Aortic Stent Grafts Pipeline by Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies

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Aortic Stent Grafts Pipeline Market Report Overview

Aortic Stent grafts are used to reinforce a weak aorta to prevent ruptures. These grafts can be of allografts or synthetic materials. These are used to manage urinary incontinence and urinary retention in both men and women. The Aortic Stent Grafts pipeline market research report provides a comprehensive understanding of the pipeline products along with their comparative analysis at various stages of development. The report also includes information about the territories wherein the clinical trials are in progress, the regulatory paths followed by the trials, and the companies associated with the trials.

Key Segments ·        Abdominal Aortic Stent Grafts

·        Thoracic Aortic Stent Grafts

Key Territories ·        The US

·        Europe

·        Canada

·        China

·        Taiwan

Key Regulatory Paths ·        PMA

·        CE

·        TGA

·        MDL

·        NMPA

Leading Companies ·        Angiolutions UG

·        APT Medical Inc

·        Artivion Inc

·        Ascyrus Medical LLC

·        Beijing Tianzhu Ruichang Medical Technology Co Ltd

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Aortic Stent Grafts Pipeline Market by Segments

The key segments in the Aortic Stent Grafts pipeline market are Abdominal Aortic Stent Grafts and Thoracic Aortic Stent Grafts. As of December 2023, Abdominal Aortic Stent Grafts accounted for the highest number of pipeline products. These grafts are used to treat abdominal aortic aneurysms by reinforcing a part of the aorta using a minimally invasive procedure.

Aortic Stent Grafts Pipeline Market Analysis by Segments, 2023 (%)

Aortic Stent Grafts Pipeline Market Analysis by Segments, 2023 (%)

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Aortic Stent Grafts Pipeline Market Segmentation by Territories

A few of the key territories for Aortic Stent Grafts pipeline products are the US, Europe, Canada, China, and Taiwan among others. As of December 2023, the US accounted for the highest number of pipeline products.

Aortic Stent Grafts Pipeline Market Analysis by Territories, 2023 (%)

Aortic Stent Grafts Pipeline Market Analysis by Territories, 2023 (%)

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Aortic Stent Grafts Pipeline Market Segmentation by Regulatory Paths

A few of the key regulatory paths followed by the Aortic Stent Grafts pipeline market are PMA, CE, TGA, MDL, and NMPA among others. As of December 2023, PMA was the most followed pathway for pipeline products in the market.

Aortic Stent Grafts Pipeline Market Analysis by Regulatory Paths, 2023 (%)

Aortic Stent Grafts Pipeline Market Analysis by Regulatory Paths, 2023 (%)

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Aortic Stent Grafts Pipeline Market – Competitive Landscape

A few of the key companies associated with the Aortic Stent Grafts pipeline market are Angiolutions UGy, APT Medical Inc., Artivion Inc., Ascyrus Medical LLC, and Beijing Tianzhu Ruichang Medical Technology Co Ltd among others.

Artivion Inc (Artivion): Artivion is headquartered in Atlanta, Georgia, the US. It manufactures and distributes bio-surgical devices and implantable human tissues for cardiac and vascular surgical procedures for the aortic disease treatment. The company’s portfolio enlists preserved human cardiac allografts, vascular allografts, surgical adhesives and sealants, heart valves, bovine pericardium, mitral chordal repair products, photofix products, and Jotec products. It has manufacturing facilities in Texas Georgia in the US and Hechinger, Germany. The company distributes its products through a network of direct sales forces in the UK, Austria, France, and Germany among others. It commercializes products in more than 85 countries worldwide.

Aortic Stent Grafts Pipeline Market Analysis by Companies, 2023

Aortic Stent Grafts Pipeline Market Analysis by Companies, 2023

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Segments Covered in the Report

Aortic Stent Grafts Pipeline Market Segments Outlook

  • Abdominal Aortic Stent Grafts
  • Thoracic Aortic Stent Grafts

Aortic Stent Grafts Pipeline Market Territories Outlook

  • The US
  • Europe
  • Canada
  • China
  • Taiwan

Aortic Stent Grafts Pipeline Market Regulatory Paths Outlook

  • PMA
  • CE
  • TGA
  • MDL
  • NMPA

Scope

This report provides:

  • Extensive coverage of the Aortic Stent Grafts under development.
  • An exhaustive list of major pipeline products and their details, including product descriptions, licensing and collaboration details, and other developmental activities.
  • Reviews of major players involved in the development of Aortic Stent Grafts and lists all their pipeline projects.
  • Coverage of pipeline products based on various stages of development ranging from early development to approved/issued stage.
  • Key clinical trial data of ongoing clinical trials specific to pipeline products.
  • Recent developments in the segment/industry.

Reasons to Buy

The report will enable you to:

  • Formulate significant competitor information, analysis, and insights to improve R&D strategies.
  • Identify emerging players with potentially strong product portfolios and create effective counter strategies to gain a competitive advantage.
  • Identify and understand important and diverse types of Aortic Stent Grafts under development.
  • Develop market-entry and market-expansion strategies.
  • Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline.
  • Carry out In-depth analysis of the product’s current stage of development, territory, and estimated launch date.

Affluent Medical SASU
Angiolutions UG
APT Medical Inc
Artivion Inc
Ascyrus Medical LLC
Beijing Tianzhu Ruichang Medical Technology Co Ltd
BiFlow Medical Ltd
BioQ Devices Pty Ltd
Cook Medical Inc
Cytograft Tissue Engineering Inc (Inactive)
Endologix LLC
Endoluminal Sciences Pty Ltd.
EndoSpan Ltd
Evasc Medical Systems Corp
Hadassah Medical Center
Hangzhou Endonom Medtech Co Ltd
Intressa Vascular SA
Johns Hopkins University
JOTEC GmbH
Kawasumi Laboratories Inc
Lifetech Scientific (Shenzhen) Co Ltd
Lombard Medical Technologies Inc.
Lombard Medical Technologies Ltd (Inactive)
Lundquist
Medtronic Plc
Merit Medical Systems Inc
MicroPort Scientific Corp
PerMed Biomedical Engineering Co Ltd
Red Vascular Technologies LLC
Shanghai MicroPort Endovascular MedTech Group Co Ltd
Sree Chitra Tirunal Institute for Medical Sciences & Technology
St. Jude Medical LLC
Terumo Aortic
Terumo Corp
The Lundquist Institute
TriVascular Inc
University of Arizona
University of Colorado Denver
University of Limerick
University of Nebraska Medical Center
Venus Medtech Hangzhou Inc
W. L. Gore & Associates Inc
Zylox-Tonbridge Medical Technology Co Ltd

Table of Contents

1 Table of Contents 3

1.1 List of Tables 7

1.2 List of Figures 13

2 Introduction 14

2.1 Aortic Stent Grafts Overview 14

3 Products under Development 15

3.1 Aortic Stent Grafts – Pipeline Products by Stage of Development 15

3.2 Aortic Stent Grafts – Pipeline Products by Segment 16

3.3 Aortic Stent Grafts – Pipeline Products by Territory 17

3.4 Aortic Stent Grafts – Pipeline Products by Regulatory Path 18

3.5 Aortic Stent Grafts – Pipeline Products by Estimated Approval Date 19

3.6 Aortic Stent Grafts – Ongoing Clinical Trials 20

4 Aortic Stent Grafts – Pipeline Products under Development by Companies 21

4.1 Aortic Stent Grafts Companies – Pipeline Products by Stage of Development 21

4.2 Aortic Stent Grafts – Pipeline Products by Stage of Development 23

5 Aortic Stent Grafts Companies and Product Overview 25

5.1 Affluent Medical SASU Company Overview 25

5.1.1 Affluent Medical SASU Pipeline Products & Ongoing Clinical Trials Overview 25

5.2 Angiolutions UG Company Overview 26

5.2.1 Angiolutions UG Pipeline Products & Ongoing Clinical Trials Overview 26

5.3 APT Medical Inc Company Overview 27

5.3.1 APT Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 27

5.4 Artivion Inc Company Overview 28

5.4.1 Artivion Inc Pipeline Products & Ongoing Clinical Trials Overview 28

5.5 Ascyrus Medical LLC Company Overview 29

5.5.1 Ascyrus Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 29

5.6 Beijing Tianzhu Ruichang Medical Technology Co Ltd Company Overview 34

5.6.1 Beijing Tianzhu Ruichang Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 34

5.7 BiFlow Medical Ltd Company Overview 35

5.7.1 BiFlow Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 35

5.8 BioQ Devices Pty Ltd Company Overview 36

5.8.1 BioQ Devices Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 36

5.9 Cook Medical Inc Company Overview 37

5.9.1 Cook Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 37

5.10 Cytograft Tissue Engineering Inc (Inactive) Company Overview 42

5.10.1 Cytograft Tissue Engineering Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 42

5.11 Endologix LLC Company Overview 43

5.11.1 Endologix LLC Pipeline Products & Ongoing Clinical Trials Overview 43

5.12 Endoluminal Sciences Pty Ltd. Company Overview 54

5.12.1 Endoluminal Sciences Pty Ltd. Pipeline Products & Ongoing Clinical Trials Overview 54

5.13 EndoSpan Ltd Company Overview 55

5.13.1 EndoSpan Ltd Pipeline Products & Ongoing Clinical Trials Overview 55

5.14 Evasc Medical Systems Corp Company Overview 59

5.14.1 Evasc Medical Systems Corp Pipeline Products & Ongoing Clinical Trials Overview 59

5.15 Hadassah Medical Center Company Overview 60

5.15.1 Hadassah Medical Center Pipeline Products & Ongoing Clinical Trials Overview 60

5.16 Hangzhou Endonom Medtech Co Ltd Company Overview 61

5.16.1 Hangzhou Endonom Medtech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 61

5.17 Intressa Vascular SA Company Overview 66

5.17.1 Intressa Vascular SA Pipeline Products & Ongoing Clinical Trials Overview 66

5.18 Johns Hopkins University Company Overview 67

5.18.1 Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 67

5.19 JOTEC GmbH Company Overview 68

5.19.1 JOTEC GmbH Pipeline Products & Ongoing Clinical Trials Overview 68

5.20 Kawasumi Laboratories Inc Company Overview 77

5.20.1 Kawasumi Laboratories Inc Pipeline Products & Ongoing Clinical Trials Overview 77

5.21 Lifetech Scientific (Shenzhen) Co Ltd Company Overview 78

5.21.1 Lifetech Scientific (Shenzhen) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 78

5.22 Lombard Medical Technologies Inc. Company Overview 81

5.22.1 Lombard Medical Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview 81

5.23 Lombard Medical Technologies Ltd (Inactive) Company Overview 85

5.23.1 Lombard Medical Technologies Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 85

5.24 Lundquist Company Overview 86

5.24.1 Lundquist Pipeline Products & Ongoing Clinical Trials Overview 86

5.25 Medtronic Plc Company Overview 87

5.25.1 Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 87

5.26 Merit Medical Systems Inc Company Overview 95

5.26.1 Merit Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 95

5.27 MicroPort Scientific Corp Company Overview 100

5.27.1 MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 100

5.28 PerMed Biomedical Engineering Co Ltd Company Overview 101

5.28.1 PerMed Biomedical Engineering Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 101

5.29 Red Vascular Technologies LLC Company Overview 104

5.29.1 Red Vascular Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 104

5.30 Shanghai MicroPort Endovascular MedTech Group Co Ltd Company Overview 105

5.30.1 Shanghai MicroPort Endovascular MedTech Group Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 105

5.31 Sree Chitra Tirunal Institute for Medical Sciences & Technology Company Overview 108

5.31.1 Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 108

5.32 St. Jude Medical LLC Company Overview 109

5.32.1 St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 109

5.33 Terumo Aortic Company Overview 112

5.33.1 Terumo Aortic Pipeline Products & Ongoing Clinical Trials Overview 112

5.34 Terumo Corp Company Overview 121

5.34.1 Terumo Corp Pipeline Products & Ongoing Clinical Trials Overview 121

5.35 The Lundquist Institute Company Overview 122

5.35.1 The Lundquist Institute Pipeline Products & Ongoing Clinical Trials Overview 122

5.36 TriVascular Inc Company Overview 123

5.36.1 TriVascular Inc Pipeline Products & Ongoing Clinical Trials Overview 123

5.37 University of Arizona Company Overview 124

5.37.1 University of Arizona Pipeline Products & Ongoing Clinical Trials Overview 124

5.38 University of Colorado Denver Company Overview 125

5.38.1 University of Colorado Denver Pipeline Products & Ongoing Clinical Trials Overview 125

5.39 University of Limerick Company Overview 126

5.39.1 University of Limerick Pipeline Products & Ongoing Clinical Trials Overview 126

5.40 University of Nebraska Medical Center Company Overview 127

5.40.1 University of Nebraska Medical Center Pipeline Products & Ongoing Clinical Trials Overview 127

5.41 Venus Medtech Hangzhou Inc Company Overview 128

5.41.1 Venus Medtech Hangzhou Inc Pipeline Products & Ongoing Clinical Trials Overview 128

5.42 W. L. Gore & Associates Inc Company Overview 129

5.42.1 W. L. Gore & Associates Inc Pipeline Products & Ongoing Clinical Trials Overview 129

5.43 Zylox-Tonbridge Medical Technology Co Ltd Company Overview 132

5.43.1 Zylox-Tonbridge Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 132

6 Aortic Stent Grafts- Recent Developments 136

6.1 Nov 10, 2023: Microport Appointment of Director 136

6.2 Nov 09, 2023: Artivion Announces Completion of Enrollment in PERSEVERE Trial 136

6.3 Oct 26, 2023: Boston Scientific Announces Results for Third Quarter 2023 137

6.4 Oct 18, 2023: Abbott Reports Third-Quarter 2023 Results and Raises Midpoint of Full-Year EPS Guidance Range 139

6.5 Oct 05, 2023: Artivion Announces Presentation of Late-Breaking Interim Data from AMDS PERSEVERE Trial at the 37th European Association for Cardio-Thoracic Surgery Annual Meeting 141

6.6 Oct 04, 2023: Medtronic Names Paolo Di Vincenzo President of the Neuromodulation Business 142

6.7 Sep 29, 2023: Barry Slowey Named Vice President and Chief Sustainability Officer 143

6.8 Sep 21, 2023: Microport Endovastec Completes the First Clinical Implantation of Minos Stent Graft System in Azerbaijan 143

6.9 Sep 21, 2023: Microport Scientific Corp. Announces 2023 Interim Report 143

6.10 Sep 15, 2023: Amber Beauchamp Named Vice President of Global Human Resources 146

6.11 Sep 08, 2023: MicroPort Endovastec’s Three Products in the Aortic Intervention Field Have Been Approved in Thailand 146

6.12 Sep 01, 2023: Japan Lifeline Announces Changes in Organizations and Personnel 147

6.13 Aug 26, 2023: Medtronic Q2 2024 Earnings Estimates Increased by William Blair 147

6.14 Aug 24, 2023: Endologix Announces that Lucas Buchanan Joins Board of Directors 147

6.15 Aug 17, 2023: Mayo Clinic Reports Strong Finances for 2023 So Far with Q2 Revenue of $4.47 billion 147

6.16 Aug 11, 2023: Kristin Peck, CEO of Zoetis, to join Mayo Clinic Board of Trustees 147

6.17 Aug 11, 2023: W. L. Gore & Associates to Present New Mosa Paper At Gvsets Conference 148

6.18 Aug 08, 2023: Medtronic to Announce Financial Results for its First Quarter of Fiscal Year 2024 148

6.19 Aug 04, 2023: Merit Medical concludes patient enrolment in WAVE trial 149

6.20 Jul 19, 2023: Boston Scientific lays off 52 workers as it closes another Silicon Valley facility 149

6.21 Jul 19, 2023: Boston Scientific Lays off 52 Amid California Facility Closure 149

6.22 Jul 11, 2023: Microport Scientific Provides Consolidated Earnings Guidance for the Six Months Ended June 30, 2023 150

6.23 Jul 04, 2023: Terumo Aortic Announces PMDA Approval for Thoraflex Hybrid in Japan 150

6.24 Jun 23, 2023: FDA approves clinical study of Zenith Fenestrated+ Endovascular Graft for treatment of aortic aneurysms 150

6.25 Jun 19, 2023: Endospan Announces First Experience with the Personalized NEXUS DUO Aortic Arch Stent Graft System 151

6.26 Jun 13, 2023: Terumo Aortic Announces Launch of the Global Thoraflex Hybrid EXTEND Study 151

6.27 Jun 12, 2023: Abbott Names Philip Boudreau CFO effective Sept. 1 152

6.28 May 31, 2023: Endovastec receives approval for the Minos Abdominal aortic Stent-Graft and Delivery System in Singapore 152

6.29 May 30, 2023: ‘Korea Needs to Localize Rare Medical Devices Amid Global Supply Shortage’ 153

6.30 May 23, 2023: Endologix announces 150th Patient Enrolled in JAGUAR Randomized Controlled Trial 154

6.31 May 15, 2023: Terumo announces consolidated financial results for the fiscal year ended March 31, 2023 154

6.32 May 11, 2023: Medtronic to announce financial results for its fourth quarter and full fiscal year 2023 154

6.33 May 02, 2023: LeMaitre Q1 2023 financial results 155

6.34 Apr 27, 2023: Five-Year results of the LEOPARD Trial published in the Journal of Vascular Surgery (JVS) 155

6.35 Apr 26, 2023: 10-year data from the medtronic ENGAGE OUS registry is the first and only prospective, industry sponsored global EVAR registry to demonstrate a decade of durable outcomes in real-world setting 156

6.36 Apr 26, 2023: Merit Medical reports results for first quarter March 31, 2023 157

6.37 Apr 26, 2023: MicroPort announces annual results for 2022 157

6.38 Apr 24, 2023: Endovastec has completed the first clinical cases of two products in Colombia 158

6.39 Apr 24, 2023: Endovastec received approval for Hercules -LP Thoracic Stent Graft in Singapore 159

6.40 Apr 12, 2023: Medtronic has a layoff in California 159

6.41 Apr 06, 2023: Merit Medical Systems to Announce First Quarter 2023 Results on April 26, 2023 159

6.42 Mar 16, 2023: Medtronic joins in $25M funding round for home monitoring company 160

6.43 Feb 23, 2023: LeMaitre Q4 2022 Financial Results 160

6.44 Feb 15, 2023: First Implantation of Endovastec’s Castor Branched Aortic Stent-Graft System Completed in Netherlands 161

6.45 Feb 09, 2023: Terumo Notice Concerning Revision of the Full-Year Financial Guidance for Fiscal Year Ending March 31, 2023 161

6.46 Feb 09, 2023: Terumo Corp Announces Consolidated Financial Results for the Third Quarter Ended December 31, 2022 162

6.47 Feb 03, 2023: Merit Medical Systems to Announce Fourth Quarter and Year End 2022 Results and Issue Fiscal Year 2023 Guidance on February 22, 2023 163

6.48 Feb 01, 2023: Japan Lifeline Announces Consolidated Financial Results for the Nine months Ended December 31, 2022 163

6.49 Jan 11, 2023: Medtronic announces first enrollment in head-to-head global randomized trial evaluating durability of endovascular aneurysm repair 164

6.50 Jan 04, 2023: Endovastec Minos abdominal aortic stent-graft and delivery system receives approval for marketing in South Korea 165

6.51 Dec 30, 2022: 6 Endovastec products approved for marketing in Belarus 165

6.52 Dec 07, 2022: Endologix receives FDA approval of PMA supplement for AFX2 system 166

6.53 Dec 07, 2022: Cook Medical welcomes Dr. John A. Kaufman as Chief Medical Officer 166

7 Appendix 168

7.1 Methodology 168

7.2 About GlobalData 171

7.3 Contact Us 171

7.4 Disclaimer 171

Table

Aortic Stent Grafts – Pipeline Products by Stage of Development 15

Aortic Stent Grafts – Pipeline Products by Segment 16

Aortic Stent Grafts – Pipeline Products by Territory 17

Aortic Stent Grafts – Pipeline Products by Regulatory Path 18

Aortic Stent Grafts – Pipeline Products by Estimated Approval Date 19

Aortic Stent Grafts – Ongoing Clinical Trials 20

Aortic Stent Grafts Companies – Pipeline Products by Stage of Development 21

Aortic Stent Grafts – Pipeline Products by Stage of Development 23

Affluent Medical SASU Pipeline Products & Ongoing Clinical Trials Overview 25

Kardiozis – Product Status 25

Kardiozis – Product Description 25

Angiolutions UG Pipeline Products & Ongoing Clinical Trials Overview 26

Vascular Graft (A3-Shield) – Product Status 26

Vascular Graft (A3-Shield) – Product Description 26

APT Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 27

Thoracic Aortic Stent – Product Status 27

Thoracic Aortic Stent – Product Description 27

Artivion Inc Pipeline Products & Ongoing Clinical Trials Overview 28

Neo 2.0 – Product Status 28

Neo 2.0 – Product Description 28

Ascyrus Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 29

Ascyrus Medical Dissection Stent – Product Status 29

Ascyrus Medical Dissection Stent – Product Description 30

Ascyrus Medical LLC – Ongoing Clinical Trials Overview 31

Ascyrus Medical Dissection Stent – A Prospective, Single Arm, Multi-center Clinical Investigation to Evaluate the Safety and Effectiveness of AMDS in the Treatment of Acute DeBakey Type I Dissection: PERSEVERE 32

Ascyrus Medical Dissection Stent – Dissected Aorta Repair Through Stent Implantation (DARTS): A Feasibility Study 32

Ascyrus Medical Dissection Stent – Dissected Aorta Repair Through Stent Implantation (DARTS): A Feasibility, Safety and Performance Trial 32

Ascyrus Medical Dissection Stent – Dissected Aorta Repair through Stent Implantation (DARTS): A Post-market Registry 33

Ascyrus Medical Dissection Stent – Randomized Trial on Acutely Dissected Aorta Repair with Hemiarch Replacement With or Without Stent Implantation (RADAR Trial) 33

Beijing Tianzhu Ruichang Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 34

Three-Branch Thoracic Aorta Stent Graft System – Product Status 34

Three-Branch Thoracic Aorta Stent Graft System – Product Description 34

BiFlow Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 35

Nitinol Side Branch Stent – Product Status 35

Nitinol Side Branch Stent – Product Description 35

BioQ Devices Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 36

BioQ Aortic Stent Graft Assist – Product Status 36

BioQ Aortic Stent Graft Assist – Product Description 36

Cook Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 37

Zenith Fenestrated+ Endovascular Graft – Product Status 37

Zenith Fenestrated+ Endovascular Graft – Product Description 37

Zenith P-Branch – Product Status 38

Zenith P-Branch – Product Description 38

Cook Medical Inc – Ongoing Clinical Trials Overview 39

Zenith P-Branch – Zenith p-Branch Pivotal Study 40

Zenith Fenestrated+ Endovascular Graft – Safety and Effectiveness of Surgeon-Modified Fenestrated and Branched Endografts in Treating Subjects With Complex Aortic Aneurysms 41

Zenith Fenestrated+ Endovascular Graft – Zenith Fenestrated+ Endovascular Graft Clinical Study 41

Cytograft Tissue Engineering Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 42

LifeJacket AAA Stent Graft – Product Status 42

LifeJacket AAA Stent Graft – Product Description 42

Endologix LLC Pipeline Products & Ongoing Clinical Trials Overview 43

AFX2 Bifurcated Endograft System – Product Status 43

AFX2 Bifurcated Endograft System – Product Description 44

AFX3 – Product Status 44

AFX3 – Product Description 44

AFX4 – Product Status 45

AFX4 – Product Description 45

Nellix 3.5 – Product Status 45

Nellix 3.5 – Product Description 46

Nellix CHEVAS – Product Status 46

Nellix CHEVAS – Product Description 46

Nellix EVAS System – Product Status 47

Nellix EVAS System – Product Description 47

Nellix With Snorkels – Product Status 47

Nellix With Snorkels – Product Description 48

Next Gen EVAS – Product Status 48

Next Gen EVAS – Product Description 48

Paravisceral System – Product Status 49

Paravisceral System – Product Description 49

Ventana 2 – Product Status 49

Ventana 2 – Product Description 50

Xpand BX Covered Stent – Product Status 50

Xpand BX Covered Stent – Product Description 50

Endologix LLC – Ongoing Clinical Trials Overview 51

Nellix EVAS System – Multicenter, Observational, Registry to Assess Outcomes of Patients Treated With the CE Marked Nellix System for Endovascular Abdominal Aortic Aneurysm Repair 52

Nellix EVAS System – Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix System IDE Study: EVAS 2 Confirmatory IDE Study 52

Nellix CHEVAS – Prospective, Multicenter, Non-randomized Study with Consecutive, Eligible Subject Enrollment at Each Site, for the Evaluation of the ChEVAS System for Endovascular Repair of Paravisceral, Juxtarenal, and Pararenal Abdominal Aortic Aneurysms 53

Endoluminal Sciences Pty Ltd. Pipeline Products & Ongoing Clinical Trials Overview 54

Stent-Graft With Adhesive Delivery Platform – Product Status 54

Stent-Graft With Adhesive Delivery Platform – Product Description 54

EndoSpan Ltd Pipeline Products & Ongoing Clinical Trials Overview 55

Nexus Aortic Arch Stent Graft System – Product Status 55

Nexus Aortic Arch Stent Graft System – Product Description 55

EndoSpan Ltd – Ongoing Clinical Trials Overview 56

Nexus Aortic Arch Stent Graft System – A Multi-arm, Multi-center, Non-randomized, Prospective, Clinical Study to Evaluate the Safety and Effectiveness of the NEXUS Aortic Arch Stent Graft System in Treating Thoracic Aortic Lesions Involving the Aortic Arch 57

Nexus Aortic Arch Stent Graft System – A Non-Randomized, Prospective, Open-Label, Multi-Center, Observational Clinical Study to Further Evaluate Safety and Performance of the NEXUS Aortic Arch Stent Graft System 57

Nexus Aortic Arch Stent Graft System – ENDOBARC-S Study: “Endovascular Branched Stent-grafts for Aortic ARCh Pathologies in Spain” 57

Nexus Aortic Arch Stent Graft System – NEXUS Aortic Arch Stent Graft System Data Collection Study for Compassionate-Use Procedures 58

Evasc Medical Systems Corp Pipeline Products & Ongoing Clinical Trials Overview 59

TAS System – Product Status 59

TAS System – Product Description 59

Hadassah Medical Center Pipeline Products & Ongoing Clinical Trials Overview 60

In Situ Weldable Hybrid Stent – Product Status 60

In Situ Weldable Hybrid Stent – Product Description 60

Hangzhou Endonom Medtech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 61

WeFlow-Arch Modeler Embedded Branch Stent Graft System – Product Status 61

WeFlow-Arch Modeler Embedded Branch Stent Graft System – Product Description 61

WeFlow-Tbranch Stent Graft System – Product Status 62

WeFlow-Tbranch Stent Graft System – Product Description 62

Hangzhou Endonom Medtech Co Ltd – Ongoing Clinical Trials Overview 63

WeFlow-Arch Modeler Embedded Branch Stent Graft System – Guo’s Aortic Arch Reconstruction: The First in Man Study of WeFlow-Arch Modular Embedded Branch Stent Graft System 64

WeFlow-Arch Modeler Embedded Branch Stent Graft System – Guo’s Aortic Arch Reconstruction: The Prospective, Multiple Center Study About the Safety and Efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System (GIANT Study) 64

WeFlow-Tbranch Stent Graft System – Guo’s Endovascular Aortic Arch Replacement of Aortic Dissection by WeFlow-Tribranch Endoprothesis: A Multicenter Pilot Study (Graft Study) 65

WeFlow-Tbranch Stent Graft System – Guo’s Subclavian Artery Reconstruction: The Prospective, Multiple Center Study of WeFlow-Tbranch Stent Graft System (GUEST Study) 65

WeFlow-Tbranch Stent Graft System – New Technology Clinical Study on the Safety and Efficacy of WeFlow-Tribranch Aortic Arch Stent Graft System in the Treatment of Patients with Aortic Arch Dissection 65

Intressa Vascular SA Pipeline Products & Ongoing Clinical Trials Overview 66

Bifurcated Multilayer Flow Modulator Kit – Product Status 66

Bifurcated Multilayer Flow Modulator Kit – Product Description 66

Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 67

Scaly Aortic Stent Graft – Product Status 67

Scaly Aortic Stent Graft – Product Description 67

JOTEC GmbH Pipeline Products & Ongoing Clinical Trials Overview 68

E-liac Stent Graft System – Product Status 68

E-liac Stent Graft System – Product Description 68

E-nside TAAA Stent Graft – Product Status 69

E-nside TAAA Stent Graft – Product Description 69

E-nya Thoracic Stent Graft – Product Status 69

E-nya Thoracic Stent Graft – Product Description 70

E-Ventus SX – Product Status 70

E-Ventus SX – Product Description 70

E-Vita Open Neo – Product Status 71

E-Vita Open Neo – Product Description 71

JOTEC GmbH – Ongoing Clinical Trials Overview 72

E-liac Stent Graft System – Prospective Multicenter Registry to Examine the Real-world Performance of the E-liac Stent Graft System for Treatment of Uni- or Bilateral Aorto-iliac or Iliac Aneurysms 73

E-liac Stent Graft System – Prospective Multicenter Study for the Endovascular Treatment of Iliac Aneurysm with the Branched E-liac Stent Graft 73

E-nya Thoracic Stent Graft – CONFORM-TAA – A Post-market Clinical Follow-up Study in Patients with a Descending Thoracic Aortic Aneurysm or Penetrating Aortic Ulcer (PAU) Treated with the E-nya Thoracic Stent Graft System 74

E-nya Thoracic Stent Graft – CONFORM-TAD- A Post-market Clinical Follow-up Study in Patients with Complicated Acute, Subacute or Chronic Type B Aortic Dissection with Double Lumen Treated with the E-nya Thoracic Stent Graft System 74

E-nside TAAA Stent Graft – INNER-B – A Post-market Clinical Follow-up Study in Patients with Thoracoabdominal Aortic Aneurysms Treated with E-nside TAAA Multibranch Stent Graft System 75

E-nside TAAA Stent Graft – INNER-B-APAC – Asian Pacific Post-market Clinical Follow-up Study in Patients with Thoracoabdominal Aortic Aneurysms Treated with E-nside TAAA Multibranch Stent Graft System 75

E-Vita Open Neo – A Post-market Clinical Follow-up Study in Patients with Acute or Chronic Aortic Dissection or Aortic Aneurysm Treated with E-vita OPEN NEO: NEOS 76

E-Vita Open Neo – NEO – E-vita Open Neo Treatment of Aortic Arch Aneurysms and Dissections 76

E-Vita Open Neo – NEOS-APAC – Asian Pacific Post-market Clinical Follow-up Study in Patients with Acute or Chronic Aortic Dissection or Aortic Aneurysm Treated with E-vita OPEN NEO 76

Kawasumi Laboratories Inc Pipeline Products & Ongoing Clinical Trials Overview 77

Abdominal Aortic Aneurysm Stent Graft – Product Status 77

Abdominal Aortic Aneurysm Stent Graft – Product Description 77

Lifetech Scientific (Shenzhen) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 78

G-Branch Thoracic-Abdominal Aorta Stent Graft System – Product Status 78

G-Branch Thoracic-Abdominal Aorta Stent Graft System – Product Description 78

Lifetech Scientific (Shenzhen) Co Ltd – Ongoing Clinical Trials Overview 79

G-Branch Thoracic-Abdominal Aorta Stent Graft System – Guo’s Renovisceral Artery Reconstruction-1: A Prospective, Multicenter, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of a Multi-branched Stent Graft System for Thoracoabdominal Aortic Aneurysm (GUARANTEE Study) 80

Lombard Medical Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview 81

FEVAR – Product Status 81

FEVAR – Product Description 81

TEVAR – Product Status 82

TEVAR – Product Description 82

Lombard Medical Technologies Inc. – Ongoing Clinical Trials Overview 83

TEVAR – Scandinavian Trial of Uncomplicated Aortic Dissection Therapy 84

Lombard Medical Technologies Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 85

Low Profile Stent Graft – Product Status 85

Low Profile Stent Graft – Product Description 85

Lundquist Pipeline Products & Ongoing Clinical Trials Overview 86

Thoracic-Abdominal Endoluminal Graft – Product Status 86

Thoracic-Abdominal Endoluminal Graft – Product Description 86

Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 87

Endurant Evo AAA Stent Graft System – Product Status 87

Endurant Evo AAA Stent Graft System – Product Description 88

Unitary Manifold Stent Graft System – Product Status 88

Unitary Manifold Stent Graft System – Product Description 88

Valiant Mona LSA System – Product Status 89

Valiant Mona LSA System – Product Description 89

Valiant TAAA Stent Graft System – Product Status 89

Valiant TAAA Stent Graft System – Product Description 90

Medtronic Plc – Ongoing Clinical Trials Overview 91

Valiant Mona LSA System – Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Descending Thoracic Aortic Aneurysms and Chronic Dissections 92

Valiant TAAA Stent Graft System – Endograft Repair of Thoracoabdominal Aortic Aneurysms (TAAA) 93

Valiant TAAA Stent Graft System – Visceral Manifold and Unitary Device Study for the Repair of Thoracoabdominal Aortic Aneurysms 93

Valiant TAAA Stent Graft System – Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms 93

Unitary Manifold Stent Graft System – Visceral Manifold and Unitary Device Study for the Repair of Thoracoabdominal Aortic Aneurysms 94

Merit Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 95

WRAPSODY Endovascular Stent Graft – Arteriovenous Fistula – Product Status 95

WRAPSODY Endovascular Stent Graft – Arteriovenous Fistula – Product Description 96

WRAPSODY Endovascular Stent Graft – Arteriovenous Graft – Product Status 96

WRAPSODY Endovascular Stent Graft – Arteriovenous Graft – Product Description 97

Merit Medical Systems Inc – Ongoing Clinical Trials Overview 98

WRAPSODY Endovascular Stent Graft – Arteriovenous Fistula – Prospective, Multicenter, Observational Study to Evaluate the Merit WRAPSODY Endoprosthesis for Treatment of Stenosis or Occlusion within the Dialysis Outflow Circuit of an Arteriovenous (AVF) Fistula or AV Graft (AVG) (The WRAP Registry) 99

MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 100

Aegis II Abdominal Aortic Stent Graft System – Product Status 100

Aegis II Abdominal Aortic Stent Graft System – Product Description 100

PerMed Biomedical Engineering Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 101

PerMed Branch Stent Graft – Product Status 101

PerMed Branch Stent Graft – Product Description 101

PerMed Biomedical Engineering Co Ltd – Ongoing Clinical Trials Overview 102

PerMed Branch Stent Graft – A Prospective, Multicenter, Open, Randomized Controlled, Non Inferiority Clinical Trial to Evaluate the Safety and Efficacy the Branch-based Intraoperative Stent System in the Treatment of Stanford A Aortic Dissection 103

Red Vascular Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 104

Non Modular Branched Endoprosthesis – Product Status 104

Non Modular Branched Endoprosthesis – Product Description 104

Shanghai MicroPort Endovascular MedTech Group Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 105

Cratos Branched Aortic Stent Graft System – Product Status 105

Cratos Branched Aortic Stent Graft System – Product Description 105

Shanghai MicroPort Endovascular MedTech Group Co Ltd – Ongoing Clinical Trials Overview 106

Cratos Branched Aortic Stent Graft System – A Prospective, Multicenter, Single-group Clinical Trial to Evaluate the Efficacy and Safety of the Cratos Branch Aortic Covered Stent System in the Treatment of Stanford Type B Aortic Dissection 107

Cratos Branched Aortic Stent Graft System – Evaluation of Cratos Branch Stent Graft System in Treatment of Descending Aorta Lesions 107

Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 108

Aortic Stent Graft – Product Status 108

Aortic Stent Graft – Product Description 108

St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 109

Amplatzer AAA Vascular Graft – Product Status 109

Amplatzer AAA Vascular Graft – Product Description 109

Amplatzer Peripheral Vascular Graft – Product Status 110

Amplatzer Peripheral Vascular Graft – Product Description 110

Amplatzer TAA Vascular Graft – Product Status 110

Amplatzer TAA Vascular Graft – Product Description 111

Terumo Aortic Pipeline Products & Ongoing Clinical Trials Overview 112

BoulEVARd Stent – Product Status 112

BoulEVARd Stent – Product Description 112

RelayBranch Thoracic Stent-Graft System – Product Status 113

RelayBranch Thoracic Stent-Graft System – Product Description 113

RelayPro Thoracic Stent-Graft System – Acute Complicated Type B Thoracic Aortic Dissection – Product Status 113

RelayPro Thoracic Stent-Graft System – Acute Complicated Type B Thoracic Aortic Dissection – Product Description 114

RelayPro Thoracic Stent-Graft System – Blunt Traumatic Aortic Injury – Product Status 114

RelayPro Thoracic Stent-Graft System – Blunt Traumatic Aortic Injury – Product Description 115

Thoracoabdominal Hybrid Device – Product Status 115

Thoracoabdominal Hybrid Device – Product Description 115

TREOVANCE Abdominal Stent Graft With Navitel Delivery System – Product Status 116

TREOVANCE Abdominal Stent Graft With Navitel Delivery System – Product Description 116

Terumo Aortic – Ongoing Clinical Trials Overview 117

TREOVANCE Abdominal Stent Graft With Navitel Delivery System – Anatomical Feasibility of an Off-the-shelf Scalloped Stent-graft for Infrarenal Abdominal Aneurysm with a Hostile Neck (ReSTHoNe Study) 118

RelayBranch Thoracic Stent-Graft System – A Prospective, Multicenter, Non-blinded, Non-randomized Early Feasibility Study of the Relay Branch Thoracic Stent-graft System in Subjects with Thoracic Aortic Pathologies Requiring Treatment Proximal to the Origin of the Innominate Artery 119

RelayBranch Thoracic Stent-Graft System – Cerebral Hemodynamics and Microemboli During Placement of RelayBranch Thoracic Stent-Graft System 119

RelayBranch Thoracic Stent-Graft System – ENDOBARC-S Study: “Endovascular Branched Stent-grafts for Aortic ARCh Pathologies in Spain” 119

RelayPro Thoracic Stent-Graft System – Acute Complicated Type B Thoracic Aortic Dissection – A Prospective, Multi-center, Non-blinded, Non-randomized Study of the RelayPro Thoracic Stent-graft in Subjects with an Acute, Complicated Type B Aortic Dissection 120

RelayPro Thoracic Stent-Graft System – Acute Complicated Type B Thoracic Aortic Dissection – Thoraflex Hybrid and Relay Extension Post-Approval Study 120

Terumo Corp Pipeline Products & Ongoing Clinical Trials Overview 121

Hybrid Stent Graft – Product Status 121

Hybrid Stent Graft – Product Description 121

The Lundquist Institute Pipeline Products & Ongoing Clinical Trials Overview 122

Multi-Branched Stent Graft – Product Status 122

Multi-Branched Stent Graft – Product Description 122

TriVascular Inc Pipeline Products & Ongoing Clinical Trials Overview 123

Ovation Thoracic Stent Graft System – Product Status 123

Ovation Thoracic Stent Graft System – Product Description 123

University of Arizona Pipeline Products & Ongoing Clinical Trials Overview 124

Expansible Ascending Aortic Graft – Product Status 124

Expansible Ascending Aortic Graft – Product Description 124

University of Colorado Denver Pipeline Products & Ongoing Clinical Trials Overview 125

Shape Memory Polymer Arterial Stent – Product Status 125

Shape Memory Polymer Arterial Stent – Product Description 125

University of Limerick Pipeline Products & Ongoing Clinical Trials Overview 126

Cardiovascular Graft – Product Status 126

Cardiovascular Graft – Product Description 126

University of Nebraska Medical Center Pipeline Products & Ongoing Clinical Trials Overview 127

Aortic Stent Graft – Product Status 127

Aortic Stent Graft – Product Description 127

Venus Medtech Hangzhou Inc Pipeline Products & Ongoing Clinical Trials Overview 128

Tumbao EndoVascular Aortic Repair System – Product Status 128

Tumbao EndoVascular Aortic Repair System – Product Description 128

W. L. Gore & Associates Inc Pipeline Products & Ongoing Clinical Trials Overview 129

GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis – Product Status 129

GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis – Product Description 129

W. L. Gore & Associates Inc – Ongoing Clinical Trials Overview 130

GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis – Evaluation of the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms 131

GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis – Evaluation of the GORE EXCLUDER Thoracoabdominal BranchTreatment of the Thoracoabdominal and Pararenal Aortic Aneurysms (TAMBE) 131

Zylox-Tonbridge Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 132

Thoracic Aorta Stent Graft System – Product Status 132

Thoracic Aorta Stent Graft System – Product Description 133

Zylox-Tonbridge Medical Technology Co Ltd – Ongoing Clinical Trials Overview 134

Thoracic Aorta Stent Graft System – A Prospective, Multicenter, Objective Performance Criteria-controlled Study for National Medical Products Administration Approval of the Thoracic Aortic Stent Graft System 135

Glossary 170

Figures

Aortic Stent Grafts – Pipeline Products by Stage of Development 15

Aortic Stent Grafts – Pipeline Products by Segment 16

Aortic Stent Grafts – Pipeline Products by Territory 17

Aortic Stent Grafts – Pipeline Products by Regulatory Path 18

Aortic Stent Grafts – Pipeline Products by Estimated Approval Date 19

Aortic Stent Grafts – Ongoing Clinical Trials 20

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