Implantable Cardioverter Defibrillators (ICD) - Medical Devices Pipeline Assessment, 2016

SKU ID :GD-10160237 | Published Date: 01-May-2016 | No. of pages: 119
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
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
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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