Table of Contents
1 Table of Contents 2
1.1 List of Tables 4
1.2 List of Figures 5
2 Introduction 6
2.1 Total Artificial Heart Overview 6
3 Products under Development 7
3.1 Total Artificial Heart - Pipeline Products by Stage of Development 7
3.2 Total Artificial Heart - Pipeline Products by Territory 8
3.3 Total Artificial Heart - Pipeline Products by Regulatory Path 9
3.4 Total Artificial Heart - Pipeline Products by Estimated Approval Date 10
3.5 Total Artificial Heart - Ongoing Clinical Trials 11
4 Total Artificial Heart - Pipeline Products under Development by Companies 12
4.1 Total Artificial Heart Companies - Pipeline Products by Stage of Development 12
4.2 Total Artificial Heart - Pipeline Products by Stage of Development 13
5 Total Artificial Heart Companies and Product Overview 14
5.1 Abiomed, Inc. Company Overview 14
5.1.1 Abiomed, Inc. Pipeline Products & Ongoing Clinical Trials Overview 14
5.2 BiVacor Pty Ltd Company Overview 16
5.2.1 BiVacor Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 16
5.3 Carmat SAS Company Overview 17
5.3.1 Carmat SAS Pipeline Products & Ongoing Clinical Trials Overview 17
5.4 Cleveland Heart, Inc. Company Overview 21
5.4.1 Cleveland Heart, Inc. Pipeline Products & Ongoing Clinical Trials Overview 21
5.5 Foster-Miller, Inc. (Inactive) Company Overview 23
5.5.1 Foster-Miller, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 23
5.6 MicroMed Cardiovascular, Inc. Company Overview 24
5.6.1 MicroMed Cardiovascular, Inc. Pipeline Products & Ongoing Clinical Trials Overview 24
5.7 SynCardia Systems, Inc. Company Overview 25
5.7.1 SynCardia Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 25
5.8 The University of Tokyo Company Overview 34
5.8.1 The University of Tokyo Pipeline Products & Ongoing Clinical Trials Overview 34
6 Total Artificial Heart- Recent Developments 35
6.1 Apr 13, 2016: World's Leading Artificial Heart Center, La Pitié Hospital, Paris, Celebrates 30 Years and 249 Implants of the SynCardia Total Artificial Heart 35
6.2 Feb 29, 2016: Early Findings of the 50cc SynCardia Heart Indicate That It Fits Underserved Patients - Women & Adolescents 36
6.3 Feb 26, 2016: Carmat Raises USD55 Million in Private Placement of Shares 37
6.4 Jan 26, 2016: Altaris Capital Partners Acquires Minority Interest in Minnetronix for USD20 Million 37
6.5 Jan 21, 2016: Information regarding the Feasibility study of the CARMAT bioprosthetic artificial heart 37
6.6 Nov 12, 2015: Arrhythmia Research Technology Reports 2015 Third Quarter Results 38
6.7 Sep 16, 2015: SynCardia Systems Withdraws IPO for up to USD30 Million 39
6.8 Aug 31, 2015: Interim Results of the Feasibility Study Presented at the ESC Congress in London 40
6.9 Aug 18, 2015: The Start of SynCardia Total Artificial Heart Destination Clinical Study Wins Edison Awards' Top Honor 40
6.10 Jun 15, 2015: SynCardia Systems - TAH-t Companion 2 Driver System - Letter to Health Care Providers 41
6.11 Jun 03, 2015: Carmat To Implant Artificial Heart In Fourth Patient In Next Three Months 42
7 Appendix 43
7.1 Methodology 43
7.2 About GlobalData 45
7.3 Contact Us 46
7.4 Disclaimer 46
List of Tables
Table 1: Total Artificial Heart - Pipeline Products by Stage of Development 7
Table 2: Total Artificial Heart - Pipeline Products by Territory 8
Table 3: Total Artificial Heart - Pipeline Products by Regulatory Path 9
Table 4: Total Artificial Heart - Pipeline Products by Estimated Approval Date 10
Table 5: Total Artificial Heart - Ongoing Clinical Trials 11
Table 6: Total Artificial Heart Companies - Pipeline Products by Stage of Development 12
Table 7: Total Artificial Heart - Pipeline Products by Stage of Development 13
Table 8: Abiomed, Inc. Pipeline Products & Ongoing Clinical Trials Overview 14
Table 9: AbioCor II - Product Status 15
Table 10: AbioCor II - Product Description 15
Table 11: BiVacor Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 16
Table 12: BiVACOR Device - Product Status 16
Table 13: BiVACOR Device - Product Description 16
Table 14: Carmat SAS Pipeline Products & Ongoing Clinical Trials Overview 17
Table 15: Artificial Heart - Product Status 18
Table 16: Artificial Heart - Product Description 18
Table 17: Carmat SAS - Ongoing Clinical Trials Overview 19
Table 18: Artificial Heart - First-in-man CARMAT's Bioprosthetic Heart Trial For End-stage Heart Failure 20
Table 19: Cleveland Heart, Inc. Pipeline Products & Ongoing Clinical Trials Overview 21
Table 20: SmartHeart TAH - Product Status 22
Table 21: SmartHeart TAH - Product Description 22
Table 22: Foster-Miller, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 23
Table 23: MagScrew Total Artificial Heart - Product Status 23
Table 24: MagScrew Total Artificial Heart - Product Description 23
Table 25: MicroMed Cardiovascular, Inc. Pipeline Products & Ongoing Clinical Trials Overview 24
Table 26: Pulse Less Total Artificial Heart - Product Status 24
Table 27: Pulse Less Total Artificial Heart - Product Description 24
Table 28: SynCardia Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 25
Table 29: 50cc Total Artificial Heart - Adults Bridge To Transplant - Product Status 26
Table 30: 50cc Total Artificial Heart - Adults Bridge To Transplant - Product Description 26
Table 31: 50cc Total Artificial Heart - Destination Therapy - Product Status 27
Table 32: 50cc Total Artificial Heart - Destination Therapy - Product Description 27
Table 33: 50cc Total Artificial Heart - Pediatric Bridge To Transplant - Product Status 28
Table 34: 50cc Total Artificial Heart - Pediatric Bridge To Transplant - Product Description 28
Table 35: SynCardia Temporary 70cc Total Artificial Heart - Destination Therapy - Product Status 29
Table 36: SynCardia Temporary 70cc Total Artificial Heart - Destination Therapy - Product Description 29
Table 37: SynCardia Systems, Inc. - Ongoing Clinical Trials Overview 30
Table 38: SynCardia Temporary 70cc Total Artificial Heart - Destination Therapy - SynCardia 70cc Temporary Total Artificial Heart (TAH-t) for Destination Therapy (DT) 31
Table 39: 50cc Total Artificial Heart - Pediatric Bridge To Transplant - SynCardia 50cc Temporary Total Artificial Heart (TAH-t) as a Bridge to Transplant 32
Table 40: 50cc Total Artificial Heart - Adults Bridge To Transplant - SynCardia 50cc Temporary Total Artificial Heart (TAH-t) as a Bridge to Transplant 33
Table 41: The University of Tokyo Pipeline Products & Ongoing Clinical Trials Overview 34
Table 42: Total Artificial Heart - Product Status 34
Table 43: Total Artificial Heart - Product Description 34
Table 44: Glossary 44
List of Figures
Figure 1: Total Artificial Heart - Pipeline Products by Stage of Development 7
Figure 2: Total Artificial Heart - Pipeline Products by Territory 8
Figure 3: Total Artificial Heart - Pipeline Products by Regulatory Path 9
Figure 4: Total Artificial Heart - Pipeline Products by Estimated Approval Date 10
Figure 5: Total Artificial Heart - Ongoing Clinical Trials 11