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

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

2 Implantable Cardioverter Defibrillators (ICD) - Medical Devices Pipeline Assessment, 2016 BioPortfolio has been marketing business and market research reports from selected publishers for over fifteen years. BioPortfolio offers a personal service to our customers with dedicated research managers who will work with you to source the best report for your needs. Based in the UK, BioPortfolio is well positioned to coordinate our customers' orders sourced from over 50 global report publishers. We are pleased to present details of this report to assist your buying decision and administrative process. You will find easy-to-use How To Buy information on the last page of this document. We look forward to being of service to you. If you have bulk and/or recurring requirements, please get in touch - we can liaise with publishers to obtain sample pages and negotiate discounts on your behalf. Phone: +44 (0) or 2

3 Implantable Cardioverter Defibrillators (ICD) - Medical Devices Pipeline Assessment, 2016 Implantable Cardioverter Defibrillators (ICD) - Medical Devices Pipeline Assessment, 2016 Summary GlobalData's Medical Devices sector report, Implantable Cardioverter Defibrillators (ICD) - Medical Devices Pipeline Assessment, 2016" provides an overview of Implantable Cardioverter Defibrillators (ICD) 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 Implantable Cardioverter Defibrillators (ICD) pipeline products. This report is prepared using data sourced from in-house databases, secondary and primary research by GlobalData's team of industry experts. *Note: Certain sections in the report may be removed or altered based on the availability and relevance of data in relation to the equipment type. Scope - Extensive coverage of the Implantable Cardioverter Defibrillators (ICD) under development - The report reviews details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities - The report reviews the major players involved in the development of Implantable Cardioverter Defibrillators (ICD) and list all their pipeline projects - The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage - The report provides key clinical trial data of ongoing trials specific to pipeline products - Recent developments in the segment / industry Reasons to buy The report enables you to - - Formulate significant competitor information, analysis, and insights to improve R&D strategies - Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage 3

4 - Identify and understand important and diverse types of Implantable Cardioverter Defibrillators (ICD) under development - Develop market-entry and market expansion strategies - Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline - In-depth analysis of the product s current stage of development, territory and estimated launch date Additional Details Publisher : Global Data Reference : GDME0180EPD Number of Pages : 119 Report Format : PDF Publisher Information : 4

5 Table Of Contents for Implantable Cardioverter Defibrillators (ICD) - Medical Devices Pipeline Assessment, Table of Contents1 Table of Contents 21.1 List of Tables 51.2 List of Figures 72 Introduction 82.1 Implantable Cardioverter Defibrillators (ICD) Overview 83 Products under Development 93.1 Implantable Cardioverter Defibrillators (ICD) - Pipeline Products by Stage of Development 93.2 Implantable Cardioverter Defibrillators (ICD) - Pipeline Products by Segment Implantable Cardioverter Defibrillators (ICD) - Pipeline Products by Territory Implantable Cardioverter Defibrillators (ICD) - Pipeline Products by Regulatory Path Implantable Cardioverter Defibrillators (ICD) - Pipeline Products by Estimated Approval Date Implantable Cardioverter Defibrillators (ICD) - Ongoing Clinical Trials 144 Implantable Cardioverter Defibrillators (ICD) - Pipeline Products under Development by Companies Implantable Cardioverter Defibrillators (ICD) Companies - Pipeline Products by Stage of Development Implantable Cardioverter Defibrillators (ICD) - Pipeline Products by Stage of Development 165 Implantable Cardioverter Defibrillators (ICD) Companies and Product Overview AIS Inc. Company Overview AIS Inc. Pipeline Products & Ongoing Clinical Trials Overview Biotronik SE & Co. KG Company Overview Biotronik SE & Co. KG Pipeline Products & Ongoing Clinical Trials Overview Boston Scientific Corporation Company Overview Boston Scientific Corporation Pipeline Products & Ongoing Clinical Trials Overview CardiaLen, Inc. Company Overview CardiaLen, Inc. Pipeline Products & Ongoing Clinical Trials Overview InnerPulse, Inc. Company Overview InnerPulse, Inc. Pipeline Products & Ongoing Clinical Trials Overview Kenergy Inc. Company Overview Kenergy Inc. Pipeline Products & Ongoing Clinical Trials Overview Max Planck Institute for Dynamics and Self-Organization Company Overview Max Planck Institute for Dynamics and Self-Organization Pipeline Products & Ongoing Clinical Trials Overview Medtronic plc Company Overview Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview Smartwave Medical Ltd Company Overview Smartwave Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview The Johns Hopkins University Company Overview The Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview University of Leicester Company Overview University of Leicester Pipeline Products & Ongoing Clinical Trials Overview 526 Implantable Cardioverter Defibrillators (ICD)- Recent Developments Apr 25, 2016: Philips' First Quarter Results Apr 20, 2016: Boston Scientific Announces CE Mark For MRI Labeling Of Emblem S-ICD Systems Apr 20, 2016: Boston Scientific Announces CE Mark For MRI Labeling Of Emblem S-ICD Systems Apr 13, 2016: Nihon Kohden Evolves Brand, Website to Meet Needs of Changing Healthcare Environment Apr 06, 2016: Medtronic Statement on U.S. Department of Treasury's Recent Temporary and Proposed Regulations Mar 17, 2016: Medtronic Proposes Proxy Access Mar 10, 2016: Philips meets stringent U.S. government security requirements for pathology medical data Mar 09, 2016: Management Changes at ZOLL Signal Stable Leadership and Steady Growth Mar 01, 2016: Medtronic Reports Third Quarter Financial Results Feb 22, 2016: Philips to introduce next-generation monitoring solution enabled by wearable biosensors Feb 19, 2016: Medtronic to Announce Financial Results for Its Third Quarter of Fiscal Year Feb 11, 2016: BIOTRONIK Announces CE Approval for new series of ICDs and CRT-Ds with MRI AutoDetect Feb 03, 2016: Nihon Kohden America Receives Great Place to Work Certification Jan 27, 2016: CONMED Announces Fourth Quarter and Fiscal Year 2015 Financial Results Jan 11, 2016: Medtronic Updates Capital Allocation Plans and Fiscal 2016 EPS Guidance Jan 11, 2016: HeartWare International Provides Corporate Updates And Announces Preliminary Revenue For Fourth Quarter Jan 05, 2016: Philips wants you to be the picture of health: showcases cloudbased technologies for every stage of life at CES Dec 22, 2015: FDA Approves BIOTRONIK Iperia ICD Systems with Full-Body ProMRI Technology Dec 21, 2015: Medtronic Receives First Health Canada License for MRI Conditional Implantable Cardioverter Defibrillator System Dec 14, 2015: The Medtronic Bakken Invitation Award Honors 12 Patients from Around the World for Giving Back Nov 23, 2015: Philips partnership with the RSNA Research & Education Foundation awards more than 110 grant recipients since Nov 20, 2015: Medtronic Statement on U.S. Department of Treasury's Notice Nov 02, 2015: LivaNova Announces the Launch of the PLATINIUM ICD & CRT-D Family Providing the World s Longest Projected Longevity 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 Oct 29, 5

6 2015: HeartWare International Reports Third Quarter 2015 Results Oct 21, 2015: CONMED Announces Third Quarter 2015 Financial Results Oct 01, 2015: World s First and Only ICD Offering 3 Tesla MRI Access Launched in Japan Sep 28, 2015: Medtronic InFuse Lawsuit May Reach Supreme Court, Parker Waichman LLP Comments 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 Sep 14, 2015: Medtronic First To Receive FDA Approval For MR-Conditional Implantable Cardioverter Defibrillator System Sep 13, 2015: Physio-Control to Acquire HeartSine Technologies Sep 10, 2015: Sorin and Cyberonics Announce Appointment of LivaNova s Chief Financial Officer Sep 08, 2015: No Further Legal Action By Italian State's Attorney To Enjoin The Combination Of Sorin And Cyberonics Sep 04, 2015: NORDIC ICD Trial Calls Defibrillation Testing during ICD Implantation into Question Sep 03, 2015: Medtronic Reports First Quarter Financial Results Sep 03, 2015: Philips introduces personal health programs at IFA in Berlin Sep 02, 2015: Philips Healthcare Receives DOD Contract For Biomedical Equipment Aug 31, 2015: Medtronic Study Detects Gene Associated with Sudden Cardiac Death Aug 09, 2015: Philips Healthcare India Plans To Invest $60m To Double Production Capacity At Pune Facility Aug 07, 2015: Financial Results for the First Quarter of Fiscal Year Ending March 31, Jul 31, 2015: Consolidated Financial Results for the 1st Quarter of the Fiscal Year Ending March 31, Jul 30, 2015: Sorin Group Announces Results for the Second Quarter of Jul 30, 2015: HeartWare Reports $73.6 Million In Second Quarter 2015 Revenue, Driven By Strong Global Unit Growth Jul 28, 2015: BIOTRONIK Becomes First Manufacturer of Single- and Dual-Chamber Pacemakers and ICDs Approved for Use in 3 Tesla MRI Scans Worldwide 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 Jul 27, 2015: Philips : Second Quarter Results Jul 21, 2015: Heart Failure Patients Now Have Expanded Therapy Options and Unique Pacing Features with New BIOTRONIK CRT-D Device Jul 21, 2015: CONMED Announces Second Quarter 2015 Financial Results Jul 14, 2015: Philips appoints Andy Ho as CEO for Greater China Jul 01, 2015: BIOTRONIK Expands Japanese Portfolio with Itrevia 7 HF-T QP, Approved for 1.5 Tesla Scanning Jun 25, 2015: Sorin And Cyberonics Unveil Name Of Combined Company: LivaNova Jun 15, 2015: BIOTRONIK ProMRI ICD Clinical Study Results Published in HeartRhythm Journal Jun 02, 2015: Medtronic Reports Fourth Quarter and Fiscal Year 2015 Financial Results May 22, 2015: BIOTRONIK Brings Iforia 7 DR-T and VR-T DF4 Systems with ProMRI Technology to the Japanese Market May 19, 2015: Medtronic Announces Preliminary Fourth Quarter and Fiscal Year 2015 Revenue Results May 15, 2015: BIOTRONIK Presents ProMRI ICD Clinical Study Results at Heart Rhythm 2015 Scientific Sessions May 14, 2015: Medtronic Evera MRI ICD Clinical Study Meets Safety and Efficacy Endpoints May 13, 2015: St. Jude Medical Expands Portfolio of MRI-Compatible Devices to High Voltage in Europe May 13, 2015: Zoll To Demonstrate Pediatric Cpr Electrodes, Advanced Resuscitation And Temperature Management Technologies At Nti May 12, 2015: Sorin And Cyberonics Announce Executive Leadership Team For The New Company Upon Close Of Merger May 11, 2015: Nihon Kohden Consolidated Financial Results For The Fiscal Year Ended March 31, May 08, 2015: JMS: Financial Results for the Fiscal Year Ended March 31, May 06, 2015: Medtronic to Unveil First-of-Its-Kind Clinical Data for Evera MRI SureScan implantable cardioverter-defibrillator (ICD) System at Heart Rhythm May 06, 2015: HeartWare Announces Private Placement of Notes Due 2021 for USD66 Million May 05, 2015: Physio-Control Plans to Raise USD150 Million in Public Offering of Debt 1157 Appendix Methodology About GlobalData Contact Us Disclaimer 119 6

7 List Of Tables in Implantable Cardioverter Defibrillators (ICD) - Medical Devices Pipeline Assessment, 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 7

8 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 Product Status 33 Table 39: S-ICD System Product Description 33 Table 40: S-ICD System Product Status 34 Table 41: S-ICD System 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 8

9 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 9

10 List Of Figures, Charts and Diagrams in Implantable Cardioverter Defibrillators (ICD) - Medical Devices Pipeline Assessment, 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 10

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