clinical Trials Overview 128

CyberHeart System – Product Status 128

CyberHeart System – Product Description 128

CyberHeart Inc – Ongoing Clinical Trials Overview 129

CyberHeart System – CyberHeart’s Cardiac Arrhythmia Ablation Treatment: Patients with Refractory Ventricular Tachycardia 130

EPD Solutions Ltd Pipeline Products & Ongoing Clinical Trials Overview 131

KODEX-EPD System – Balloon Visualization – Product Status 131

KODEX-EPD System – Balloon Visualization – Product Description 131

EPD Solutions Ltd – Ongoing Clinical Trials Overview 132

KODEX-EPD System – Balloon Visualization – Prospective Procedural Data Collection for Continuous Improvement of the KODEX – EPD System Performance 133

Epicardial Technologies Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 134

Epicardial Access Device – Product Status 134

Epicardial Access Device – Product Description 134

EPMap-System GmbH & Co KG Pipeline Products & Ongoing Clinical Trials Overview 135

EP Map System – Product Status 135

EP Map System – Product Description 136

Ethicon US LLC Pipeline Products & Ongoing Clinical Trials Overview 137

Next Generation Ablation Catheter – Product Status 137

Next Generation Ablation Catheter – Product Description 137

Eximo Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 138

AURYON Atherectomy System – CAD – Product Status 138

AURYON Atherectomy System – CAD – Product Description 138

Farapulse Inc Pipeline Products & Ongoing Clinical Trials Overview 139

FARAFLEX – Product Status 139

FARAFLEX – Product Description 139

FARAONE – Product Status 140

FARAONE – Product Description 140

FARAPOINT – Product Status 140

FARAPOINT – Product Description 141

Next Gen FARAWAVE Catheter – Product Status 141

Next Gen FARAWAVE Catheter – Product Description 141

FocusStart LLC Pipeline Products & Ongoing Clinical Trials Overview 142

Anti-coagulum Cardiac Ablation Catheter – Product Status 142

Anti-coagulum Cardiac Ablation Catheter – Product Description 142

Fundacion para la Investigacion Biomedica del Hospital Gregorio Maranon Pipeline Products & Ongoing Clinical Trials Overview 143

Fibrillation Catheter – Product Status 143

Fibrillation Catheter – Product Description 143

Galvanize Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 144

QuickShot – Product Status 144

QuickShot – Product Description 144

Galvanize Therapeutics Inc – Ongoing Clinical Trials Overview 145

QuickShot – The First Human Use of QuickShot – A Novel Contact-Sensing, Large Area, Focal Pulsed Electric Field Mapping & Ablation Catheter 146

Hansen Medical Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 147

Sensei Robotic Catheter System – Percutaneous Aortic Valve Replacement – Product Status 147

Sensei Robotic Catheter System – Percutaneous Aortic Valve Replacement – Product Description 147

Sensei X Robotic Catheter System – Atrial Fibrillation – Product Status 148

Sensei X Robotic Catheter System – Atrial Fibrillation – Product Description 148

Hyblate Medical Pipeline Products & Ongoing Clinical Trials Overview 149

Hybrid Ablation Catheter – Product Status 149

Hybrid Ablation Catheter – Product Description 149

Imricor Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 150

Advantage-MR EP Recorder/Stimulator System – Product Status 150

Advantage-MR EP Recorder/Stimulator System – Product Description 151

Vision-MR Ablation Catheter – Product Status 151

Vision-MR Ablation Catheter – Product Description 151

Vision-MR Ablation Catheter 2.0 – Product Status 152

Vision-MR Ablation Catheter 2.0 – Product Description 152

Vision-MR Diagnostic Catheter – Product Status 152

Vision-MR Diagnostic Catheter – Product Description 153

Vision-MR Dispersive Electrode – Product Status 153

Vision-MR Dispersive Electrode – Product Description 153

Imricor Medical Systems Inc – Ongoing Clinical Trials Overview 154

Vision-MR Ablation Catheter 2.0 – A Global, Prospective Study of Vision-MR Ablation of VisionMR Ablation Catheter (Vision-MR Ablation of Atrial FLutter) – VISABL-ALF 155

Vision-MR Ablation Catheter 2.0 – Vision-MR Ablation Catheter 2.0 for the Treatment of Ventricular Tachycardia 155

Interventional Imaging, Inc. Pipeline Products & Ongoing Clinical Trials Overview 156

Atrial Fibrillation Catheter – Product Status 156

Atrial Fibrillation Catheter – Product Description 156

Iowa Approach Inc. Pipeline Products & Ongoing Clinical Trials Overview 157

MaPP-CS – Product Status 157

MaPP-CS – Product Description 157

ROF-AC – Product Status 158

ROF-AC – Product Description 158

ROF-AS – Product Status 158

ROF-AS – Product Description 159

Japan Lifeline Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 160

ALPHA1 Ablation Catheter – Product Status 160

ALPHA1 Ablation Catheter – Product Description 161

Jiangsu Tingsheng Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 162

2D Intracardiac Ultrasound – Product Status 162

2D Intracardiac Ultrasound – Product Description 162

4D Intracardiac Ultrasound – Product Status 163

4D Intracardiac Ultrasound – Product Description 163

Disposable Intracardiac Ultrasound Catheter – Product Status 163

Disposable Intracardiac Ultrasound Catheter – Product Description 164

Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 165

RF Ablation Lesion Assessment System – Product Status 165

RF Ablation Lesion Assessment System – Product Description 165

King’s College London Pipeline Products & Ongoing Clinical Trials Overview 166

Steerable Catheter – Product Status 166

Steerable Catheter – Product Description 166

Koninklijke Philips NV Pipeline Products & Ongoing Clinical Trials Overview 167

FL.ICE Catheter – Product Status 167

FL.ICE Catheter – Product Description 167

Lepu Medical Technology (Beijing) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 168

Pulsed Acoustical Generator – Product Status 168

Pulsed Acoustical Generator – Product Description 168

Lepu Scientech Medical Technology (Shanghai) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 169

Radiofrequency Ablation Device – Product Status 169

Radiofrequency Ablation Device – Product Description 169

Maestro Heart SA Pipeline Products & Ongoing Clinical Trials Overview 170

Maestro-AF Catheter System – Product Status 170

Maestro-AF Catheter System – Product Description 170

MC10 Inc Pipeline Products & Ongoing Clinical Trials Overview 171

Sensor-Covered Cardiac Catheter – Product Status 171

Sensor-Covered Cardiac Catheter – Product Description 171

Medlumics SL Pipeline Products & Ongoing Clinical Trials Overview 172

AblaView – Product Status 172

AblaView – Product Description 172

Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 173

Osteocool 2.0 – Product Status 173

Osteocool 2.0 – Product Description 174

Sphere-9 – Product Status 174

Sphere-9 – Product Description 174

Symplicity G3 Generator – Product Status 175

Symplicity G3 Generator – Product Description 175

Medtronic Plc – Ongoing Clinical Trials Overview 176

Symplicity G3 Generator – Cardiac Sympathetic Neuromodulation by Renal Denervation in Hypertrophic Cardiomyopathy (SNYPER Pilot Study) 177

Sphere-9 – Treatment of Persistent Atrial Fibrillation with the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System 178

MedWaves Inc Pipeline Products & Ongoing Clinical Trials Overview 179

Arrhythmia Catheters – Product Status 179

Arrhythmia Catheters – Product Description 179

Medyria AG Pipeline Products & Ongoing Clinical Trials Overview 180

PhysioCath System – Product Status 180

PhysioCath System – Product Description 180

MicroPort NeuroTech Ltd Pipeline Products & Ongoing Clinical Trials Overview 181

Renal RF Ablation System – Product Status 181

Renal RF Ablation System – Product Description 181

MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 182

Circular Ablation Catheter – Product Status 182

Circular Ablation Catheter – Product Description 182

Circular Diagnostic Catheter – Product Status 183

Circular Diagnostic Catheter – Product Description 183

Variable Loop – Product Status 183

Variable Loop – Product Description 184

Voyager Irrigated RF Ablation Catheter – Product Status 184

Voyager Irrigated RF Ablation Catheter – Product Description 184

NeuTrace Inc Pipeline Products & Ongoing Clinical Trials Overview 185

AI-Guided Cardiac Mapping Device – Product Status 185

AI-Guided Cardiac Mapping Device – Product Description 185

NeuTrace Inc – Ongoing Clinical Trials Overview 186

AI-Guided Cardiac Mapping Device – Physician Acceptance of the NeuTrace System for Cardiac Electroanatomic Mapping 187

Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 188

Cardiac Catheter – Product Status 188

Cardiac Catheter – Product Description 188

Novasentis Inc Pipeline Products & Ongoing Clinical Trials Overview 189

Electroactive Polymer Based Steerable Catheter – Product Status 189

Electroactive Polymer Based Steerable Catheter – Product Description 189

OrbusNeich Pipeline Products & Ongoing Clinical Trials Overview 190

Ablation Catheter – Product Status 190

Ablation Catheter – Product Description 190

Mapping Catheter – Product Status 191

Mapping Catheter – Product Description 191

Philips Healthcare Pipeline Products & Ongoing Clinical Trials Overview 192

Integrated X-Ray And Robotic Catheter System – Product Status 192

Integrated X-Ray And Robotic Catheter System – Product Description 192

S4 Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 193

esolution Device – Product Status 193

esolution Device – Product Description 193

SCR, Inc. Pipeline Products & Ongoing Clinical Trials Overview 194

Atrial Fibrillation Device – Product Status 194

Atrial Fibrillation Device – Product Description 194

Seattle Children’s Hospital Pipeline Products & Ongoing Clinical Trials Overview 195

Ablation Catheter – Heart Arrhythmia – Product Status 195

Ablation Catheter – Heart Arrhythmia – Product Description 195

Seoul National University Hospital Pipeline Products & Ongoing Clinical Trials Overview 196

Cardiac Stimulator – Product Status 196

Cardiac Stimulator – Product Description 196

Shanghai HeartCare Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 197

Cryoablation Catheter – Product Status 197

Cryoablation Catheter – Product Description 197

Shanghai MicroPort EP MedTech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 198

Contact Force-Sensing RF Ablation Catheter – Product Status 198

Contact Force-Sensing RF Ablation Catheter – Product Description 199

EasyFinder 3D Star High Density Mapping Catheter – Product Status 199

EasyFinder 3D Star High Density Mapping Catheter – Product Description 199

EasyLoop Intracardiac Mapping Catheter – Product Status 200

EasyLoop Intracardiac Mapping Catheter – Product Description 200

FireMagic TT 3D Ablation Catheter – Product Status 200

FireMagic TT 3D Ablation Catheter – Product Description 200

IceMagic Cryoablation Catheter – Product Status 201

IceMagic Cryoablation Catheter – Product Description 201

IceMagic Cryoablation System – Product Status 201

IceMagic Cryoablation System – Product Description 202

ST Cardio Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 203

Z6 Cardiac Stimulator With Integrated iPad – Product Status 203

Z6 Cardiac Stimulator With Integrated iPad – Product Description 203

St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 204

All-in-one Catheter Ablation System – Product Status 204

All-in-one Catheter Ablation System – Product Description 204

FlexAbility Irrigated Ablation Catheter Sensor Enabled – Monomorphic Ventricular Tachycardia – Product Status 205

FlexAbility Irrigated Ablation Catheter Sensor Enabled – Monomorphic Ventricular Tachycardia – Product Description 205

St. Jude Medical LLC – Ongoing Clinical Trials Overview 206

FlexAbility Irrigated Ablation Catheter Sensor Enabled – Monomorphic Ventricular Tachycardia – Flexability Sensor Enabled Substrate Targeted Ablation for the Reduction of Ventricular Tachycardia (LESS-VT) Study 207

Stanford University Pipeline Products & Ongoing Clinical Trials Overview 208

Cardiac-Mapping Catheter – Product Status 208

Cardiac-Mapping Catheter – Product Description 208

Stereotaxis Inc Pipeline Products & Ongoing Clinical Trials Overview 209

MAGiC Ablation Catheter – Product Status 209

MAGiC Ablation Catheter – Product Description 209

Next Generation Irrigated Magnetic Catheter – Product Status 210

Next Generation Irrigated Magnetic Catheter – Product Description 210

Robotic Magnetic Navigation System – Pulmonary Hypertension – Product Status 210

Robotic Magnetic Navigation System – Pulmonary Hypertension – Product Description 211

Stereotaxis Genesis RMN – Product Status 211

Stereotaxis Genesis RMN – Product Description 211

Suzhou Aikemai Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 212

3D Mapping System – Product Status 212

3D Mapping System – Product Description 212

Suzhou Bingjing Intelligent Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 213

3D Imaging ICE Device – Product Status 213

3D Imaging ICE Device – Product Description 213

4D Imaging ICE Device – Product Status 214

4D Imaging ICE Device – Product Description 214

HD-ICE – Product Status 214

HD-ICE – Product Description 215

Suzhou Hengruihongyuan Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 216

Endovenous Radiofrequency Ablation Closure System – Product Status 216

Endovenous Radiofrequency Ablation Closure System – Product Description 216

Suzhou Hengruihongyuan Medical Technology Co Ltd – Ongoing Clinical Trials Overview 217

Endovenous Radiofrequency Ablation Closure System – Prospective, Multi-center, Randomized Controlled Study to Evaluate the Effectiveness and Safety of Endovenous Radiofrequency Ablation Closure System in the Treatment of Varicose Veins 218

Suzhou Xinmai Medical Equipment Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 219

RF System – Product Status 219

RF System – Product Description 219

The Cleveland Clinic Foundation Pipeline Products & Ongoing Clinical Trials Overview 220

EP Mapping Catheter – Product Status 220

EP Mapping Catheter – Product Description 220

University of Arkansas at Little Rock Pipeline Products & Ongoing Clinical Trials Overview 221

Robotic Catheter – Product Status 221

Robotic Catheter – Product Description 221

University of Auckland Pipeline Products & Ongoing Clinical Trials Overview 222

3D Heart Mapping Device – Product Status 222

3D Heart Mapping Device – Product Description 222

University of Maryland Pipeline Products & Ongoing Clinical Trials Overview 223

Steerable Actuated Catheter – Product Status 223

Steerable Actuated Catheter – Product Description 223

University of Michigan Pipeline Products & Ongoing Clinical Trials Overview 224

Non-Contact Mapping Catheter – Product Status 224

Non-Contact Mapping Catheter – Product Description 224

University of Rochester Pipeline Products & Ongoing Clinical Trials Overview 225

RF Ablation Catheter – Product Status 225

RF Ablation Catheter – Product Description 225

University of Texas Medical Branch at Galveston Pipeline Products & Ongoing Clinical Trials Overview 226

Ablation Catheter – Product Status 226

Ablation Catheter – Product Description 226

University of Utah Pipeline Products & Ongoing Clinical Trials Overview 227

Cardiac Tissue Imaging Catheter – Product Status 227

Cardiac Tissue Imaging Catheter – Product Description 227

Vanderbilt University Pipeline Products & Ongoing Clinical Trials Overview 228

Temperature Controlled Catheter – Product Status 228

Temperature Controlled Catheter – Product Description 228

Vimecon GmbH Pipeline Products & Ongoing Clinical Trials Overview 229

Vimecon Laser CAI Catheter – Product Status 229

Vimecon Laser CAI Catheter – Product Description 229

Viscardia Inc Pipeline Products & Ongoing Clinical Trials Overview 230

VisONE System – Product Status 230

VisONE System – Product Description 230

Viscardia Inc – Ongoing Clinical Trials Overview 231

VisONE System – RECOVER-HF Pilot Study – Randomized, Single-Center, Double-blinded Study of Synchronized Diaphragmatic Stimulation (SDS) for Improvement of Symptomatic Reduced Ejection Fraction Heart Failure 232

Vivonics Inc Pipeline Products & Ongoing Clinical Trials Overview 233

Catheter Guidance System – Product Status 233

Catheter Guidance System – Product Description 233

Voyage Medical (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 234

IRIS Ablation System – Product Status 234

IRIS Ablation System – Product Description 234

Zylox-Tonbridge Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 235

Radiofrequency Generator – Product Status 235

Radiofrequency Generator – Product Description 235

Glossary 277

Figures

Electrophysiology Devices – Pipeline Products by Stage of Development 20

Electrophysiology Devices – Pipeline Products by Segment 21

Electrophysiology Devices – Pipeline Products by Territory 23

Electrophysiology Devices – Pipeline Products by Regulatory Path 24

Electrophysiology Devices – Pipeline Products by Estimated Approval Date 25

Frequently asked questions

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