Cardiac Assist Devices - Medical Devices Pipeline Assessment, 2015

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1 Cardiac Assist Devices - Medical Devices Pipeline Assessment, 2015

2 Cardiac Assist Devices - Medical Devices Pipeline Assessment, 2015 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 Cardiac Assist Devices - Medical Devices Pipeline Assessment, 2015 Cardiac Assist Devices - Medical Devices Pipeline Assessment, 2015 Summary GlobalData's Medical Devices sector report, Cardiac Assist Devices - Medical Devices Pipeline Assessment, 2015" provides an overview of Cardiac Assist 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 Assist Devices 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 Cardiac Assist Devices 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 Cardiac Assist Devices 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 - Identify and understand important and diverse types of Cardiac Assist Devices under development 3

4 - 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 : GDME0142EPD Number of Pages : 323 Report Format : PDF Publisher Information : 4

5 Table Of Contents for Cardiac Assist Devices - Medical Devices Pipeline Assessment, Table of Contents1 Table of Contents 21.1 List of Tables 61.2 List of Figures 152 Introduction Cardiac Assist Devices Overview 163 Products under Development Cardiac Assist Devices - Pipeline Products by Stage of Development Cardiac Assist Devices - Pipeline Products by Segment Cardiac Assist Devices - Pipeline Products by Territory Cardiac Assist Devices - Pipeline Products by Regulatory Path Cardiac Assist Devices - Pipeline Products by Estimated Approval Date Cardiac Assist Devices - Ongoing Clinical Trials 234 Cardiac Assist Devices - Pipeline Products under Development by Companies Cardiac Assist Devices Companies - Pipeline Products by Stage of Development Cardiac Assist Devices - Pipeline Products by Stage of Development 275 Cardiac Assist Devices Companies and Product Overview Abiomed, Inc. Company Overview Abiomed, Inc. Pipeline Products & Ongoing Clinical Trials Overview Acorn Cardiovascular, Inc. Company Overview Acorn Cardiovascular, Inc. Pipeline Products & Ongoing Clinical Trials Overview Arrow International Cr, A.S. Company Overview Arrow International Cr, A.S. Pipeline Products & Ongoing Clinical Trials Overview Biophan Technologies, Inc. Company Overview Biophan Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview BioQ Devices Pty Ltd Company Overview BioQ Devices Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview BioVentrix, Inc. Company Overview BioVentrix, Inc. Pipeline Products & Ongoing Clinical Trials Overview BiVacor Pty Ltd Company Overview BiVacor Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview Braile Biomedica Ltda. Company Overview Braile Biomedica Ltda. Pipeline Products & Ongoing Clinical Trials Overview Calon Cardio-Technology Ltd Company Overview Calon Cardio-Technology Ltd Pipeline Products & Ongoing Clinical Trials Overview Cardiac Power Inc. Company Overview Cardiac Power Inc. Pipeline Products & Ongoing Clinical Trials Overview CardiacAssist, Inc. Company Overview CardiacAssist, Inc. Pipeline Products & Ongoing Clinical Trials Overview Cardiak Ltd. Company Overview Cardiak Ltd. Pipeline Products & Ongoing Clinical Trials Overview CARDIAnove Company Overview CARDIAnove Pipeline Products & Ongoing Clinical Trials Overview Cardio Vox, Inc. Company Overview Cardio Vox, Inc. Pipeline Products & Ongoing Clinical Trials Overview CardioBridge GmbH Company Overview CardioBridge GmbH Pipeline Products & Ongoing Clinical Trials Overview CardioKinetix, Inc. Company Overview CardioKinetix, Inc. Pipeline Products & Ongoing Clinical Trials Overview CardioPlus, Inc. Company Overview CardioPlus, Inc. Pipeline Products & Ongoing Clinical Trials Overview Carmat SAS Company Overview Carmat SAS Pipeline Products & Ongoing Clinical Trials Overview Charite - Universitatsmedizin Berlin Company Overview Charite - Universitatsmedizin Berlin Pipeline Products & Ongoing Clinical Trials Overview Cleveland Heart, Inc. Company Overview Cleveland Heart, Inc. Pipeline Products & Ongoing Clinical Trials Overview CorasMedical Company Overview CorasMedical Pipeline Products & Ongoing Clinical Trials Overview CorAssist Cardiovascular Ltd. Company Overview CorAssist Cardiovascular Ltd. Pipeline Products & Ongoing Clinical Trials Overview CorInnova, Inc. Company Overview CorInnova, Inc. Pipeline Products & Ongoing Clinical Trials Overview CorWave Company Overview CorWave Pipeline Products & Ongoing Clinical Trials Overview Drexel University Company Overview Drexel University Pipeline Products & Ongoing Clinical Trials Overview DUALIS MedTech GmbH Company Overview DUALIS MedTech GmbH Pipeline Products & Ongoing Clinical Trials Overview Ension, Inc. Company Overview Ension, Inc. Pipeline Products & Ongoing Clinical Trials Overview Evaheart, Inc. Company Overview Evaheart, Inc. Pipeline Products & Ongoing Clinical Trials Overview Everheart Systems, LLC Company Overview Everheart Systems, LLC Pipeline Products & Ongoing Clinical Trials Overview Foster-Miller, Inc. (Inactive) Company Overview Foster-Miller, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview Fundacion para la Investigacion Biomedica del Hospital Gregorio Maranon Company Overview Fundacion para la Investigacion Biomedica del Hospital Gregorio Maranon Pipeline Products & Ongoing Clinical Trials Overview Gold Medical Technologies, Inc. Company Overview Gold Medical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview Harvard University Company Overview Harvard University Pipeline Products & Ongoing Clinical Trials Overview HeartWare International, Inc. Company Overview HeartWare International, Inc. Pipeline Products & Ongoing Clinical Trials Overview Jarvik Heart, Inc. Company Overview Jarvik Heart, Inc. Pipeline 5

6 Products & Ongoing Clinical Trials Overview LaunchPoint Technologies, Inc. Company Overview LaunchPoint Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview Leviticus Cardio Ltd. Company Overview Leviticus Cardio Ltd. Pipeline Products & Ongoing Clinical Trials Overview Levram Medical Systems Ltd Company Overview Levram Medical Systems Ltd Pipeline Products & Ongoing Clinical Trials Overview Lonestar Heart, Inc. Company Overview Lonestar Heart, Inc. Pipeline Products & Ongoing Clinical Trials Overview Mayo Clinic. Company Overview Mayo Clinic. Pipeline Products & Ongoing Clinical Trials Overview MicroMed Cardiovascular, Inc. Company Overview MicroMed Cardiovascular, Inc. Pipeline Products & Ongoing Clinical Trials Overview Microstim GmbH Company Overview Microstim GmbH Pipeline Products & Ongoing Clinical Trials Overview MyoCardioCare, Inc. Company Overview MyoCardioCare, Inc. Pipeline Products & Ongoing Clinical Trials Overview MyoPowers Medical Technologies SA Company Overview MyoPowers Medical Technologies SA Pipeline Products & Ongoing Clinical Trials Overview NeoCardial Technologies, LLC Company Overview NeoCardial Technologies, LLC Pipeline Products & Ongoing Clinical Trials Overview New Heart Company Overview New Heart Pipeline Products & Ongoing Clinical Trials Overview Nipro Corporation Company Overview Nipro Corporation Pipeline Products & Ongoing Clinical Trials Overview NuVascular Technologies Inc Company Overview NuVascular Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview Orqis Medical Corporation Company Overview Orqis Medical Corporation Pipeline Products & Ongoing Clinical Trials Overview Penn State Milton S. Hershey Medical Center Company Overview Penn State Milton S. Hershey Medical Center Pipeline Products & Ongoing Clinical Trials Overview Perfusion Solutions Company Overview Perfusion Solutions Pipeline Products & Ongoing Clinical Trials Overview PlugMed Heart SAS Company Overview PlugMed Heart SAS Pipeline Products & Ongoing Clinical Trials Overview Procyrion Company Overview Procyrion Pipeline Products & Ongoing Clinical Trials Overview Purdue University Company Overview Purdue University Pipeline Products & Ongoing Clinical Trials Overview QRS Diagnostic, LLC Company Overview QRS Diagnostic, LLC Pipeline Products & Ongoing Clinical Trials Overview ReliantHeart, Inc. Company Overview ReliantHeart, Inc. Pipeline Products & Ongoing Clinical Trials Overview Saint Louis University Company Overview Saint Louis University Pipeline Products & Ongoing Clinical Trials Overview St. Jude Medical, Inc. Company Overview St. Jude Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview Sunshine Heart Company, Pty. Ltd. Company Overview Sunshine Heart Company, Pty. Ltd. Pipeline Products & Ongoing Clinical Trials Overview SynCardia Systems, Inc. Company Overview SynCardia Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview Teleflex Incorporated Company Overview Teleflex Incorporated Pipeline Products & Ongoing Clinical Trials Overview Terumo Corporation Company Overview Terumo Corporation Pipeline Products & Ongoing Clinical Trials Overview The Artificial Heart Laboratory of Foundation for Cardiac Surgery Development Company Overview The Artificial Heart Laboratory of Foundation for Cardiac Surgery Development Pipeline Products & Ongoing Clinical Trials Overview The University of Tokyo Company Overview The University of Tokyo Pipeline Products & Ongoing Clinical Trials Overview U.S. Stem Cell, Inc. Company Overview U.S. Stem Cell, Inc. Pipeline Products & Ongoing Clinical Trials Overview University of Minnesota Company Overview University of Minnesota Pipeline Products & Ongoing Clinical Trials Overview University of Zurich Company Overview University of Zurich Pipeline Products & Ongoing Clinical Trials Overview Vadovations, Inc. Company Overview Vadovations, Inc. Pipeline Products & Ongoing Clinical Trials Overview Vienna University of Technology Company Overview Vienna University of Technology Pipeline Products & Ongoing Clinical Trials Overview Windmill Cardiovascular Systems, Inc. Company Overview Windmill Cardiovascular Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 2086 Cardiac Assist Devices- Recent Developments 2097 Appendix Methodology About GlobalData Contact Us Disclaimer 323 6

7 List Of Tables in Cardiac Assist Devices - Medical Devices Pipeline Assessment, List of Tables Table 1: Cardiac Assist Devices - Pipeline Products by Stage of Development 18 Table 2: Cardiac Assist Devices - Pipeline Products by Segment 19 Table 3: Cardiac Assist Devices - Pipeline Products by Territory 20 Table 4: Cardiac Assist Devices - Pipeline Products by Regulatory Path 21 Table 5: Cardiac Assist Devices - Pipeline Products by Estimated Approval Date 22 Table 6: Cardiac Assist Devices - Ongoing Clinical Trials 23 Table 7: Cardiac Assist Devices Companies - Pipeline Products by Stage of Development 24 Table 8: Cardiac Assist Devices - Pipeline Products by Stage of Development 27 Table 9: Abiomed, Inc. Pipeline Products & Ongoing Clinical Trials Overview 31 Table 10: AbioCor II - Product Status 32 Table 11: AbioCor II - Product Description 32 Table 12: Impella 5.0/LD - High Risk PCI - Product Status 33 Table 13: Impella 5.0/LD - High Risk PCI - Product Description 33 Table 14: Impella CP - High Risk PCI - Product Status 34 Table 15: Impella CP - High Risk PCI - Product Description 34 Table 16: Impella Pediatric Pump - Product Status 35 Table 17: Impella Pediatric Pump - Product Description 35 Table 18: Symphony Heart Pump - Product Status 36 Table 19: Symphony Heart Pump - Product Description 36 Table 20: Acorn Cardiovascular, Inc. Pipeline Products & Ongoing Clinical Trials Overview 37 Table 21: CorCap Cardiac Support Device - Product Status 37 Table 22: CorCap Cardiac Support Device - Product Description 37 Table 23: Acorn Cardiovascular, Inc. - Ongoing Clinical Trials Overview 38 Table 24: CorCap Cardiac Support Device - Clinical Evaluation Of Acorn CorCap Cardiac Support Device Concomitant To MVR - A Confirmatory Trial 39 Table 25: Arrow International Cr, A.S. Pipeline Products & Ongoing Clinical Trials Overview 40 Table 26: CorAide Left Ventricular Assist System - Product Status 40 Table 27: CorAide Left Ventricular Assist System - Product Description 40 7

8 Table 28: Biophan Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 41 Table 29: Myotech Circulatory Support System - Product Status 42 Table 30: Myotech Circulatory Support System - Product Description 42 Table 31: BioQ Devices Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 43 Table 32: BioQ IntraAortic Counterpulsation Prosthesis - Product Status 43 Table 33: BioQ IntraAortic Counterpulsation Prosthesis - Product Description 43 Table 34: BioVentrix, Inc. Pipeline Products & Ongoing Clinical Trials Overview 44 Table 35: Next Generation Revivent System - Product Status 44 Table 36: Next Generation Revivent System - Product Description 44 Table 37: PliCath HF - Product Status 45 Table 38: PliCath HF - Product Description 45 Table 39: BioVentrix, Inc. - Ongoing Clinical Trials Overview 46 Table 40: PliCath HF - Phase II Study of the BioVentrix PliCath HF System for the Treatment of Ischemic Cardiomyopathy. 47 Table 41: PliCath HF - This Study is a Multi-center, Prospective, Single-armed, Study Designed to Evaluate the Safety and Feasibility of the BioVentrix PliCath HF System for Left Ventricular (LV) Volume and Radius Reduction Through Scar Exclusion in Patients Whose Systolic HF is Due to Ischemic Cardiomyopathy 47 Table 42: BiVacor Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 48 Table 43: BiVACOR Device - Product Status 48 Table 44: BiVACOR Device - Product Description 48 Table 45: Braile Biomedica Ltda. Pipeline Products & Ongoing Clinical Trials Overview 49 Table 46: Blood Pump - Product Status 49 Table 47: Blood Pump - Product Description 49 Table 48: Calon Cardio-Technology Ltd Pipeline Products & Ongoing Clinical Trials Overview 50 Table 49: BridgeVAD - Product Status 50 Table 50: BridgeVAD - Product Description 50 Table 51: Calon MiniVAD - Product Status 51 Table 52: Calon MiniVAD - Product Description 51 Table 53: CathVAD - Product Status 52 Table 54: CathVAD - Product Description 52 Table 55: Cardiac Power Inc. Pipeline Products & Ongoing Clinical Trials Overview 53 Table 56: Repower - Product Status 53 8

9 Table 57: Repower - Product Description 53 Table 58: CardiacAssist, Inc. Pipeline Products & Ongoing Clinical Trials Overview 54 Table 59: TandemHeart Circulatory Support System - Product Status 54 Table 60: TandemHeart Circulatory Support System - Product Description 54 Table 61: CardiacAssist, Inc. - Ongoing Clinical Trials Overview 55 Table 62: TandemHeart Circulatory Support System - TandemHeart Experiences and Methods (THEME Registry) 56 Table 63: Cardiak Ltd. Pipeline Products & Ongoing Clinical Trials Overview 57 Table 64: Akpulsor - Product Status 57 Table 65: Akpulsor - Product Description 57 Table 66: CARDIAnove Pipeline Products & Ongoing Clinical Trials Overview 58 Table 67: CARDIAnove Pump - Product Status 58 Table 68: CARDIAnove Pump - Product Description 58 Table 69: Cardio Vox, Inc. Pipeline Products & Ongoing Clinical Trials Overview 59 Table 70: Transcatheter Ventricular Assist Device - Product Status 59 Table 71: Transcatheter Ventricular Assist Device - Product Description 59 Table 72: CardioBridge GmbH Pipeline Products & Ongoing Clinical Trials Overview 60 Table 73: 10F RCP System - Product Status 61 Table 74: 10F RCP System - Product Description 61 Table 75: 14F RCP System - Product Status 62 Table 76: 14F RCP System - Product Description 62 Table 77: CardioKinetix, Inc. Pipeline Products & Ongoing Clinical Trials Overview 63 Table 78: Parachute Ventricular Partitioning Device - Product Status 63 Table 79: Parachute Ventricular Partitioning Device - Product Description 63 Table 80: CardioKinetix, Inc. - Ongoing Clinical Trials Overview 64 Table 81: Parachute Ventricular Partitioning Device - A Dual-Arm, Open-Label, Multi-Center Registry Designed To Evaluate The Parachute Implant in Ischemic Heart Failure Patients 65 Table 82: Parachute Ventricular Partitioning Device - A Multinational Trial To Evaluate the Parachute Implant System: Parachute Percutaneous Ventricular Restoration in Chronic Heart Failure Due to Ischemic Heart Disease 65 Table 83: Parachute Ventricular Partitioning Device - PARACHUTE III: A Multinational Trial to Evaluate the Longterm Safety of the Parachute System 65 Table 84: Parachute Ventricular Partitioning Device - Percutaneous Ventricular Restoration in Chronic Heart Failure Due to Ischemic Heart Disease 66 9

10 Table 85: CardioPlus, Inc. Pipeline Products & Ongoing Clinical Trials Overview 67 Table 86: CardioPlus - Product Status 67 Table 87: CardioPlus - Product Description 67 Table 88: Carmat SAS Pipeline Products & Ongoing Clinical Trials Overview 68 Table 89: Artificial Heart - Product Status 69 Table 90: Artificial Heart - Product Description 69 Table 91: Carmat SAS - Ongoing Clinical Trials Overview 70 Table 92: Artificial Heart - First-in-man CARMAT s Bioprosthetic Heart Trial For End-stage Heart Failure 71 Table 93: Charite - Universitatsmedizin Berlin Pipeline Products & Ongoing Clinical Trials Overview 72 Table 94: Low - Stress Rotary Blood Pump - Product Status 72 Table 95: Low - Stress Rotary Blood Pump - Product Description 72 Table 96: Cleveland Heart, Inc. Pipeline Products & Ongoing Clinical Trials Overview 73 Table 97: SmartHeart LVAD - Product Status 74 Table 98: SmartHeart LVAD - Product Description 74 Table 99: SmartHeart TAH - Product Status 75 Table 100: SmartHeart TAH - Product Description 75 Table 101: CorasMedical Pipeline Products & Ongoing Clinical Trials Overview 76 Table 102: CORAS Hotor - Product Status 76 Table 103: CORAS Hotor - Product Description 76 Table 104: CorAssist Cardiovascular Ltd. Pipeline Products & Ongoing Clinical Trials Overview 77 Table 105: CORolla - Product Status 77 Table 106: CORolla - Product Description 77 Table 107: ImCardia - Product Status 78 Table 108: ImCardia - Product Description 78 Table 109: CorAssist Cardiovascular Ltd. - Ongoing Clinical Trials Overview 79 Table 110: CORolla - CORolla TAA for Heart Failure and Preserved Ejection Fraction and Diastolic Dysfunction 80 Table 111: CORolla - CORolla TAA for Heart Failure with Preserved Ejection Fraction (HFpEF) and Diastolic Dysfunction (DD) Safety and Feasibility 80 Table 112: CorInnova, Inc. Pipeline Products & Ongoing Clinical Trials Overview 81 Table 113: CardiacSTAR - Bridge To Decision - Product Status 81 Table 114: CardiacSTAR - Bridge To Decision - Product Description 81 10

11 Table 115: CardiacSTAR - Bridge To Recovery - Product Status 82 Table 116: CardiacSTAR - Bridge To Recovery - Product Description 82 Table 117: CardiacSTAR - Bridge To Transplant - Product Status 83 Table 118: CardiacSTAR - Bridge To Transplant - Product Description 83 11

12 List Of Figures, Charts and Diagrams in Cardiac Assist Devices - Medical Devices Pipeline Assessment, List of Figures Figure 1: Cardiac Assist Devices - Pipeline Products by Stage of Development 18 Figure 2: Cardiac Assist Devices - Pipeline Products by Segment 19 Figure 3: Cardiac Assist Devices - Pipeline Products by Territory 20 Figure 4: Cardiac Assist Devices - Pipeline Products by Regulatory Path 21 Figure 5: Cardiac Assist Devices - Pipeline Products by Estimated Approval Date 22 Figure 6: Cardiac Assist Devices - Ongoing Clinical Trials 23 12

13 How to Buy... Cardiac Assist Devices - Medical Devices Pipeline Assessment, 2015 Option 1 - Online Go to our website and pay online with any major debit or credit card: Option 2 - Request a Proforma Invoice Fill in the details below, and either Scan this page and it to us at or Fax it to us at +44 (0) We will send you a Proforma Invoice and deliver your report on settlement. Your Name: Job Title: Your Your Contact Phone: Company Name: Address: Post/Zip Code: Country: P.O. Number: Any Other Instructions: Pricing Options: (please tick one) $4000 Single User Price $8000 Site License Price $12000 Enterprise License Price Payment Options: (please tick one) Online Credit Card (we will you the invoice with a payment link) Direct Wire Transfer (we will you the invoice with our bank details) Authorising Signature: Option 3 - Phone Us on +44 (0) We will be delighted to give you our personal attention. 13

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