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Cardiac Rhythm Management Devices - Medical Devices Pipeline Assessment, 2018

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Cardiac Rhythm Management Devices - Medical Devices Pipeline Assessment, 2018


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Cardiac Rhythm Management Devices - Medical Devices Pipeline Assessment, 2018



Executive Summary

Cardiac Rhythm Management Devices-Medical Devices Pipeline Assessment, 2018

Summary

GlobalData's Medical Devices sector report, Cardiac Rhythm Management Devices-Medical Devices Pipeline Assessment, 2018" provides an overview of Cardiac Rhythm Management Devices currently in pipeline stage.

The report provides comprehensive information on the pipeline products with comparative analysis of the products at various stages of development. The report reviews major players involved in the pipeline product development. It also provides information about clinical trials in progress, which includes trial phase, trial status, trial start and end dates, and, the number of trials for the key Cardiac Rhythm Management Devices pipeline products.

This report is prepared using data sourced from in-house databases, secondary and primary research by GlobalData's team of industry experts.

*Note: Certain sections in the report may be removed or altered based on the availability and relevance of data in relation to the equipment type.

Scope

- Extensive coverage of the Cardiac Rhythm Management Devices under development

- The report reviews details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities

- The report reviews the major players involved in the development of Cardiac Rhythm Management 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

- The report provides key clinical trial data of ongoing trials specific to pipeline products

- Recent developments in the segment / industry

Reasons to buy

The report enables you to-

- Formulate significant competitor information, analysis, and insights to improve R&D strategies

- Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

- Identify and understand important and diverse types of Cardiac Rhythm Management 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

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 10

1.2 List of Figures 17

2 Introduction 18

2.1 Cardiac Rhythm Management Devices Overview 18

3 Products under Development 20

3.1 Cardiac Rhythm Management Devices-Pipeline Products by Stage of Development 20

3.2 Cardiac Rhythm Management Devices-Pipeline Products by Segment 21

3.3 Cardiac Rhythm Management Devices-Pipeline Products by Territory 23

3.4 Cardiac Rhythm Management Devices-Pipeline Products by Regulatory Path 24

3.5 Cardiac Rhythm Management Devices-Pipeline Products by Estimated Approval Date 25

3.6 Cardiac Rhythm Management Devices-Ongoing Clinical Trials 26

4 Cardiac Rhythm Management Devices-Pipeline Products under Development by Companies 27

4.1 Cardiac Rhythm Management Devices Companies-Pipeline Products by Stage of Development 27

4.2 Cardiac Rhythm Management Devices-Pipeline Products by Stage of Development 30

5 Cardiac Rhythm Management Devices Companies and Product Overview 34

5.1 A3 Remote Monitoring Technologies Pvt. Ltd. Company Overview 34

5.2 AI Medical Semiconductor Ltd. Company Overview 35

5.3 AIS Inc. Company Overview 36

5.4 Angel Medical Systems Inc Company Overview 37

5.5 BackBeat Medical, Inc. Company Overview 38

5.6 Ben-Gurion University of the Negev Company Overview 41

5.7 Boston Scientific Corp Company Overview 42

5.8 Boston TransTec LLC Company Overview 60

5.9 CardiaLen, Inc. Company Overview 61

5.10 Cardioalarm, Inc Company Overview 63

5.11 Children's National Health System Company Overview 64

5.12 Columbia University Company Overview 65

5.13 Corhythm Inc Company Overview 66

5.14 CVRx Inc Company Overview 67

5.15 DHS Medical Company Overview 71

5.16 Drexel University Company Overview 73

5.17 Duke University Company Overview 74

5.18 EBR Systems Inc Company Overview 75

5.19 Endurance Rhythm Inc. Company Overview 79

5.20 Hadasit Medical Research Services and Development Ltd Company Overview 80

5.21 Impulse Dynamics NV Company Overview 81

5.22 Imricor Medical Systems Inc Company Overview 86

5.23 InnerPulse Inc (Inactive) Company Overview 87

5.24 Integer Holdings Corp Company Overview 89

5.25 IRadimed Corp Company Overview 90

5.26 Johns Hopkins University Company Overview 91

5.27 Kenergy Inc. Company Overview 95

5.28 Krisara Engineering, LLC Company Overview 97

5.29 LivaNova PLC Company Overview 98

5.30 Massachusetts General Hospital Company Overview 109

5.31 Mathematical Bio-Solutions Inc. Company Overview 111

5.32 Max Planck Institute for Dynamics and Self-Organization Company Overview 112

5.33 Mayo Clinic Company Overview 113

5.34 Medtronic plc Company Overview 115

5.35 MicroPort Scientific Corp Company Overview 128

5.36 NanoLinea Company Overview 132

5.37 NDSU Research Foundation Company Overview 133

5.38 NewPace Ltd Company Overview 134

5.39 NuVascular Technologies Inc Company Overview 137

5.40 Odem Medical Ltd Company Overview 138

5.41 Ohio State University Company Overview 140

5.42 Osypka Medical GmbH Company Overview 141

5.43 Perpetuum Ltd. Company Overview 142

5.44 Queen Mary University of London Company Overview 143

5.45 Rice University Company Overview 144

5.46 Rochester Institute of Technology Company Overview 146

5.47 Seoul National University Hospital Company Overview 147

5.48 Shaanxi Qinming Medical Instruments Co Ltd Company Overview 148

5.49 Shanghai MicroPort Medical Group Co Ltd Company Overview 149

5.50 Silver Bullet Therapeutics, Inc. Company Overview 152

5.51 Smartwave Medical Ltd (Inactive) Company Overview 153

5.52 Spectranetics Corp Company Overview 154

5.53 St. Jude Medical LLC Company Overview 155

5.54 SUNY Downstate Medical Center Company Overview 163

5.55 Teleflex Inc Company Overview 164

5.56 TransWorld Med Corp Company Overview 165

5.57 U.S. Stem Cell Inc Company Overview 166

5.58 University of Bern Company Overview 167

5.59 University of California Los Angeles Company Overview 168

5.60 University of Glasgow Company Overview 170

5.61 University of Michigan Company Overview 171

5.62 University of Southern California Company Overview 172

5.63 University of Utah Company Overview 173

6 Cardiac Rhythm Management Devices- Recent Developments 174

6.1 May 24, 2018: Medtronic Reports Fourth Quarter And Fiscal Year 2018 Financial Results 174

6.2 May 17, 2018: Mr. Jonathan Chen Promoted to Chief International Business Officer of MPSC 176

6.3 May 16, 2018: Surmodics Announces Leadership Change and Appointment of Interim CFO 176

6.4 May 15, 2018: MRI Interventions Announces First Quarter 2018 Results 177

6.5 May 14, 2018: Autologous Stem Cell Therapy May Hold Key to Regeneration 179

6.6 May 11, 2018: Boston Scientific Announces Real-World Data Demonstrating Success Of SMART Pass On The S-ICD System 180

6.7 May 11, 2018: Medtronic Study Confirms Feasibility of New Extravascular Approach to ICD Therapy 180

6.8 May 11, 2018: New Study Demonstrates Feasibility of Novel Mechanical Sensor in Medtronic Micra Transcatheter Pacing System to Detect Atrial Contractions and Restore AV Synchrony 181

6.9 May 10, 2018: FIX-HF-5C Late-Breaking Clinical Trial Data Presented at HRS 2018 with Simultaneous Publication in the JACC: Heart Failure 182

6.10 May 09, 2018: Data Reinforce Reduced Complications with Medtronic Micra Transcatheter Pacing System Over Traditional Pacemakers in Real-World Use 183

6.11 May 09, 2018: U.S. Stem Cell Reports First Quarter Results 185

6.12 May 08, 2018: T2 Biosystems Announces First Quarter 2018 Financial Results 185

6.13 May 07, 2018: Medtronic Appoints Mike Weinstein As Senior Vice President Of Strategy 186

6.14 May 03, 2018: Integer Holdings Reports First Quarter 2018 Results 187

6.15 May 02, 2018: Surmodics Reports Second Quarter Fiscal 2018 Results, Increases Fiscal 2018 Guidance 188

6.16 May 02, 2018: CORRECTING and REPLACING Surmodics Reports Second Quarter Fiscal 2018 Results, Increases Fiscal 2018 Guidance 189

6.17 May 02, 2018: iRhythm Technologies Announces First Quarter Financial Results 190

6.18 May 01, 2018: Stereotaxis Announces Publication of Clinical Research Supplement Highlighting Robotic Navigation for Cardiac Arrhythmias 191

6.19 Apr 30, 2018: Orthofix Announces First Quarter 2018 Financial Results 191

6.20 Apr 25, 2018: Boston Scientific Reports Financial Results For First Quarter 2018 193

6.21 Apr 25, 2018: CONMED Announces First Quarter 2018 Financial Results 195

6.22 Apr 23, 2018: Philips First Quarter Results 2018 196

6.23 Apr 19, 2018: Philips showcases dedicated radiation oncology workflow solutions spanning image acquisition to treatment planning at ESTRO 2018 198

6.24 Apr 16, 2018: USRM Reports 2017 Financial Results 200

6.25 Apr 10, 2018: iRhythm Technologies Appoints UCLA and Cedars-Sinai Professor C. Noel Bairey Merz, M.D. to its Board of Directors 201

6.26 Apr 05, 2018: Dr. Laura Mauri to Join Medtronic as Vice President, Global Clinical Research & Analytics 201

6.27 Apr 03, 2018: Nihon Kohden Announces Change in Representative Director and Director 202

6.28 Mar 28, 2018: MicroPort Scientific Announces 2017 Annual Results 203

6.29 Mar 27, 2018: MicroPort Scientific Announces Year Ended 31 December 2017 Financial Results 204

6.30 Mar 26, 2018: Solid ion conductors could improve pacemaker safety and reliability 205

6.31 Mar 19, 2018: Texas Cardiac Arrhythmia Institute at St. David's Medical Center draws cardiac experts from across the globe for EPLive 2018 206

6.32 Mar 19, 2018: Philips convenes the 2018 Annual General Meeting of Shareholders 206

6.33 Mar 15, 2018: MRI Interventions Reports 34% Year-Over-Year Increase in Functional Neurology Revenues, 50% increase in Capital Sales 207

6.34 Mar 13, 2018: Orthofix Announces Appointment of John Sicard to Board of Directors 209

6.35 Mar 10, 2018: LifeVest Wearable Defibrillator Reduces Total Mortality By 36 Percent At 90 Days 210

6.36 Mar 07, 2018: EBR Systems Initiates Global Trial of World's Only Wireless CRT Pacing Technology 211

6.37 Mar 07, 2018: Philips again ranks first in ‘medical technology' patents filed at the European Patent Office 212

6.38 Mar 06, 2018: Presbyterian Heart and Vascular Care First Team in Albuquerque to Offer the World's Smallest Pacemaker 212

6.39 Mar 06, 2018: Stereotaxis Reports 2017 Fourth Quarter And Full Year Financial Results 213

6.40 Mar 06, 2018: T2 Biosystems Reports Fourth Quarter and Full-Year 2017 Financial Results and Business Update 215

6.41 Mar 01, 2018: Results of Landmark Wearable Defibrillator Trial to Be Presented as ACC.18 Late-Breaker 216

6.42 Mar 01, 2018: Safety and Effectiveness of BioTrace Medical's Tempo Lead Further Demonstrated in Multi-Center Analysis of More Than 200 Cardiac Procedures 217

6.43 Mar 01, 2018: First BIOTRONIK Pacemakers in Japan Approved for 3 Tesla Full-Body MRIs 218

6.44 Feb 28, 2018: LivaNova Announces Fourth Quarter and Full-Year 2017 Results 219

6.45 Feb 27, 2018: genedrive Receives Significant Funding for TB Test Development 221

6.46 Feb 26, 2018: Medtronic Recalls Cardiac Resynchronization Therapy and Implantable Cardioverter Defibrillators Due to Manufacturing Error Preventing Electrical Shock Delivery 221

6.47 Feb 26, 2018: Tissue Regenix Group: Launch of TRX BioSurgery and new distributor agreement 222

6.48 Feb 26, 2018: Orthofix International Reports Fourth Quarter And Fiscal 2017 Financial Results 222

6.49 Feb 22, 2018: Integer Holdings Reports Results for Fourth Quarter and Full Year 2017 224

6.50 Feb 22, 2018: Integer Announces Strategy Focused on Portfolio Management and Operational Excellence; Aligns Senior Management to Execute Strategic Imperatives 225

6.51 Feb 21, 2018: NICE Issues Medtech Innovation Briefing Recognizing Medtronic Reveal LINQ in the Detection of Atrial Fibrillation After Stroke of Unknown Cause 226

6.52 Feb 20, 2018: Philips increases Green Revenues to EUR 10.7 billion, 60% of total sales in 2017 227

6.53 Feb 13, 2018: Proteus Digital Health Appoints Joseph Swedish As Board Director 228

6.54 Feb 12, 2018: Integer Elects James Hinrichs to its Board of Directors 229

6.55 Feb 08, 2018: Defibtech Receives U.S. FDA Premarket Approval (PMA) for AEDs 229

6.56 Feb 08, 2018: MemorialCare Saddleback Medical Center Offers World's Smallest Pacemaker the Size of a Vitamin Weighing Less Than a Penny 229

6.57 Feb 08, 2018: Surmodics Reports First Quarter Fiscal 2018 Results, Updates Fiscal 2018 Guidance 230

6.58 Feb 07, 2018: TMC: Small Device Promises Big Fix 231

6.59 Feb 07, 2018: Caisson Interventional Expanding in Maple Grove 232

6.60 Feb 06, 2018: New device trial for heart failure patients in Scotland 233

6.61 Feb 06, 2018: MRI Interventions Announces Record 629 ClearPoint Cases in 2017 234

6.62 Feb 06, 2018: USRM Seeing Explosive Increase in Demand for Stem Cell Therapy 235

6.63 Feb 05, 2018: T2 Biosystems Names John Sprague As CFO 236

6.64 Feb 01, 2018: Boston Scientific Announces Results for Fourth Quarter and Full Year 2017 236

6.65 Jan 31, 2018: CONMED Announces Fourth Quarter and Fiscal Year 2017 Financial Results 238

6.66 Jan 30, 2018: Philips' Fourth Quarter and Annual Results 2017 239

6.67 Jan 30, 2018: Alex Gu Named Senior Vice President and President of Medtronic's Greater China Region 242

6.68 Jan 25, 2018: MSC Hosts Product Launch of Rega Family Implantable Pacemakers 243

6.69 Jan 17, 2018: Texas Cardiac Arrhythmia Institute at St. Davids Medical Center First in Texas to Use New Smartphone Compatible, Insertable Cardiac Monitor 244

6.70 Jan 11, 2018: Andover will lose nearly 2,000 jobs with Philips move 245

6.71 Jan 10, 2018: Ventripoint Appoints Head of Sales for North America 245

6.72 Jan 09, 2018: Boston Scientific Announces Preliminary Unaudited Sales For The Fourth Quarter And Full Year Ended December 31, 2017 245

6.73 Jan 09, 2018: Orthofix Announces Preliminary 2017 Fourth Quarter and Full Year Net Sales Results 246

6.74 Jan 08, 2018: LivaNova Announces Matthew J. Dodds as Senior Vice President, Corporate Development 247

6.75 Jan 08, 2018: Stereotaxis Reports Preliminary Fourth Quarter 2017 Revenue Results 247

6.76 Jan 03, 2018: New FDA MR-Conditional Labeling Approvals Further Expand Abbott's Fortify Assura Implantable Cardioverter Defibrillator 248

6.77 Jan 02, 2018: Integer Names Kirk Thor Chief Human Resources Officer 249

6.78 Jan 02, 2018: CONMED Appoints Todd W. Garner as Executive Vice President and Chief Financial Officer 249

7 Appendix 350

7.1 Methodology 350

7.2 About GlobalData 353

7.3 Contact Us 353

7.4 Disclaimer 353

To know more information on Purchase by Section, please send a mail to sales@kenresearch.com

1.2 List of Figures

Figure 1: Cardiac Rhythm Management Devices-Pipeline Products by Stage of Development 20

Figure 2: Cardiac Rhythm Management Devices-Pipeline Products by Segment 21

Figure 3: Cardiac Rhythm Management Devices-Pipeline Products by Territory 23

Figure 4: Cardiac Rhythm Management Devices-Pipeline Products by Regulatory Path 24

Figure 5: Cardiac Rhythm Management Devices-Pipeline Products by Estimated Approval Date 25

Figure 6: Cardiac Rhythm Management Devices-Ongoing Clinical Trials 26

1.1 List of Tables

Table 1: Cardiac Rhythm Management Devices-Pipeline Products by Stage of Development 20

Table 2: Cardiac Rhythm Management Devices-Pipeline Products by Segment 21

Table 3: Cardiac Rhythm Management Devices-Pipeline Products by Territory 23

Table 4: Cardiac Rhythm Management Devices-Pipeline Products by Regulatory Path 24

Table 5: Cardiac Rhythm Management Devices-Pipeline Products by Estimated Approval Date 25

Table 6: Cardiac Rhythm Management Devices-Ongoing Clinical Trials 26

Table 7: Cardiac Rhythm Management Devices Companies-Pipeline Products by Stage of Development 27

Table 8: Cardiac Rhythm Management Devices-Pipeline Products by Stage of Development 30

Table 9: A3 Remote Monitoring Technologies Pvt. Ltd. Pipeline Products & Ongoing Clinical Trials Overview 34

Table 10: Wireless Device-Wearable Cardiac Rhythm Management System-Product Status 34

Table 11: Wireless Device-Wearable Cardiac Rhythm Management System-Product Description 34

Table 12: AI Medical Semiconductor Ltd. Pipeline Products & Ongoing Clinical Trials Overview 35

Table 13: Adaptive CRT And Vagal Stimulation Device-Product Status 35

Table 14: Adaptive CRT And Vagal Stimulation Device-Product Description 35

Table 15: AIS Inc. Pipeline Products & Ongoing Clinical Trials Overview 36

Table 16: Guardian-Product Status 36

Table 17: Guardian-Product Description 36

Table 18: Angel Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 37

Table 19: Acute Ischemia Monitor-Product Status 37

Table 20: Acute Ischemia Monitor-Product Description 37

Table 21: BackBeat Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 38

Table 22: Moderato-Product Status 38

Table 23: Moderato-Product Description 38

Table 24: BackBeat Medical, Inc.-Ongoing Clinical Trials Overview 39

Table 25: Moderato-Clinical Evaluation of Safety and Effectiveness of the BackBeat Medical Moderato System in Patients with Hypertension-A Double-Blind Randomized Trial-PV Loops Sub Study 40

Table 26: Moderato-Clinical Evaluation of Safety and Effectiveness of the BackBeat Medical Moderato System in Patients with Hypertension: A Double-blind Randomized Trial 40

Table 27: Ben-Gurion University of the Negev Pipeline Products & Ongoing Clinical Trials Overview 41

Table 28: Heart Pacing System-Product Status 41

Table 29: Heart Pacing System-Product Description 41

Table 30: Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 42

Table 31: Acuity X4 Quad LV Lead-1.5T MRI-Product Status 43

Table 32: Acuity X4 Quad LV Lead-1.5T MRI-Product Description 43

Table 33: Acuity X4 Quad LV Lead-3T MRI-Product Status 43

Table 34: Acuity X4 Quad LV Lead-3T MRI-Product Description 44

Table 35: EMBLEM MRI S-ICD System-Aged Patients-Product Status 44

Table 36: EMBLEM MRI S-ICD System-Aged Patients-Product Description 44

Table 37: EMPOWER Leadless Pacer-Product Status 45

Table 38: EMPOWER Leadless Pacer-Product Description 45

Table 39: ICM Monitoring & Dx-Product Status 45

Table 40: ICM Monitoring & Dx-Product Description 45

Table 41: INGENIO 2 PG-MICS-Product Status 46

Table 42: INGENIO 2 PG-MICS-Product Description 46

Table 43: Loop Recorder-Product Status 46

Table 44: Loop Recorder-Product Description 46

Table 45: MRI-Safe Implantable Cardiac Rhythm Management Lead-Product Status 47

Table 46: MRI-Safe Implantable Cardiac Rhythm Management Lead-Product Description 47

Table 47: Next Generation ICD Lead-Product Status 47

Table 48: Next Generation ICD Lead-Product Description 47

Table 49: Next Generation ICD/CRT-D-Product Status 48

Table 50: Next Generation ICD/CRT-D-Product Description 48

Table 51: Next Generation Quad Polar CRT-D-Product Status 48

Table 52: Next Generation Quad Polar CRT-D-Product Description 49

Table 53: NG3 Non Quad System-Product Status 49

Table 54: NG3 Non Quad System-Product Description 49

Table 55: Reliance 4-Front Lead-Product Status 49

Table 56: Reliance 4-Front Lead-Product Description 50

Table 57: S-ICD System 1.5-Product Status 50

Table 58: S-ICD System 1.5-Product Description 50

Table 59: S-ICD System 2.0-Product Status 51

Table 60: S-ICD System 2.0-Product Description 51

Table 61: Temporary RV VVI pacing-Product Status 51

Table 62: Temporary RV VVI pacing-Product Description 52

Table 63: VITALITY NXT Defibrillator-Product Status 52

Table 64: VITALITY NXT Defibrillator-Product Description 52

Table 65: X4 SYSTEM + QUAD LEAD-Product Status 52

Table 66: X4 SYSTEM + QUAD LEAD-Product Description 53

Table 67: Boston Scientific Corp-Ongoing Clinical Trials Overview 54

Table 68: Next Generation Quad Polar CRT-D-Heart Failure Indication and Sudden Cardiac Death Prevention Trial Japan 55

Table 69: Reliance 4-Front Lead-Evaluation of Acuity X4 Quadripolar Coronary Venous Leads and Reliance 4-Front Defibrillation Leads: NAVIGATE X4 56

Table 70: Reliance 4-Front Lead-Expanding MRI Access for Patients with New and Existing ICDs and CRT-Ds: ENABLE MRI 56

Table 71: S-ICD System 2.0-A Prospective Randomized Comparative Trial of Subcutaneous Implantable Cardioverter-Defibrillator Implantation with and Without Defibrillation Testing 57

Table 72: S-ICD System 1.5-A Prospective Randomized Comparative Trial of Subcutaneous Implantable Cardioverter-Defibrillator Implantation with and Without Defibrillation Testing 58

Table 73: EMBLEM MRI S-ICD System-Aged Patients-Multicenter Automatic Defibrillator Implantation Trial with Subcutaneous Implantable Cardioverter Defibrillator: MADIT S-ICD 59

Table 74: Boston TransTec LLC Pipeline Products & Ongoing Clinical Trials Overview 60

Table 75: Raul Pacemaker-Product Status 60

Table 76: Raul Pacemaker-Product Description 60

Table 77: CardiaLen, Inc. Pipeline Products & Ongoing Clinical Trials Overview 61

Table 78: CardiaLen Device-Atrial Fibrillation-Product Status 61

Table 79: CardiaLen Device-Atrial Fibrillation-Product Description 61

Table 80: CardiaLen Device-Ventricular Arrhythmia-Product Status 62

Table 81: CardiaLen Device-Ventricular Arrhythmia-Product Description 62

Table 82: Cardioalarm, Inc Pipeline Products & Ongoing Clinical Trials Overview 63

Table 83: CardioAlarm System-Product Status 63

Table 84: CardioAlarm System-Product Description 63

Table 85: Children's National Health System Pipeline Products & Ongoing Clinical Trials Overview 64

Table 86: Delivery Tool-Epicardial Pacing And Defibrillation-Product Status 64

Table 87: Delivery Tool-Epicardial Pacing And Defibrillation-Product Description 64

Table 88: Columbia University Pipeline Products & Ongoing Clinical Trials Overview 65

Table 89: Biological Pacemaker-Product Status 65

Table 90: Biological Pacemaker-Product Description 65

Table 91: Corhythm Inc Pipeline Products & Ongoing Clinical Trials Overview 66

Table 92: Corhythm Implantable Device-Product Status 66

Table 93: Corhythm Implantable Device-Product Description 66

Table 94: CVRx Inc Pipeline Products & Ongoing Clinical Trials Overview 67

Table 95: Barostim neo-Heart Failure-Product Status 67

Table 96: Barostim neo-Heart Failure-Product Description 67

Table 97: CVRx Inc-Ongoing Clinical Trials Overview 68

Table 98: Barostim neo-Heart Failure-Barostim HOPE4HF Study 69

Table 99: Barostim neo-Heart Failure-Barostim Neo-Baroreflex Activation Therapy for Heart Failure 69

Table 100: Barostim neo-Heart Failure-Barostim Therapy In Heart Failure With Preserved Ejection Fraction (HFPEF) 69

Table 101: Barostim neo-Heart Failure-Barostim Therapy in Heart Failure with Reduced Ejection Fraction: A Post-Market Registry with the CE-Marked Barostim Neo System 70

Table 102: Barostim neo-Heart Failure-Evaluation of Baroreflex Activation Therapy in Patients with Advanced Heart Failure 70

Table 103: DHS Medical Pipeline Products & Ongoing Clinical Trials Overview 71

Table 104: Drimmer-Product Status 71

Table 105: Drimmer-Product Description 71

Table 106: Twistek-Product Status 72

Table 107: Twistek-Product Description 72

Table 108: Drexel University Pipeline Products & Ongoing Clinical Trials Overview 73

Table 109: Conductance Controller Implant-Product Status 73

Table 110: Conductance Controller Implant-Product Description 73

Table 111: Duke University Pipeline Products & Ongoing Clinical Trials Overview 74

Table 112: Tissue-Engineered Autonomous Pacemaker-Product Status 74

Table 113: Tissue-Engineered Autonomous Pacemaker-Product Description 74

Table 114: EBR Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 75

Table 115: Second Generation WiSE CRT System-Product Status 75

Table 116: Second Generation WiSE CRT System-Product Description 75

Table 117: WiSE CRT System-Product Status 76

Table 118: WiSE CRT System-Product Description 76

Table 119: EBR Systems Inc-Ongoing Clinical Trials Overview 77

Table 120: WiSE CRT System-Multicenter, Prospective Evaluation of Safety and Performance of the WiCS-LV System in Patients Indicated for Cardiac Resynchronization Therapy 78

Table 121: WiSE CRT System-Stimulation of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-responders and Previously Untreatable Patients: SOLVE CRT 78

Table 122: WiSE CRT System-WiCS-LV Post Market Surveillance Registry 78

Table 123: Endurance Rhythm Inc. Pipeline Products & Ongoing Clinical Trials Overview 79

Table 124: Endurance Rhythm Micro-Generator-Product Status 79

Table 125: Endurance Rhythm Micro-Generator-Product Description 79

Table 126: Hadasit Medical Research Services and Development Ltd Pipeline Products & Ongoing Clinical Trials Overview 80

Table 127: Aortic Pacemaker-Product Status 80

Table 128: Aortic Pacemaker-Product Description 80

Table 129: Impulse Dynamics NV Pipeline Products & Ongoing Clinical Trials Overview 81

Table 130: Optimizer IVs System-Product Status 81

Table 131: Optimizer IVs System-Product Description 81

Table 132: Optimizer Smart-Product Status 82

Table 133: Optimizer Smart-Product Description 82

Table 134: Impulse Dynamics NV-Ongoing Clinical Trials Overview 83

Table 135: Optimizer IVs System-Evaluation of the Safety and Efficacy of the OPTIMIZER System in Subjects with Moderate-to-Severe Heart Failure with Ejection Fraction Between 25% and 45%: FIX-HF-5C 84

Table 136: Optimizer Smart-Cardiac Contractility Modulation (CCM) Therapy in Subjects with Heart Failure with Preserved Ejection Fraction 85

Table 137: Optimizer Smart-Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System in Subjects with Moderate-to-severe Heart Failure with Ejection Fraction Between 25% and 45%: FIX-HF-5CA 85

Table 138: Optimizer Smart-FIX-HF-5C2: Evaluation of the Safety and Efficacy of the 2-lead OPTIMIZER Smart System in Subjects with Moderate-to-Severe Heart Failure With Ejection Fraction Between 25% and 45% 85

Table 139: Imricor Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 86

Table 140: Magnetic Resonance Imaging (MRI) Compatible Lead-Product Status 86

Table 141: Magnetic Resonance Imaging (MRI) Compatible Lead-Product Description 86

Table 142: InnerPulse Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 87

Table 143: InnerPulse Pacemaker-Product Status 87

Table 144: InnerPulse Pacemaker-Product Description 87

Table 145: PICD-Product Status 88

Table 146: PICD-Product Description 88

Table 147: Integer Holdings Corp Pipeline Products & Ongoing Clinical Trials Overview 89

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A3 Remote Monitoring Technologies Pvt. Ltd.

AI Medical Semiconductor Ltd.

AIS Inc.

Angel Medical Systems Inc

BackBeat Medical, Inc.

Ben-Gurion University of the Negev

Boston Scientific Corp

Boston TransTec LLC

CardiaLen, Inc.

Cardioalarm, Inc

Children's National Health System

Columbia University

Corhythm Inc

CVRx Inc

DHS Medical

Drexel University

Duke University

EBR Systems Inc

Endurance Rhythm Inc.

Hadasit Medical Research Services and Development Ltd

Impulse Dynamics NV

Imricor Medical Systems Inc

InnerPulse Inc

Integer Holdings Corp

IRadimed Corp

Johns Hopkins University

Kenergy Inc.

Krisara Engineering, LLC

LivaNova PLC

Massachusetts General Hospital

Mathematical Bio-Solutions Inc.

Max Planck Institute for Dynamics and Self-Organization

Mayo Clinic

Medtronic plc

MicroPort Scientific Corp

NanoLinea

NDSU Research Foundation

NewPace Ltd

NuVascular Technologies Inc

Odem Medical Ltd

Ohio State University

Osypka Medical GmbH

Perpetuum Ltd.

Queen Mary University of London

Rice University

Rochester Institute of Technology

Seoul National University Hospital

Shaanxi Qinming Medical Instruments Co Ltd

Shanghai MicroPort Medical Group Co Ltd

Silver Bullet Therapeutics, Inc.

Smartwave Medical Ltd

Spectranetics Corp

St. Jude Medical LLC

SUNY Downstate Medical Center

Teleflex Inc

TransWorld Med Corp

U.S. Stem Cell Inc

University of Bern

University of California Los Angeles

University of Glasgow

University of Michigan

University of Southern California

University of Utah

A3 Remote Monitoring Technologies Pvt. Ltd., Wireless Device - Wearable Cardiac Rhythm Management System; AI Medical Semiconductor Ltd., Adaptive CRT And Vagal Stimulation Device; AIS Inc., Guardian; Angel Medical Systems Inc, Acute Ischemia Monitor; BackBeat Medical, Inc., Moderato; Ben-Gurion University of the Negev, Heart Pacing System; Boston Scientific Corp, Acuity X4 Quad LV Lead - 1.5T MRI; Boston Scientific Corp, Acuity X4 Quad LV Lead - 3T MRI; Boston Scientific Corp, EMBLEM MRI S-ICD System - Aged Patients; Boston Scientific Corp, EMPOWER Leadless Pacer; Boston Scientific Corp, ICM Monitoring &; Dx; Boston Scientific Corp, INGENIO 2 PG - MICS; Boston Scientific Corp, Loop Recorder; Boston Scientific Corp, MRI-Safe Implantable Cardiac Rhythm Management Lead; Boston Scientific Corp, Next Generation ICD Lead; Boston Scientific Corp, Next Generation ICD/CRT-D; Boston Scientific Corp, Next Generation Quad Polar CRT-D; Boston Scientific Corp, NG3 Non Quad System; Boston Scientific Corp, Reliance 4-Front Lead; Boston Scientific Corp, S-ICD System 1.5; Boston Scientific Corp, S-ICD System 2.0; Boston Scientific Corp, Temporary RV VVI pacing; Boston Scientific Corp, VITALITY NXT Defibrillator; Boston Scientific Corp, X4 SYSTEM + QUAD LEAD; Boston TransTec LLC, Raul Pacemaker; CardiaLen, Inc., CardiaLen Device - Atrial Fibrillation; CardiaLen, Inc., CardiaLen Device - Ventricular Arrhythmia; Cardioalarm, Inc, CardioAlarm System; Children's National Health System, Delivery Tool - Epicardial Pacing And Defibrillation; Columbia University, Biological Pacemaker; Corhythm Inc, Corhythm Implantable Device; CVRx Inc, Barostim neo - Heart Failure; DHS Medical, Drimmer; DHS Medical, Twistek; Drexel University, Conductance Controller Implant; Duke University, Tissue-Engineered Autonomous Pacemaker; EBR Systems Inc, Second Generation WiSE CRT System; EBR Systems Inc, WiSE CRT System; Endurance Rhythm Inc., Endurance Rhythm Micro-Generator; Hadasit Medical Research Services and Development Ltd, Aortic Pacemaker; Impulse Dynamics NV, Optimizer IVs System; Impulse Dynamics NV, Optimizer Smart; Imricor Medical Systems Inc, Magnetic Resonance Imaging (MRI) Compatible Lead; InnerPulse Inc (Inactive), InnerPulse Pacemaker; InnerPulse Inc (Inactive), PICD; Integer Holdings Corp, Cardiomonix; IRadimed Corp, MRI Defibrillator; Johns Hopkins University, Cardiac Arrhythmia Termination Device; Johns Hopkins University, Cardiac Sock Electrode And Implantable Defibrillator System; Johns Hopkins University, Implantable Cardioverter Defibrillator System; Johns Hopkins University, PrestoPatch Integrated Electrode System; Johns Hopkins University, QRSTee; Kenergy Inc., Unconditional MRI Compatible Implantable Defibrillator; Kenergy Inc., Unconditional MRI Compatible Implantable Pacemaker; Krisara Engineering, LLC, Wireless Pacemaker; LivaNova PLC , Beflex Brady Lead; LivaNova PLC , Nano Lead System; LivaNova PLC , NAVIGO 4LV 2D; LivaNova PLC , NAVIGO 4LV ARC; LivaNova PLC , NAVIGO 4LV PILOT; LivaNova PLC , Reply MRI Pacemaker; LivaNova PLC , SonR Tist Lead Positioning; LivaNova PLC , SonRFix Lead; LivaNova PLC , Tachy Lead; LivaNova PLC , Triple-Site Ventricular (Tri-V) Pacing CRT-D; LivaNova PLC , TX Brady Lead; Massachusetts General Hospital, Implantable Cardioverter Defibrillator - Ventricular Arrhythmias; Massachusetts General Hospital, Vagal Stimulation Device; Mathematical Bio-Solutions Inc., ECN Pacemaker; Max Planck Institute for Dynamics and Self-Organization, Implantable Defibrillator; Mayo Clinic, Atrial Fibrillation Device; Mayo Clinic, Pacemaker/ICD Lead; Medtronic plc, Amplia MRI Quad CRT-D SureScan System - Multiple Point Pacing; Medtronic plc, Attain Stability Quad MRI SureScan; Medtronic plc, Brady Wireless; Medtronic plc, Chronicle ICD; Medtronic plc, Claria MRI Quad CRT-D SureScan System - Multiple Point Pacing; Medtronic plc, EV-ICD System; Medtronic plc, Heart Pacemaker; Medtronic plc, LINQ II ICM; Medtronic plc, Micra AAIR Pacemaker; Medtronic plc, Micra DDDR Pacemaker; Medtronic plc, Micra VDDR Pacemaker; Medtronic plc, MRI Safe CRT-D; Medtronic plc, Reveal LINQ 2.0; MicroPort Scientific Corp, BonaFire - Active Pacing Lead; MicroPort Scientific Corp, BonaFire - Passive Pacing Lead; MicroPort Scientific Corp, Implantable Pulse Generator; MicroPort Scientific Corp, MicroPort Pacing Analyzer; MicroPort Scientific Corp, PARADYM RF SonR CRT-D; NanoLinea, CardioLinea; NDSU Research Foundation, Multi-Electrode Cardiac Pacing System; NewPace Ltd, The Implantable Subcutaneous String Defibrillator (ISSD); NuVascular Technologies Inc, Biological Pacemaker; Odem Medical Ltd, Epicardial Lead Delivery Tool; Odem Medical Ltd, Odem Device; Odem Medical Ltd, Pericardial Access Device; Ohio State University, Chronicle; Osypka Medical GmbH, PACE 300; Perpetuum Ltd., Implantable Self-Energising Pacemaker; Queen Mary University of London, Non-Invasive Device - Abnormal Heart Rhythm; Rice University, Battery-Less Pacemaker; Rice University, Second-Chance AED Pads; Rochester Institute of Technology, Catheter Guidance Algorithm; Seoul National University Hospital, Cardiac Stimulator; Shaanxi Qinming Medical Instruments Co Ltd, QM7211 Electrode; Shanghai MicroPort Medical Group Co Ltd, CompassAnalyzer; Silver Bullet Therapeutics, Inc., Galvanis Defibrillator/Pacemaker; Smartwave Medical Ltd (Inactive), Fully Automatic Implantable Atrial Defibrillator; Spectranetics Corp, Next Gen Lead Management (LM) Tool; St. Jude Medical LLC, Nanostim Leadless Pacemaker; St. Jude Medical LLC, Next Generation Confirm; St. Jude Medical LLC, Quadra Allure MP CRT-P - MRI Labeling; St. Jude Medical LLC, Quartet NXT - Double Blend Lead; St. Jude Medical LLC, Quartet NXT - Large S-Curve Lead; St. Jude Medical LLC, Quartet NXT - Small S-Curve Lead; St. Jude Medical LLC, Quartet Quadripolar LV Lead - MRI Labelling; SUNY Downstate Medical Center, Vagus Nerve Stimulator - Ventricular Arrhythmia; Teleflex Inc, Pacemaker Lead; TransWorld Med Corp, Soul Mate - Pacemaker; U.S. Stem Cell Inc, BioPace; University of Bern, Batteryless Cardiac Pacemaker; University of California Los Angeles, Cardiac Disease Monitoring Device; University of California Los Angeles, MR3 Next-Generation Pacemaker; University of Glasgow, Implantable Cardiac Monitor; University of Michigan, Cardiac Energy Harvesting Pacemaker; University of Southern California, Fetal Micro-Pacemaker; University of Utah, Blood Pressure Response Algorithm


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