Implantable Cardioverter Defibrillators (ICD) - Medical Devices Pipeline Assessment, 2016
SKU ID :GD-10160237 | Published Date: 01-May-2016 | No. of pages: 119Description
TOC
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 5
1.2 List of Figures 7
2 Introduction 8
2.1 Implantable Cardioverter Defibrillators (ICD) Overview 8
3 Products under Development 9
3.1 Implantable Cardioverter Defibrillators (ICD) - Pipeline Products by Stage of Development 9
3.2 Implantable Cardioverter Defibrillators (ICD) - Pipeline Products by Segment 10
3.3 Implantable Cardioverter Defibrillators (ICD) - Pipeline Products by Territory 11
3.4 Implantable Cardioverter Defibrillators (ICD) - Pipeline Products by Regulatory Path 12
3.5 Implantable Cardioverter Defibrillators (ICD) - Pipeline Products by Estimated Approval Date 13
3.6 Implantable Cardioverter Defibrillators (ICD) - Ongoing Clinical Trials 14
4 Implantable Cardioverter Defibrillators (ICD) - Pipeline Products under Development by Companies 15
4.1 Implantable Cardioverter Defibrillators (ICD) Companies - Pipeline Products by Stage of Development 15
4.2 Implantable Cardioverter Defibrillators (ICD) - Pipeline Products by Stage of Development 16
5 Implantable Cardioverter Defibrillators (ICD) Companies and Product Overview 17
5.1 AIS Inc. Company Overview 17
5.1.1 AIS Inc. Pipeline Products & Ongoing Clinical Trials Overview 17
5.2 Biotronik SE & Co. KG Company Overview 18
5.2.1 Biotronik SE & Co. KG Pipeline Products & Ongoing Clinical Trials Overview 18
5.3 Boston Scientific Corporation Company Overview 29
5.3.1 Boston Scientific Corporation Pipeline Products & Ongoing Clinical Trials Overview 29
5.4 CardiaLen, Inc. Company Overview 38
5.4.1 CardiaLen, Inc. Pipeline Products & Ongoing Clinical Trials Overview 38
5.5 InnerPulse, Inc. Company Overview 40
5.5.1 InnerPulse, Inc. Pipeline Products & Ongoing Clinical Trials Overview 40
5.6 Kenergy Inc. Company Overview 41
5.6.1 Kenergy Inc. Pipeline Products & Ongoing Clinical Trials Overview 41
5.7 Max Planck Institute for Dynamics and Self-Organization Company Overview 42
5.7.1 Max Planck Institute for Dynamics and Self-Organization Pipeline Products & Ongoing Clinical Trials Overview 42
5.8 Medtronic plc Company Overview 43
5.8.1 Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 43
5.9 Smartwave Medical Ltd Company Overview 47
5.9.1 Smartwave Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 47
5.10 The Johns Hopkins University Company Overview 48
5.10.1 The Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 48
5.11 University of Leicester Company Overview 52
5.11.1 University of Leicester Pipeline Products & Ongoing Clinical Trials Overview 52
6 Implantable Cardioverter Defibrillators (ICD)- Recent Developments 54
6.1 Apr 25, 2016: Philips' First Quarter Results 2016 54
6.2 Apr 20, 2016: Boston Scientific Announces CE Mark For MRI Labeling Of Emblem S-ICD Systems 55
6.3 Apr 20, 2016: Boston Scientific Announces CE Mark For MRI Labeling Of Emblem S-ICD Systems 56
6.4 Apr 13, 2016: Nihon Kohden Evolves Brand, Website to Meet Needs of Changing Healthcare Environment 56
6.5 Apr 06, 2016: Medtronic Statement on U.S. Department of Treasury's Recent Temporary and Proposed Regulations 57
6.6 Mar 17, 2016: Medtronic Proposes Proxy Access 57
6.7 Mar 10, 2016: Philips meets stringent U.S. government security requirements for pathology medical data 57
6.8 Mar 09, 2016: Management Changes at ZOLL Signal Stable Leadership and Steady Growth 58
6.9 Mar 01, 2016: Medtronic Reports Third Quarter Financial Results 59
6.10 Feb 22, 2016: Philips to introduce next-generation monitoring solution enabled by wearable biosensors 60
6.11 Feb 19, 2016: Medtronic to Announce Financial Results for Its Third Quarter of Fiscal Year 2016 61
6.12 Feb 11, 2016: BIOTRONIK Announces CE Approval for new series of ICDs and CRT-Ds with MRI AutoDetect 61
6.13 Feb 03, 2016: Nihon Kohden America Receives Great Place to Work Certification 62
6.14 Jan 27, 2016: CONMED Announces Fourth Quarter and Fiscal Year 2015 Financial Results 62
6.15 Jan 11, 2016: Medtronic Updates Capital Allocation Plans and Fiscal 2016 EPS Guidance 63
6.16 Jan 11, 2016: HeartWare International Provides Corporate Updates And Announces Preliminary Revenue For Fourth Quarter 2015 64
6.17 Jan 05, 2016: Philips wants you to be the picture of health: showcases cloud-based technologies for every stage of life at CES 65
6.18 Dec 22, 2015: FDA Approves BIOTRONIK Iperia ICD Systems with Full-Body ProMRI Technology 66
6.19 Dec 21, 2015: Medtronic Receives First Health Canada License for MRI Conditional Implantable Cardioverter Defibrillator System 67
6.20 Dec 14, 2015: The Medtronic Bakken Invitation Award Honors 12 Patients from Around the World for Giving Back 68
6.21 Nov 23, 2015: Philips partnership with the RSNA Research & Education Foundation awards more than 110 grant recipients since 1991 69
6.22 Nov 20, 2015: Medtronic Statement on U.S. Department of Treasury's Notice 2015-79 70
6.23 Nov 02, 2015: LivaNova Announces the Launch of the PLATINIUM ICD & CRT-D Family Providing the World’s Longest Projected Longevity 70
6.24 Oct 30, 2015: Nearly 500 Hospitals Pay United States More Than $250 Million to Resolve False Claims Act Allegations Related to Implantation of Cardiac Devices 71
6.25 Oct 29, 2015: HeartWare International Reports Third Quarter 2015 Results 72
6.26 Oct 21, 2015: CONMED Announces Third Quarter 2015 Financial Results 73
6.27 Oct 01, 2015: World’s First and Only ICD Offering 3 Tesla MRI Access Launched in Japan 74
6.28 Sep 28, 2015: Medtronic InFuse Lawsuit May Reach Supreme Court, Parker Waichman LLP Comments 75
6.29 Sep 15, 2015: Philips provides update on its performance trajectory and strategy to capture the opportunities in the HealthTech market at its Capital Markets Day 75
6.30 Sep 14, 2015: Medtronic First To Receive FDA Approval For MR-Conditional Implantable Cardioverter Defibrillator System 76
6.31 Sep 13, 2015: Physio-Control to Acquire HeartSine Technologies 77
6.32 Sep 10, 2015: Sorin and Cyberonics Announce Appointment of LivaNova’s Chief Financial Officer 77
6.33 Sep 08, 2015: No Further Legal Action By Italian State's Attorney To Enjoin The Combination Of Sorin And Cyberonics 77
6.34 Sep 04, 2015: NORDIC ICD Trial Calls Defibrillation Testing during ICD Implantation into Question 78
6.35 Sep 03, 2015: Medtronic Reports First Quarter Financial Results 78
6.36 Sep 03, 2015: Philips introduces personal health programs at IFA in Berlin 81
6.37 Sep 02, 2015: Philips Healthcare Receives DOD Contract For Biomedical Equipment 82
6.38 Aug 31, 2015: Medtronic Study Detects Gene Associated with Sudden Cardiac Death 82
6.39 Aug 09, 2015: Philips Healthcare India Plans To Invest $60m To Double Production Capacity At Pune Facility 83
6.40 Aug 07, 2015: Financial Results for the First Quarter of Fiscal Year Ending March 31, 2016 84
6.41 Jul 31, 2015: Consolidated Financial Results for the 1st Quarter of the Fiscal Year Ending March 31, 2016 86
6.42 Jul 30, 2015: Sorin Group Announces Results for the Second Quarter of 2015 87
6.43 Jul 30, 2015: HeartWare Reports $73.6 Million In Second Quarter 2015 Revenue, Driven By Strong Global Unit Growth 90
6.44 Jul 28, 2015: BIOTRONIK Becomes First Manufacturer of Single- and Dual-Chamber Pacemakers and ICDs Approved for Use in 3 Tesla MRI Scans Worldwide 91
6.45 Jul 27, 2015: Sorin And Cyberonics Announce Intent To Vigorously Contest Claim By Italian State's Attorney Seeking To Enjoin The Proposed Combination Of The Companies 92
6.46 Jul 27, 2015: Philips : Second Quarter Results 2015 92
6.47 Jul 21, 2015: Heart Failure Patients Now Have Expanded Therapy Options and Unique Pacing Features with New BIOTRONIK CRT-D Device 94
6.48 Jul 21, 2015: CONMED Announces Second Quarter 2015 Financial Results 94
6.49 Jul 14, 2015: Philips appoints Andy Ho as CEO for Greater China 95
6.50 Jul 01, 2015: BIOTRONIK Expands Japanese Portfolio with Itrevia 7 HF-T QP, Approved for 1.5 Tesla Scanning 96
6.51 Jun 25, 2015: Sorin And Cyberonics Unveil Name Of Combined Company: LivaNova 96
6.52 Jun 15, 2015: BIOTRONIK ProMRI ICD Clinical Study Results Published in HeartRhythm Journal 97
6.53 Jun 02, 2015: Medtronic Reports Fourth Quarter and Fiscal Year 2015 Financial Results 98
6.54 May 22, 2015: BIOTRONIK Brings Iforia 7 DR-T and VR-T DF4 Systems with ProMRI Technology to the Japanese Market 101
6.55 May 19, 2015: Medtronic Announces Preliminary Fourth Quarter and Fiscal Year 2015 Revenue Results 102
6.56 May 15, 2015: BIOTRONIK Presents ProMRI ICD Clinical Study Results at Heart Rhythm 2015 Scientific Sessions 105
6.57 May 14, 2015: Medtronic Evera MRI ICD Clinical Study Meets Safety and Efficacy Endpoints 105
6.58 May 13, 2015: St. Jude Medical Expands Portfolio of MRI-Compatible Devices to High Voltage in Europe 107
6.59 May 13, 2015: Zoll To Demonstrate Pediatric Cpr Electrodes, Advanced Resuscitation And Temperature Management Technologies At Nti 2015 108
6.60 May 12, 2015: Sorin And Cyberonics Announce Executive Leadership Team For The New Company Upon Close Of Merger 109
6.61 May 11, 2015: Nihon Kohden Consolidated Financial Results For The Fiscal Year Ended March 31, 2015 110
6.62 May 08, 2015: JMS: Financial Results for the Fiscal Year Ended March 31, 2015 113
6.63 May 06, 2015: Medtronic to Unveil First-of-Its-Kind Clinical Data for Evera MRI SureScan implantable cardioverter-defibrillator (ICD) System at Heart Rhythm 2015 114
6.64 May 06, 2015: HeartWare Announces Private Placement of Notes Due 2021 for USD66 Million 115
6.65 May 05, 2015: Physio-Control Plans to Raise USD150 Million in Public Offering of Debt 115
7 Appendix 116
7.1 Methodology 116
7.2 About GlobalData 118
7.3 Contact Us 119
7.4 Disclaimer 119
Tables & Figures
1.1 List of Tables
Table 1: Implantable Cardioverter Defibrillators (ICD) - Pipeline Products by Stage of Development 9
Table 2: Implantable Cardioverter Defibrillators (ICD) - Pipeline Products by Segment 10
Table 3: Implantable Cardioverter Defibrillators (ICD) - Pipeline Products by Territory 11
Table 4: Implantable Cardioverter Defibrillators (ICD) - Pipeline Products by Regulatory Path 12
Table 5: Implantable Cardioverter Defibrillators (ICD) - Pipeline Products by Estimated Approval Date 13
Table 6: Implantable Cardioverter Defibrillators (ICD) - Ongoing Clinical Trials 14
Table 7: Implantable Cardioverter Defibrillators (ICD) Companies - Pipeline Products by Stage of Development 15
Table 8: Implantable Cardioverter Defibrillators (ICD) - Pipeline Products by Stage of Development 16
Table 9: AIS Inc. Pipeline Products & Ongoing Clinical Trials Overview 17
Table 10: Guardian - Product Status 17
Table 11: Guardian - Product Description 17
Table 12: Biotronik SE & Co. KG Pipeline Products & Ongoing Clinical Trials Overview 18
Table 13: ProMRI Iforia 5 HF-T ICD - Product Status 19
Table 14: ProMRI Iforia 5 HF-T ICD - Product Description 19
Table 15: ProMRI Iforia 5 Series DR-T ICD - Product Status 20
Table 16: ProMRI Iforia 5 Series DR-T ICD - Product Description 20
Table 17: ProMRI Iforia 5 VR-T DX ICD - Product Status 21
Table 18: ProMRI Iforia 5 VR-T DX ICD - Product Description 21
Table 19: ProMRI Iforia 5 VR-T ICD - Product Status 22
Table 20: ProMRI Iforia 5 VR-T ICD - Product Description 22
Table 21: ProMRI Iforia 7 DR-T ICD - Product Status 23
Table 22: ProMRI Iforia 7 DR-T ICD - Product Description 23
Table 23: ProMRI Iforia 7 HF-T ICD - Product Status 24
Table 24: ProMRI Iforia 7 HF-T ICD - Product Description 24
Table 25: ProMRI Iforia 7 VR-T DX ICD - Product Status 25
Table 26: ProMRI Iforia 7 VR-T DX ICD - Product Description 25
Table 27: ProMRI Iforia 7 VR-T ICD - Product Status 26
Table 28: ProMRI Iforia 7 VR-T ICD - Product Description 26
Table 29: Biotronik SE & Co. KG - Ongoing Clinical Trials Overview 27
Table 30: ProMRI Iforia 5 Series DR-T ICD - ProMRI 3T ENHANCED Master Study 28
Table 31: Boston Scientific Corporation Pipeline Products & Ongoing Clinical Trials Overview 29
Table 32: EMBLEM MRI S-ICD System - Product Status 30
Table 33: EMBLEM MRI S-ICD System - Product Description 30
Table 34: EMBLEM S-ICD - Product Status 31
Table 35: EMBLEM S-ICD - Product Description 31
Table 36: MRI Compatible S-ICD - Product Status 32
Table 37: MRI Compatible S-ICD - Product Description 32
Table 38: S-ICD System 1.5 - Product Status 33
Table 39: S-ICD System 1.5 - Product Description 33
Table 40: S-ICD System 2.0 - Product Status 34
Table 41: S-ICD System 2.0 - Product Description 34
Table 42: VITALITY NXT Defibrillator - Product Status 35
Table 43: VITALITY NXT Defibrillator - Product Description 35
Table 44: Boston Scientific Corporation - Ongoing Clinical Trials Overview 36
Table 45: EMBLEM S-ICD - Understanding Outcomes with the EMBLEM S-ICD in Primary Prevention Patients with Low Ejection Fraction 37
Table 46: CardiaLen, Inc. Pipeline Products & Ongoing Clinical Trials Overview 38
Table 47: CardiaLen Device - Atrial Fibrillation - Product Status 38
Table 48: CardiaLen Device - Atrial Fibrillation - Product Description 38
Table 49: CardiaLen Device - Ventricular Arrhythmia - Product Status 39
Table 50: CardiaLen Device - Ventricular Arrhythmia - Product Description 39
Table 51: InnerPulse, Inc. Pipeline Products & Ongoing Clinical Trials Overview 40
Table 52: PICD - Product Status 40
Table 53: PICD - Product Description 40
Table 54: Kenergy Inc. Pipeline Products & Ongoing Clinical Trials Overview 41
Table 55: Unconditional MRI Compatible Implantable Defibrillator - Product Status 41
Table 56: Unconditional MRI Compatible Implantable Defibrillator - Product Description 41
Table 57: Max Planck Institute for Dynamics and Self-Organization Pipeline Products & Ongoing Clinical Trials Overview 42
Table 58: Implantable Defibrillator - Product Status 42
Table 59: Implantable Defibrillator - Product Description 42
Table 60: Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 43
Table 61: Chronicle ICD - Product Status 44
Table 62: Chronicle ICD - Product Description 44
Table 63: Visia AF MRI SureScan Single-chamber ICD - Product Status 45
Table 64: Visia AF MRI SureScan Single-chamber ICD - Product Description 45
Table 65: Visia AF SureScan Single-chamber ICD - Product Status 46
Table 66: Visia AF SureScan Single-chamber ICD - Product Description 46
Table 67: Smartwave Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 47
Table 68: Fully Automatic Implantable Atrial Defibrillator - Product Status 47
Table 69: Fully Automatic Implantable Atrial Defibrillator - Product Description 47
Table 70: The Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 48
Table 71: Implantable Cardioverter Defibrillator System - Product Status 49
Table 72: Implantable Cardioverter Defibrillator System - Product Description 49
Table 73: The Johns Hopkins University - Ongoing Clinical Trials Overview 50
Table 74: Implantable Cardioverter Defibrillator System - UMBRELLA - Incidence of Arrhythmias in Spanish Population with a Medtronic ICD Implant 51
Table 75: University of Leicester Pipeline Products & Ongoing Clinical Trials Overview 52
Table 76: Implantable Cardioverter Defibrillator - Product Status 53
Table 77: Implantable Cardioverter Defibrillator - Product Description 53
Table 78: Glossary 117
1.2 List of Figures
Figure 1: Implantable Cardioverter Defibrillators (ICD) - Pipeline Products by Stage of Development 9
Figure 2: Implantable Cardioverter Defibrillators (ICD) - Pipeline Products by Segment 10
Figure 3: Implantable Cardioverter Defibrillators (ICD) - Pipeline Products by Territory 11
Figure 4: Implantable Cardioverter Defibrillators (ICD) - Pipeline Products by Regulatory Path 12
Figure 5: Implantable Cardioverter Defibrillators (ICD) - Pipeline Products by Estimated Approval Date 13
Figure 6: Implantable Cardioverter Defibrillators (ICD) - Ongoing Clinical Trials 14
Companies
AIS Inc.
Biotronik SE & Co. KG
Boston Scientific Corporation
CardiaLen, Inc.
InnerPulse, Inc.
Kenergy Inc.
Max Planck Institute for Dynamics and Self-Organization
Medtronic plc
Smartwave Medical Ltd
The Johns Hopkins University
University of Leicester
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