PTA Peripheral DCB Catheters Pipeline by Development Stages, Segments, Region and Countries, Regulatory Path and Key Companies

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Published: March 29, 2024 Report Code: GDME1723EPD-ST

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PTA Peripheral DCB Catheters Pipeline Market Report Overview

A PTA Peripheral DCB Catheter is a drug-coated percutaneous transluminal angioplasty (PTA) balloon intended to prevent restenosis or restenosis of the peripheral arteries. PTA Peripheral DCB catheters provide fast, short-term, homogenous, local drug delivery to the vessel wall while preserving the anatomy of the vessel, promoting enhanced vessel healing, and reducing the need for prolonged dual antiplatelet therapy. They can be used to treat native and in-stent restenosis (ISR), bifurcations, small vessels, and long lesions. One unit refers to one PTA Peripheral DCB Catheter.

The PTA Peripheral DCB Catheter pipeline market research report provides extensive coverage of the PTA Peripheral DCB Catheters under development. The report reviews details of major pipeline products which include product description, licensing and collaboration details, and other developmental activities. It also includes pipeline territories, regulatory paths, and estimated approval dates. Additionally, the report reviews major players involved in the pipeline product development.

Key Territories ·        The United States

·        China

·        Europe

·        Japan

·        Singapore
Key Regulatory Paths ·        PMA

·        NMPA

·        CE

·        510(k)

·        Shonin
Key Companies ·        Acotec Scientific Co Ltd

·        AnGes Inc

·        AngioCure, Inc.

·        Ascenion GmbH

·        Becton Dickinson and Co
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PTA Peripheral DCB Catheters Pipeline Market Segmentation by Territories

A few of the key territories in the PTA Peripheral DCB Catheters pipeline market are the United States, China, Europe, Japan, and Singapore among others. As of March 2024, the US accounted for the highest number of products in the PTA Peripheral DCB Catheters pipeline market.

PTA Peripheral DCB Catheters Pipeline Market by Territories, 2024 (%)

PTA Peripheral DCB Catheters Pipeline Market by Territories, 2024 (%)

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PTA Peripheral DCB Catheters Pipeline Market Segmentation by Regulatory Paths

A few of the key regulatory paths in the PTA Peripheral DCB Catheters pipeline market are PMA, NMPA, CE, 510(k), and Shonin. As of March 2024, most of the pipeline products followed the PMA regulatory pathway.

PTA Peripheral DCB Catheters Pipeline Market by Regulatory Paths (%)

PTA Peripheral DCB Catheters Pipeline Market by Regulatory Paths (%)

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PTA Peripheral DCB Catheters Pipeline Market by Companies

A few of the major companies in the PTA Peripheral DCB Catheters pipeline market are:

  • Acotec Scientific Co Ltd
  • AnGes Inc
  • AngioCure, Inc.
  • Ascenion GmbH
  • Becton Dickinson and Co
  • Others

Acotec Scientific Co Ltd: Acotec Scientific Co Ltd, a subsidiary of Acotec Scientific Holdings Ltd, is a research and development firm that offers medical devices such as electrophysiologic catheters, drug-coated balloons, percutaneous transluminal angioplasty, and vascular interventional treatments. The company is headquartered in Beijing, China.

PTA Peripheral DCB Catheters Pipeline Market Company Analysis

PTA Peripheral DCB Catheters Pipeline Market Company Analysis

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Segments Covered in the Report

PTA Peripheral DCB Catheters Pipeline Market Territories Outlook

  • The United States
  • China
  • Europe
  • Japan
  • Singapore

PTA Peripheral DCB Catheters Pipeline Market Regulatory Paths Outlook

  • PMA
  • NMPA
  • CE
  • 510(k)
  • Shonin

Scope

  • The report provides extensive coverage of the PTA Peripheral DCB Catheters 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 PTA Peripheral DCB Catheters and lists all their pipeline projects.

  • The report provides 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.

  • The report also provides recent developments in the segment/industry.

Reasons to Buy

  • 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 competitive

  • Identify and understand important and diverse types of PTA Peripheral DCB Catheters under

  • Develop market-entry and market-expansion

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

  • In-depth analysis of the product’s current stage of development, territory, and estimated launch date

Acotec Scientific Co Ltd
AnGes Inc
AngioCure, Inc.
Ascenion GmbH
Becton Dickinson and Co
Boston Scientific Corp
Cardionovum GmbH
Chansu Vascular Technologies LLC
Concept Medical Inc
Contego Medical LLC
Cordis US Corp
Dingke Medical Technology (Suzhou) Co Ltd
eucatech AG
Lifetech Scientific (Shenzhen) Co Ltd
Lutonix Inc
Medtronic Plc
Micell Technologies Inc
OrbusNeich
Orchestra BioMed Inc
Pulsus Medical LLC (Inactive)
QualiMed Innovative Medizinprodukte GmbH
Shanghai Easy-Flow Medical Tech Co Ltd
Shenzhen Salubris Pharmaceuticals Co Ltd
SiL Vascular Ltd
Spectranetics Corp
Stemplant LLC
SurModics Inc
Tailored Medical Devices Inc
TransMed7 LLC
Vascular Nanotransfer Technologies
Zhejiang Batai Medical Technology Co Ltd
Zylox-Tonbridge Medical Technology Co Ltd

Table of Contents

1 Table of Contents 3

1.1 List of Tables 6

1.2 List of Figures 10

2 Introduction 11

2.1 PTA Peripheral DCB Catheters Overview 11

3 Products under Development 12

3.1 PTA Peripheral DCB Catheters – Pipeline Products by Stage of Development 12

3.2 PTA Peripheral DCB Catheters – Pipeline Products by Territory 13

3.3 PTA Peripheral DCB Catheters – Pipeline Products by Regulatory Path 14

3.4 PTA Peripheral DCB Catheters – Pipeline Products by Estimated Approval Date 15

3.5 PTA Peripheral DCB Catheters – Ongoing Clinical Trials 16

4 PTA Peripheral DCB Catheters – Pipeline Products under Development by Companies 17

4.1 PTA Peripheral DCB Catheters Companies – Pipeline Products by Stage of Development 17

4.2 PTA Peripheral DCB Catheters – Pipeline Products by Stage of Development 19

5 PTA Peripheral DCB Catheters Companies and Product Overview 21

5.1 Acotec Scientific Co Ltd Company Overview 21

5.1.1 Acotec Scientific Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 21

5.2 AnGes Inc Company Overview 26

5.2.1 AnGes Inc Pipeline Products & Ongoing Clinical Trials Overview 26

5.3 AngioCure, Inc. Company Overview 27

5.3.1 AngioCure, Inc. Pipeline Products & Ongoing Clinical Trials Overview 27

5.4 Ascenion GmbH Company Overview 28

5.4.1 Ascenion GmbH Pipeline Products & Ongoing Clinical Trials Overview 28

5.5 Becton Dickinson and Co Company Overview 29

5.5.1 Becton Dickinson and Co Pipeline Products & Ongoing Clinical Trials Overview 29

5.6 Boston Scientific Corp Company Overview 32

5.6.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 32

5.7 Cardionovum GmbH Company Overview 37

5.7.1 Cardionovum GmbH Pipeline Products & Ongoing Clinical Trials Overview 37

5.8 Chansu Vascular Technologies LLC Company Overview 38

5.8.1 Chansu Vascular Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 38

5.9 Concept Medical Inc Company Overview 41

5.9.1 Concept Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 41

5.10 Contego Medical LLC Company Overview 45

5.10.1 Contego Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 45

5.11 Cordis US Corp Company Overview 46

5.11.1 Cordis US Corp Pipeline Products & Ongoing Clinical Trials Overview 46

5.12 Dingke Medical Technology (Suzhou) Co Ltd Company Overview 50

5.12.1 Dingke Medical Technology (Suzhou) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 50

5.13 eucatech AG Company Overview 51

5.13.1 eucatech AG Pipeline Products & Ongoing Clinical Trials Overview 51

5.14 Lifetech Scientific (Shenzhen) Co Ltd Company Overview 52

5.14.1 Lifetech Scientific (Shenzhen) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 52

5.15 Lutonix Inc Company Overview 55

5.15.1 Lutonix Inc Pipeline Products & Ongoing Clinical Trials Overview 55

5.16 Medtronic Plc Company Overview 56

5.16.1 Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 56

5.17 Micell Technologies Inc Company Overview 57

5.17.1 Micell Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 57

5.18 OrbusNeich Company Overview 58

5.18.1 OrbusNeich Pipeline Products & Ongoing Clinical Trials Overview 58

5.19 Orchestra BioMed Inc Company Overview 59

5.19.1 Orchestra BioMed Inc Pipeline Products & Ongoing Clinical Trials Overview 59

5.20 Pulsus Medical LLC (Inactive) Company Overview 60

5.20.1 Pulsus Medical LLC (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 60

5.21 QualiMed Innovative Medizinprodukte GmbH Company Overview 61

5.21.1 QualiMed Innovative Medizinprodukte GmbH Pipeline Products & Ongoing Clinical Trials Overview 61

5.22 Shanghai Easy-Flow Medical Tech Co Ltd Company Overview 62

5.22.1 Shanghai Easy-Flow Medical Tech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 62

5.23 Shenzhen Salubris Pharmaceuticals Co Ltd Company Overview 65

5.23.1 Shenzhen Salubris Pharmaceuticals Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 65

5.24 SiL Vascular Ltd Company Overview 66

5.24.1 SiL Vascular Ltd Pipeline Products & Ongoing Clinical Trials Overview 66

5.25 Spectranetics Corp Company Overview 67

5.25.1 Spectranetics Corp Pipeline Products & Ongoing Clinical Trials Overview 67

5.26 Stemplant LLC Company Overview 68

5.26.1 Stemplant LLC Pipeline Products & Ongoing Clinical Trials Overview 68

5.27 SurModics Inc Company Overview 69

5.27.1 SurModics Inc Pipeline Products & Ongoing Clinical Trials Overview 69

5.28 Tailored Medical Devices Inc Company Overview 71

5.28.1 Tailored Medical Devices Inc Pipeline Products & Ongoing Clinical Trials Overview 71

5.29 TransMed7 LLC Company Overview 72

5.29.1 TransMed7 LLC Pipeline Products & Ongoing Clinical Trials Overview 72

5.30 Vascular Nanotransfer Technologies Company Overview 73

5.30.1 Vascular Nanotransfer Technologies Pipeline Products & Ongoing Clinical Trials Overview 73

5.31 Zhejiang Batai Medical Technology Co Ltd Company Overview 75

5.31.1 Zhejiang Batai Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 75

5.32 Zylox-Tonbridge Medical Technology Co Ltd Company Overview 76

5.32.1 Zylox-Tonbridge Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 76

6 PTA Peripheral DCB Catheters- Recent Developments 83

6.1 Mar 12, 2024: Medtronic To Present At Barclays Global Healthcare Conference 83

6.2 Feb 28, 2024: Boston Scientific Raises $2.2B to Support Purchase of California Medical Device Company 83

6.3 Feb 23, 2024: Medical Tech Leader, Boston Scientific (BSX), Announces Notes Offering 83

6.4 Feb 21, 2024: Zylox-Tonbridge Receives Marketing Approvals for Multiple Products in the Uae 83

6.5 Feb 19, 2024: Boston Scientific Appoints Madan Krishnan to Lead India Subcontinent 83

6.6 Feb 07, 2024: Terumo Announces Change of Executive Officers (PDF

232.27 KB) 83

6.7 Jan 31, 2024: Boston Scientific Announces Results for Fourth Quarter and Full Year 2023 84

6.8 Jan 16, 2024: Surmodics to Report First Quarter of Fiscal 2024 Financial Results on February 1 85

6.9 Jan 11, 2024: Biblios Study Full Cohort Results on BTK Lesions Presented at PVI 86

6.10 Jan 05, 2024: Boston Scientific Announces Conference Call Discussing Fourth Quarter 2023 Results 86

6.11 Dec 20, 2023: AnGes Laying Off 110 EmendoBio Employees Three Years After $250 million Acquisition 86

6.12 Nov 16, 2023: Surmodics Announces TRANSCEND Trial 36-Month Data Presented at 50th Annual VEITH Symposium 87

6.13 Nov 16, 2023: Surmodics Announces 24-Month Data from the SWING Trial Presented at VEITHsymposium 88

6.14 Nov 01, 2023: Final Round of Late-Breaking Clinical Trial Results Announced at VIVA23 89

6.15 Oct 31, 2023: Second Round of Late-Breaking Clinical Trial Results Announced at VIVA23 90

6.16 Oct 26, 2023: Boston Scientific Announces Results for Third Quarter 2023 92

6.17 Oct 04, 2023: Medtronic Names Paolo Di Vincenzo President of the Neuromodulation Business 94

6.18 Sep 29, 2023: Barry Slowey Named Vice President and Chief Sustainability Officer 94

6.19 Sep 15, 2023: Amber Beauchamp Named Vice President of Global Human Resources 95

6.20 Sep 14, 2023: BIOLUX P-III BENELUX All-Comers Registry Demonstrates Safety and Efficacy of BIOTRONIK’s Drug-Coated Balloon in Isolated Popliteal Lesions at 24 Months 95

6.21 Sep 01, 2023: MicroPort Endovastec Achieves Its First Clinical Implantation of Reewarm PTX DCB Catheter in Brazil 96

6.22 Aug 30, 2023: Zylox-Tonbridge’s ZENFlow Tiger LD PTA Dilatation Catheter Receives ANVISA Marketing Approval 96

6.23 Aug 26, 2023: Medtronic Q2 2024 Earnings Estimates Increased by William Blair 97

6.24 Aug 08, 2023: Medtronic to Announce Financial Results for its First Quarter of Fiscal Year 2024 97

6.25 Aug 07, 2023: MCRA Aids Surmodics in Obtaining FDA Pre-market Approval for Cardiovascular Drug-Coated Balloon 97

6.26 Jul 21, 2023: Medtronic Statement on the Safety of Paclitaxel Coated Devices to Treat Peripheral Arterial Disease 98

6.27 Jul 19, 2023: Boston Scientific lays off 52 workers as it closes another Silicon Valley facility 98

6.28 Jul 13, 2023: BIOPACT RCT Subgroup Analyses Show Consistently Great Results for Passeo-18 Lux Drug-Coated Balloon 98

6.29 Jun 07, 2023: Endovastec Participates in the Congresso International de Cirurgia Endovascular 99

6.30 May 30, 2023: Excellent 12-Month Results from SELUTION SFA Trial Presented at JET 100

6.31 May 15, 2023: Terumo announces consolidated financial results for the fiscal year ended March 31, 2023 101

6.32 May 11, 2023: Medtronic to announce financial results for its fourth quarter and full fiscal year 2023 101

6.33 Apr 12, 2023: Medtronic has a layoff in California 101

6.34 Mar 28, 2023: Surmodics provides regulatory update on its strategy to submit an amended Premarket Approval Application for the SurVeil Drug-Coated Balloon 102

7 Appendix 103

7.1 Methodology 103

7.2 About GlobalData 106

7.3 Contact Us 106

7.4 Disclaimer 106

Table

PTA Peripheral DCB Catheters – Pipeline Products by Stage of Development 12

PTA Peripheral DCB Catheters – Pipeline Products by Territory 13

PTA Peripheral DCB Catheters – Pipeline Products by Regulatory Path 14

PTA Peripheral DCB Catheters – Pipeline Products by Estimated Approval Date 15

PTA Peripheral DCB Catheters – Ongoing Clinical Trials 16

PTA Peripheral DCB Catheters Companies – Pipeline Products by Stage of Development 17

PTA Peripheral DCB Catheters – Pipeline Products by Stage of Development 19

Acotec Scientific Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 21

AcoArt-Litos Drug-Eluting Balloon – Product Status 21

AcoArt-Litos Drug-Eluting Balloon – Product Description 21

AcoArt-Tulip – Product Status 22

AcoArt-Tulip – Product Description 22

Acotec Scientific Co Ltd – Ongoing Clinical Trials Overview 23

AcoArt-Litos Drug-Eluting Balloon – A Post Market Clinical Study to Evaluate the Safety and Efficacy of the Acotec Drug-coated Balloon in the Treatment of the Below-the-knee Artery 24

AcoArt-Litos Drug-Eluting Balloon – All Comers Post Market Clinical Follow-up to Continue the Surveillance of the Acotec Drug Coated PTA Catheter Orchid, Tulip and Litos in Lower Limb Treatment 24

AcoArt-Litos Drug-Eluting Balloon – Comparison of Sirolimus Vs Paclitaxel Drug Eluting Balloon for Below-the-knee Angioplasty in Critical Limb Ischemia 24

AcoArt-Tulip – A Post Market Clinical Study to Evaluate the Safety and Efficacy of the Acotec Drug-coated Balloon in the Treatment of the Below-the-knee Artery 25

AcoArt-Tulip – All Comers Post Market Clinical Follow-up to Continue the Surveillance of the Acotec Drug Coated PTA Catheter Orchid, Tulip and Litos in Lower Limb Treatment 25

AnGes Inc Pipeline Products & Ongoing Clinical Trials Overview 26

NF-kB Decoy Oligo Coated PTA Balloon Catheter – Product Status 26

NF-kB Decoy Oligo Coated PTA Balloon Catheter – Product Description 26

AngioCure, Inc. Pipeline Products & Ongoing Clinical Trials Overview 27

AngioCure TOP-C Smart Balloon Catheter – Product Status 27

AngioCure TOP-C Smart Balloon Catheter – Product Description 27

Ascenion GmbH Pipeline Products & Ongoing Clinical Trials Overview 28

Paclitaxel-Coated Balloon Catheter – Product Status 28

Paclitaxel-Coated Balloon Catheter – Product Description 28

Becton Dickinson and Co Pipeline Products & Ongoing Clinical Trials Overview 29

BD Sirolimus Drug Coated Balloon Catheter – Product Status 29

BD Sirolimus Drug Coated Balloon Catheter – Product Description 29

Becton Dickinson and Co – Ongoing Clinical Trials Overview 30

BD Sirolimus Drug Coated Balloon Catheter – A Prospective, Multicenter, Single Arm, Non-Randomized, Study to Assess the Performance and Safety of BD Sirolimus Drug Coated Balloon Catheter for Treatment of Femoropopliteal Arteries 31

Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 32

Ranger Paclitaxel-Coated PTA Balloon Catheter – Product Status 32

Ranger Paclitaxel-Coated PTA Balloon Catheter – Product Description 33

Boston Scientific Corp – Ongoing Clinical Trials Overview 34

Ranger Paclitaxel-Coated PTA Balloon Catheter – Combination Therapy of Atherectomy Plus Drug-coated Balloon Versus Drug-coated Balloon for Complex Femoropopliteal Artery Disease (ARTEMIS Trial) 35

Ranger Paclitaxel-Coated PTA Balloon Catheter – Drug-eluting Registry: Real-world Treatment of Lesions in the Peripheral Vasculature (ELEGANCE) 35

Ranger Paclitaxel-Coated PTA Balloon Catheter – Efficacy of Rotational Atherectomy System Associated with Drug Coated Balloon Angioplasty (with or without Stent Placement) in the Management of Lower Limb Ischemia (ELLIPSE): “Real Life” Observational Study 35

Ranger Paclitaxel-Coated PTA Balloon Catheter – Ranger Drug-coated Balloon Catheters Post Market Surveillance 36

Cardionovum GmbH Pipeline Products & Ongoing Clinical Trials Overview 37

LEGFLOW OTW – Product Status 37

LEGFLOW OTW – Product Description 37

Chansu Vascular Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 38

Peripheral Everolimus Drug-Coated Balloon – Product Status 38

Peripheral Everolimus Drug-Coated Balloon – Product Description 38

Chansu Vascular Technologies LLC – Ongoing Clinical Trials Overview 39

Peripheral Everolimus Drug-Coated Balloon – A First in-human Study Evaluating the Efficacy of Peripheral Everolimus Drug-coated Balloon in Patients with Peripheral Artery Disease: CVT-SFA 40

Peripheral Everolimus Drug-Coated Balloon – Chansu Vascular Technologies Everolimus-Coated Balloon Percutaneous Transluminal Angioplasty Catheter First-in-Human Clinical Investigation 40

Concept Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 41

MagicTouch PTA Balloon Catheter – Product Status 41

MagicTouch PTA Balloon Catheter – Product Description 41

Concept Medical Inc – Ongoing Clinical Trials Overview 42

MagicTouch PTA Balloon Catheter – Comparison of Sirolimus Vs Paclitaxel Drug Eluting Balloon for Below-the-knee Angioplasty in Critical Limb Ischemia 43

MagicTouch PTA Balloon Catheter – Head-to-Head Comparison of Sirolimus Versus Paclitaxel Drug-Eluting Balloon Angioplasty in the Femoropopliteal Artery 43

MagicTouch PTA Balloon Catheter – Major Adverse Limb Events in Patients with Femoro-popliteal and Below-the-knee Peripheral Arterial Disease Treated with Either Sirolimus-coated Balloon or Standard Uncoated Balloon Angioplasty 43

MagicTouch PTA Balloon Catheter – Randomized Controlled Trial of First SirolimUs Coated Balloon Versus Standard Balloon Angioplasty in the Treatment of Below the Knee Arterial Disease: FUTURE BTK 44

MagicTouch PTA Balloon Catheter – Randomized Controlled Trial of First Sirolimus Coated Balloon Versus Standard Balloon Angioplasty in the Treatment of Superficial Femoral Artery and Popliteal Artery Disease 44

MagicTouch PTA Balloon Catheter – Randomized Controlled Trial of Magictouch – Sirolimus Coated Balloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease 44

Contego Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 45

Tibial Artery Drug Eluting Balloon – Product Status 45

Tibial Artery Drug Eluting Balloon – Product Description 45

Cordis US Corp Pipeline Products & Ongoing Clinical Trials Overview 46

SELUTION SLR 018 DEB – Peripheral Artery Disease – Product Status 46

SELUTION SLR 018 DEB – Peripheral Artery Disease – Product Description 46

Cordis US Corp – Ongoing Clinical Trials Overview 47

SELUTION SLR 018 DEB – Peripheral Artery Disease – Intervention with Selution SLR Agent Balloon for Endovascular Latent Limus Therapy for Failing AV Fistulas (ISABELLA) Trial 48

SELUTION SLR 018 DEB – Peripheral Artery Disease – Pivotal Clinical Trial for the Treatment of Occlusive Disease of the Superficial Femoral Artery (SFA) Using SELUTION SLR Sirolimus-eluting Balloon 48

SELUTION SLR 018 DEB – Peripheral Artery Disease – SAVE Trial – Use of the Selution Sirolimus Eluting Balloon for Dysfunctional AV accEss Treatment Indications 48

SELUTION SLR 018 DEB – Peripheral Artery Disease – Scientific Proposal to Substantiate Vascular Effects Through Sirolimus vs. Paclitaxel DCB Implantation 49

SELUTION SLR 018 DEB – Peripheral Artery Disease – SELUTION SLR 014 ISR: A Prospective Randomized Single Blind Multicenter Study to Assess the Safety and Effectiveness of the SELUTION SLR 014 Drug Eluting Balloon in the Treatment of Subjects with In-stent Restenosis 49

SELUTION SLR 018 DEB – Peripheral Artery Disease – SUCCESS (Selution, Safety, Efficacy, Health Economics and Proms) PTA Study 49

Dingke Medical Technology (Suzhou) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 50

Dissolve AV – Product Status 50

Dissolve AV – Product Description 50

eucatech AG Pipeline Products & Ongoing Clinical Trials Overview 51

Support – Product Status 51

Support – Product Description 51

Lifetech Scientific (Shenzhen) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 52

FemFlow Drug-Eluting Peripheral Balloon Catheter (DEB) – Product Status 52

FemFlow Drug-Eluting Peripheral Balloon Catheter (DEB) – Product Description 52

Lifetech Scientific (Shenzhen) Co Ltd – Ongoing Clinical Trials Overview 53

FemFlow Drug-Eluting Peripheral Balloon Catheter (DEB) – Safety and Efficacy Study of FemFlow Drug-eluting Peripheral Balloon Catheter for Lesions with Femoral-popliteal Artery Stenosis or Occlusion: A Prospective, Multi-center, Objective Performance Criteria Clinical Trial 54

Lutonix Inc Pipeline Products & Ongoing Clinical Trials Overview 55

Lutonix 014 Drug Coated Balloon PTA Catheter – Product Status 55

Lutonix 014 Drug Coated Balloon PTA Catheter – Product Description 55

Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 56

IN.PACT Admiral DEB – BTK – Product Status 56

IN.PACT Admiral DEB – BTK – Product Description 56

Micell Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 57

Drug-Coated Balloon – Product Status 57

Drug-Coated Balloon – Product Description 57

OrbusNeich Pipeline Products & Ongoing Clinical Trials Overview 58

Limus Drug Coated Balloon – Peripheral – Product Status 58

Limus Drug Coated Balloon – Peripheral – Product Description 58

Orchestra BioMed Inc Pipeline Products & Ongoing Clinical Trials Overview 59

Virtue Sirolimus-Eluting Balloon – BTK – Product Status 59

Virtue Sirolimus-Eluting Balloon – BTK – Product Description 59

Pulsus Medical LLC (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 60

Micro-Perforated Catheter Balloon Drug Delivery System – Product Status 60

Micro-Perforated Catheter Balloon Drug Delivery System – Product Description 60

QualiMed Innovative Medizinprodukte GmbH Pipeline Products & Ongoing Clinical Trials Overview 61

Kinesyx-Based Peripheral Drug Coated Balloon – Product Status 61

Kinesyx-Based Peripheral Drug Coated Balloon – Product Description 61

Shanghai Easy-Flow Medical Tech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 62

Below-The-Knee Rapamycin Drug Coated Balloon – Product Status 62

Below-The-Knee Rapamycin Drug Coated Balloon – Product Description 62

Shanghai Easy-Flow Medical Tech Co Ltd – Ongoing Clinical Trials Overview 63

Below-The-Knee Rapamycin Drug Coated Balloon – To Evaluate the Safety and Efficacy of Drug-eluting Below-the-knee Balloon Dilatation Catheter in the Treatment of Infrapopliteal Artery Stenosis or Occlusion in a Prospective, Multicenter, Randomized Controlled Clinical Trial 64

Shenzhen Salubris Pharmaceuticals Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 65

Rapamycin Drug-Eluting Peripheral Balloon Catheter – Product Status 65

Rapamycin Drug-Eluting Peripheral Balloon Catheter – Product Description 65

SiL Vascular Ltd Pipeline Products & Ongoing Clinical Trials Overview 66

Peripheral Vascular Balloon – Product Status 66

Peripheral Vascular Balloon – Product Description 66

Spectranetics Corp Pipeline Products & Ongoing Clinical Trials Overview 67

Stellarex 0.014″ Over-The-Wire Drug-Coated Angioplasty Balloon – Product Status 67

Stellarex 0.014″ Over-The-Wire Drug-Coated Angioplasty Balloon – Product Description 67

Stemplant LLC Pipeline Products & Ongoing Clinical Trials Overview 68

Peripheral Vascular Angioplasty Delivery Device – Product Status 68

Peripheral Vascular Angioplasty Delivery Device – Product Description 68

SurModics Inc Pipeline Products & Ongoing Clinical Trials Overview 69

Avess Arteriovenous Access Drug Coated Balloon (DCB) – Product Status 69

Avess Arteriovenous Access Drug Coated Balloon (DCB) – Product Description 70

Sundance BTK DCB – Product Status 70

Sundance BTK DCB – Product Description 70

Tailored Medical Devices Inc Pipeline Products & Ongoing Clinical Trials Overview 71

MR-PEO-DCB – Product Status 71

MR-PEO-DCB – Product Description 71

TransMed7 LLC Pipeline Products & Ongoing Clinical Trials Overview 72

Zeppelin II – Product Status 72

Zeppelin II – Product Description 72

Vascular Nanotransfer Technologies Pipeline Products & Ongoing Clinical Trials Overview 73

Mitomycin-Based Drug Coated Balloon – Peripheral – Product Status 73

Mitomycin-Based Drug Coated Balloon – Peripheral – Product Description 73

Paclitaxel-Based Drug Coated Balloon – Peripheral – Product Status 74

Paclitaxel-Based Drug Coated Balloon – Peripheral – Product Description 74

Zhejiang Batai Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 75

Peripherally Constrained Drug Balloon – Product Status 75

Peripherally Constrained Drug Balloon – Product Description 75

Zylox-Tonbridge Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 76

Second Generation UltraFree Drug Coated PTA Balloon Catheter – Product Status 76

Second Generation UltraFree Drug Coated PTA Balloon Catheter – Product Description 77

Ultrafree Drug Coated PTA Balloon Catheter – BTK – Product Status 77

Ultrafree Drug Coated PTA Balloon Catheter – BTK – Product Description 77

Ultrafree Drug Coated PTA Balloon Catheter – Dialysis Access – Product Status 78

Ultrafree Drug Coated PTA Balloon Catheter – Dialysis Access – Product Description 78

Ultrafree Drug Coated PTA Balloon Catheter – Vertebral Artery Stenosis – Product Status 78

Ultrafree Drug Coated PTA Balloon Catheter – Vertebral Artery Stenosis – Product Description 79

Zylox-Tonbridge Medical Technology Co Ltd – Ongoing Clinical Trials Overview 80

Ultrafree Drug Coated PTA Balloon Catheter – BTK – A Prospective, Multicenter, Randomized Controlled Trail Using Drug-coated Balloon to Treat Below The Knee Arterial Stenosis or Occlusion 81

Ultrafree Drug Coated PTA Balloon Catheter – Dialysis Access – Study to Evaluate the Safety and Efficacy of Ultrafree Drug Coated PTA Balloon Catheter for Dialysis Access 82

Glossary 105

Figures

PTA Peripheral DCB Catheters – Pipeline Products by Stage of Development 12

PTA Peripheral DCB Catheters – Pipeline Products by Territory 13

PTA Peripheral DCB Catheters – Pipeline Products by Regulatory Path 14

PTA Peripheral DCB Catheters – Pipeline Products by Estimated Approval Date 15

PTA Peripheral DCB Catheters – Ongoing Clinical Trials 16

Frequently asked questions

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