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Pharmaceuticals and Healthcare » Medical Devices » Cardiovascular Devices

Cardiac Rhythm Management Devices - Medical Devices Pipeline Assessment, 2015

  • ID:RM00343094
  • Published: January-2016
  • Pages:393
  • GlobalData
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Cardiac Rhythm Management Devices - Medical Devices Pipeline Assessment, 2015

Summary

The author's Medical Devices sector report, Cardiac Rhythm Management Devices - Medical Devices Pipeline Assessment, 2015" 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 i........
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1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 5
1.2 List of Figures 14
2 Introduction 15
2.1 Cardiac Rhythm Management Devices Overview 15
3 Products under Development 17
3.1 Cardiac Rhythm Management Devices - Pipeline Products by Stage of Development 17
3.2 Cardiac Rhythm Management Devices - Pipeline Products by Segment 18
3.3 Cardiac Rhythm Management Devices - Pipeline Products by Territory 20
3.4 Cardiac Rhythm Management Devices - Pipeline Products by Regulatory Path 21
3.5 Cardiac Rhythm Management Devices - Pipeline Products by Estimated Approval Date 22
3.6 Cardiac Rhythm Management Devices - Ongoing Clinical Trials 24
4 Cardiac Rhythm Management Devices - Pipeline Products under Development by Companies 25
4.1 Cardiac Rhythm Management Devices Companies - Pipeline Products by Stage of Development 25
4.2 Cardiac Rhythm Management Devices - Pipeline Products by Stage of Development 27
5 Cardiac Rhythm Management Devices Companies and Product Overview 31
5.1 AI Medical Semiconductor Ltd. Company Overview 31
5.1.1 AI Medical Semiconductor Ltd. Pipeline Products & Ongoing Clinical Trials Overview 31
5.2 AIS Inc. Company Overview 33
5.2.1 AIS Inc. Pipeline Products & Ongoing Clinical Trials Overview 33
5.3 Biotronik SE & Co. KG Company Overview 34
5.3.1 Biotronik SE & Co. KG Pipeline Products & Ongoing Clinical Trials Overview 34
5.4 Boston Scientific Corporation Company Overview 45
5.4.1 Boston Scientific Corporation Pipeline Products & Ongoing Clinical Trials Overview 45
5.5 Boston TransTec, LLC Company Overview 76
5.5.1 Boston TransTec, LLC Pipeline Products & Ongoing Clinical Trials Overview 76
5.6 CardiaLen, Inc. Company Overview 78
5.6.1 CardiaLen, Inc. Pipeline Products & Ongoing Clinical Trials Overview 78
5.7 CVRx, Inc. Company Overview 80
5.7.1 CVRx, Inc. Pipeline Products & Ongoing Clinical Trials Overview 80
5.8 DHS Medical Company Overview 84
5.8.1 DHS Medical Pipeline Products & Ongoing Clinical Trials Overview 84
5.9 Duke University Company Overview 86
5.9.1 Duke University Pipeline Products & Ongoing Clinical Trials Overview 86
5.10 EBR Systems, Inc. Company Overview 88
5.10.1 EBR Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 88
5.11 Endurance Rhythm Inc. Company Overview 92
5.11.1 Endurance Rhythm Inc. Pipeline Products & Ongoing Clinical Trials Overview 92
5.12 Greatbatch, Inc. Company Overview 93
5.12.1 Greatbatch, Inc. Pipeline Products & Ongoing Clinical Trials Overview 93
5.13 Hadasit Medical Research Services & Development Ltd Company Overview 95
5.13.1 Hadasit Medical Research Services & Development Ltd Pipeline Products & Ongoing Clinical Trials Overview 95
5.14 Impulse Dynamics N.V. Company Overview 97
5.14.1 Impulse Dynamics N.V. Pipeline Products & Ongoing Clinical Trials Overview 97
5.15 Imricor Medical Systems, Inc. Company Overview 102
5.15.1 Imricor Medical Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 102
5.16 InnerPulse, Inc. Company Overview 103
5.16.1 InnerPulse, Inc. Pipeline Products & Ongoing Clinical Trials Overview 103
5.17 Kenergy Inc. Company Overview 105
5.17.1 Kenergy Inc. Pipeline Products & Ongoing Clinical Trials Overview 105
5.18 Krisara Engineering, LLC Company Overview 107
5.18.1 Krisara Engineering, LLC Pipeline Products & Ongoing Clinical Trials Overview 107
5.19 LifeWave Hi-Tech Medical Devices Ltd. Company Overview 108
5.19.1 LifeWave Hi-Tech Medical Devices Ltd. Pipeline Products & Ongoing Clinical Trials Overview 108
5.20 Mathematical Bio-Solutions Inc. Company Overview 110
5.20.1 Mathematical Bio-Solutions Inc. Pipeline Products & Ongoing Clinical Trials Overview 110
5.21 Mayo Clinic. Company Overview 111
5.21.1 Mayo Clinic. Pipeline Products & Ongoing Clinical Trials Overview 111
5.22 Medtronic plc Company Overview 115
5.22.1 Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 115
5.23 MicroPort Scientific Corporation Company Overview 126
5.23.1 MicroPort Scientific Corporation Pipeline Products & Ongoing Clinical Trials Overview 126
5.24 MRI Interventions, Inc Company Overview 130
5.24.1 MRI Interventions, Inc Pipeline Products & Ongoing Clinical Trials Overview 130
5.25 NanoLinea Company Overview 132
5.25.1 NanoLinea Pipeline Products & Ongoing Clinical Trials Overview 132
5.26 NDSU Research Foundation Company Overview 133
5.26.1 NDSU Research Foundation Pipeline Products & Ongoing Clinical Trials Overview 133
5.27 NuVascular Technologies Inc Company Overview 134
5.27.1 NuVascular Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 134
5.28 Odem Medical Ltd. Company Overview 135
5.28.1 Odem Medical Ltd. Pipeline Products & Ongoing Clinical Trials Overview 135
5.29 Perpetuum Ltd. Company Overview 138
5.29.1 Perpetuum Ltd. Pipeline Products & Ongoing Clinical Trials Overview 138
5.30 Queen Mary University of London Company Overview 139
5.30.1 Queen Mary University of London Pipeline Products & Ongoing Clinical Trials Overview 139
5.31 Rochester Institute of Technology Company Overview 140
5.31.1 Rochester Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 140
5.32 Semprus BioSciences Company Overview 141
5.32.1 Semprus BioSciences Pipeline Products & Ongoing Clinical Trials Overview 141
5.33 Smartwave Medical Ltd Company Overview 142
5.33.1 Smartwave Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 142
5.34 Sorin Group Italia S.r.l Company Overview 143
5.34.1 Sorin Group Italia S.r.l Pipeline Products & Ongoing Clinical Trials Overview 143
5.35 Sorin S.p.A. (Inactive) Company Overview 148
5.35.1 Sorin S.p.A. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 148
5.36 St. Jude Medical, Inc. Company Overview 174
5.36.1 St. Jude Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 174
5.37 The Johns Hopkins University Company Overview 189
5.37.1 The Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 189
5.38 The University of Utah Company Overview 197
5.38.1 The University of Utah Pipeline Products & Ongoing Clinical Trials Overview 197
5.39 TransWorld Med Corporation Company Overview 198
5.39.1 TransWorld Med Corporation Pipeline Products & Ongoing Clinical Trials Overview 198
5.40 U.S. Stem Cell, Inc. Company Overview 201
5.40.1 U.S. Stem Cell, Inc. Pipeline Products & Ongoing Clinical Trials Overview 201
5.41 University of Bern Company Overview 203
5.41.1 University of Bern Pipeline Products & Ongoing Clinical Trials Overview 203
5.42 University of California, Los Angeles Company Overview 204
5.42.1 University of California, Los Angeles Pipeline Products & Ongoing Clinical Trials Overview 204
5.43 University of Leicester Company Overview 205
5.43.1 University of Leicester Pipeline Products & Ongoing Clinical Trials Overview 205
5.44 University of Michigan Company Overview 206
5.44.1 University of Michigan Pipeline Products & Ongoing Clinical Trials Overview 206
6 Cardiac Rhythm Management Devices- Recent Developments 208
7 Appendix 390
7.1 Methodology 390
7.2 About The author 392
7.3 Contact Us 393
7.4 Disclaimer 393


List Of Tables

1.1 List of Tables
Table 1: Cardiac Rhythm Management Devices - Pipeline Products by Stage of Development 17
Table 2: Cardiac Rhythm Management Devices - Pipeline Products by Segment 19
Table 3: Cardiac Rhythm Management Devices - Pipeline Products by Territory 20
Table 4: Cardiac Rhythm Management Devices - Pipeline Products by Regulatory Path 21
Table 5: Cardiac Rhythm Management Devices - Pipeline Products by Estimated Approval Date 23
Table 6: Cardiac Rhythm Management Devices - Ongoing Clinical Trials 24
Table 7: Cardiac Rhythm Management Devices Companies - Pipeline Products by Stage of Development 25
Table 8: Cardiac Rhythm Management Devices - Pipeline Products by Stage of Development 27
Table 9: AI Medical Semiconductor Ltd. Pipeline Products & Ongoing Clinical Trials Overview 31
Table 10: Adaptive CRT And Vagal Stimulation Device - Product Status 32
Table 11: Adaptive CRT And Vagal Stimulation Device - Product Description 32
Table 12: AIS Inc. Pipeline Products & Ongoing Clinical Trials Overview 33
Table 13: Guardian - Product Status 33
Table 14: Guardian - Product Description 33
Table 15: Biotronik SE & Co. KG Pipeline Products & Ongoing Clinical Trials Overview 34
Table 16: ProMRI Iforia 5 HF-T ICD - Product Status 35
Table 17: ProMRI Iforia 5 HF-T ICD - Product Description 35
Table 18: ProMRI Iforia 5 Series DR-T ICD - Product Status 36
Table 19: ProMRI Iforia 5 Series DR-T ICD - Product Description 36
Table 20: ProMRI Iforia 5 VR-T DX ICD - Product Status 37
Table 21: ProMRI Iforia 5 VR-T DX ICD - Product Description 37
Table 22: ProMRI Iforia 5 VR-T ICD - Product Status 38
Table 23: ProMRI Iforia 5 VR-T ICD - Product Description 38
Table 24: ProMRI Iforia 7 DR-T ICD - Product Status 39
Table 25: ProMRI Iforia 7 DR-T ICD - Product Description 39
Table 26: ProMRI Iforia 7 HF-T ICD - Product Status 40
Table 27: ProMRI Iforia 7 HF-T ICD - Product Description 40
Table 28: ProMRI Iforia 7 VR-T DX ICD - Product Status 41
Table 29: ProMRI Iforia 7 VR-T DX ICD - Product Description 41
Table 30: ProMRI Iforia 7 VR-T ICD - Product Status 42
Table 31: ProMRI Iforia 7 VR-T ICD - Product Description 42
Table 32: Biotronik SE & Co. KG - Ongoing Clinical Trials Overview 43
Table 33: ProMRI Iforia 5 Series DR-T ICD - ProMRI 3T ENHANCED Master Study 44
Table 34: Boston Scientific Corporation Pipeline Products & Ongoing Clinical Trials Overview 45
Table 35: Acuity X4 Quad LV Lead - Product Status 47
Table 36: Acuity X4 Quad LV Lead - Product Description 47
Table 37: Autogen X4 CRT-D - Product Status 48
Table 38: Autogen X4 CRT-D - Product Description 48
Table 39: Brady MRI-Safe System - Product Status 49
Table 40: Brady MRI-Safe System - Product Description 49
Table 41: EMBLEM MRI S-ICD System - Product Status 50
Table 42: EMBLEM MRI S-ICD System - Product Description 50
Table 43: EMBLEM S-ICD - Product Status 51
Table 44: EMBLEM S-ICD - Product Description 51
Table 45: ENDOTAK RELIANCE 4-SITE Defibrillation Lead System - Product Status 52
Table 46: ENDOTAK RELIANCE 4-SITE Defibrillation Lead System - Product Description 52
Table 47: HF Multi-Sensor - Product Status 53
Table 48: HF Multi-Sensor - Product Description 53
Table 49: ImageReady Pacing System - Product Status 54
Table 50: ImageReady Pacing System - Product Description 54
Table 51: INGENIO 2 PG - MICS - Product Status 55
Table 52: INGENIO 2 PG - MICS - Product Description 55
Table 53: INGEVITY Pacing Lead - Product Status 56
Table 54: INGEVITY Pacing Lead - Product Description 56
Table 55: MRI Compatible S-ICD - Product Status 57
Table 56: MRI Compatible S-ICD - Product Description 57
Table 57: Next Generation ICD Lead - Product Status 58
Table 58: Next Generation ICD Lead - Product Description 58
Table 59: Next Generation ICD/CRT-D - Product Status 59
Table 60: Next Generation ICD/CRT-D - Product Description 59
Table 61: Next Generation Quad Polar CRT-D - Product Status 60
Table 62: Next Generation Quad Polar CRT-D - Product Description 60
Table 63: NG3 Non Quad System - Product Status 61
Table 64: NG3 Non Quad System - Product Description 61
Table 65: Reliance 4-Front Lead - Product Status 62
Table 66: Reliance 4-Front Lead - Product Description 62
Table 67: S-ICD System 1.5 - Product Status 63
Table 68: S-ICD System 1.5 - Product Description 63
Table 69: S-ICD System 2.0 - Product Status 64
Table 70: S-ICD System 2.0 - Product Description 64
Table 71: Temporary RV VVI pacing - Product Status 65
Table 72: Temporary RV VVI pacing - Product Description 65
Table 73: VITALITY NXT Defibrillator - Product Status 66
Table 74: VITALITY NXT Defibrillator - Product Description 66
Table 75: X4 SYSTEM + QUAD LEAD - Product Status 67
Table 76: X4 SYSTEM + QUAD LEAD - Product Description 67
Table 77: Boston Scientific Corporation - Ongoing Clinical Trials Overview 68
Table 78: ENDOTAK RELIANCE 4-SITE Defibrillation Lead System - Longitudinal Surveillance Study of the 4-SITE Lead/Header System 69
Table 79: INGENIO 2 PG - MICS - Optimizing Pacing Therapy by Using Multi-Programmable Pulse Generators for Cardiac Resynchronization Pacing (CRT-P) 70
Table 80: INGEVITY Pacing Lead - INGEVITY Active Fixation and Passive Fixation Pace/ Sense Lead Clinical Study 71
Table 81: INGEVITY Pacing Lead - INGEVITY Observational Trial: Assessment of Routine Experience and Magnet Resonance Imaging (Mri) Usage with a New Lead for Bradycardia Pacing 71
Table 82: Reliance 4-Front Lead - Evaluation of Acuity X4 Quadripolar Coronary Venous Leads and Reliance 4-Front Defibrillation Leads: NAVIGATE X4 72
Table 83: Reliance 4-Front Lead - Reliance 4-Front Active Fixation Defibrillation Lead Post Market Clinical Follow-Up (PMCF) Study 72
Table 84: Reliance 4-Front Lead - RELIANCE 4-FRONT Passive Fixation Defibrillation Lead Post Market Clinical Follow-Up (PMCF) Study 72
Table 85: Autogen X4 CRT-D - Capture Information Via Automatic Threshold Evaluation 73
Table 86: Acuity X4 Quad LV Lead - Evaluation of Acuity X4 Quadripolar Coronary Venous Leads and Reliance 4-Front Defibrillation Leads: NAVIGATE X4 74
Table 87: Acuity X4 Quad LV Lead - Maximizing CRT Delivery by Using Multipolar Coronary Sinus Lead Family ACUITY X4 74
Table 88: EMBLEM S-ICD - Understanding Outcomes with the EMBLEM S-ICD in Primary Prevention Patients with Low Ejection Fraction 75
Table 89: Boston TransTec, LLC Pipeline Products & Ongoing Clinical Trials Overview 76
Table 90: Raul Pacemaker - Product Status 77
Table 91: Raul Pacemaker - Product Description 77
Table 92: CardiaLen, Inc. Pipeline Products & Ongoing Clinical Trials Overview 78
Table 93: CardiaLen Device - Atrial Fibrillation - Product Status 78
Table 94: CardiaLen Device - Atrial Fibrillation - Product Description 78
Table 95: CardiaLen Device - Ventricular Arrhythmia - Product Status 79
Table 96: CardiaLen Device - Ventricular Arrhythmia - Product Description 79
Table 97: CVRx, Inc. Pipeline Products & Ongoing Clinical Trials Overview 80
Table 98: Barostim neo - Heart Failure - Product Status 81
Table 99: Barostim neo - Heart Failure - Product Description 81
Table 100: CVRx, Inc. - Ongoing Clinical Trials Overview 82
Table 101: Barostim neo - Heart Failure - Baroreflex Activation Therapy for Heart Failure Pivotal Clinical Trial (BeAT-HF) 83
Table 102: Barostim neo - Heart Failure - Baroreflex Activation Therapy in Heart Failure 83
Table 103: Barostim neo - Heart Failure - Barostim HOPE4HF Study 83
Table 104: DHS Medical Pipeline Products & Ongoing Clinical Trials Overview 84
Table 105: Drimmer - Product Status 84
Table 106: Drimmer - Product Description 84
Table 107: Twistek - Product Status 85
Table 108: Twistek - Product Description 85
Table 109: Duke University Pipeline Products & Ongoing Clinical Trials Overview 86
Table 110: Tissue-Engineered Autonomous Pacemaker - Product Status 87
Table 111: Tissue-Engineered Autonomous Pacemaker - Product Description 87
Table 112: EBR Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 88
Table 113: Second Generation Wireless Pacing System - Product Status 88
Table 114: Second Generation Wireless Pacing System - Product Description 88
Table 115: WiSE System - Product Status 89
Table 116: WiSE System - Product Description 89


List of Figures

1.2 List of Figures
Figure 1: Cardiac Rhythm Management Devices - Pipeline Products by Stage of Development 17
Figure 2: Cardiac Rhythm Management Devices - Pipeline Products by Segment 18
Figure 3: Cardiac Rhythm Management Devices - Pipeline Products by Territory 20
Figure 4: Cardiac Rhythm Management Devices - Pipeline Products by Regulatory Path 21
Figure 5: Cardiac Rhythm Management Devices - Pipeline Products by Estimated Approval Date 22
Figure 6: Cardiac Rhythm Management Devices - Ongoing Clinical Trials 24

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