Septal Occluders - Medical Devices Pipeline Assessment, 2018

Septal Occluders - Medical Devices Pipeline Assessment, 2018


  • Products Id :- GDME0590EPD
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  • Pages: 78
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Executive Summary

Septal Occluders-Medical Devices Pipeline Assessment, 2018

Summary

GlobalData's Medical Devices sector report, Septal Occluders-Medical Devices Pipeline Assessment, 2018 provides an overview of 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 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 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 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 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



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Ankur Gupta, Head Marketing & Communications

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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 Septal Occluders Overview 6

3 Products under Development 7

3.1 Septal Occluders-Pipeline Products by Stage of Development 7

3.2 Septal Occluders-Pipeline Products by Segment 8

3.3 Septal Occluders-Pipeline Products by Territory 9

3.4 Septal Occluders-Pipeline Products by Regulatory Path 10

3.5 Septal Occluders-Pipeline Products by Estimated Approval Date 11

3.6 Septal Occluders-Ongoing Clinical Trials 12

4 Septal Occluders-Pipeline Products under Development by Companies 13

4.1 Septal Occluders Companies-Pipeline Products by Stage of Development 13

4.2 Septal Occluders-Pipeline Products by Stage of Development 14

5 Septal Occluders Companies and Product Overview 15

5.1 Aporo Biomedical, Inc. (Inactive) Company Overview 15

5.1.1 Aporo Biomedical, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 15

5.2 CARAG AG Company Overview 16

5.2.1 CARAG AG Pipeline Products & Ongoing Clinical Trials Overview 16

5.3 Celyad SA Company Overview 19

5.3.1 Celyad SA Pipeline Products & Ongoing Clinical Trials Overview 19

5.4 Cierra, Inc. (Inactive) Company Overview 20

5.4.1 Cierra, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 20

5.5 Dextera Surgical Inc Company Overview 21

5.5.1 Dextera Surgical Inc Pipeline Products & Ongoing Clinical Trials Overview 21

5.6 Ension, Inc. Company Overview 22

5.6.1 Ension, Inc. Pipeline Products & Ongoing Clinical Trials Overview 22

5.7 Lifetech Scientific (Shenzhen) Co Ltd Company Overview 23

5.7.1 Lifetech Scientific (Shenzhen) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 23

5.8 Micro Interventional Devices, Inc. Company Overview 29

5.8.1 Micro Interventional Devices, Inc. Pipeline Products & Ongoing Clinical Trials Overview 29

5.9 Occlutech International AB Company Overview 30

5.9.1 Occlutech International AB Pipeline Products & Ongoing Clinical Trials Overview 30

5.10 SeptRx, Inc. (Inactive) Company Overview 31

5.10.1 SeptRx, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 31

5.11 St. Jude Medical LLC Company Overview 32

5.11.1 St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 32

5.12 Sutura, Inc. (Inactive) Company Overview 38

5.12.1 Sutura, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 38

5.13 Swissimplant AG (Inactive) Company Overview 39

5.13.1 Swissimplant AG (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 39

5.14 University of Minnesota Company Overview 40

5.14.1 University of Minnesota Pipeline Products & Ongoing Clinical Trials Overview 40

5.15 Vanderbilt University Company Overview 41

5.15.1 Vanderbilt University Pipeline Products & Ongoing Clinical Trials Overview 41

5.16 Vascular Concepts Ltd Company Overview 42

5.16.1 Vascular Concepts Ltd Pipeline Products & Ongoing Clinical Trials Overview 42

5.17 W. L. Gore & Associates Inc Company Overview 43

5.17.1 W. L. Gore & Associates Inc Pipeline Products & Ongoing Clinical Trials Overview 43

6 Septal Occluders- Recent Developments 47

6.1 May 24, 2018: Real-World Study Results Support Use of Abbott s AMPLATZER Amulet to Reduce Stroke in Patients Suffering from Atrial Fibrillation Without the Need for Lifetime Blood Thinners 47

6.2 Apr 25, 2018: Xianjian Technology Receives the Most Attention from Institutional Investors 48

6.3 Apr 24, 2018: Edwards Lifesciences Announces First Quarter 2018 Financial Results 49

6.4 Apr 20, 2018: Cook Medical Appoints Christina Anne Vice President of Distribution Channel Management 50

6.5 Apr 03, 2018: FDA Approves GORE CARDIOFORM Septal Occluder for PFO Closure to Prevent Recurrent Ischemic Stroke 51

6.6 Feb 01, 2018: Edwards Lifesciences Reports Fourth Quarter Results 52

6.7 Jan 08, 2018: Dongguan Kewei Attends 17th National Thoracic and Cardiovascular Surgery Congress 53

6.8 Jan 07, 2018: LifeTech Scientific and Ally Bridge Group Form China-Global Medtech Investment and Operating Partnership 54

6.9 Dec 07, 2017: Edwards Lifesciences Outlines Growth Strategy At Annual Investor Conference 54

6.10 Nov 09, 2017: Dextera Surgical Reports Fiscal 2018 First Quarter Financial Results 56

6.11 Oct 24, 2017: LifeTech Helps the Treatment of Patients with a Heart Disease in Linzhi, Tibet 57

6.12 Oct 24, 2017: Edwards Lifesciences Announces Third Quarter Results 58

6.13 Oct 13, 2017: LAmbre Overcomes Rare Difficulty and Achieves Perfect Occlusion 59

6.14 Oct 05, 2017: Dextera Surgical Provides Corporate Update 60

6.15 Sep 26, 2017: Gore Completes Patient Enrollment in U.S. Pivotal Clinical Study of GORE CARDIOFORM ASD Occluder 60

6.16 Sep 26, 2017: The LAmbre LAA Closure System is Successfully Implanted at Xijing Hospital in Northwest China for the First Time 61

6.17 Sep 24, 2017: Edwards Announces Key Events For PCR London Valves 2017 61

6.18 Sep 19, 2017: Organogenesis Names New Chief Commercial Officer and Chief Operating Officer 62

6.19 Sep 14, 2017: Landmark Study Published in the New England Journal of Medicine Shows Abbott's AMPLATZER Device Significantly Reduces Risk of Recurrent Stroke for People Living With a Hole in Their Heart 63

6.20 Aug 30, 2017: Abbott initiates ground-breaking U.S. pivotal study of AMPLATZER device to correct common congenital heart defect in newborns 64

6.21 Aug 29, 2017: Celyad Reports First Half 2017 Financial Results and Operational Progress 65

6.22 Aug 08, 2017: Prof. Huang Weijian and His Team Performed Four Challenging LAA Occlusion Procedures Using LAmbre Device 67

6.23 Aug 08, 2017: Southern Hospital Peng Jian Team Completed the First LAmbre LAA Occluder Implanting in Guangdong 68

6.24 Aug 08, 2017: Dextera Surgical Reports Fiscal 2017 Fourth Quarter Financial Results 68

6.25 Jul 30, 2017: The First LAmbre LAA Occluder Training Course Successfully Held by LifeTech 69

6.26 Jul 26, 2017: Edwards Lifesciences Reports Second Quarter Results 70

6.27 Jul 24, 2017: The Grand Unveiling of LifeTech's LAmbre Device at CSI 2017 72

6.28 Jul 24, 2017: LifeTech with LAmbre Appeared On CAFS 2017 72

6.29 Jul 05, 2017: LAmbre in the Eyes of World-renowned Physicians 73

6.30 Jul 03, 2017: Lifetech Announced the Launch of its Global Post-market Surveillance Study for Lambre LAA Closure System 73

7 Appendix 75

7.1 Methodology 75

7.2 About GlobalData 78

7.3 Contact Us 78

7.4 Disclaimer 78

1.2 List of Figures

Figure 1: Septal Occluders-Pipeline Products by Stage of Development 7

Figure 2: Septal Occluders-Pipeline Products by Segment 8

Figure 3: Septal Occluders-Pipeline Products by Territory 9

Figure 4: Septal Occluders-Pipeline Products by Regulatory Path 10

Figure 5: Septal Occluders-Pipeline Products by Estimated Approval Date 11

Figure 6: Septal Occluders-Ongoing Clinical Trials 12

1.1 List of Tables

Table 1: Septal Occluders-Pipeline Products by Stage of Development 7

Table 2: Septal Occluders-Pipeline Products by Segment 8

Table 3: Septal Occluders-Pipeline Products by Territory 9

Table 4: Septal Occluders-Pipeline Products by Regulatory Path 10

Table 5: Septal Occluders-Pipeline Products by Estimated Approval Date 11

Table 6: Septal Occluders-Ongoing Clinical Trials 12

Table 7: Septal Occluders Companies-Pipeline Products by Stage of Development 13

Table 8: Septal Occluders-Pipeline Products by Stage of Development 14

Table 9: Aporo Biomedical, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 15

Table 10: Patent Foramen Ovale Closure Device-Product Status 15

Table 11: Patent Foramen Ovale Closure Device-Product Description 15

Table 12: CARAG AG Pipeline Products & Ongoing Clinical Trials Overview 16

Table 13: Solysafe Septal Occluder-Degradable Version-Product Status 16

Table 14: Solysafe Septal Occluder-Degradable Version-Product Description 16

Table 15: CARAG AG-Ongoing Clinical Trials Overview 17

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) 18

Table 17: Celyad SA Pipeline Products & Ongoing Clinical Trials Overview 19

Table 18: Cardiao3 Closure Device-Product Status 19

Table 19: Cardiao3 Closure Device-Product Description 19

Table 20: Cierra, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 20

Table 21: PFx Closure System-Product Status 20

Table 22: PFx Closure System-Product Description 20

Table 23: Dextera Surgical Inc Pipeline Products & Ongoing Clinical Trials Overview 21

Table 24: PFO Closure Device-Product Status 21

Table 25: PFO Closure Device-Product Description 21

Table 26: Ension, Inc. Pipeline Products & Ongoing Clinical Trials Overview 22

Table 27: Atrial Septal Defect Correction Device-Product Status 22

Table 28: Atrial Septal Defect Correction Device-Product Description 22

Table 29: Lifetech Scientific (Shenzhen) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 23

Table 30: Absnow Absorbable Occluder-Product Status 23

Table 31: Absnow Absorbable Occluder-Product Description 23

Table 32: IrisFIT PFO Occluder-Product Status 24

Table 33: IrisFIT PFO Occluder-Product Description 24

Table 34: LAmbre LAA Closure System-Product Status 24

Table 35: LAmbre LAA Closure System-Product Description 25

Table 36: Lifetech Scientific (Shenzhen) Co Ltd-Ongoing Clinical Trials Overview 26

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 27

Table 38: LAmbre LAA Closure System-LifeTech LAmbre Keft Atrial Appendage (LAA) Closure System Post-market Clinical Follow-up 27

Table 39: LAmbre LAA Closure System-Study of Safety and Efficacy of a Left Atrial Appendage Occulder 27

Table 40: IrisFIT PFO Occluder-Post Market Clinical Follow-up Study of IrisFIT PFO (Patent Foramen Ovale) 28

Table 41: Micro Interventional Devices, Inc. Pipeline Products & Ongoing Clinical Trials Overview 29

Table 42: Patent Foramen Ovale Fixation Device-Product Status 29

Table 43: Patent Foramen Ovale Fixation Device-Product Description 29

Table 44: Occlutech International AB Pipeline Products & Ongoing Clinical Trials Overview 30

Table 45: Occlutech Figulla Flex UNI-Product Status 30

Table 46: Occlutech Figulla Flex UNI-Product Description 30

Table 47: SeptRx, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 31

Table 48: SeptRx IPO-Product Status 31

Table 49: SeptRx IPO-Product Description 31

Table 50: St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 32

Table 51: Amplatzer Amulet Left Atrial Appendage Occluder-Product Status 32

Table 52: Amplatzer Amulet Left Atrial Appendage Occluder-Product Description 32

Table 53: AMPLATZER Duct Occluder II AS-Product Status 33

Table 54: AMPLATZER Duct Occluder II AS-Product Description 33

Table 55: St. Jude Medical LLC-Ongoing Clinical Trials Overview 34

Table 56: Amplatzer Amulet Left Atrial Appendage Occluder-AMPLATZER Amulet Left Atrial Appendage Occluder Randomized Controlled Trial 35

Table 57: Amplatzer Amulet Left Atrial Appendage Occluder-Amplatzer Amulet Observational Post-market Study 35

Table 58: Amplatzer Amulet Left Atrial Appendage Occluder-Comparison of Amplatzer Amulet vs Watchman Device in Patients Undergoing Left Atrial Appendage Closure: the SWISS-APERO Randomized Clinical Trial 35

Table 59: 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 36

Table 60: AMPLATZER Duct Occluder II AS-AMPLATZER Duct Occluder II Additional Sizes: ADO II AS Clinical Study 37

Table 61: Sutura, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 38

Table 62: HeartStitch-Product Status 38

Table 63: HeartStitch-Product Description 38

Table 64: Swissimplant AG (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 39

Table 65: Solysafe Septal Occluder-10Fr Sheath-Product Status 39

Table 66: Solysafe Septal Occluder-10Fr Sheath-Product Description 39

Table 67: University of Minnesota Pipeline Products & Ongoing Clinical Trials Overview 40

Table 68: Bioresorbable Occlusion Device-Product Status 40

Table 69: Bioresorbable Occlusion Device-Product Description 40

Table 70: Vanderbilt University Pipeline Products & Ongoing Clinical Trials Overview 41

Table 71: Self Expanding Ductal Occluder-Product Status 41

Table 72: Self Expanding Ductal Occluder-Product Description 41

Table 73: Vascular Concepts Ltd Pipeline Products & Ongoing Clinical Trials Overview 42

Table 74: VSD (Ventricular Septal Device)-Product Status 42

Table 75: VSD (Ventricular Septal Device)-Product Description 42

Table 76: W. L. Gore & Associates Inc Pipeline Products & Ongoing Clinical Trials Overview 43

Table 77: BioTREK-Product Status 43

Table 78: BioTREK-Product Description 43

Table 79: GORE HELEX Septal Occluder-PFO-Product Status 44

Table 80: GORE HELEX Septal Occluder-PFO-Product Description 44

Table 81: W. L. Gore & Associates Inc-Ongoing Clinical Trials Overview 45

Table 82: GORE HELEX Septal Occluder-PFO-GORE HELEX Septal Occluder / GORE CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke or Imaging-confirmed TIA in Patients with Patent Foramen Ovale (PFO) 46

Table 83: Glossary 77

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To know more information on Purchase by Section, please send a mail to sales [@] kenresearch.com
 

Aporo Biomedical, Inc.

CARAG AG

Celyad SA

Cierra, Inc.

Dextera Surgical Inc

Ension, 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

Vanderbilt University

Vascular Concepts Ltd

W. L. Gore & Associates Inc

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; Dextera Surgical Inc, PFO Closure Device; Ension, Inc., Atrial Septal Defect Correction Device; Lifetech Scientific (Shenzhen) Co Ltd, Absnow 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, Occlutech Figulla Flex UNI; 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; Vanderbilt University, Self Expanding Ductal Occluder; Vascular Concepts Ltd, VSD (Ventricular Septal Device); W. L. Gore &; Associates Inc, BioTREK; W. L. Gore &; Associates Inc, GORE HELEX Septal Occluder - PFO

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