1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 6
1.2 List of Figures 10
2 Introduction 11
2.1 Cardiac Valve Repairs Overview 11
3 Products under Development 12
3.1 Cardiac Valve Repairs – Pipeline Products by Stage of Development 12
3.2 Cardiac Valve Repairs – Pipeline Products by Segment 13
3.3 Cardiac Valve Repairs – Pipeline Products by Territory 14
3.4 Cardiac Valve Repairs – Pipeline Products by Regulatory Path 15
3.5 Cardiac Valve Repairs – Pipeline Products by Estimated Approval Date 16
3.6 Cardiac Valve Repairs – Ongoing Clinical Trials 17
4 Cardiac Valve Repairs – Pipeline Products under Development by Companies 18
4.1 Cardiac Valve Repairs Companies – Pipeline Products by Stage of Development 18
4.2 Cardiac Valve Repairs – Pipeline Products by Stage of Development 20
5 Cardiac Valve Repairs Companies and Product Overview 22
5.1 4tech Cardio Ireland Limited Company Overview 22
5.1.1 4tech Cardio Ireland Limited Pipeline Products & Ongoing Clinical Trials Overview 22
5.2 Admedus Ltd Company Overview 24
5.2.1 Admedus Ltd Pipeline Products & Ongoing Clinical Trials Overview 24
5.3 Agamit Medical Ltd (Inactive) Company Overview 26
5.3.1 Agamit Medical Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 26
5.4 Ample Medical Inc Company Overview 27
5.4.1 Ample Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 27
5.5 Ancora Heart Inc Company Overview 28
5.5.1 Ancora Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 28
5.6 Arbor Surgical Technologies, Inc. Company Overview 30
5.6.1 Arbor Surgical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 30
5.7 BioStable Science & Engineering, Inc. Company Overview 31
5.7.1 BioStable Science & Engineering, Inc. Pipeline Products & Ongoing Clinical Trials Overview 31
5.8 Cardiosolutions Inc Company Overview 33
5.8.1 Cardiosolutions Inc Pipeline Products & Ongoing Clinical Trials Overview 33
5.9 Cardious, Inc. Company Overview 34
5.9.1 Cardious, Inc. Pipeline Products & Ongoing Clinical Trials Overview 34
5.10 Children’s Hospital Boston Company Overview 35
5.10.1 Children’s Hospital Boston Pipeline Products & Ongoing Clinical Trials Overview 35
5.11 CollPlant Ltd. Company Overview 38
5.11.1 CollPlant Ltd. Pipeline Products & Ongoing Clinical Trials Overview 38
5.12 coramaze technologies GmbH Company Overview 39
5.12.1 coramaze technologies GmbH Pipeline Products & Ongoing Clinical Trials Overview 39
5.13 Coroneo Inc. Company Overview 40
5.13.1 Coroneo Inc. Pipeline Products & Ongoing Clinical Trials Overview 40
5.14 CUBE SRL Company Overview 41
5.14.1 CUBE SRL Pipeline Products & Ongoing Clinical Trials Overview 41
5.15 Edwards Lifesciences Corp Company Overview 42
5.15.1 Edwards Lifesciences Corp Pipeline Products & Ongoing Clinical Trials Overview 42
5.16 Emory University Company Overview 45
5.16.1 Emory University Pipeline Products & Ongoing Clinical Trials Overview 45
5.17 Lartim Medical Ltd Company Overview 47
5.17.1 Lartim Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 47
5.18 Mardil Medical, Inc. Company Overview 48
5.18.1 Mardil Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 48
5.19 Mayo Clinic US Company Overview 50
5.19.1 Mayo Clinic US Pipeline Products & Ongoing Clinical Trials Overview 50
5.20 Medtentia AB Company Overview 51
5.20.1 Medtentia AB Pipeline Products & Ongoing Clinical Trials Overview 51
5.21 MiCardia Corp Company Overview 54
5.21.1 MiCardia Corp Pipeline Products & Ongoing Clinical Trials Overview 54
5.22 Michigan Critical Care Consultants, Inc. Company Overview 56
5.22.1 Michigan Critical Care Consultants, Inc. Pipeline Products & Ongoing Clinical Trials Overview 56
5.23 Middle Peak Medical Inc Company Overview 58
5.23.1 Middle Peak Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 58
5.24 Millipede, LLC Company Overview 59
5.24.1 Millipede, LLC Pipeline Products & Ongoing Clinical Trials Overview 59
5.25 Mitral Heal Company Overview 60
5.25.1 Mitral Heal Pipeline Products & Ongoing Clinical Trials Overview 60
5.26 Mitralix Ltd. Company Overview 61
5.26.1 Mitralix Ltd. Pipeline Products & Ongoing Clinical Trials Overview 61
5.27 Mitre Medical Corp. Company Overview 62
5.27.1 Mitre Medical Corp. Pipeline Products & Ongoing Clinical Trials Overview 62
5.28 Neochord Inc Company Overview 64
5.28.1 Neochord Inc Pipeline Products & Ongoing Clinical Trials Overview 64
5.29 North Carolina State University Company Overview 68
5.29.1 North Carolina State University Pipeline Products & Ongoing Clinical Trials Overview 68
5.30 Phoenix Cardiac Devices, Inc. Company Overview 69
5.30.1 Phoenix Cardiac Devices, Inc. Pipeline Products & Ongoing Clinical Trials Overview 69
5.31 QuantumCor Inc. (Inactive) Company Overview 71
5.31.1 QuantumCor Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 71
5.32 Rambam Health Care Campus Company Overview 72
5.32.1 Rambam Health Care Campus Pipeline Products & Ongoing Clinical Trials Overview 72
5.33 ReCor Medical, Inc. Company Overview 73
5.33.1 ReCor Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 73
5.34 Sree Chitra Tirunal Institute for Medical Sciences & Technology Company Overview 74
5.34.1 Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 74
5.35 St. Jude Medical Inc Company Overview 75
5.35.1 St. Jude Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 75
5.36 TransCardiac Therapeutics, LLC Company Overview 77
5.36.1 TransCardiac Therapeutics, LLC Pipeline Products & Ongoing Clinical Trials Overview 77
5.37 Trinity College Dublin Company Overview 78
5.37.1 Trinity College Dublin Pipeline Products & Ongoing Clinical Trials Overview 78
5.38 Valcare Medical Company Overview 79
5.38.1 Valcare Medical Pipeline Products & Ongoing Clinical Trials Overview 79
5.39 Valtech Cardio Ltd Company Overview 81
5.39.1 Valtech Cardio Ltd Pipeline Products & Ongoing Clinical Trials Overview 81
5.40 Viacor Inc Company Overview 88
5.40.1 Viacor Inc Pipeline Products & Ongoing Clinical Trials Overview 88
6 Cardiac Valve Repairs- Recent Developments 89
6.1 Nov 26, 2016: Edwards Lifesciences to Acquire Valtech Cardio for USD340 Million 89
6.2 Nov 22, 2016: Medtronic Reports Second Quarter Financial Results 89
6.3 Nov 16, 2016: Medtronic Releases FY16 Integrated Performance Report 92
6.4 Nov 15, 2016: CEVA to work with Medtronic for distribution facility construction 92
6.5 Nov 09, 2016: First Patient Treated in U.S. Randomized Trial of NeoChord’s, Off-Pump, Minimally Invasive Repair for Degenerative Mitral Regurgitation 93
6.6 Nov 08, 2016: Corindus Vascular Robotics Reports Third Quarter 2016 Results 94
6.7 Nov 07, 2016: Dextera Surgical Reports Fiscal 2017 First Quarter Financial Results 95
6.8 Oct 31, 2016: Guided Delivery Systems Announces Senior Leaders and Company Name Change to Ancora Heart 96
6.9 Oct 28, 2016: NeoChord Passes 500 Patient Treatment Milestone 97
6.10 Oct 28, 2016: 4Tech Elects Ex-Medtronic CEO William (“Bill”) A. Hawkins as its Chairman 97
6.11 Oct 25, 2016: Edwards Lifesciences Reports Third Quarter Results 98
6.12 Oct 20, 2016: Corindus Vascular Robotics Appoints Jeff Lemaster Chief Commercial Officer 100
6.13 Oct 19, 2016: St. Jude Medical Reports Third Quarter 2016 Results 100
6.14 Oct 11, 2016: BioStable Science & Engineering Completes Direct De Novo Application to FDA for the HAART 300 Aortic Annuloplasty Device 101
6.15 Sep 16, 2016: World’s first Transcatheter Tricuspid Valve Repair (TTVR) has been successfully achieved without use of TEE and General Anesthesia in feasibility study of 4Tech TriCinch at San Raffaele Hospital, Milan, Italy 102
6.16 Sep 16, 2016: Valtech Cardio Presents: Cardioband Tricuspid Successful First in Man Cases and 2-Year Cardioband Mitral Data at PCR London Valves 2016 103
6.17 Sep 15, 2016: Medtronic Names Mark Ploof Senior Vice President of Global Operations and Business Services 104
6.18 Aug 25, 2016: Medtronic Reports First Quarter Financial Results 104
6.19 Aug 09, 2016: Dextera Surgical Reports FY 2016 Fourth Quarter Financial Results 107
6.20 Aug 04, 2016: Corindus Vascular Robotics Reports Second Quarter 2016 Results 108
6.21 Jul 26, 2016: Edwards Lifesciences Reports Second Quarter Results 109
6.22 Jul 20, 2016: St. Jude Medical Reports Second Quarter 2016 Results 111
6.23 Jun 30, 2016: NuVasive Agrees to Settle Patent Litigation With Medtronic 112
6.24 Jun 29, 2016: Dextera Surgical Appoints Mark Soberman M.D., Leader in Thoracic Surgery, as Medical Director 113
6.25 Jun 20, 2016: Valcare Medical, an Accelmed Portfolio Company, Announces Successful First-In-Human Procedures of the Amend Catheter Delivered Annuloplasty Ring 113
6.26 Jun 20, 2016: Cardica Changes Company Name to Dextera Surgical 114
6.27 Jun 15, 2016: Transcatheter Tricuspid Valve Repair (TTVR) Has Been Successfully Achieved in Feasibility Study of 4Tech TriCinch at San Raffaele Hospital, Milan, Italy 115
6.28 Jun 06, 2016: Medtronic Outlines Future Growth Vision at Investor Day 115
6.29 May 31, 2016: Medtronic Reports Fourth Quarter and Fiscal Year 2016 Financial Results 116
6.30 May 16, 2016: BioStable Science & Engineering Initiates European Commercialization of the HAART 300 Aortic Annuloplasty Device 118
6.31 May 16, 2016: 4Tech and Dr. Jean-Claude Laborde enter into partnership to accelerate 4Tech R&D and clinical development 119
6.32 May 16, 2016: Otsuka Invests in ReCor Medical 120
6.33 May 13, 2016: NeoChord Receives FDA Approval to begin Clinical Trial for Treatment of Degenerative Mitral Valve Regurgitation 120
6.34 May 12, 2016: ReCor Medical Raises USD10 Million in Venture Financing 120
6.35 Apr 08, 2016: Admedus Expands Distribution Agreement With Coroneo 120
6.36 Apr 08, 2016: Admedus Extends Distribution Agreement with Coroneo 121
6.37 Mar 29, 2016: David H. Adams, MD and Michael A. Borger, MD, PhD to Serve as National Principal Investigators for NeoChord’s U.S. Pivotal Trial 121
6.38 Mar 09, 2016: LivaNova Receives Regulatory Approval in Canada for its Innovative Memo 3D ReChord Annuloplasty Ring for Mitral Valve Repair 122
6.39 Mar 09, 2016: 4Tech Raises USD29 Million in Series B Financing 122
6.40 Mar 08, 2016: BioStable Science & Engineering Announces CE Mark Approval For The HAART 300 Aortic Annuloplasty Device 122
6.41 Feb 10, 2016: NeoChord Again Awarded NUB Status 1 in Germany 123
6.42 Feb 09, 2016: Valtech Cardioband Reconstruction System for Mitral Valve Repair Receives Reimbursement in Germany 123
6.43 Feb 02, 2016: Edwards Lifesciences Reports Fourth Quarter Results 124
6.44 Jan 27, 2016: Admedus Enters into Distribution Agreement with Coroneo 125
6.45 Jan 27, 2016: Admedus Signs Exclusive Distribution Agreement With Coroneo 125
7 Appendix 127
7.1 Methodology 127
7.2 About GlobalData 130
7.3 Contact Us 130
7.4 Disclaimer 130