Published : Sep-2017
No. of Pages : 135
1 Table of Contents 2
1.1 List of Tables 5
1.2 List of Figures 7
2 Introduction 8
2.1 Cardiac Pacemakers Overview 8
3 Products under Development 9
3.1 Cardiac Pacemakers - Pipeline Products by Stage of Development 9
3.2 Cardiac Pacemakers - Pipeline Products by Segment 10
3.3 Cardiac Pacemakers - Pipeline Products by Territory 11
3.4 Cardiac Pacemakers - Pipeline Products by Regulatory Path 12
3.5 Cardiac Pacemakers - Pipeline Products by Estimated Approval Date 13
3.6 Cardiac Pacemakers - Ongoing Clinical Trials 14
4 Cardiac Pacemakers - Pipeline Products under Development by Companies 15
4.1 Cardiac Pacemakers Companies - Pipeline Products by Stage of Development 15
4.2 Cardiac Pacemakers - Pipeline Products by Stage of Development 17
5 Cardiac Pacemakers Companies and Product Overview 18
5.1 BackBeat Medical, Inc. Company Overview 18
5.1.1 BackBeat Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 18
5.2 Ben-Gurion University of the Negev Company Overview 21
5.2.1 Ben-Gurion University of the Negev Pipeline Products & Ongoing Clinical Trials Overview 21
5.3 Boston Scientific Corp Company Overview 22
5.3.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 22
5.4 Boston TransTec LLC Company Overview 24
5.4.1 Boston TransTec LLC Pipeline Products & Ongoing Clinical Trials Overview 24
5.5 Columbia University Company Overview 25
5.5.1 Columbia University Pipeline Products & Ongoing Clinical Trials Overview 25
5.6 Duke University Company Overview 26
5.6.1 Duke University Pipeline Products & Ongoing Clinical Trials Overview 26
5.7 EBR Systems Inc Company Overview 27
5.7.1 EBR Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 27
5.8 Hadasit Medical Research Services and Development Ltd Company Overview 32
5.8.1 Hadasit Medical Research Services and Development Ltd Pipeline Products & Ongoing Clinical Trials Overview 32
5.9 InnerPulse, Inc. Company Overview 33
5.9.1 InnerPulse, Inc. Pipeline Products & Ongoing Clinical Trials Overview 33
5.10 Kenergy Inc. Company Overview 34
5.10.1 Kenergy Inc. Pipeline Products & Ongoing Clinical Trials Overview 34
5.11 Krisara Engineering, LLC Company Overview 35
5.11.1 Krisara Engineering, LLC Pipeline Products & Ongoing Clinical Trials Overview 35
5.12 Lifetech Scientific (Shenzhen) Co Ltd Company Overview 36
5.12.1 Lifetech Scientific (Shenzhen) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 36
5.13 LivaNova PLC Company Overview 37
5.13.1 LivaNova PLC Pipeline Products & Ongoing Clinical Trials Overview 37
5.14 Mathematical Bio-Solutions Inc. Company Overview 44
5.14.1 Mathematical Bio-Solutions Inc. Pipeline Products & Ongoing Clinical Trials Overview 44
5.15 Mayo Clinic US Company Overview 45
5.15.1 Mayo Clinic US Pipeline Products & Ongoing Clinical Trials Overview 45
5.16 Medtronic plc Company Overview 46
5.16.1 Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 46
5.17 MicroPort Scientific Corp Company Overview 50
5.17.1 MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 50
5.18 NDSU Research Foundation Company Overview 52
5.18.1 NDSU Research Foundation Pipeline Products & Ongoing Clinical Trials Overview 52
5.19 NuVascular Technologies Inc Company Overview 53
5.19.1 NuVascular Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 53
5.20 Osypka Medical GmbH Company Overview 54
5.20.1 Osypka Medical GmbH Pipeline Products & Ongoing Clinical Trials Overview 54
5.21 Perpetuum Ltd. Company Overview 55
5.21.1 Perpetuum Ltd. Pipeline Products & Ongoing Clinical Trials Overview 55
5.22 Rice University Company Overview 56
5.22.1 Rice University Pipeline Products & Ongoing Clinical Trials Overview 56
5.23 St. Jude Medical LLC Company Overview 57
5.23.1 St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 57
5.24 U.S. Stem Cell Inc Company Overview 60
5.24.1 U.S. Stem Cell Inc Pipeline Products & Ongoing Clinical Trials Overview 60
5.25 University of Bern Company Overview 61
5.25.1 University of Bern Pipeline Products & Ongoing Clinical Trials Overview 61
5.26 University of California Los Angeles Company Overview 62
5.26.1 University of California Los Angeles Pipeline Products & Ongoing Clinical Trials Overview 62
5.27 University of Michigan Company Overview 63
5.27.1 University of Michigan Pipeline Products & Ongoing Clinical Trials Overview 63
6 Cardiac Pacemakers - Recent Developments 64
6.1 Aug 22, 2017: Medtronic Reports First Quarter Financial Results 64
6.2 Aug 17, 2017: First Leadless Pacemaker has been inserted at Peninsula Private Hospital 66
6.3 Aug 17, 2017: First Leadless Pacemaker has been inserted at Peninsula Private Hospital 66
6.4 Aug 09, 2017: LivaNova Reports Second Quarter 2017 Results 67
6.5 Jul 27, 2017: Boston Scientific Announces Results for Second Quarter 2017 68
6.6 Jul 27, 2017: Integer Holdings Reports Second Quarter 2017 Results 70
6.7 Jul 17, 2017: Integer Announces Appointment of Joseph W. Dziedzic as President and Chief Executive Officer 71
6.8 Jun 27, 2017: Boston Scientific Outlines Strategy for Sustained Growth at 2017 Investor Day 71
6.9 Jun 20, 2017: EBR Systems Awarded Favorite Innovation for WiSE CRT at 2017 EHRA Europace Cardiostim Congress 73
6.10 Jun 19, 2017: Europace-Cardiostim 2017: Challenges and New Opportunities in Heart Failure Management 74
6.11 Jun 12, 2017: LivaNova Appoints Keyna Skeffington as Senior Vice President and General Counsel 75
6.12 Jun 05, 2017: Rice University: Texas team debuts battery-less pacemaker 75
6.13 May 25, 2017: Medtronic Reports Fourth Quarter and Fiscal Year 2017 Financial Results 76
6.14 May 18, 2017: World's smallest, leadless pacemaker yields positive results in Emory-led study 79
6.15 May 16, 2017: LivaNova Announces Thad Huston as Chief Financial Officer 80
6.16 May 11, 2017: New Medtronic Study Reinforces Safety and Performance of the World's Smallest Pacemaker in a Real-World Patient Population 80
6.17 May 10, 2017: Battery-free implantable medical device draws energy directly from human body 82
6.18 May 08, 2017: Integer Holdings Reports First Quarter 2017 Results 83
6.19 May 03, 2017: LivaNova Reports First Quarter 2017 Results 84
6.20 Apr 27, 2017: Boston Scientific Announces Results For First Quarter 2017 85
6.21 Mar 31, 2017: LivaNova Announces Chief Financial Officer Resignation 86
6.22 Mar 31, 2017: LivaNova Reiterates Full-Year 2017 Guidance 87
6.23 Mar 27, 2017: Integer Announces Leadership Change 87
6.24 Mar 20, 2017: BIOTRONIK Launches its Smallest and Lightest MR-Conditional Pacemakers and a New Range of Quadripolar CRT-Ps with MRI AutoDetect 88
6.25 Mar 16, 2017: Nynex Therapeutics Launched to Target Oncogenic Proteins in the Treatment of Cancer 88
6.26 Mar 10, 2017: Medtronic Announces Medicare Reimbursement for the First and Only Leadless Pacemaker Available for Use in the U.S. 89
6.27 Mar 01, 2017: LivaNova Reports Fourth Quarter and Full-Year 2016 Results 90
6.28 Feb 27, 2017: Gary Haire to Join Integer as Executive Vice President and Chief Financial Officer 93
6.29 Feb 27, 2017: Integer Holdings Reports Results for Fourth Quarter and Full Year 2016 94
6.30 Feb 23, 2017: LivaNova Announces Its Intent to Delist from London Stock Exchange 96
6.31 Feb 21, 2017: Medtronic Reports Third Quarter Financial Results 97
6.32 Feb 20, 2017: World's Smallest Pacemaker Available to Wake Forest Baptist Patients 99
6.33 Feb 17, 2017: Medtronic Announces Japanese Regulatory Approval For Micra Transcatheter Pacing System 100
6.34 Feb 06, 2017: Medtronic Awarded U.S. Department of Veterans Affairs National Contracts for Home Telehealth Technologies, with Three Other Vendors 101
6.35 Feb 02, 2017: Boston Scientific Announces Results For Fourth Quarter And Full Year Ended December 31, 2016 102
6.36 Feb 01, 2017: Abbott Announces U.S. Approval for its Assurity MRI Pacemaker, the World's Smallest, Longest-Lasting Wireless MRI-Compatible Pacemaker 103
6.37 Jan 26, 2017: Medtronic Announces Medicare Coverage Decision for the First and Only Leadless Pacemaker Available for Use in the U.S. 104
6.38 Nov 29, 2016: Clinical Data for BackBeat Medical's Programmable Hypertension Control Therapy to Be Presented at ICI Meeting 2016 105
6.39 Nov 22, 2016: Medtronic Reports Second Quarter Financial Results 106
6.40 Nov 16, 2016: Medtronic Releases FY16 Integrated Performance Report 108
6.41 Nov 15, 2016: CEVA to work with Medtronic for distribution facility construction 109
6.42 Nov 02, 2016: LivaNova Announces CEO Transition: Damien McDonald to Succeed Andre-Michel Ballester 110
6.43 Nov 02, 2016: LivaNova Reports Third Quarter 2016 Results 110
6.44 Oct 31, 2016: BackBeat Medical Clinical Data Presented at TCT 2016 Show Continued Reduction in Blood Pressure Over One Year with Cardiac Pacing-Based Hypertension Treatment 112
6.45 Oct 26, 2016: Clinical Data for BackBeat Medical's Programmable Hypertension Control Therapy to Be Presented at TCT 2016 112
6.46 Oct 26, 2016: Boston Scientific Announces Results For Third Quarter 2016 113
6.47 Oct 26, 2016: Nihon Kohden Announces Consolidation and Relocation of Offices 114
6.48 Oct 22, 2016: World's Smallest Pacemaker Licenced for Canadian Patients 115
6.49 Oct 19, 2016: St. Jude Medical Reports Third Quarter 2016 Results 116
6.50 Oct 13, 2016: Medtronic Cardiac Devices Gain FDA Approval to Enable Patient Access to the Most Advanced Diagnostic Imaging 118
6.51 Oct 10, 2016: Professor Ian Meredith To Join Boston Scientific As Executive Vice President And Global Chief Medical Officer 119
6.52 Sep 29, 2016: BIOTRONIK Begins Manufacturing High-Tech Products in Singapore 119
6.53 Sep 29, 2016: LivaNova Announces Half-Year Financial Report 120
6.54 Sep 15, 2016: Medtronic Names Mark Ploof Senior Vice President of Global Operations and Business Services 128
6.55 Sep 13, 2016: EBR Systems Receives FDA Approval to Begin U.S. Pivotal Study of Wireless Cardiac Pacing System for Heart Failure 129
7 Appendix 132
7.1 Methodology 132
7.2 About GlobalData 135
7.3 Contact Us 135
7.4 Disclaimer 135
1.1 List of Tables
Table 1: Cardiac Pacemakers - Pipeline Products by Stage of Development 9
Table 2: Cardiac Pacemakers - Pipeline Products by Segment 10
Table 3: Cardiac Pacemakers - Pipeline Products by Territory 11
Table 4: Cardiac Pacemakers - Pipeline Products by Regulatory Path 12
Table 5: Cardiac Pacemakers - Pipeline Products by Estimated Approval Date 13
Table 6: Cardiac Pacemakers - Ongoing Clinical Trials 14
Table 7: Cardiac Pacemakers Companies - Pipeline Products by Stage of Development 15
Table 8: Cardiac Pacemakers - Pipeline Products by Stage of Development 17
Table 9: BackBeat Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 18
Table 10: Moderato - Product Status 18
Table 11: Moderato - Product Description 18
Table 12: BackBeat Medical, Inc. - Ongoing Clinical Trials Overview 19
Table 13: 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 20
Table 14: Moderato - Clinical Evaluation of Safety and Effectiveness of the BackBeat Medical Moderato System in Patients with Hypertension: A Double-blind Randomized Trial 20
Table 15: Moderato - Clinical Evaluation of Safety and Performance of the BackBeat Moderato System 20
Table 16: Ben-Gurion University of the Negev Pipeline Products & Ongoing Clinical Trials Overview 21
Table 17: Heart Pacing System - Product Status 21
Table 18: Heart Pacing System - Product Description 21
Table 19: Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 22
Table 20: EMPOWER Modular Pacing System - Product Status 22
Table 21: EMPOWER Modular Pacing System - Product Description 22
Table 22: INGENIO 2 PG - MICS - Product Status 23
Table 23: INGENIO 2 PG - MICS - Product Description 23
Table 24: Boston TransTec LLC Pipeline Products & Ongoing Clinical Trials Overview 24
Table 25: Raul Pacemaker - Product Status 24
Table 26: Raul Pacemaker - Product Description 24
Table 27: Columbia University Pipeline Products & Ongoing Clinical Trials Overview 25
Table 28: Biological Pacemaker - Product Status 25
Table 29: Biological Pacemaker - Product Description 25
Table 30: Duke University Pipeline Products & Ongoing Clinical Trials Overview 26
Table 31: Tissue-Engineered Autonomous Pacemaker - Product Status 26
Table 32: Tissue-Engineered Autonomous Pacemaker - Product Description 26
Table 33: EBR Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 27
Table 34: Second Generation WiSE CRT System - Product Status 27
Table 35: Second Generation WiSE CRT System - Product Description 27
Table 36: WiSE CRT System - Product Status 28
Table 37: WiSE CRT System - Product Description 28
Table 38: EBR Systems Inc - Ongoing Clinical Trials Overview 29
Table 39: WiSE CRT System - Multicenter, Prospective Evaluation of Safety and Performance of the WiCS-LV System in Patients Indicated for Cardiac Resynchronization Therapy 30
Table 40: WiSE CRT System - WiCS-LV Post Market Surveillance Registry 30
Table 41: Second Generation WiSE CRT System - Stimulation of the Left Ventricle Endocardially-CRT study (SOLVE-CRT) 31
Table 42: Hadasit Medical Research Services and Development Ltd Pipeline Products & Ongoing Clinical Trials Overview 32
Table 43: Aortic Pacemaker - Product Status 32
Table 44: Aortic Pacemaker - Product Description 32
Table 45: InnerPulse, Inc. Pipeline Products & Ongoing Clinical Trials Overview 33
Table 46: InnerPulse Pacemaker - Product Status 33
Table 47: InnerPulse Pacemaker - Product Description 33
Table 48: Kenergy Inc. Pipeline Products & Ongoing Clinical Trials Overview 34
Table 49: Unconditional MRI Compatible Implantable Pacemaker - Product Status 34
Table 50: Unconditional MRI Compatible Implantable Pacemaker - Product Description 34
Table 51: Krisara Engineering, LLC Pipeline Products & Ongoing Clinical Trials Overview 35
Table 52: Wireless Pacemaker - Product Status 35
Table 53: Wireless Pacemaker - Product Description 35
Table 54: Lifetech Scientific (Shenzhen) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 36
Table 55: HeartTone - Product Status 36
Table 56: HeartTone - Product Description 36
Table 57: LivaNova PLC Pipeline Products & Ongoing Clinical Trials Overview 37
Table 58: KORA 100 Pacing System - Product Status 37
Table 59: KORA 100 Pacing System - Product Description 38
Table 60: REPLY 200 DR - Product Status 38
Table 61: REPLY 200 DR - Product Description 38
Table 62: REPLY 200 SR - Product Status 39
Table 63: REPLY 200 SR - Product Description 39
Table 64: Reply MRI Pacemaker - Product Status 39
Table 65: Reply MRI Pacemaker - Product Description 40
Table 66: LivaNova PLC - Ongoing Clinical Trials Overview 41
Table 67: REPLY 200 SR - Sustainability of Cardiology Services: Economic Evaluation and Communication in Remote Monitoring of People with Pacemakers 42
Table 68: REPLY 200 DR - Sustainability of Cardiology Services: Economic Evaluation and Communication in Remote Monitoring of People with Pacemakers 43
Table 69: Mathematical Bio-Solutions Inc. Pipeline Products & Ongoing Clinical Trials Overview 44
Table 70: ECN Pacemaker - Product Status 44
Table 71: ECN Pacemaker - Product Description 44
Table 72: Mayo Clinic US Pipeline Products & Ongoing Clinical Trials Overview 45
Table 73: Temporary Epicardial Pacemaker - Product Status 45
Table 74: Temporary Epicardial Pacemaker - Product Description 45
Table 75: Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 46
Table 76: Azure Pacemaker - Product Status 46
Table 77: Azure Pacemaker - Product Description 46
Table 78: Brady Wireless - Product Status 47
Table 79: Brady Wireless - Product Description 47
Table 80: Heart Pacemaker - Product Status 47
Table 81: Heart Pacemaker - Product Description 47
Table 82: Micra AAIR Pacemaker - Product Status 48
Table 83: Micra AAIR Pacemaker - Product Description 48
Table 84: Micra DDDR Pacemaker - Product Status 48
Table 85: Micra DDDR Pacemaker - Product Description 49
Table 86: Micra VDDR Pacemaker - Product Status 49
Table 87: Micra VDDR Pacemaker - Product Description 49
Table 88: MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 50
Table 89: Implantable Pulse Generator - Product Status 50
Table 90: Implantable Pulse Generator - Product Description 50
Table 91: MicroPort Pacemaker - Product Status 51
Table 92: MicroPort Pacemaker - Product Description 51
Table 93: NDSU Research Foundation Pipeline Products & Ongoing Clinical Trials Overview 52
Table 94: Multi-Electrode Cardiac Pacing System - Product Status 52
Table 95: Multi-Electrode Cardiac Pacing System - Product Description 52
Table 96: NuVascular Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 53
Table 97: Biological Pacemaker - Product Status 53
Table 98: Biological Pacemaker - Product Description 53
Table 99: Osypka Medical GmbH Pipeline Products & Ongoing Clinical Trials Overview 54
Table 100: PACE 300 - Product Status 54
Table 101: PACE 300 - Product Description 54
Table 102: Perpetuum Ltd. Pipeline Products & Ongoing Clinical Trials Overview 55
Table 103: Implantable Self-Energising Pacemaker - Product Status 55
Table 104: Implantable Self-Energising Pacemaker - Product Description 55
Table 105: Rice University Pipeline Products & Ongoing Clinical Trials Overview 56
Table 106: Battery-Less Pacemaker - Product Status 56
Table 107: Battery-Less Pacemaker - Product Description 56
Table 108: St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 57
Table 109: Nanostim Leadless Pacemaker - Product Status 57
Table 110: Nanostim Leadless Pacemaker - Product Description 57
Table 111: St. Jude Medical LLC - Ongoing Clinical Trials Overview 58
Table 112: Nanostim Leadless Pacemaker - Nanostim Study for a Leadless Cardiac Pacemaker System 59
Table 113: U.S. Stem Cell Inc Pipeline Products & Ongoing Clinical Trials Overview 60
Table 114: BioPace - Product Status 60
Table 115: BioPace - Product Description 60
Table 116: University of Bern Pipeline Products & Ongoing Clinical Trials Overview 61
Table 117: Batteryless Cardiac Pacemaker - Product Status 61
Table 118: Batteryless Cardiac Pacemaker - Product Description 61
Table 119: University of California Los Angeles Pipeline Products & Ongoing Clinical Trials Overview 62
Table 120: MR3 Next-Generation Pacemaker - Product Status 62
Table 121: MR3 Next-Generation Pacemaker - Product Description 62
Table 122: University of Michigan Pipeline Products & Ongoing Clinical Trials Overview 63
Table 123: Cardiac Energy Harvesting Pacemaker - Product Status 63
Table 124: Cardiac Energy Harvesting Pacemaker - Product Description 63
Table 125: Glossary 134
1.2 List of Figures
Figure 1: Cardiac Pacemakers - Pipeline Products by Stage of Development 9
Figure 2: Cardiac Pacemakers - Pipeline Products by Segment 10
Figure 3: Cardiac Pacemakers - Pipeline Products by Territory 11
Figure 4: Cardiac Pacemakers - Pipeline Products by Regulatory Path 12
Figure 5: Cardiac Pacemakers - Pipeline Products by Estimated Approval Date 13
Figure 6: Cardiac Pacemakers - Ongoing Clinical Trials 14
