Cardiac Septal Occluders-Medical Devices Pipeline Assessment, 2017
August 2017
98
About the Report
About the Report
Cardiac Septal Occluders-Medical Devices Pipeline Assessment, 2017
Summary
GlobalData's Medical Devices sector report, "Cardiac Septal Occluders-Medical Devices Pipeline Assessment, 2017" provides an overview of Cardiac Septal Occluders 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 Septal Occluders 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 Septal Occluders 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 Septal Occluders 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 Septal Occluders 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
Products
Products
Aporo Biomedical, Inc. (Inactive), Patent Foramen Ovale Closure Device; CARAG AG, Solysafe Septal Occluder-Degradable Version; Celyad SA, Cardiao3 Closure Device; Cierra, Inc. (Inactive), PFx Closure System; CoAptus Medical Corporation, Non-Implant Therapeutic Catheter Device; Dextera Surgical Inc, PFO Closure Device; Lifetech Scientific (Shenzhen) Co Ltd, Absorbable Occluder; Lifetech Scientific (Shenzhen) Co Ltd, IrisFIT PFO Occluder; Lifetech Scientific (Shenzhen) Co Ltd, LAmbre LAA Closure System; Micro Interventional Devices, Inc., Patent Foramen Ovale Fixation Device; Occlutech International AB, mVSD Device; Occlutech International AB, Occlutech Figulla Flex II ASD Occluder; Occlutech International AB, Occlutech Figulla Flex II PFO Occluder; Occlutech International AB, Occlutech Figulla Flex UNI; Occlutech International AB, Occlutech LAA Occluder; Occlutech International AB, Occlutech PDA Occluder; SeptRx, Inc. (Inactive), SeptRx IPO; St. Jude Medical LLC, Amplatzer Amulet Left Atrial Appendage Occluder; St. Jude Medical LLC, AMPLATZER Duct Occluder II AS; Sutura, Inc. (Inactive), HeartStitch; Swissimplant AG (Inactive), Solysafe Septal Occluder-10Fr Sheath; University of Minnesota, Bioresorbable Occlusion Device; Vascular Concepts Ltd, VSD (Ventricular Septal Device); W. L. Gore ; Associates Inc, BioTREK; W. L. Gore ; Associates Inc, GORE CARDIOFORM Septal Occluder-Patent Foramen Ovale; W. L. Gore ; Associates Inc, GORE HELEX Septal Occluder-PFO
Companies
Aporo Biomedical, Inc.
CARAG AG
Celyad SA
Cierra, Inc.
CoAptus Medical Corporation
Dextera Surgical Inc
Lifetech Scientific (Shenzhen) Co Ltd
Micro Interventional Devices, Inc.
Occlutech International AB
SeptRx, Inc.
St. Jude Medical LLC
Sutura, Inc.
Swissimplant AG
University of Minnesota
Vascular Concepts Ltd
W. L. Gore Associates Inc
Table of Contents
Table of Contents
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 4
1.2 List of Figures 6
2 Introduction 7
2.1 Cardiac Septal Occluders Overview 7
3 Products under Development 8
3.1 Cardiac Septal Occluders-Pipeline Products by Stage of Development 8
3.2 Cardiac Septal Occluders-Pipeline Products by Segment 9
3.3 Cardiac Septal Occluders-Pipeline Products by Territory 10
3.4 Cardiac Septal Occluders-Pipeline Products by Regulatory Path 11
3.5 Cardiac Septal Occluders-Pipeline Products by Estimated Approval Date 12
3.6 Cardiac Septal Occluders-Ongoing Clinical Trials 13
4 Cardiac Septal Occluders-Pipeline Products under Development by Companies 14
4.1 Cardiac Septal Occluders Companies-Pipeline Products by Stage of Development 14
4.2 Cardiac Septal Occluders-Pipeline Products by Stage of Development 15
5 Cardiac Septal Occluders Companies and Product Overview 16
5.1 Aporo Biomedical, Inc. (Inactive) Company Overview 16
5.1.1 Aporo Biomedical, Inc. (Inactive) Pipeline Products Ongoing Clinical Trials Overview 16
5.2 CARAG AG Company Overview 17
5.2.1 CARAG AG Pipeline Products Ongoing Clinical Trials Overview 17
5.3 Celyad SA Company Overview 20
5.3.1 Celyad SA Pipeline Products Ongoing Clinical Trials Overview 20
5.4 Cierra, Inc. (Inactive) Company Overview 21
5.4.1 Cierra, Inc. (Inactive) Pipeline Products Ongoing Clinical Trials Overview 21
5.5 CoAptus Medical Corporation Company Overview 22
5.5.1 CoAptus Medical Corporation Pipeline Products Ongoing Clinical Trials Overview 22
5.6 Dextera Surgical Inc Company Overview 23
5.6.1 Dextera Surgical Inc Pipeline Products Ongoing Clinical Trials Overview 23
5.7 Lifetech Scientific (Shenzhen) Co Ltd Company Overview 24
5.7.1 Lifetech Scientific (Shenzhen) Co Ltd Pipeline Products Ongoing Clinical Trials Overview 24
5.8 Micro Interventional Devices, Inc. Company Overview 30
5.8.1 Micro Interventional Devices, Inc. Pipeline Products Ongoing Clinical Trials Overview 30
5.9 Occlutech International AB Company Overview 31
5.9.1 Occlutech International AB Pipeline Products Ongoing Clinical Trials Overview 31
5.10 SeptRx, Inc. (Inactive) Company Overview 39
5.10.1 SeptRx, Inc. (Inactive) Pipeline Products Ongoing Clinical Trials Overview 39
5.11 St. Jude Medical LLC Company Overview 40
5.11.1 St. Jude Medical LLC Pipeline Products Ongoing Clinical Trials Overview 40
5.12 Sutura, Inc. (Inactive) Company Overview 45
5.12.1 Sutura, Inc. (Inactive) Pipeline Products Ongoing Clinical Trials Overview 45
5.13 Swissimplant AG (Inactive) Company Overview 46
5.13.1 Swissimplant AG (Inactive) Pipeline Products Ongoing Clinical Trials Overview 46
5.14 University of Minnesota Company Overview 47
5.14.1 University of Minnesota Pipeline Products Ongoing Clinical Trials Overview 47
5.15 Vascular Concepts Ltd Company Overview 48
5.15.1 Vascular Concepts Ltd Pipeline Products Ongoing Clinical Trials Overview 48
5.16 W. L. Gore Associates Inc Company Overview 49
5.16.1 W. L. Gore Associates Inc Pipeline Products Ongoing Clinical Trials Overview 49
6 Cardiac Septal Occluders-Recent Developments 54
6.1 Jul 03, 2017: Lifetech Announced the Launch of its Global Post-market Surveillance Study for Lambre LAA Closure System 54
6.2 May 19, 2017: Celyad Announces First Quarter 2017 Business Update 54
6.3 May 16, 2017: Gore Announces Positive Results from REDUCE Clinical Study for PFO Closure 55
6.4 May 04, 2017: Dextera Surgical Reports Fiscal 2017 Third Quarter Financial Results 57
6.5 Apr 25, 2017: Edwards Lifesciences Reports First Quarter Results 58
6.6 Apr 24, 2017: Dextera Surgical Announces Preliminary Fiscal 2017 Third Quarter Financial Highlights 60
6.7 Apr 05, 2017: Occlutech Obtains European CE Mark for its Novel PmVSD Occluder 60
6.8 Mar 30, 2017: MPSC Announces 2016 Annual Results 60
6.9 Mar 24, 2017: LifeTech Announces 2016 Annual Results 62
6.10 Mar 13, 2017: Cook Medical Announces Umesh Patel as President of Cook Biotech 64
6.11 Mar 07, 2017: Anteo Technologies Announces Verification Study With Cook Medical Australia 65
6.12 Feb 08, 2017: Texas Cardiac Arrhythmia Institute at St. David's Medical Center First in Texas to Use AMPLATZER Amulet Left Atrial Appendage Occluder 66
6.13 Feb 07, 2017: Dextera Surgical Reports Fiscal 2017 Second Quarter Financial Results 66
6.14 Feb 01, 2017: Edwards Lifesciences Reports Fourth Quarter Results 68
6.15 Dec 13, 2016: Aurora St. Luke's Medical Center is first hospital in Wisconsin to implant device to close holes in heart 69
6.16 Dec 08, 2016: Edwards Lifesciences Outlines Growth Strategy At Annual Investor Conference 70
6.17 Nov 18, 2016: Only FDA-Approved Device to Repair "Hole in the Heart" Condition Now Available at Baylor Heart and Vascular Services at Fort Worth 72
6.18 Nov 18, 2016: Celyad Announces Third Quarter 2016 Business Update 73
6.19 Nov 07, 2016: Dextera Surgical Reports Fiscal 2017 First Quarter Financial Results 74
6.20 Nov 02, 2016: Largest Observational Study to Date of the St. Jude Medical AMPLATZER Amulet Left Atrial Appendage Occluder Demonstrates High Implant Success and Strong Safety Profile 76
6.21 Nov 01, 2016: St. Jude Medical Welcomes Landmark Stroke Data from the RESPECT Trial 77
6.22 Nov 01, 2016: Long-Term Study Results Show That PFO Closure is More Effective than Medical Management in Preventing Recurrent Stroke 78
6.23 Oct 28, 2016: FDA approves new device for prevention of recurrent strokes in certain patients 79
6.24 Oct 25, 2016: Edwards Lifesciences Reports Third Quarter Results 80
6.25 Oct 24, 2016: St. Jude Medical Announces Data to be Presented as Late-Breaking Clinical Trials and Highlights Its Latest Cardiovascular Portfolio at the 2016 TCT Conference 81
6.26 Oct 19, 2016: St. Jude Medical Reports Third Quarter 2016 Results 82
6.27 Oct 18, 2016: St. Jude Medical, FDA And Top Pediatric Cardiology Experts Announce New Clinical Trial To Treat Congenital Heart Defects 84
6.28 Sep 19, 2016: Organogenesis Announces New Chief Financial Officer 85
6.29 Sep 01, 2016: St. Jude Medical Launches Global Clinical Trial to Evaluate a New Therapy Option for Patients at an Increased Risk of Stroke Due to Atrial Fibrillation 86
6.30 Aug 31, 2016: Cook Medical Names Jean-Marc Creissel Vice President of Operations in Greater China 87
6.31 Aug 30, 2016: MPSC Announces 2016 Interim Results 87
6.32 Aug 25, 2016: Celyad Reports First Half 2016 Financial Results and Operational Progress 89
6.33 Aug 09, 2016: Dextera Surgical Reports FY 2016 Fourth Quarter Financial Results 90
6.34 Jul 26, 2016: Edwards Lifesciences Reports Second Quarter Results 92
7 Appendix 95
7.1 Methodology 95
7.2 About GlobalData 98
7.3 Contact Us 98
7.4 Disclaimer 98
List of Figure
1.2 List of Figures
Figure 1: Cardiac Septal Occluders-Pipeline Products by Stage of Development 8
Figure 2: Cardiac Septal Occluders-Pipeline Products by Segment 9
Figure 3: Cardiac Septal Occluders-Pipeline Products by Territory 10
Figure 4: Cardiac Septal Occluders-Pipeline Products by Regulatory Path 11
Figure 5: Cardiac Septal Occluders-Pipeline Products by Estimated Approval Date 12
Figure 6: Cardiac Septal Occluders-Ongoing Clinical Trials 13
List of Table
1.1 List of Tables
Table 1: Cardiac Septal Occluders-Pipeline Products by Stage of Development 8
Table 2: Cardiac Septal Occluders-Pipeline Products by Segment 9
Table 3: Cardiac Septal Occluders-Pipeline Products by Territory 10
Table 4: Cardiac Septal Occluders-Pipeline Products by Regulatory Path 11
Table 5: Cardiac Septal Occluders-Pipeline Products by Estimated Approval Date 12
Table 6: Cardiac Septal Occluders-Ongoing Clinical Trials 13
Table 7: Cardiac Septal Occluders Companies-Pipeline Products by Stage of Development 14
Table 8: Cardiac Septal Occluders-Pipeline Products by Stage of Development 15
Table 9: Aporo Biomedical, Inc. (Inactive) Pipeline Products Ongoing Clinical Trials Overview 16
Table 10: Patent Foramen Ovale Closure Device-Product Status 16
Table 11: Patent Foramen Ovale Closure Device-Product Description 16
Table 12: CARAG AG Pipeline Products Ongoing Clinical Trials Overview 17
Table 13: Solysafe Septal Occluder-Degradable Version-Product Status 17
Table 14: Solysafe Septal Occluder-Degradable Version-Product Description 17
Table 15: CARAG AG-Ongoing Clinical Trials Overview 18
Table 16: Solysafe Septal Occluder-Degradable Version-Prospective Single Center Pilot Clinical Study to Evaluate the Safety and Effectiveness of an Intracardiac Septal Closure Device with Biodegradable Framework in Patients with Clinically Significant Atrial Septum Defect (ASD) or Patent Foramen Ovale (PFO) 19
Table 17: Celyad SA Pipeline Products Ongoing Clinical Trials Overview 20
Table 18: Cardiao3 Closure Device-Product Status 20
Table 19: Cardiao3 Closure Device-Product Description 20
Table 20: Cierra, Inc. (Inactive) Pipeline Products Ongoing Clinical Trials Overview 21
Table 21: PFx Closure System-Product Status 21
Table 22: PFx Closure System-Product Description 21
Table 23: CoAptus Medical Corporation Pipeline Products Ongoing Clinical Trials Overview 22
Table 24: Non-Implant Therapeutic Catheter Device-Product Status 22
Table 25: Non-Implant Therapeutic Catheter Device-Product Description 22
Table 26: Dextera Surgical Inc Pipeline Products Ongoing Clinical Trials Overview 23
Table 27: PFO Closure Device-Product Status 23
Table 28: PFO Closure Device-Product Description 23
Table 29: Lifetech Scientific (Shenzhen) Co Ltd Pipeline Products Ongoing Clinical Trials Overview 24
Table 30: Absorbable Occluder-Product Status 24
Table 31: Absorbable Occluder-Product Description 24
Table 32: IrisFIT PFO Occluder-Product Status 25
Table 33: IrisFIT PFO Occluder-Product Description 25
Table 34: LAmbre LAA Closure System-Product Status 25
Table 35: LAmbre LAA Closure System-Product Description 26
Table 36: Lifetech Scientific (Shenzhen) Co Ltd-Ongoing Clinical Trials Overview 27
Table 37: LAmbre LAA Closure System-Evaluation of Safety and Efficacy of the New Generation of Left Appendage Closure With the Lambre Device in AF Patients Not Suitable for Use of Warfarin 28
Table 38: LAmbre LAA Closure System-LifeTech LAmbre Keft Atrial Appendage (LAA) Closure System Post-market Clinical Follow-up 28
Table 39: LAmbre LAA Closure System-Study of Safety and Efficacy of a Left Atrial Appendage Occulder 28
Table 40: IrisFIT PFO Occluder-Post Market Clinical Follow-up Study of IrisFIT PFO (Patent Foramen Ovale) 29
Table 41: Micro Interventional Devices, Inc. Pipeline Products Ongoing Clinical Trials Overview 30
Table 42: Patent Foramen Ovale Fixation Device-Product Status 30
Table 43: Patent Foramen Ovale Fixation Device-Product Description 30
Table 44: Occlutech International AB Pipeline Products Ongoing Clinical Trials Overview 31
Table 45: mVSD Device-Product Status 31
Table 46: mVSD Device-Product Description 32
Table 47: Occlutech Figulla Flex II ASD Occluder-Product Status 32
Table 48: Occlutech Figulla Flex II ASD Occluder-Product Description 32
Table 49: Occlutech Figulla Flex II PFO Occluder-Product Status 33
Table 50: Occlutech Figulla Flex II PFO Occluder-Product Description 33
Table 51: Occlutech Figulla Flex UNI-Product Status 33
Table 52: Occlutech Figulla Flex UNI-Product Description 34
Table 53: Occlutech LAA Occluder-Product Status 34
Table 54: Occlutech LAA Occluder-Product Description 34
Table 55: Occlutech PDA Occluder-Product Status 35
Table 56: Occlutech PDA Occluder-Product Description 35
Table 57: Occlutech International AB-Ongoing Clinical Trials Overview 36
Table 58: Occlutech LAA Occluder-Prospective, Non-randomized, Safety and Efficacy Study of a New Occluder Design for Minimally Invasive Closure of the Left Atrial Appendage in Patients with Atrial Fibrillation 37
Table 59: Occlutech Figulla Flex II ASD Occluder-International Registry for Secundum Atrial Septal Defects Closure by Using the Occlutech Flex II Device in More than 2000 Patients 38
Table 60: SeptRx, Inc. (Inactive) Pipeline Products Ongoing Clinical Trials Overview 39
Table 61: SeptRx IPO-Product Status 39
Table 62: SeptRx IPO-Product Description 39
Table 63: St. Jude Medical LLC Pipeline Products Ongoing Clinical Trials Overview 40
Table 64: Amplatzer Amulet Left Atrial Appendage Occluder-Product Status 40
Table 65: Amplatzer Amulet Left Atrial Appendage Occluder-Product Description 41
Table 66: AMPLATZER Duct Occluder II AS-Product Status 41
Table 67: AMPLATZER Duct Occluder II AS-Product Description 41
Table 68: St. Jude Medical LLC-Ongoing Clinical Trials Overview 42
Table 69: Amplatzer Amulet Left Atrial Appendage Occluder-AMPLATZER Amulet Left Atrial Appendage Occluder Randomized Controlled Trial 43
Table 70: Amplatzer Amulet Left Atrial Appendage Occluder-Amplatzer Amulet Observational Post-market Study 43
Table 71: Amplatzer Amulet Left Atrial Appendage Occluder-Prevention of Stroke by Left Atrial Appendage Closure in Atrial Fibrillation Patients after Intracerebral Hemorrhage: A Multicenter Randomized Clinical Trial 43
Table 72: AMPLATZER Duct Occluder II AS-AMPLATZER Duct Occluder II Additional Sizes: ADO II AS Clinical Study 44
Table 73: Sutura, Inc. (Inactive) Pipeline Products Ongoing Clinical Trials Overview 45
Table 74: HeartStitch-Product Status 45
Table 75: HeartStitch-Product Description 45
Table 76: Swissimplant AG (Inactive) Pipeline Products Ongoing Clinical Trials Overview 46
Table 77: Solysafe Septal Occluder-10Fr Sheath-Product Status 46
Table 78: Solysafe Septal Occluder-10Fr Sheath-Product Description 46
Table 79: University of Minnesota Pipeline Products Ongoing Clinical Trials Overview 47
Table 80: Bioresorbable Occlusion Device-Product Status 47
Table 81: Bioresorbable Occlusion Device-Product Description 47
Table 82: Vascular Concepts Ltd Pipeline Products Ongoing Clinical Trials Overview 48
Table 83: VSD (Ventricular Septal Device)-Product Status 48
Table 84: VSD (Ventricular Septal Device)-Product Description 48
Table 85: W. L. Gore Associates Inc Pipeline Products Ongoing Clinical Trials Overview 49
Table 86: BioTREK-Product Status 49
Table 87: BioTREK-Product Description 49
Table 88: GORE CARDIOFORM Septal Occluder-Patent Foramen Ovale-Product Status 50
Table 89: GORE CARDIOFORM Septal Occluder-Patent Foramen Ovale-Product Description 50
Table 90: GORE HELEX Septal Occluder-PFO-Product Status 50
Table 91: GORE HELEX Septal Occluder-PFO-Product Description 51
Table 92: W. L. Gore Associates Inc-Ongoing Clinical Trials Overview 52
Table 93: GORE CARDIOFORM Septal Occluder-Patent Foramen Ovale-GORE CARDIOFORM ASD Occluder Clinical Study: A Study to Evaluate Safety and Efficacy in the Treatment of Transcatheter Closure of Ostium Secundum Atrial Septal Defects (ASDs)-The Gore ASSURED Clinical Study 53
Table 94: Glossary 97
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