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

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

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