Drug Eluting Stents (DES) Pipeline by Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies

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Drug Eluting Stents (DES) Pipeline Market Report Overview

Drug eluting stents (DES) release drugs locally and can be coated with a polymeric material. The Drug Eluting Stents (DES) 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 Territories ·        Europe

·        The US

·        Japan

·        China

·        Canada

Key Regulatory Paths ·        CE

·        PMA

·        Shonin

·        NMPA

·        MDL

Leading Companies ·        Abbott Vascular Inc

·        Adcomp Technologies Inc.

·        Advanced Bifurcation Systems Inc

·        Aeon Bioscience

·        B. Braun Melsungen AG

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Drug Eluting Stents (DES) Pipeline Market Segmentation by Territories

A few of the key territories for Drug Eluting Stents (DES) pipeline products are Europe, the US, Japan, China, and Canada. As of December 2023, Europe accounted for the highest number of pipeline products.

Drug Eluting Stents (DES) Pipeline Market Analysis by Territories, 2023 (%)

Drug Eluting Stents (DES) Pipeline Market Analysis by Territories, 2023 (%)

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Drug Eluting Stents (DES) Pipeline Market Segmentation by Regulatory Paths

A few of the key regulatory paths followed by the Drug Eluting Stents (DES) pipeline market are CE, PMA, Shonin, NMPA, and MDL. As of December 2023, CE was the most followed pathway for pipeline products in the market.

Drug Eluting Stents (DES) Pipeline Market Analysis by Regulatory Paths, 2023 (%)

Drug Eluting Stents (DES) Pipeline Market Analysis by Regulatory Paths, 2023 (%)

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Drug Eluting Stents (DES) Pipeline Market – Competitive Landscape

A few of the key companies associated with the Drug Eluting Stents (DES) pipeline market are Abbott Vascular Inc., Adcomp Technologies Inc., Advanced Bifurcation Systems Inc., Aeon Bioscience, and B. Braun Melsungen AG, among others.

Abbott Vascular Inc.: Abbott Vascular is headquartered in Santa Clara, California, the US. It is a medical device company that develops, manufactures, and markets cardiovascular devices. Abbott Vascular provides minimally invasive treatment for mitral regurgitation and other structural defects of the heart. It also offers education and training services for healthcare professionals.

Braun Melsungen AG: B. Braun is headquartered in Melsungen, Germany. The company develops, manufactures, and distributes medical technology and pharmaceutical products, and provides medical services. B. Braun provides products and systems in the fields of anesthesia, extracorporeal blood treatment, intensive care, cardiology, and surgery. It also offers services for clinics, physician practices, and the home care segment.

Drug Eluting Stents (DES) Pipeline Market Analysis by Companies, 2023

Drug Eluting Stents (DES) Pipeline Market Analysis by Companies, 2023

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Segments Covered in the Report

Drug Eluting Stents (DES) Pipeline Market Territories Outlook

  • Europe
  • The US
  • Japan
  • China
  • Canada

Drug Eluting Stents (DES) Pipeline Market Regulatory Paths Outlook

  • CE
  • PMA
  • Shonin
  • NMPA
  • MDL

Scope

This report provides:

  • Extensive coverage of the Drug Eluting Stents (DES) under development.
  • Exhaustive list of major pipeline products and their details, including product description, licensing and collaboration details, and other developmental activities.
  • Reviews of major players involved in the development of Drug Eluting Stents (DES) 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 portfolio and create effective counter strategies to gain a competitive advantage.
  • Identify and understand important and diverse types of Drug Eluting Stents (DES) 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.

Abbott Vascular Inc
Adcomp Technologies Inc.
Advanced Bifurcation Systems Inc
Aeon Bioscience
B. Braun Melsungen AG
Biosensors International Group Ltd
Biotronik AG
Biotronik SE & Co KG
Boston Scientific Corp
Cardionovum GmbH
Cardiorev Pte Ltd (Inactive)
Columbia University
Concept Medical Inc
Cordis Corp
DISA Vascular (Pty) Ltd
Elixir Medical Corp
Endomimetics LLC
Envision Scientific Pvt Ltd
I.B.S. S.p.A.
InspireMD Inc
JW Medical Systems Ltd
Kaneka Corp
MangoGen Pharma Inc
Medinol Ltd
Medlogics Device Corp (Inactive)
Medtronic Plc
MicroPort Scientific Corp
MIV Therapeutics Inc
Northwestern University
NuVascular Technologies Inc
Relisys Medical Devices Ltd
REVA Medical Inc
Shandong Rientech Medical Tech Co Ltd
Shanghai BIOMAGIC Medical Device Co Ltd
Shanghai MicroPort Medical Group Co Ltd
Sino Medical Sciences Technology Inc
Stentys SA
Svelte Medical Systems Inc
Terumo Corp
Terumo Interventional Systems
TissueGen Inc
Translumina Therapeutics LLP
University of Strathclyde
VasoTech Inc.

Table of Contents

1 Table of Contents 3

1.1 List of Tables 6

1.2 List of Figures 12

2 Introduction 13

2.1 Drug Eluting Stents (DES) Overview 13

3 Products under Development 14

3.1 Drug Eluting Stents (DES) – Pipeline Products by Stage of Development 14

3.2 Drug Eluting Stents (DES) – Pipeline Products by Territory 15

3.3 Drug Eluting Stents (DES) – Pipeline Products by Regulatory Path 16

3.4 Drug Eluting Stents (DES) – Pipeline Products by Estimated Approval Date 17

3.5 Drug Eluting Stents (DES) – Ongoing Clinical Trials 18

4 Drug Eluting Stents (DES) – Pipeline Products under Development by Companies 19

4.1 Drug Eluting Stents (DES) Companies – Pipeline Products by Stage of Development 19

4.2 Drug Eluting Stents (DES) – Pipeline Products by Stage of Development 21

5 Drug Eluting Stents (DES) Companies and Product Overview 23

5.1 Abbott Vascular Inc Company Overview 23

5.1.1 Abbott Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 23

5.2 Adcomp Technologies Inc. Company Overview 29

5.2.1 Adcomp Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview 29

5.3 Advanced Bifurcation Systems Inc Company Overview 30

5.3.1 Advanced Bifurcation Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 30

5.4 Aeon Bioscience Company Overview 31

5.4.1 Aeon Bioscience Pipeline Products & Ongoing Clinical Trials Overview 31

5.5 B. Braun Melsungen AG Company Overview 32

5.5.1 B. Braun Melsungen AG Pipeline Products & Ongoing Clinical Trials Overview 32

5.6 Biosensors International Group Ltd Company Overview 33

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

5.7 Biotronik AG Company Overview 39

5.7.1 Biotronik AG Pipeline Products & Ongoing Clinical Trials Overview 39

5.8 Biotronik SE & Co KG Company Overview 40

5.8.1 Biotronik SE & Co KG Pipeline Products & Ongoing Clinical Trials Overview 40

5.9 Boston Scientific Corp Company Overview 41

5.9.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 41

5.10 Cardionovum GmbH Company Overview 46

5.10.1 Cardionovum GmbH Pipeline Products & Ongoing Clinical Trials Overview 46

5.11 Cardiorev Pte Ltd (Inactive) Company Overview 49

5.11.1 Cardiorev Pte Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 49

5.12 Columbia University Company Overview 50

5.12.1 Columbia University Pipeline Products & Ongoing Clinical Trials Overview 50

5.13 Concept Medical Inc Company Overview 51

5.13.1 Concept Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 51

5.14 Cordis Corp Company Overview 55

5.14.1 Cordis Corp Pipeline Products & Ongoing Clinical Trials Overview 55

5.15 DISA Vascular (Pty) Ltd Company Overview 58

5.15.1 DISA Vascular (Pty) Ltd Pipeline Products & Ongoing Clinical Trials Overview 58

5.16 Elixir Medical Corp Company Overview 59

5.16.1 Elixir Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 59

5.17 Endomimetics LLC Company Overview 65

5.17.1 Endomimetics LLC Pipeline Products & Ongoing Clinical Trials Overview 65

5.18 Envision Scientific Pvt Ltd Company Overview 66

5.18.1 Envision Scientific Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 66

5.19 I.B.S. S.p.A. Company Overview 67

5.19.1 I.B.S. S.p.A. Pipeline Products & Ongoing Clinical Trials Overview 67

5.20 InspireMD Inc Company Overview 68

5.20.1 InspireMD Inc Pipeline Products & Ongoing Clinical Trials Overview 68

5.21 JW Medical Systems Ltd Company Overview 69

5.21.1 JW Medical Systems Ltd Pipeline Products & Ongoing Clinical Trials Overview 69

5.22 Kaneka Corp Company Overview 70

5.22.1 Kaneka Corp Pipeline Products & Ongoing Clinical Trials Overview 70

5.23 MangoGen Pharma Inc Company Overview 71

5.23.1 MangoGen Pharma Inc Pipeline Products & Ongoing Clinical Trials Overview 71

5.24 Medinol Ltd Company Overview 72

5.24.1 Medinol Ltd Pipeline Products & Ongoing Clinical Trials Overview 72

5.25 Medlogics Device Corp (Inactive) Company Overview 75

5.25.1 Medlogics Device Corp (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 75

5.26 Medtronic Plc Company Overview 77

5.26.1 Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 77

5.27 MicroPort Scientific Corp Company Overview 81

5.27.1 MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 81

5.28 MIV Therapeutics Inc Company Overview 86

5.28.1 MIV Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 86

5.29 Northwestern University Company Overview 88

5.29.1 Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 88

5.30 NuVascular Technologies Inc Company Overview 89

5.30.1 NuVascular Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 89

5.31 Relisys Medical Devices Ltd Company Overview 90

5.31.1 Relisys Medical Devices Ltd Pipeline Products & Ongoing Clinical Trials Overview 90

5.32 REVA Medical Inc Company Overview 91

5.32.1 REVA Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 91

5.33 Shandong Rientech Medical Tech Co Ltd Company Overview 93

5.33.1 Shandong Rientech Medical Tech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 93

5.34 Shanghai BIOMAGIC Medical Device Co Ltd Company Overview 96

5.34.1 Shanghai BIOMAGIC Medical Device Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 96

5.35 Shanghai MicroPort Medical Group Co Ltd Company Overview 97

5.35.1 Shanghai MicroPort Medical Group Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 97

5.36 Sino Medical Sciences Technology Inc Company Overview 102

5.36.1 Sino Medical Sciences Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 102

5.37 Stentys SA Company Overview 107

5.37.1 Stentys SA Pipeline Products & Ongoing Clinical Trials Overview 107

5.38 Svelte Medical Systems Inc Company Overview 108

5.38.1 Svelte Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 108

5.39 Terumo Corp Company Overview 112

5.39.1 Terumo Corp Pipeline Products & Ongoing Clinical Trials Overview 112

5.40 Terumo Interventional Systems Company Overview 116

5.40.1 Terumo Interventional Systems Pipeline Products & Ongoing Clinical Trials Overview 116

5.41 TissueGen Inc Company Overview 118

5.41.1 TissueGen Inc Pipeline Products & Ongoing Clinical Trials Overview 118

5.42 Translumina Therapeutics LLP Company Overview 119

5.42.1 Translumina Therapeutics LLP Pipeline Products & Ongoing Clinical Trials Overview 119

5.43 University of Strathclyde Company Overview 123

5.43.1 University of Strathclyde Pipeline Products & Ongoing Clinical Trials Overview 123

5.44 VasoTech Inc. Company Overview 124

5.44.1 VasoTech Inc. Pipeline Products & Ongoing Clinical Trials Overview 124

6 Drug Eluting Stents (DES)- Recent Developments 125

6.1 Nov 10, 2023: Microport Appointment of Director 125

6.2 Oct 26, 2023: Five-Year Superiority Proven for Orsiro Des Over Xience Des in Stemi Patients 125

6.3 Oct 26, 2023: Boston Scientific Announces Results for Third Quarter 2023 126

6.4 Oct 25, 2023: TCT 2023: Six-Month Clinical Data from DESyne BDS Plus Randomized Controlled Trial (RCT) Support Safety and Effectiveness of World’s First Site-Specific Antithrombotic Drug Therapy 128

6.5 Oct 24, 2023: Medinol Receives FDA Approval for Next Generation Elunir-Perl Drug-Eluting Coronary Stent System 129

6.6 Oct 23, 2023: Advanced Bifurcation Systems Receives FDA Breakthrough Device Designation 129

6.7 Oct 18, 2023: Abbott Reports Third-Quarter 2023 Results and Raises Midpoint of Full-Year EPS Guidance Range 130

6.8 Oct 05, 2023: Elixir Medical to Present Randomized Clinical Dataset Featuring World’s First Triple Drug-Eluting Coronary Implant Eluting Two Anticoagulants and Sirolimus at TCT 2023 132

6.9 Oct 04, 2023: Elixir Medical Completes Submission of DynamX Coronary Bioadaptor System to Japan’s PMDA Agency for Regulatory Approval 134

6.10 Oct 04, 2023: Medtronic Names Paolo Di Vincenzo President of the Neuromodulation Business 135

6.11 Sep 21, 2023: Microport Scientific Corp. Announces 2023 Interim Report 135

6.12 Sep 11, 2023: Multiple MicroPort Business Groups Make an Appearance at SOLACI-SBHCI 2023 137

6.13 Aug 26, 2023: Medtronic Q2 2024 Earnings Estimates Increased by William Blair 139

6.14 Aug 08, 2023: Medtronic to Announce Financial Results for its First Quarter of Fiscal Year 2024 139

6.15 Jul 19, 2023: Boston Scientific lays off 52 workers as it closes another Silicon Valley facility 139

6.16 Jul 19, 2023: Boston Scientific Lays off 52 Amid California Facility Closure 139

6.17 Jul 13, 2023: Elixir Medical Completes Enrollment of INFINITY-SWEDEHEART Clinical Trial 139

6.18 Jul 11, 2023: Late-Breaking Study Data: BIOTRONIK’s Orsiro DES Outperforms Other Ultrathin Strut Drug-Eluting Stent 140

6.19 Jul 11, 2023: Microport Scientific Provides Consolidated Earnings Guidance for the Six Months Ended June 30, 2023 141

6.20 Jun 12, 2023: Abbott Names Philip Boudreau CFO effective Sept. 1 141

6.21 Jun 02, 2023: MicroPort Group’s Multiple Business Units Participate in the European Cardiovascular Intervention Conference 141

6.22 May 30, 2023: Medinol partners with CoSo Health to Launch the EluNIR Drug-Eluting Stent in the U.S. 142

6.23 May 15, 2023: Terumo announces consolidated financial results for the fiscal year ended March 31, 2023 143

6.24 May 11, 2023: Medtronic to announce financial results for its fourth quarter and full fiscal year 2023 143

6.25 Apr 26, 2023: MicroPort announces annual results for 2022 143

6.26 Apr 23, 2023: MicroPort announces release of TARGET-FIRST study design for the Firehawk Coronary Stent 143

6.27 Apr 12, 2023: Medtronic has a layoff in California 144

6.28 Mar 16, 2023: Medtronic joins in $25M funding round for home monitoring company 144

6.29 Mar 08, 2023: OrbusNeich Announces Record Revenue of US$136.8 Million, Adjusted Net Profit Up 25% to US$26.7 Million 144

6.30 Feb 09, 2023: Terumo Notice Concerning Revision of the Full-Year Financial Guidance for Fiscal Year Ending March 31, 2023 146

6.31 Feb 09, 2023: Terumo Corp Announces Consolidated Financial Results for the Third Quarter Ended December 31, 2022 146

6.32 Jan 20, 2023: MicroPort joins Singapore LIVE 2023 147

6.33 Jan 04, 2023: Firehawk Liberty Rapamycin target eluting coronary stent system approved for marketing in Russia 148

6.34 Dec 08, 2022: Ultimaster Drug Eluting Stent family (Terumo) first stent to receive the mention 1-month DAPT in the reimbursement conditions in France 148

7 Appendix 150

7.1 Methodology 150

7.2 About GlobalData 153

7.3 Contact Us 153

7.4 Disclaimer 153

Table

Drug Eluting Stents (DES) – Pipeline Products by Stage of Development 14

Drug Eluting Stents (DES) – Pipeline Products by Territory 15

Drug Eluting Stents (DES) – Pipeline Products by Regulatory Path 16

Drug Eluting Stents (DES) – Pipeline Products by Estimated Approval Date 17

Drug Eluting Stents (DES) – Ongoing Clinical Trials 18

Drug Eluting Stents (DES) Companies – Pipeline Products by Stage of Development 19

Drug Eluting Stents (DES) – Pipeline Products by Stage of Development 21

Abbott Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 23

Xience Bioprime – Product Status 23

Xience Bioprime – Product Description 23

Xience Max – Product Status 24

Xience Max – Product Description 24

Xience SBA Everolimus Eluting Coronary Stent System – Product Status 24

Xience SBA Everolimus Eluting Coronary Stent System – Product Description 25

XIENCE Thinman DES – Product Status 25

XIENCE Thinman DES – Product Description 25

ZoMaxx Drug Eluting Coronary Stent System – Product Status 26

ZoMaxx Drug Eluting Coronary Stent System – Product Description 26

Abbott Vascular Inc – Ongoing Clinical Trials Overview 27

Xience SBA Everolimus Eluting Coronary Stent System – A Multi-center, Randomized, Controlled Trial to Demonstrate the Safety and Effectiveness of the MiStent II for the Revascularization of Coronary Arteries: CRYSTAL Study 28

Xience SBA Everolimus Eluting Coronary Stent 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 28

Xience SBA Everolimus Eluting Coronary Stent System – Intracoronary Stenting and Restenosis – Randomized Trial of Drug-eluting Stent Implantation or Drug-coated Balloon Angioplasty According to Neointima Morphology in Drug-eluting Stent Restenosis 5 28

Adcomp Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview 29

Dual Drug Eluting Stent – Product Status 29

Dual Drug Eluting Stent – Product Description 29

Advanced Bifurcation Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 30

ABS Stenting System – Drug Eluting Stent – Product Status 30

ABS Stenting System – Drug Eluting Stent – Product Description 30

Aeon Bioscience Pipeline Products & Ongoing Clinical Trials Overview 31

Drug Eluting Stent – Product Status 31

Drug Eluting Stent – Product Description 31

B. Braun Melsungen AG Pipeline Products & Ongoing Clinical Trials Overview 32

Coroflex DEBlue – Product Status 32

Coroflex DEBlue – Product Description 32

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

BioFreedom Ultra – Product Status 33

BioFreedom Ultra – Product Description 33

Biosensors International Group Ltd – Ongoing Clinical Trials Overview 34

BioFreedom Ultra – A Pilot Study Registry of the BioFreedom BA9 Ultra Drug-Coated Coronary Stent for Patients With ST Elevation Myocardial Infarct (STEMI) Undergoing Percutaneous Coronary Intervention (PCI) 35

BioFreedom Ultra – A Post-Market Registry of the BioFreedom Ultra CoCr Biolimus A9 Coated Coronary Stent System 35

BioFreedom Ultra – A Prospective Multicenter Single Arm Trial to Assess the Safety and Effectiveness of Additional Sizes of the BioFreedom Ultra CoCr Biolimus A9 Coated Coronary Stent System 35

BioFreedom Ultra – A Prospective Study of the BioFreedom Biolimus A9 Drug Coated Stent in Patients at High Risk for Bleeding 36

BioFreedom Ultra – BioFreedom Ultra Stent in Hong Kong All Comers Registry 36

BioFreedom Ultra – Comparison of Polymer-free Cobalt-Chromium Thin Drug-coated Stents with Biodegradable Polymer Ultrathin Sirolimus-Eluting Stents and Prasugrel Monotherapy with Conventional 12-Month Dual Antiplatelet Therapy 36

BioFreedom Ultra – Evaluation of Effectiveness and Safety of Biofreedom Family Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study 37

BioFreedom Ultra – Evaluation of Effectiveness and Safety of the First, Second, and New Drug-eluting Stents in Routine Clinical Practice 37

BioFreedom Ultra – P2Y12 Inhibitor-based Single Antiplatelet Therapy Versus Conventional Dual Antiplatelet Therapy After Percutaneous Coronary Intervention With BioFreedom Ultra Drug-coated Stent for Unprotected Left Main Coronary Artery Disease (ULTRA-LM) 37

BioFreedom Ultra – Randomized Comparison of a Polymer-free Biolimus-eluting BioFreedom Stent with a Biodegradable-polymer Sirolimus-eluting Orsiro Stent in Patients Treated with Percutaneous Coronary Intervention 38

BioFreedom Ultra – Randomized Comparison of Vascular Healing of a Polymer-free Biolimus-eluting BIOFREEDOM Stent with a Biodegradable-polymer Sirolimus-eluting ORSIRO Stent in Patients with ST-segment Elevation Myocardial Infarction 38

Biotronik AG Pipeline Products & Ongoing Clinical Trials Overview 39

Coronary Stent System – Product Status 39

Coronary Stent System – Product Description 39

Biotronik SE & Co KG Pipeline Products & Ongoing Clinical Trials Overview 40

ProGenic Pimecrolimus-eluting Coronary Stent System – Product Status 40

ProGenic Pimecrolimus-eluting Coronary Stent System – Product Description 40

Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 41

JACTAX Drug Eluting Stent – Product Status 41

JACTAX Drug Eluting Stent – Product Description 41

SYNERGY 48 Stent – Product Status 42

SYNERGY 48 Stent – Product Description 42

SYNERGY XD Stent – Product Status 42

SYNERGY XD Stent – Product Description 43

TAXUS Petal Bifurcation Paclitaxel-Eluting Stent System – Product Status 43

TAXUS Petal Bifurcation Paclitaxel-Eluting Stent System – Product Description 43

Boston Scientific Corp – Ongoing Clinical Trials Overview 44

SYNERGY XD Stent – Evaluation of Effectiveness and Safety of Synergy™ XD Stent and Synergy Megatron™ Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study 45

Cardionovum GmbH Pipeline Products & Ongoing Clinical Trials Overview 46

DEBLIMUS – Product Status 46

DEBLIMUS – Product Description 46

PROTECT – Product Status 47

PROTECT – Product Description 47

ReNATURAL (M) – Product Status 47

ReNATURAL (M) – Product Description 48

ReNATURAL (P) – Product Status 48

ReNATURAL (P) – Product Description 48

Cardiorev Pte Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 49

Peptide-Eluting Coronary Stent – Product Status 49

Peptide-Eluting Coronary Stent – Product Description 49

Columbia University Pipeline Products & Ongoing Clinical Trials Overview 50

C3 Exoenzyme Coated Stent – Product Status 50

C3 Exoenzyme Coated Stent – Product Description 50

Concept Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 51

Abluminus DES+ – Product Status 51

Abluminus DES+ – Product Description 51

Concept Medical Inc – Ongoing Clinical Trials Overview 52

Abluminus DES+ – A Multicenter, Prospective, Study to Evaluate the Safety and Effcacy of the Abluminus DES+ in an All-Comers Population 53

Abluminus DES+ – A Post Market Registry of Abluminus Sirolimus Eluting Coronary Stent System for Percutaneous Intervention in Patients with Diabetes Mellitus 53

Abluminus DES+ – ABILITY Diabetes Global 53

Abluminus DES+ – ABLUMINUS Below the Knee (BTK) Drug Eluting Stent (DES) Registry (ABLUMINUS BTK) – First in Men 54

Abluminus DES+ – Randomized Trial Investigating Clinical Outcomes of Two Sirolimus-Eluting Stents in Diabetes Mellitus 54

Cordis Corp Pipeline Products & Ongoing Clinical Trials Overview 55

Corio Pimecrolimus-Eluting Stent – Product Status 55

Corio Pimecrolimus-Eluting Stent – Product Description 55

Cypher Elite – Product Status 56

Cypher Elite – Product Description 56

NEVO Sirolimus-Eluting Coronary Stent – Product Status 56

NEVO Sirolimus-Eluting Coronary Stent – Product Description 57

Next Generation Coronary Stent – Product Status 57

Next Generation Coronary Stent – Product Description 57

DISA Vascular (Pty) Ltd Pipeline Products & Ongoing Clinical Trials Overview 58

Stellium Stent – Product Status 58

Stellium Stent – Product Description 58

Elixir Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 59

DESolve Myolimus Eluting Bioresorbable Coronary Scaffold System – Product Status 59

DESolve Myolimus Eluting Bioresorbable Coronary Scaffold System – Product Description 59

DynamX Drug Eluting Coronary Bioadaptor System – Product Status 60

DynamX Drug Eluting Coronary Bioadaptor System – Product Description 60

Myolimus Eluting Coronary Stent – Durable Polymer – Product Status 60

Myolimus Eluting Coronary Stent – Durable Polymer – Product Description 61

Elixir Medical Corp – Ongoing Clinical Trials Overview 62

DynamX Drug Eluting Coronary Bioadaptor System – DynamX Bioadaptor Global Post-Market Registry: Clinical Trial of the Elixir Medical DynamX Novolimus Eluting Coronary Bioadaptor System (Bio-RESTORE) 63

DynamX Drug Eluting Coronary Bioadaptor System – DYNAMX Bioadaptor Implantation for the Treatment of Complex Coronary Lesions (DYNAMITE Study) 63

DynamX Drug Eluting Coronary Bioadaptor System – Evaluation of a Sirolimus Eluting Bioadaptor as Compared to a Zotarolimus Eluting Stent in De Novo Native Coronary Arteries ELX-CL-1805 63

DynamX Drug Eluting Coronary Bioadaptor System – Infinity-swedeheart Study: Registry Based Randomized Clinical Trial (R-RCT) Comparing Long Term Outcomes of the DynamX Bioadaptor to the Resolute Onyx Stent in a More-comer PCI Patient Population 64

Endomimetics LLC Pipeline Products & Ongoing Clinical Trials Overview 65

Coronary Artery Stent – Product Status 65

Coronary Artery Stent – Product Description 65

Envision Scientific Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 66

Paclitaxel Eluting Stent – Product Status 66

Paclitaxel Eluting Stent – Product Description 66

I.B.S. S.p.A. Pipeline Products & Ongoing Clinical Trials Overview 67

Drug Eluting Stent – Product Status 67

Drug Eluting Stent – Product Description 67

InspireMD Inc Pipeline Products & Ongoing Clinical Trials Overview 68

MGuard Drug Eluting Stent – Product Status 68

MGuard Drug Eluting Stent – Product Description 68

JW Medical Systems Ltd Pipeline Products & Ongoing Clinical Trials Overview 69

Excel II DES – Product Status 69

Excel II DES – Product Description 69

Kaneka Corp Pipeline Products & Ongoing Clinical Trials Overview 70

MAHOROBA Stent – Product Status 70

MAHOROBA Stent – Product Description 70

MangoGen Pharma Inc Pipeline Products & Ongoing Clinical Trials Overview 71

Gene-Delivering Stent – Product Status 71

Gene-Delivering Stent – Product Description 71

Medinol Ltd Pipeline Products & Ongoing Clinical Trials Overview 72

IoNIR Ridaforolimus-Eluting Coronary Stent System – Product Status 72

IoNIR Ridaforolimus-Eluting Coronary Stent System – Product Description 72

Medinol Ltd – Ongoing Clinical Trials Overview 73

IoNIR Ridaforolimus-Eluting Coronary Stent System – IonMAN II Trial- Early Feasibility Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System 74

IoNIR Ridaforolimus-Eluting Coronary Stent System – IonMAN Trial-First In Human Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System 74

Medlogics Device Corp (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 75

COBRA-Q Drug Eluting Stent – Product Status 75

COBRA-Q Drug Eluting Stent – Product Description 75

SYNERGY – Product Status 76

SYNERGY – Product Description 76

Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 77

Drug Filled Stent – Product Status 77

Drug Filled Stent – Product Description 78

Resolute Onyx DES – DAPT – Product Status 78

Resolute Onyx DES – DAPT – Product Description 78

Medtronic Plc – Ongoing Clinical Trials Overview 79

Resolute Onyx DES – DAPT – BIOTRONIK- A Prospective, Randomised, Multi-center Study to Assess the Safety of the Orsiro Mission Stent Compared to Resolute Onyx Stent in Subjects at High Risk of Bleeding in Combination With 1-month Dual Antiplatelet Therapy (DAPT) 80

MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 81

Fantasy Drug-Eluting Stent – Product Status 81

Fantasy Drug-Eluting Stent – Product Description 81

Firebird Pro+ – Product Status 82

Firebird Pro+ – Product Description 82

Firebird2 Pro – Product Status 82

Firebird2 Pro – Product Description 82

Firehawk Plus – Product Status 83

Firehawk Plus – Product Description 83

MicroPort Scientific Corp – Ongoing Clinical Trials Overview 84

Firehawk Plus – LARGE-ONE: A Prospective, Multicenter, Randomized Controlled Trial of the Use of Drug-coating Balloons(DCB) or Drug-eluting Stents(DES) in the Treatment of Large Diameter Coronary Atherosclerotic Lesions 85

MIV Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 86

Smart-2 DES – Product Status 86

Smart-2 DES – Product Description 86

Smart-3 DES – Product Status 87

Smart-3 DES – Product Description 87

Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 88

Liquid Drug Eluting Stent – Product Status 88

Liquid Drug Eluting Stent – Product Description 88

NuVascular Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 89

NuSpun DE Stent Sheath – Product Status 89

NuSpun DE Stent Sheath – Product Description 89

Relisys Medical Devices Ltd Pipeline Products & Ongoing Clinical Trials Overview 90

Corel + C Drug Eluting Stent – Product Status 90

Corel + C Drug Eluting Stent – Product Description 90

REVA Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 91

ReZolve Sirolimus-Eluting Bioresorbable Coronary Scaffold – Product Status 91

ReZolve Sirolimus-Eluting Bioresorbable Coronary Scaffold – Product Description 91

ReZolve2 Drug Eluting Bioresorbable Coronary Scaffold – Product Status 92

ReZolve2 Drug Eluting Bioresorbable Coronary Scaffold – Product Description 92

Shandong Rientech Medical Tech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 93

Absorbable Zinc Alloy Drug Eluting Coronary Stent System – Product Status 93

Absorbable Zinc Alloy Drug Eluting Coronary Stent System – Product Description 93

Shandong Rientech Medical Tech Co Ltd – Ongoing Clinical Trials Overview 94

Absorbable Zinc Alloy Drug Eluting Coronary Stent System – Exploratory Study on the Safety and Effectiveness of Absorbable Zinc Alloy Drug-eluting Coronary Stent System 95

Shanghai BIOMAGIC Medical Device Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 96

BIOMAGIC Biroresorbable Coronary Stent – Product Status 96

BIOMAGIC Biroresorbable Coronary Stent – Product Description 96

Shanghai MicroPort Medical Group Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 97

Firehawk Rapamycin Target Eluting Coronary Stent System – Product Status 97

Firehawk Rapamycin Target Eluting Coronary Stent System – Product Description 97

Shanghai MicroPort Medical Group Co Ltd – Ongoing Clinical Trials Overview 98

Firehawk Rapamycin Target Eluting Coronary Stent System – A Prospective Multi-center Open-label Controlled Trial of Comparison 3 Versus 12 Months of Dual Anti-platelet Therapy after Implantation of Firehawk Sirolimus Target- eluting Stent in Patients with Stable Coronary Artery Disease 99

Firehawk Rapamycin Target Eluting Coronary Stent System – A Prospective, Multicenter, Single-arm Trail in Evaluating the Safety and Efficacy of the Rapamycin Target Eluting Stent in Patients with Coronary Artery Stenosis 99

Firehawk Rapamycin Target Eluting Coronary Stent System – A Prospective, Open Label, Multi-center Trial of Firehawk Coronary Stent System in the Treatment of Coronary Chronic Total Artery Occlusion Lesion(S) by Optical Coherent Tomography (OCT) and Coronary Angiography 99

Firehawk Rapamycin Target Eluting Coronary Stent System – Assessment of In-stent Intimal Repair and Vessel Reaction After Firehawk Sirolimus Eluting Stent Implantation of STEMI Subjects – An Optical Coherence Tomography (OCT) Study 100

Firehawk Rapamycin Target Eluting Coronary Stent System – Evaluation of Effectiveness and Safety of the First, Second, and New Drug-eluting Stents in Routine Clinical Practice 100

Firehawk Rapamycin Target Eluting Coronary Stent System – LARGE-ONE: A Prospective, Multicenter, Randomized Controlled Trial of the Use of Drug-coating Balloons(DCB) or Drug-eluting Stents(DES) in the Treatment of Large Diameter Coronary Atherosclerotic Lesions 100

Firehawk Rapamycin Target Eluting Coronary Stent System – Optical Coherence Tomography Compared with Intravascular Ultrasound or Quantitative Coronary Analysis to Guide Stent Implantation in the Treatment of Moderate-to-severe Calcified Lesion in Coronary Artery 101

Sino Medical Sciences Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 102

BuMA Supreme DES (Drug Eluting Stent) – Product Status 102

BuMA Supreme DES (Drug Eluting Stent) – Product Description 103

Supreme HT Drug-Eluting Stent – Product Status 103

Supreme HT Drug-Eluting Stent – Product Description 103

Sino Medical Sciences Technology Inc – Ongoing Clinical Trials Overview 104

BuMA Supreme DES (Drug Eluting Stent) – A Prospective, Multicenter First-in-man Trial Program in China to Evaluate the Efficacy and Safety of Buma Supreme (Eg Grafting) Biodegradable Polymer Sirolimus Eluting Stent in Subjects with De Novo Coronary Lesions, RCT Trial 105

BuMA Supreme DES (Drug Eluting Stent) – A Prospective, Multicenter Trial Program in China to Evaluate the Efficacy and Safety of BuMA Supreme (eG Grafting) Biodegradable Polymer Sirolimus Eluting Stent in Patients with de Novo Coronary Lesions, OPC Trial 105

Supreme HT Drug-Eluting Stent – A Prospective, Multi-center, Single-group Target Value Post-marketing Clinical Study to Evaluate the Safety and Effectiveness of the HT Supreme Drug-eluting Stent System in the Treatment of “Real-world” Patients with Coronary Heart Disease 106

Supreme HT Drug-Eluting Stent – Non-inferiority of Angiography-derived Physiology Guidance Versus Usual Care in an All-comers PCI Population Treated with Unrestricted Use of the Healing-targeted Supreme (HT Supreme) Drug-eluting Stent and P2Y12 Inhibitor Monotherapy after 1-month of Dual-antiplatelet Therapy 106

Stentys SA Pipeline Products & Ongoing Clinical Trials Overview 107

STENTYS Paclitaxel-Eluting Stent – Product Status 107

STENTYS Paclitaxel-Eluting Stent – Product Description 107

Svelte Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 108

DIRECT RX – Product Status 108

DIRECT RX – Product Description 109

Svelte Medical Systems Inc – Ongoing Clinical Trials Overview 110

DIRECT RX – OPTIMIZE Sirolimus-eluting Coronary Stent Systems Pharmacokinetics (PK) Study 111

Terumo Corp Pipeline Products & Ongoing Clinical Trials Overview 112

Ultimaster Nagomi – Product Status 112

Ultimaster Nagomi – Product Description 113

Terumo Corp – Ongoing Clinical Trials Overview 114

Ultimaster Nagomi – A Post-Market Clinical Follow-up Study With Ultimaster Nagomi Sirolimus Eluting Coronary Stent System in Complex PCI Subjects 115

Terumo Interventional Systems Pipeline Products & Ongoing Clinical Trials Overview 116

Next Generation Ultimaster Drug Eluting Bioresorbable Scaffold – Product Status 116

Next Generation Ultimaster Drug Eluting Bioresorbable Scaffold – Product Description 116

Next Ultimaster Metallic Drug Eluting Stent – Product Status 117

Next Ultimaster Metallic Drug Eluting Stent – Product Description 117

TissueGen Inc Pipeline Products & Ongoing Clinical Trials Overview 118

Cardiovascular Stent – Product Status 118

Cardiovascular Stent – Product Description 118

Translumina Therapeutics LLP Pipeline Products & Ongoing Clinical Trials Overview 119

VIVO ISAR-Sirolimus Eluting Coronary Stent System – Product Status 119

VIVO ISAR-Sirolimus Eluting Coronary Stent System – Product Description 120

Translumina Therapeutics LLP – Ongoing Clinical Trials Overview 121

VIVO ISAR-Sirolimus Eluting Coronary Stent System – A Prospective, Post Marketing Clinical Follow up Study to Evaluate the Safety and Performance of Polymer Free Sirolimus Eluting Coronary Stent System in Real World Indian Population 122

University of Strathclyde Pipeline Products & Ongoing Clinical Trials Overview 123

Drug-Eluting Stent – Product Status 123

Drug-Eluting Stent – Product Description 123

VasoTech Inc. Pipeline Products & Ongoing Clinical Trials Overview 124

PowerStent Coro DES – Product Status 124

PowerStent Coro DES – Product Description 124

Glossary 152

Figures

Drug Eluting Stents (DES) – Pipeline Products by Stage of Development 14_x000D_

Drug Eluting Stents (DES) – Pipeline Products by Territory 15_x000D_

Drug Eluting Stents (DES) – Pipeline Products by Regulatory Path 16_x000D_

Drug Eluting Stents (DES) – Pipeline Products by Estimated Approval Date 17_x000D_

Drug Eluting Stents (DES) – Ongoing Clinical Trials 18_x000D_

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