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Bioabsorbable Stents (BAS) Pipeline Report including Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies, 2022 Update

Bioabsorbable stents are also known as bioreabsorbable or biodegradable coronary stents. GlobalData's Medical Devices sector report, “Bioabsorbable Stents (BAS) Pipeline Report including Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies, 2022 Update" provides comprehensive information about the Bioabsorbable Stents (BAS) pipeline products with comparative analysis of the products at various stages of development and information about the clinical trials which are in progress.

The Bioabsorbable Stents (BAS) report provides key information and data related to:

Extensive coverage of the Bioabsorbable Stents (BAS) under development

Review details of major pipeline products which include product description, licensing and collaboration details and other developmental activities including pipeline territories, regulatory paths, and estimated approval dates

Reviews of major players involved in the pipeline product development.

Provides key clinical trial data related to ongoing clinical trials such as trial phase, trial status, trial start and end dates, and the number of trials of the major Bioabsorbable Stents (BAS) pipeline products.

Review of Recent Developments in the segment / industry

The Bioabsorbable Stents (BAS) report enables you to:

Access significant competitor information, analysis, and insights to improve your 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 Bioabsorbable Stents (BAS) under development

Formulate market-entry and market expansion strategies

Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline

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.

The GlobalData Differentiation

This report is prepared using data sourced from in-house databases, secondary and primary research by GlobalData's team of industry experts.

The data and analysis within this report are driven by GlobalData Medical Intelligence Center (GDMIC) database. GDMIC gives you the key information required to drive sales, investment and deal-making activity in your business. It includes the following:

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Custom Requirements

Contact us to discuss the areas of your business where you need external input, and we will work with you to identify the strongest way forward to meet your needs.

Scope

– Extensive coverage of the Bioabsorbable Stents (BAS) 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 Bioabsorbable Stents (BAS) 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 Bioabsorbable Stents (BAS) 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

Key Players

Abbott Vascular Inc

Amaranth Medical Inc

Arterius Ltd

Biosensors International Group Ltd

Biosten, LLC

Biotronik AG

Biotronik SE & Co KG

Biotyx Medical (Shenzhen) Co Ltd

Boston Scientific Corp

Cardionovum GmbH

Cordis Corp

HangZhou HuaAn Biotechnology Co., Ltd.

Icon Interventional Systems, Inc.

Japan Stent Technology Co., Ltd.

Kyoto Medical Planning Co Ltd

Lifetech Scientific (Shenzhen) Co Ltd

Manli Cardiology Ltd

Meril Life Sciences Pvt Ltd

Micell Technologies Inc

Michigan Technological University

MicroPort Scientific Corp

Minvasys SAS

MIV Therapeutics Inc

NanoCoeur, Inc.

North Carolina State University

Northwestern University

OrbusNeich

Pediastent LLC

QualiMed Innovative Medizinprodukte GmbH

REVA Medical Inc

S3V Vascular Technologies

Shanghai Bio-heart Biological Technology Co Ltd

Shanghai Healing Medical Instruments Co Ltd

Tepha Inc

Tremedics Medical Devices LLC

University of Alabama at Birmingham

University of Florida

University of Strathclyde

VasoTech Inc.

Xenogenics Corporation

Table of Contents

1 Table of Contents

2 Introduction 12

2.1 Bioabsorbable Stents (BAS) Overview 12

3 Products under Development 13

3.1 Bioabsorbable Stents (BAS) – Pipeline Products by Stage of Development 13

3.2 Bioabsorbable Stents (BAS) – Pipeline Products by Territory 14

3.3 Bioabsorbable Stents (BAS) – Pipeline Products by Regulatory Path 15

3.4 Bioabsorbable Stents (BAS) – Pipeline Products by Estimated Approval Date 16

3.5 Bioabsorbable Stents (BAS) – Ongoing Clinical Trials 17

4 Bioabsorbable Stents (BAS) – Pipeline Products under Development by Companies 18

4.1 Bioabsorbable Stents (BAS) Companies – Pipeline Products by Stage of Development 18

4.2 Bioabsorbable Stents (BAS) – Pipeline Products by Stage of Development 20

5 Bioabsorbable Stents (BAS) Companies and Product Overview 22

5.1 Abbott Vascular Inc Company Overview 22

5.1.1 Abbott Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 22

5.2 Amaranth Medical Inc Company Overview 23

5.2.1 Amaranth Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 23

5.3 Arterius Ltd Company Overview 32

5.3.1 Arterius Ltd Pipeline Products & Ongoing Clinical Trials Overview 32

5.4 Biosensors International Group Ltd Company Overview 33

5.4.1 Biosensors International Group Ltd Pipeline Products & Ongoing Clinical Trials Overview 33

5.5 Biosten, LLC Company Overview 34

5.5.1 Biosten, LLC Pipeline Products & Ongoing Clinical Trials Overview 34

5.6 Biotronik AG Company Overview 35

5.6.1 Biotronik AG Pipeline Products & Ongoing Clinical Trials Overview 35

5.7 Biotronik SE & Co KG Company Overview 42

5.7.1 Biotronik SE & Co KG Pipeline Products & Ongoing Clinical Trials Overview 42

5.8 Biotyx Medical (Shenzhen) Co Ltd Company Overview 43

5.8.1 Biotyx Medical (Shenzhen) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 43

5.9 Boston Scientific Corp Company Overview 46

5.9.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 46

5.10 Cardionovum GmbH Company Overview 47

5.10.1 Cardionovum GmbH Pipeline Products & Ongoing Clinical Trials Overview 47

5.11 Cordis Corp Company Overview 48

5.11.1 Cordis Corp Pipeline Products & Ongoing Clinical Trials Overview 48

5.12 HangZhou HuaAn Biotechnology Co., Ltd. Company Overview 49

5.12.1 HangZhou HuaAn Biotechnology Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 49

5.13 Icon Interventional Systems, Inc. Company Overview 50

5.13.1 Icon Interventional Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 50

5.14 Japan Stent Technology Co., Ltd. Company Overview 51

5.14.1 Japan Stent Technology Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 51

5.15 Kyoto Medical Planning Co Ltd Company Overview 52

5.15.1 Kyoto Medical Planning Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 52

5.16 Lifetech Scientific (Shenzhen) Co Ltd Company Overview 53

5.16.1 Lifetech Scientific (Shenzhen) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 53

5.17 Manli Cardiology Ltd Company Overview 57

5.17.1 Manli Cardiology Ltd Pipeline Products & Ongoing Clinical Trials Overview 57

5.18 Meril Life Sciences Pvt Ltd Company Overview 58

5.18.1 Meril Life Sciences Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 58

5.19 Micell Technologies Inc Company Overview 62

5.19.1 Micell Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 62

5.20 Michigan Technological University Company Overview 63

5.20.1 Michigan Technological University Pipeline Products & Ongoing Clinical Trials Overview 63

5.21 MicroPort Scientific Corp Company Overview 64

5.21.1 MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 64

5.22 Minvasys SAS Company Overview 68

5.22.1 Minvasys SAS Pipeline Products & Ongoing Clinical Trials Overview 68

5.23 MIV Therapeutics Inc Company Overview 69

5.23.1 MIV Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 69

5.24 NanoCoeur, Inc. Company Overview 72

5.24.1 NanoCoeur, Inc. Pipeline Products & Ongoing Clinical Trials Overview 72

5.25 North Carolina State University Company Overview 73

5.25.1 North Carolina State University Pipeline Products & Ongoing Clinical Trials Overview 73

5.26 Northwestern University Company Overview 74

5.26.1 Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 74

5.27 OrbusNeich Company Overview 75

5.27.1 OrbusNeich Pipeline Products & Ongoing Clinical Trials Overview 75

5.28 Pediastent LLC Company Overview 77

5.28.1 Pediastent LLC Pipeline Products & Ongoing Clinical Trials Overview 77

5.29 QualiMed Innovative Medizinprodukte GmbH Company Overview 78

5.29.1 QualiMed Innovative Medizinprodukte GmbH Pipeline Products & Ongoing Clinical Trials Overview 78

5.30 REVA Medical Inc Company Overview 79

5.30.1 REVA Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 79

5.31 S3V Vascular Technologies Company Overview 84

5.31.1 S3V Vascular Technologies Pipeline Products & Ongoing Clinical Trials Overview 84

5.32 Shanghai Bio-heart Biological Technology Co Ltd Company Overview 85

5.32.1 Shanghai Bio-heart Biological Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 85

5.33 Shanghai Healing Medical Instruments Co Ltd Company Overview 89

5.33.1 Shanghai Healing Medical Instruments Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 89

5.34 Tepha Inc Company Overview 90

5.34.1 Tepha Inc Pipeline Products & Ongoing Clinical Trials Overview 90

5.35 Tremedics Medical Devices LLC Company Overview 91

5.35.1 Tremedics Medical Devices LLC Pipeline Products & Ongoing Clinical Trials Overview 91

5.36 University of Alabama at Birmingham Company Overview 92

5.36.1 University of Alabama at Birmingham Pipeline Products & Ongoing Clinical Trials Overview 92

5.37 University of Florida Company Overview 93

5.37.1 University of Florida Pipeline Products & Ongoing Clinical Trials Overview 93

5.38 University of Strathclyde Company Overview 94

5.38.1 University of Strathclyde Pipeline Products & Ongoing Clinical Trials Overview 94

5.39 VasoTech Inc. Company Overview 95

5.39.1 VasoTech Inc. Pipeline Products & Ongoing Clinical Trials Overview 95

5.40 Xenogenics Corporation Company Overview 96

5.40.1 Xenogenics Corporation Pipeline Products & Ongoing Clinical Trials Overview 96

6 Bioabsorbable Stents (BAS)- Recent Developments 99

6.1 Feb 18, 2022: Shanghai MicroPort Medical Group announces Chairman of the Board of Directors, Chairman of the Supervisory Committee, and Senior Management Announcement 99

6.2 Nov 18, 2021: MicroPort RehabTech TherMotion Cryo-Thermo compression device approved for marketing in China 99

6.3 Nov 08, 2021: Boston Scientific Announces Upcoming Conference Schedule 99

6.4 Nov 04, 2021: Terumo Corp Half Yearly Results For the Period 30 September 2021 100

6.5 Oct 27, 2021: Boston Scientific Announces Results For Third Quarter 2021 100

6.6 Oct 07, 2021: Construction begins on 280,000-square-meter MicroPort MegaFactory and global medical experience center 104

6.7 Sep 09, 2021: Boston Scientific Announces 2021 Investor Day Meeting 105

6.8 Aug 04, 2021: Terumo Revises its Full-Year Financial Guidance for FY2021 105

6.9 Aug 04, 2021: Terumo Corp. Announces Consolidated Financial Results for the First Quarter Ended June 30, 2021 105

6.10 May 24, 2021: Boston Scientific to Participate in Bernstein's 37th Annual Strategic Decisions Conference 106

6.11 May 17, 2021: MicroPort Orthopedics holds joint workshop on joint surgery with China-Japan Friendship Hospital 106

7 Appendix 108

7.1 Methodology 108

7.2 About GlobalData 111

7.3 Contact Us 111

7.4 Disclaimer 111

List of Tables

Bioabsorbable Stents (BAS) – Pipeline Products by Stage of Development 13

Bioabsorbable Stents (BAS) – Pipeline Products by Territory 14

Bioabsorbable Stents (BAS) – Pipeline Products by Regulatory Path 15

Bioabsorbable Stents (BAS) – Pipeline Products by Estimated Approval Date 16

Bioabsorbable Stents (BAS) – Ongoing Clinical Trials 17

Bioabsorbable Stents (BAS) Companies – Pipeline Products by Stage of Development 18

Bioabsorbable Stents (BAS) – Pipeline Products by Stage of Development 20

Abbott Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 22

Second Generation Bioresorbable Vascular Scaffold – Product Status 22

Second Generation Bioresorbable Vascular Scaffold – Product Description 22

Amaranth Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 23

80-micron MAGNITUDE Bioresorbable Scaffold – Product Status 23

80-micron MAGNITUDE Bioresorbable Scaffold – Product Description 23

APTITUDE Sirolimus-Eluting Bioresorbable Scaffold – Product Status 24

APTITUDE Sirolimus-Eluting Bioresorbable Scaffold – Product Description 24

DEFIANCE Scaffold – Product Status 24

DEFIANCE Scaffold – Product Description 25

FORTITUDE Scaffold – Product Status 25

FORTITUDE Scaffold – Product Description 25

MAGNITUDE Sirolimus-Eluting Bioresorbable Scaffold – Product Status 26

MAGNITUDE Sirolimus-Eluting Bioresorbable Scaffold – Product Description 26

Second Generation FORTITUDE Scaffold – Product Status 26

Second Generation FORTITUDE Scaffold – Product Description 27

Amaranth Medical Inc – Ongoing Clinical Trials Overview 28

FORTITUDE Scaffold – Amaranth Endovascular Study of a Drug-eluting Bioresorbable Coronary Scaffold 29

FORTITUDE Scaffold – Restoring Endoluminal Narrowing Using Bioresorbable Scaffolds – European Trial 29

APTITUDE Sirolimus-Eluting Bioresorbable Scaffold – Restoring Endoluminal Narrowing Using Bioresorbable Scaffolds – Extended Trial II 30

MAGNITUDE Sirolimus-Eluting Bioresorbable Scaffold – Restoring Endoluminal Narrowing Using Bioresorbable Scaffolds – Extended Trial III 31

Arterius Ltd Pipeline Products & Ongoing Clinical Trials Overview 32

Arteriosorb Absorbable Drug-Eluting Scaffold – Product Status 32

Arteriosorb Absorbable Drug-Eluting Scaffold – Product Description 32

Biosensors International Group Ltd Pipeline Products & Ongoing Clinical Trials Overview 33

Sparrow Drug Eluting Stent System – Product Status 33

Sparrow Drug Eluting Stent System – Product Description 33

Biosten, LLC Pipeline Products & Ongoing Clinical Trials Overview 34

Biodegradable Endovascular Implant – Product Status 34

Biodegradable Endovascular Implant – Product Description 34

Biotronik AG Pipeline Products & Ongoing Clinical Trials Overview 35

DREAMS 3G System – Product Status 35

DREAMS 3G System – Product Description 35

Magmaris Bioresorbable Magnesium Scaffold – Product Status 36

Magmaris Bioresorbable Magnesium Scaffold – Product Description 36

Biotronik AG – Ongoing Clinical Trials Overview 37

Magmaris Bioresorbable Magnesium Scaffold – A Sirolimus Eluting Bioresorbable Magnesium Stent for Treatment of Coronary Bifurcation Lesions: The BIFSORB Pilot Study II 38

Magmaris Bioresorbable Magnesium Scaffold – BIOTRONIK – Safety and Clinical Performance of the Drug Eluting Absorbable Metal Scaffold (DREAMS 2nd Generation) in the Treatment of Subjects with de Novo Lesions in Native Coronary Arteries: BIOSOLVE-II 38

Magmaris Bioresorbable Magnesium Scaffold – Biotroniks – Safety and Performance in de Novo Lesion of Native Coronary Arteries with Magmaris- Registry: BIOSOLVE-IV 38

Magmaris Bioresorbable Magnesium Scaffold – BIOTRONIKS-Safety and Performance in de Novo Lesion of Native Coronary Arteries with Magmaris (BIOSOLVE)-IV Magmaris Swiss Satellite Registry 39

Magmaris Bioresorbable Magnesium Scaffold – Coronary Artery Healing Process after Bioresorbable Scaffold in Patients with Non-ST-segment Elevation Myocardial Infarction (NSTEMI) 39

Magmaris Bioresorbable Magnesium Scaffold – Optical Coherence Guided Treatment of ST-segment Elevation Myocardial Infarction with the Drug-eluting Resorbable Magnesium Scaffold: The BEST- MAG Multicentre Study (Belgian ST-segment Elevation Myocardial Infarction Treatment with Resorbable Magnesium Scaffold) 39

Magmaris Bioresorbable Magnesium Scaffold – Retrospective, Observational Register to Investigate the Procedural and Post Procedural Implantation of Bioabsorbable Magnesium Scaffolds Magmaris (MAGIC Registry) 40

Magmaris Bioresorbable Magnesium Scaffold – RMS (Resorbable Magnesium Scaffolds) Registry 40

Magmaris Bioresorbable Magnesium Scaffold – Scaffold Implantation in Emilia-Romagna 40

DREAMS 3G System – BIOTRONIK – Safety and Clinical Performance of the – Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold System (DREAMS 3G) in the Treatment of Subjects with de Novo Lesions in Native Coronary Arteries 41

Biotronik SE & Co KG Pipeline Products & Ongoing Clinical Trials Overview 42

AMS-2 – Product Status 42

AMS-2 – Product Description 42

Biotyx Medical (Shenzhen) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 43

IBS Angel – Product Status 43

IBS Angel – Product Description 43

Biotyx Medical (Shenzhen) Co Ltd – Ongoing Clinical Trials Overview 44

IBS Angel – A Prospective, Multi-center, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of Iron Bioresorbable Scaffold System (IBS Angel) in Patients with Pulmonary Artery Stenosis 45

Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 46

Fully Resorbable Drug-Eluting Scaffold System – Product Status 46

Fully Resorbable Drug-Eluting Scaffold System – Product Description 46

Cardionovum GmbH Pipeline Products & Ongoing Clinical Trials Overview 47

Cardiosorb – Product Status 47

Cardiosorb – Product Description 47

Cordis Corp Pipeline Products & Ongoing Clinical Trials Overview 48

SymBio Pimecrolimus/Paclitaxel-Eluting Stent – Product Status 48

SymBio Pimecrolimus/Paclitaxel-Eluting Stent – Product Description 48

HangZhou HuaAn Biotechnology Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 49

Xinsorb BRS – Product Status 49

Xinsorb BRS – Product Description 49

Icon Interventional Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 50

Biosorb Pediatric Dissolving Stent – Product Status 50

Biosorb Pediatric Dissolving Stent – Product Description 50

Japan Stent Technology Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 51

Bioabsorbable Stent – Product Status 51

Bioabsorbable Stent – Product Description 51

Kyoto Medical Planning Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 52

Igaki-Tamai Coronary Stent – Product Status 52

Igaki-Tamai Coronary Stent – Product Description 52

Lifetech Scientific (Shenzhen) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 53

IBS Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System – Product Status 53

IBS Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System – Product Description 53

Lifetech Scientific (Shenzhen) Co Ltd – Ongoing Clinical Trials Overview 54

IBS Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System – A First-in-man Study of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System (IBS) 55

IBS Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System – A Prospective, Multi-center, Single-arm Trial of the Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System in Patients with Coronary Artery Disease: IRONMAN-III 55

IBS Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System – A Prospective, Multi-center, Single-blinded, Randomized Trial of the Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System in Patients with Coronary Artery Disease: IRONMAN-II 55

IBS Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System – A Prospective, Non-randomized, Open-label, Non-comparative, First-in-Man Study to Evaluate the Feasibility and Safety of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System 56

IBS Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System – Feasibility, Efficacy and Safety of IBS for Implantation in the PDA in Duct-dependent Cyanotic CHD 56

Manli Cardiology Ltd Pipeline Products & Ongoing Clinical Trials Overview 57

Mirage – Product Status 57

Mirage – Product Description 57

Meril Life Sciences Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 58

MeRes100 – Product Status 58

MeRes100 – Product Description 58

Meriskin BRS – Product Status 59

Meriskin BRS – Product Description 59

Meril Life Sciences Pvt Ltd – Ongoing Clinical Trials Overview 60

MeRes100 – A Multi Center Randomized Control Study of MeRes100 Sirolimus Eluting BioResorbable Vascular Scaffold System in Treatment of Coronary Artery Disease Patients: MeRes – China 61

MeRes100 – A Prospective, Multinational, Multicenter, Single Arm, Open Label, Pilot Clinical Study of MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System in the Treatment of De-novo Native Coronary Artery Lesions: MeRes-1 Extend 61

Micell Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 62

Bioresorbable Scaffold (BRS) – Product Status 62

Bioresorbable Scaffold (BRS) – Product Description 62

Michigan Technological University Pipeline Products & Ongoing Clinical Trials Overview 63

Bioabsorbable Stent – Product Status 63

Bioabsorbable Stent – Product Description 63

MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 64

Firefalcon Bioresorbable Device – Product Status 64

Firefalcon Bioresorbable Device – Product Description 64

Firesorb – Product Status 65

Firesorb – Product Description 65

MicroPort Scientific Corp – Ongoing Clinical Trials Overview 66

Firesorb – A First-in-man Study of the Firesorb Sirolimus Target Eluting Bioresorbable Vascular Scaffold in Patients with Coronary Artery Disease: FUTURE-I 67

Firesorb – A Prospective Multicenter Single-arm Clinical Trial Assessing the Safety and Effectiveness of Firesorb Sirolimus Target Eluting Bioresorbable Vascular Scaffold for the Treatment of Coronary Artery Disease: FUTURE III 67

Firesorb – A Randomized Trial of the Firesorb Sirolimus Target Eluting Bioresorbable Vascular Scaffold in Patients with Coronary Artery Disease: FUTURE-II 67

Minvasys SAS Pipeline Products & Ongoing Clinical Trials Overview 68

Nile LM SIR Sirolimus Eluting Intracoronary Stent – Product Status 68

Nile LM SIR Sirolimus Eluting Intracoronary Stent – Product Description 68

MIV Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 69

Smart-1 DES – Product Status 69

Smart-1 DES – Product Description 69

Smart-4 DES – Product Status 70

Smart-4 DES – Product Description 70

VESTAsync – Product Status 70

VESTAsync – Product Description 71

NanoCoeur, Inc. Pipeline Products & Ongoing Clinical Trials Overview 72

Nanocoating Cardiac Stent – Product Status 72

Nanocoating Cardiac Stent – Product Description 72

North Carolina State University Pipeline Products & Ongoing Clinical Trials Overview 73

Biodegradable Metal Stent – Product Status 73

Biodegradable Metal Stent – Product Description 73

Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 74

Liquid Cast Drug-Eluting Biodegradable Stent – Product Status 74

Liquid Cast Drug-Eluting Biodegradable Stent – Product Description 74

OrbusNeich Pipeline Products & Ongoing Clinical Trials Overview 75

Cura Stent – Product Status 75

Cura Stent – Product Description 75

Sirolimus-Eluting Absorbable Vascular Scaffold – Product Status 76

Sirolimus-Eluting Absorbable Vascular Scaffold – Product Description 76

Pediastent LLC Pipeline Products & Ongoing Clinical Trials Overview 77

Pediatric Bioresorbable Stent – Product Status 77

Pediatric Bioresorbable Stent – Product Description 77

QualiMed Innovative Medizinprodukte GmbH Pipeline Products & Ongoing Clinical Trials Overview 78

Biodegradable Coronary Stent – Product Status 78

Biodegradable Coronary Stent – Product Description 78

REVA Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 79

Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold – Product Status 79

Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold – Product Description 80

REVA Medical Inc – Ongoing Clinical Trials Overview 81

Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold – Expanded FANTOM II Clinical Study 82

Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold – Pilot Study of the REVA Sirolimus-Eluting Bioresorbable Coronary Scaffold 82

Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold – Post Market Study of the FANTOM Sirolimus-eluting Bioresorbable Coronary Scaffold 82

Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold – Safety and Efficacy of the FANTOM ENCORE Sirolimus-eluting Bioresorbable Scaffold for Treatment of De-novo Coronary Artery Disease: The ENCORE-I Study 83

Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold – Safety and Performance Study of the FANTOM Sirolimus-eluting Bioresorbable Coronary Scaffold 83

Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold – Vascular Healing Pattern, Vasoreactivity, and Quality of Life in Patients with ST Segment Elevation Myocardial Infarction Treated with Primary Percutaneous Coronary Intervention with Sirolimus Eluting FANTOM Bioresorbable Vascular Scaffold with Long Term Clinical, Near Infrared Spectroscopy and Optical Coherence Tomography Follow-up: A FANTOM STEMI Pilot Study 83

S3V Vascular Technologies Pipeline Products & Ongoing Clinical Trials Overview 84

3V Avatar – Product Status 84

3V Avatar – Product Description 84

Shanghai Bio-heart Biological Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 85

Bioheart BRS System – Product Status 85

Bioheart BRS System – Product Description 85

Bioheart Ultra BRS System – Product Status 86

Bioheart Ultra BRS System – Product Description 86

Shanghai Bio-heart Biological Technology Co Ltd – Ongoing Clinical Trials Overview 87

Bioheart BRS System – A Randomized Controlled Trial of the Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System in Patients With Coronary Artery Disease: BIOHEART-II 88

Bioheart BRS System – A Registry Trial of the Bioheart Rapamycin Drug-eluting Bioresorbable Coronary Stent System in Patients with Coronary Artery Disease: BIOHEART III 88

Bioheart BRS System – Study of Bioheart BRS System for the Treatment of Coronary Artery Disease 88

Shanghai Healing Medical Instruments Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 89

Biodegradable Sinus Stent – Product Status 89

Biodegradable Sinus Stent – Product Description 89

Tepha Inc Pipeline Products & Ongoing Clinical Trials Overview 90

TephaFLEX Absorbable Coronary Stent – Product Status 90

TephaFLEX Absorbable Coronary Stent – Product Description 90

Tremedics Medical Devices LLC Pipeline Products & Ongoing Clinical Trials Overview 91

Illusicor – Product Status 91

Illusicor – Product Description 91

University of Alabama at Birmingham Pipeline Products & Ongoing Clinical Trials Overview 92

Endothelium Nanomatrix Coated Stent – Product Status 92

Endothelium Nanomatrix Coated Stent – Product Description 92

University of Florida Pipeline Products & Ongoing Clinical Trials Overview 93

Nanocomposite Drug Eluting Stent – Product Status 93

Nanocomposite Drug Eluting Stent – Product Description 93

University of Strathclyde Pipeline Products & Ongoing Clinical Trials Overview 94

Magnesium Alloy Stent – Product Status 94

Magnesium Alloy Stent – Product Description 94

VasoTech Inc. Pipeline Products & Ongoing Clinical Trials Overview 95

PowerStent Absorb DES – Product Status 95

PowerStent Absorb DES – Product Description 95

Xenogenics Corporation Pipeline Products & Ongoing Clinical Trials Overview 96

Ideal BioStent – First Generation – Product Status 96

Ideal BioStent – First Generation – Product Description 96

Ideal BioStent – Second Generation – Product Status 97

Ideal BioStent – Second Generation – Product Description 97

Whisper Coronary Stent System – Product Status 97

Whisper Coronary Stent System – Product Description 98

Glossary 110

List of Figures

Bioabsorbable Stents (BAS) – Pipeline Products by Stage of Development 13

Bioabsorbable Stents (BAS) – Pipeline Products by Territory 14

Bioabsorbable Stents (BAS) – Pipeline Products by Regulatory Path 15

Bioabsorbable Stents (BAS) – Pipeline Products by Estimated Approval Date 16

Bioabsorbable Stents (BAS) – Ongoing Clinical Trials 17

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