Total Artificial Heart - Medical Devices Pipeline Assessment, 2017

2017-05-10
Price :
Published : May-2017
No. of Pages : 54
1 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 20
5.4.1 Cleveland Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 20
5.5 Foster-Miller, Inc. (Inactive) Company Overview 21
5.5.1 Foster-Miller, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 21
5.6 Indian Institute of Technology Delhi Company Overview 22
5.6.1 Indian Institute of Technology Delhi Pipeline Products & Ongoing Clinical Trials Overview 22
5.7 ReliantHeart, Inc. Company Overview 23
5.7.1 ReliantHeart, Inc. Pipeline Products & Ongoing Clinical Trials Overview 23
5.8 SynCardia Systems, Inc. Company Overview 24
5.8.1 SynCardia Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 24
5.9 The University of Tokyo Company Overview 30
5.9.1 The University of Tokyo Pipeline Products & Ongoing Clinical Trials Overview 30
6 Total Artificial Heart- Recent Developments 31
6.1 May 04, 2017: Abiomed Announces Q4 FY 2017 Revenue of $124.7 Million, Up 33% Over Prior Year and Total Year Revenue of $445.3 Million, Up 35% Over Prior Year 31
6.2 May 02, 2017: CARMAT announces the resumption of the PIVOTAL study in France 32
6.3 Apr 19, 2017: Turkish Man Becomes World's Longest Supported Total Artificial Heart Patient 32
6.4 Mar 14, 2017: SynCardia Names New VP of Manufacturing and Facilities 33
6.5 Feb 06, 2017: CARMAT provides an update regarding the suspended PIVOTAL study on its bioprosthetic artificial heart 34
6.6 Jan 26, 2017: Abiomed Announces Q3 FY 2017 Revenue of $114.7 Million, Up 34% Over Prior Year 34
6.7 Jan 25, 2017: Two Cardiology Experts Join CARMAT's Board of Directors as Independent Members 35
6.8 Jan 09, 2017: Abiomed Announces Preliminary Q3 FY 2017 Revenue of $114.7 Million, Up 34% Over Prior Year 36
6.9 Jan 04, 2017: ClĂ­nica Universidad de Navarra Implants Spain's First SynCardia Total Artificial Heart 37
6.10 Nov 30, 2016: Update on the PIVOTAL study on the CARMAT bioprosthetic artificial heart 38
6.11 Nov 09, 2016: Arrhythmia Research Technology Reports 2016 Third Quarter Results 38
6.12 Oct 27, 2016: Abiomed Announces Q2 FY 2017 Revenue of $103 Million, Up 35% Over Prior Year 40
6.13 Oct 27, 2016: Amedisys Previews Third Quarter 2016 Results 41
6.14 Oct 04, 2016: EKN Duisburg Becomes First Device-Only Center to Reach 50 SynCardia Artificial Heart Implants 41
6.15 Sep 08, 2016: CARMAT: 2016 half-year results in line with the progress achieved by the Company 42
6.16 Sep 01, 2016: CARMAT announces the departure of Marcello Conviti, CEO 43
6.17 Sep 01, 2016: Stephane Piat, Previously Division Vice President of Abbott in California, Has Been Appointed CEO of CARMAT 43
6.18 Aug 29, 2016: CARMAT Announces the Start of the PIVOTAL Study 44
6.19 Aug 16, 2016: SynCardia Artificial Heart to Emerge from Chapter 11 Reorganization With New Owner on September 16, 2016 45
6.20 Aug 11, 2016: Arrhythmia Research Technology Reports 2016 Second Quarter Results 46
6.21 Jul 28, 2016: Abiomed Announces Q1 FY 2017 Revenue of $103.0 Million, Up 40% Over Prior Year 48
6.22 Jul 13, 2016: CARMAT has obtained the necessary approvals to begin the PIVOTAL study in France 49
6.23 Jun 23, 2016: CARMAT has begun, with DEKRA, the CE certification process for its bioprosthetic artificial heart 49
7 Appendix 51
7.1 Methodology 51
7.2 About GlobalData 54
7.3 Contact Us 54
7.4 Disclaimer 54

1.1 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 14
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 17
Table 16: Artificial Heart - Product Description 18
Table 17: Carmat SAS - Ongoing Clinical Trials Overview 18
Table 18: Artificial Heart - Clinical Evaluation of the Carmat Total Artificial Heart for Patients with Advanced Heart Failure 19
Table 19: Artificial Heart - First-in-man CARMAT's Bioprosthetic Heart Trial For End-stage Heart Failure 19
Table 20: Cleveland Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 20
Table 21: SmartHeart TAH - Product Status 20
Table 22: SmartHeart TAH - Product Description 20
Table 23: Foster-Miller, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 21
Table 24: MagScrew Total Artificial Heart - Product Status 21
Table 25: MagScrew Total Artificial Heart - Product Description 21
Table 26: Indian Institute of Technology Delhi Pipeline Products & Ongoing Clinical Trials Overview 22
Table 27: Artificial Heart - Product Status 22
Table 28: Artificial Heart - Product Description 22
Table 29: ReliantHeart, Inc. Pipeline Products & Ongoing Clinical Trials Overview 23
Table 30: Pulse Less Total Artificial Heart - Product Status 23
Table 31: Pulse Less Total Artificial Heart - Product Description 23
Table 32: SynCardia Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 24
Table 33: 50cc SynCardia Total Artificial Heart - Adults Bridge To Transplant - Product Status 24
Table 34: 50cc SynCardia Total Artificial Heart - Adults Bridge To Transplant - Product Description 24
Table 35: 50cc SynCardia Total Artificial Heart - Destination Therapy - Product Status 25
Table 36: 50cc SynCardia Total Artificial Heart - Destination Therapy - Product Description 25
Table 37: 50cc SynCardia Total Artificial Heart - Pediatric Bridge To Transplant - Product Status 25
Table 38: 50cc SynCardia Total Artificial Heart - Pediatric Bridge To Transplant - Product Description 26
Table 39: 70cc SynCardia Temporary Total Artificial Heart - Destination Therapy - Product Status 26
Table 40: 70cc SynCardia Temporary Total Artificial Heart - Destination Therapy - Product Description 27
Table 41: SynCardia Systems, Inc. - Ongoing Clinical Trials Overview 27
Table 42: 70cc SynCardia Temporary Total Artificial Heart - Destination Therapy - SynCardia 70cc Temporary Total Artificial Heart (TAH-t) for Destination Therapy (DT) 28
Table 43: 50cc SynCardia Total Artificial Heart - Pediatric Bridge To Transplant - SynCardia 50cc Temporary Total Artificial Heart (TAH-t) as a Bridge to Transplant 28
Table 44: 50cc SynCardia Total Artificial Heart - Adults Bridge To Transplant - SynCardia 50cc Temporary Total Artificial Heart (TAH-t) as a Bridge to Transplant 29
Table 45: The University of Tokyo Pipeline Products & Ongoing Clinical Trials Overview 30
Table 46: Helical Flow Total Artificial Heart - Product Status 30
Table 47: Helical Flow Total Artificial Heart - Product Description 30
Table 48: Glossary 53

1.2 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
Filed in: Medical Device
Publisher : GlobalData