PTA Balloon Catheters Pipeline by Stages of Development, Segments, Region, Regulatory Path and Key Companies

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PTA Balloon Catheters Pipeline Market Report Overview

The PTA Balloon Catheters pipeline market research report provides comprehensive information about the PTA Balloon Catheters pipeline products with comparative analysis of the products at various stages of development and information about the clinical trials which are in progress.

PTA Balloon Catheters Pipeline Market Segments

The key segments in the PTA Balloon Catheters pipeline market are PTA Peripheral DCB Catheters and Standard Balloon Catheters. In 2023, PTA Peripheral DCB Catheters has the highest number of pipeline products.

PTA Peripheral DCB Catheters: A PTA Peripheral DCB Catheter is a drug-coated percutaneous transluminal angioplasty (PTA) balloon intended to prevent restenosis, or restenosis of the peripheral arteries. These 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.

Standard Balloon Catheters: Standard Balloon Catheters are used to open up the arteries that are blocked by plaque build-up (atherosclerosis). These catheters compress plaque and dilate the arterial wall to restore normal blood flow through the vessel. A standard balloon catheter has a small folded balloon at the end of the catheter. One unit refers to one Standard Balloon Catheter.

PTA Balloon Catheters Pipeline Market Analysis, by Segments, 2023 (%)

PTA Balloon Catheters Pipeline Market Analysis, by Segments, 2023 (%)

For more segment insights into the PTA Balloon Catheters pipeline market, download a free report sample

PTA Balloon Catheters Pipeline Market Segmentation by Territories

The key territories in the PTA Balloon Catheters pipeline market are the US, China, Japan, Europe, Singapore, New Zealand, Australia, Austria, Germany, and Israel. In April 2023, the US has the highest number of pipeline products.

PTA Balloon Catheters Pipeline Market Analysis, by Territories, 2023 (%)

PTA Balloon Catheters Pipeline Market Analysis, by Territories, 2023 (%)

For more territory insights into the PTA Balloon Catheters pipeline market, download a free report sample

PTA Balloon Catheters Pipeline Market Segmentation by Regulatory Paths

The key regulatory paths in the PTA Balloon Catheters pipeline market are NMPA, PMA, CE, 510(k), Shonin, HAS, TGA, BOPA, de novo, and NIFDS. In April 2023, NMPA is the most followed pathway for pipeline products.

PTA Balloon Catheters Pipeline Market Analysis, by Regulatory Paths, 2023 (%)

PTA Balloon Catheters Pipeline Market Analysis, by Regulatory Paths, 2023 (%)

For more regulatory path insights into the PTA Balloon Catheters pipeline market, download a free report sample

PTA DCB Pipeline Market – Competitive Landscape

Some of the key companies in the PTA Balloon Catheters pipeline market are Acotec Scientific Co Ltd, Acotec Scientific Holdings Ltd, Andramed GmbH, AnGes Inc, AngioCure, Inc., APT Medical Inc, Ascenion GmbH, Becton Dickinson and Co, Boston Scientific Corp, and BrosMed Medical Co., Ltd.

Andramed GmbH: Headquartered in Reutlingen, Baden-Wurttemberg, Germany, Andramed GmbH (Andramed) is a medical technology company that offers niche product solutions and medical products. The company’s products include PTA-catheters, cobalt chromium bare stents, in-situ and ex-situ valvulotomies, sochman snare, flexible retrieval baskets, flexible snares, and peripheral self-expanding nitinol stents, among others. Its cobalt chromium bare stents are specifically designed for the effective treatment of large vessels.

PTA Balloon Catheters Pipeline Market Report Overview

Key Territories The US, China, Japan, Europe, Singapore, New Zealand, Australia, Austria, Germany, and Israel
Key Segments PTA Peripheral DCB Catheters and Standard Balloon Catheters
Key Regulatory Paths NMPA, PMA, CE, 510(k), Shonin, HAS, TGA, BOPA, de novo, and NIFDS
Leading Companies Acotec Scientific Co Ltd, Acotec Scientific Holdings Ltd, Andramed GmbH, AnGes Inc, AngioCure, Inc., APT Medical Inc, Ascenion GmbH, Becton Dickinson and Co, Boston Scientific Corp, and BrosMed Medical Co., Ltd

Segments Covered in the Report

PTA Balloon Catheters Pipeline Market Segments Outlook

  • PTA Peripheral DCB Catheters
  • Standard Balloon Catheters

PTA Balloon Catheters Pipeline Market Territories Outlook

  • The US
  • China
  • Japan
  • Europe
  • Singapore
  • New Zealand
  • Australia
  • Austria
  • Germany
  • Israel
  • Italy
  • South Korea
  • Switzerland
  • Taiwan
  • Thailand

PTA Balloon Catheters Pipeline Market Regulatory Paths Outlook

  • NMPA
  • PMA
  • CE
  • 510(k)
  • Shonin
  • HAS
  • TGA
  • BOPA
  • de novo
  • NIFDS

Scope

  • Extensive coverage of the PTA balloon catheters under development
  • Reviews details of major pipeline products which includes product description, licensing and collaboration details and other developmental activities
  • Reviews the major players involved in the development of PTCA balloon catheters 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
  • 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 PTCA Balloon Catheters 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

Acotec Scientific Co Ltd
Acotec Scientific Holdings Ltd
Andramed GmbH
AnGes Inc
AngioCure, Inc.
APT Medical Inc
Ascenion GmbH
Becton Dickinson and Co
Boston Scientific Corp
BrosMed Medical Co., Ltd
Cardionovum GmbH
Cardiovascular Systems Inc
Chansu Vascular Technologies LLC
Concept Medical Inc
Contego Medical LLC
Dingke Medical Technology (Suzhou) Co Ltd
Endocor GmbH
eucatech AG
Hexacath SA
InnoRa GmbH
Lifetech Scientific (Shenzhen) Co Ltd
Lutonix Inc
M.A. Med Alliance SA
Medtronic Plc
Micell Technologies Inc
Neovasc Inc
NuVascular Technologies Inc
OrbusNeich
Orchestra BioMed Inc
Pulsus Medical LLC (Inactive)
QT Vascular Ltd
QualiMed Innovative Medizinprodukte GmbH
Shanghai Changde Medical Technology Co Ltd
Shenzhen Salubris Pharmaceuticals Co Ltd
Shockwave Medical Inc
SiL Vascular Ltd
Spectranetics Corp
Stemplant LLC
SurModics Inc
Suzhou Zhonghui Medical Technology Co Ltd
Tailored Medical Devices Inc
Transit Scientific LLC
TransMed7 LLC
Vascular Nanotransfer Technologies
Zylox-Tonbridge Medical Technology Co Ltd

Table of Contents

  • 1 Table of Contents

    • 1.1 List of Tables
    • 1.2 List of Figures

  • 2 Introduction

    • 2.1 PTA Balloon Catheters Overview

  • 3 Products under Development

    • 3.1 PTA Balloon Catheters – Pipeline Products by Stage of Development
    • 3.2 PTA Balloon Catheters – Pipeline Products by Segment
    • 3.3 PTA Balloon Catheters – Pipeline Products by Territory
    • 3.4 PTA Balloon Catheters – Pipeline Products by Regulatory Path
    • 3.5 PTA Balloon Catheters – Pipeline Products by Estimated Approval Date
    • 3.6 PTA Balloon Catheters – Ongoing Clinical Trials

  • 4 PTA Balloon Catheters – Pipeline Products under Development by Companies

    • 4.1 PTA Balloon Catheters Companies – Pipeline Products by Stage of Development
    • 4.2 PTA Balloon Catheters – Pipeline Products by Stage of Development

  • 5 PTA Balloon Catheters Companies and Product Overview

    • 5.1 Acotec Scientific Co Ltd Company Overview

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

    • 5.2 Acotec Scientific Holdings Ltd Company Overview

      • 5.2.1 Acotec Scientific Holdings Ltd Pipeline Products & Ongoing Clinical Trials Overview

    • 5.3 Andramed GmbH Company Overview

      • 5.3.1 Andramed GmbH Pipeline Products & Ongoing Clinical Trials Overview

    • 5.4 AnGes Inc Company Overview

      • 5.4.1 AnGes Inc Pipeline Products & Ongoing Clinical Trials Overview

    • 5.5 AngioCure, Inc. Company Overview

      • 5.5.1 AngioCure, Inc. Pipeline Products & Ongoing Clinical Trials Overview

    • 5.6 APT Medical Inc Company Overview

      • 5.6.1 APT Medical Inc Pipeline Products & Ongoing Clinical Trials Overview

    • 5.7 Ascenion GmbH Company Overview

      • 5.7.1 Ascenion GmbH Pipeline Products & Ongoing Clinical Trials Overview

    • 5.8 Becton Dickinson and Co Company Overview

      • 5.8.1 Becton Dickinson and Co Pipeline Products & Ongoing Clinical Trials Overview

    • 5.9 Boston Scientific Corp Company Overview

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

    • 5.10 BrosMed Medical Co., Ltd Company Overview

      • 5.10.1 BrosMed Medical Co., Ltd Pipeline Products & Ongoing Clinical Trials Overview

    • 5.11 Cardionovum GmbH Company Overview

      • 5.11.1 Cardionovum GmbH Pipeline Products & Ongoing Clinical Trials Overview

    • 5.12 Cardiovascular Systems Inc Company Overview

      • 5.12.1 Cardiovascular Systems Inc Pipeline Products & Ongoing Clinical Trials Overview

    • 5.13 Chansu Vascular Technologies LLC Company Overview

      • 5.13.1 Chansu Vascular Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview

    • 5.14 Concept Medical Inc Company Overview

      • 5.14.1 Concept Medical Inc Pipeline Products & Ongoing Clinical Trials Overview

    • 5.15 Contego Medical LLC Company Overview

      • 5.15.1 Contego Medical LLC Pipeline Products & Ongoing Clinical Trials Overview

    • 5.16 Dingke Medical Technology (Suzhou) Co Ltd Company Overview

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

    • 5.17 Endocor GmbH Company Overview

      • 5.17.1 Endocor GmbH Pipeline Products & Ongoing Clinical Trials Overview

    • 5.18 eucatech AG Company Overview

      • 5.18.1 eucatech AG Pipeline Products & Ongoing Clinical Trials Overview

    • 5.19 Hexacath SA Company Overview

      • 5.19.1 Hexacath SA Pipeline Products & Ongoing Clinical Trials Overview

    • 5.20 InnoRa GmbH Company Overview

      • 5.20.1 InnoRa GmbH Pipeline Products & Ongoing Clinical Trials Overview

    • 5.21 Lifetech Scientific (Shenzhen) Co Ltd Company Overview

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

    • 5.22 Lutonix Inc Company Overview

      • 5.22.1 Lutonix Inc Pipeline Products & Ongoing Clinical Trials Overview

    • 5.23 M.A. Med Alliance SA Company Overview

      • 5.23.1 M.A. Med Alliance SA Pipeline Products & Ongoing Clinical Trials Overview

    • 5.24 Medtronic Plc Company Overview

      • 5.24.1 Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview

    • 5.25 Micell Technologies Inc Company Overview

      • 5.25.1 Micell Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview

    • 5.26 Neovasc Inc Company Overview

      • 5.26.1 Neovasc Inc Pipeline Products & Ongoing Clinical Trials Overview

    • 5.27 NuVascular Technologies Inc Company Overview

      • 5.27.1 NuVascular Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview

    • 5.28 OrbusNeich Company Overview

      • 5.28.1 OrbusNeich Pipeline Products & Ongoing Clinical Trials Overview

    • 5.29 Orchestra BioMed Inc Company Overview

      • 5.29.1 Orchestra BioMed Inc Pipeline Products & Ongoing Clinical Trials Overview

    • 5.30 Pulsus Medical LLC (Inactive) Company Overview

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

    • 5.31 QT Vascular Ltd Company Overview

      • 5.31.1 QT Vascular Ltd Pipeline Products & Ongoing Clinical Trials Overview

    • 5.32 QualiMed Innovative Medizinprodukte GmbH Company Overview

      • 5.32.1 QualiMed Innovative Medizinprodukte GmbH Pipeline Products & Ongoing Clinical Trials Overview

    • 5.33 Shanghai Changde Medical Technology Co Ltd Company Overview

      • 5.33.1 Shanghai Changde Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview

    • 5.34 Shenzhen Salubris Pharmaceuticals Co Ltd Company Overview

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

    • 5.35 Shockwave Medical Inc Company Overview

      • 5.35.1 Shockwave Medical Inc Pipeline Products & Ongoing Clinical Trials Overview

    • 5.36 SiL Vascular Ltd Company Overview

      • 5.36.1 SiL Vascular Ltd Pipeline Products & Ongoing Clinical Trials Overview

    • 5.37 Spectranetics Corp Company Overview

      • 5.37.1 Spectranetics Corp Pipeline Products & Ongoing Clinical Trials Overview

    • 5.38 Stemplant LLC Company Overview

      • 5.38.1 Stemplant LLC Pipeline Products & Ongoing Clinical Trials Overview

    • 5.39 SurModics Inc Company Overview

      • 5.39.1 SurModics Inc Pipeline Products & Ongoing Clinical Trials Overview

    • 5.40 Suzhou Zhonghui Medical Technology Co Ltd Company Overview

      • 5.40.1 Suzhou Zhonghui Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview

    • 5.41 Tailored Medical Devices Inc Company Overview

      • 5.41.1 Tailored Medical Devices Inc Pipeline Products & Ongoing Clinical Trials Overview

    • 5.42 Transit Scientific LLC Company Overview

      • 5.42.1 Transit Scientific LLC Pipeline Products & Ongoing Clinical Trials Overview

    • 5.43 TransMed7 LLC Company Overview

      • 5.43.1 TransMed7 LLC Pipeline Products & Ongoing Clinical Trials Overview

    • 5.44 Vascular Nanotransfer Technologies Company Overview

      • 5.44.1 Vascular Nanotransfer Technologies Pipeline Products & Ongoing Clinical Trials Overview

    • 5.45 Zylox-Tonbridge Medical Technology Co Ltd Company Overview

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

  • 6 PTA Balloon Catheters- Recent Developments

    • 6.1 Mar 30, 2023: Zylox-Tonbridge Announces Financial Results for 2022: Revenue Increases by

      87.8% YOY to RMB 334 million and Gross Profit Reaches RMB 253 million

    • 6.2 Mar 16, 2023: Medtronic joins in $25M funding round for home monitoring company
    • 6.3 Feb 23, 2023: Teleflex Reports Fourth Quarter and Full Year 2022 Financial Results
    • 6.4 Feb 21, 2023: Teleflex to Present at the 44th Annual Raymond James Institutional Investors Conference
    • 6.5 Feb 10, 2023: AnGes Co. Announces Consolidated financial results for the fiscal year ending December 2022
    • 6.6 Feb 09, 2023: Teleflex Announces Fourth Quarter 2022 Earnings Conference Call Information
    • 6.7 Feb 09, 2023: Terumo Notice Concerning Revision of the Full-Year Financial Guidance for Fiscal Year Ending March 31, 2023
    • 6.8 Feb 09, 2023: Terumo Corp Announces Consolidated Financial Results for the Third Quarter Ended December 31, 2022
    • 6.9 Feb 06, 2023: Surmodics Lays off 58 employees
    • 6.10 Feb 06, 2023: Surmodics Reports First Quarter of Fiscal Year 2023 Financial Results; Updates Fiscal Year 2023 Financial Guidance
    • 6.11 Jan 31, 2023: Surmodics to Host Virtual Annual Meeting of Shareholders
    • 6.12 Jan 31, 2023: Daiichi Sankyo Announces Consolidated Financial Results for the First Nine Months of the Year Ending March 31,2023
    • 6.13 Jan 30, 2023: Medtronic appoints Michael Blackwell as India vice-president
    • 6.14 Dec 08, 2022: Edwards Lifesciences Announces CEO Succession Plan
    • 6.15 Dec 07, 2022: Cook Medical welcomes Dr. John A. Kaufman as Chief Medical Officer
    • 6.16 Nov 23, 2022: Medtronic Reports Quarterly Earnings
    • 6.17 Nov 22, 2022: Medtronic reports second quarter fiscal 2023 financial results
    • 6.18 Nov 15, 2022: Medtronic Set to Announce Earnings on Tuesday
    • 6.19 Nov 10, 2022: Terumo Corp Announces Consolidated Financial Results for the Second Quarter Ended September 30, 2022
    • 6.20 Oct 31, 2022: Daiichi Sankyo announces FY2022 Q2 Financial Results Presentation
    • 6.21 Oct 31, 2022: Daiichi Sankyo announces Consolidated Financial Results for the First Six Months of the Year Ending March 31,2023
    • 6.22 Oct 27, 2022: Teleflex Reports Third Quarter Financial Results And Full Year Outlook
    • 6.23 Oct 20, 2022: Edwards Lifesciences to Host Earnings Conference Call on October 27, 2022
    • 6.24 Oct 13, 2022: Teleflex Announces Third Quarter 2022 Earnings Conference Call Information
    • 6.25 Oct 12, 2022: Cardiovascular Systems to Host Earnings Conference Call on November 3, 2022
    • 6.26 Sep 15, 2022: Zylox-Tonbridge Medical Technology Co Ltd announced interim report for 2022
    • 6.27 Sep 07, 2022: Medtronic to appear at September investor conferences
    • 6.28 Sep 06, 2022: Occlutech Appoints Chief Commercial Officer and Vice President Global Business Development & Marketing
    • 6.29 Aug 23, 2022: Surmodics to Present at Upcoming Gilmartin Emerging Growth Company Showcase Wednesday, August 31, 2022
    • 6.30 Aug 23, 2022: Medtronic reports first quarter fiscal 2023 financial results
    • 6.32 Aug 16, 2022: Boston Scientific Announces Upcoming Conference Schedule
    • 6.33 Jul 28, 2022: Quantum Healthcare Announces Appointment Of Independent Director
    • 6.34 Jul 21, 2022: Edwards Lifesciences to Host Earnings Conference Call on July 28, 2022
    • 6.35 Jul 08, 2022: Cordis Names Bryan Loo President of Asia-pacific Region
    • 6.36 Jun 28, 2022: Nipro Notice of Resolutions at the 69th Annual General Meeting of Shareholders
    • 6.37 Jun 27, 2022: Medtronic Board appoints Lidia Fonseca as a new director
    • 6.38 Jun 07, 2022: Teleflex launches new arrow pressure injectable midline catheter in Europe, the Middle East and Africa region
    • 6.39 Jun 07, 2022: Cardiovascular Systems chief operating officer Rhonda Robb exits company
    • 6.40 May 27, 2022: Medtronic reports full year and fourth quarter fiscal year 2022 financial results
    • 6.41 May 26, 2022: Medtronic reports full year and fourth quarter fiscal year 2022 financial results announces 8% dividend increase
    • 6.42 May 23, 2022: Edwards Lifesciences to Present at the Bernstein 38th Annual Strategic Decisions Conference
    • 6.43 May 02, 2022: Teleflex to Host Analyst & Investor Day on May 20, 2022
    • 6.44 Apr 28, 2022: Boston Scientific reports net sales of $3.03bn in Q1 2022
    • 6.45 Apr 28, 2022: Teleflex Reports First Quarter Financial Results And Full Year Outlook
    • 6.46 Apr 27, 2022: Boston Scientific Announces Results for First Quarter 2022
    • 6.47 Apr 19, 2022: Edwards Lifesciences to Host Earnings Conference Call on April 26, 2022

  • 7 Appendix

    • 7.1 Methodology
    • 7.2 About GlobalData
    • 7.3 Contact Us
    • 7.4 Disclaimer

Table

PTA Balloon Catheters – Pipeline Products by Stage of Development 15

PTA Balloon Catheters – Pipeline Products by Segment 16

PTA Balloon Catheters – Pipeline Products by Territory 17

PTA Balloon Catheters – Pipeline Products by Regulatory Path 18

PTA Balloon Catheters – Pipeline Products by Estimated Approval Date 19

PTA Balloon Catheters – Ongoing Clinical Trials 20

PTA Balloon Catheters Companies – Pipeline Products by Stage of Development 21

PTA Balloon Catheters – Pipeline Products by Stage of Development 23

Acotec Scientific Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 25

AcoArt-Litos Drug-Eluting Balloon – Product Status 25

AcoArt-Litos Drug-Eluting Balloon – Product Description 25

AcoArt-Tulip – Product Status 26

AcoArt-Tulip – Product Description 26

Acotec Scientific Co Ltd – Ongoing Clinical Trials Overview 27

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 28

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 28

AcoArt-Litos Drug-Eluting Balloon – Comparison of Sirolimus Vs Paclitaxel Drug Eluting Balloon for Below-the-knee Angioplasty in Critical Limb Ischemia 28

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 29

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 29

Acotec Scientific Holdings Ltd Pipeline Products & Ongoing Clinical Trials Overview 30

Above-The-Knee PTA Balloon – Product Status 30

Above-The-Knee PTA Balloon – Product Description 30

Below-The-Knee PTA Balloon – Product Status 31

Below-The-Knee PTA Balloon – Product Description 31

Andramed GmbH Pipeline Products & Ongoing Clinical Trials Overview 32

Zero-Profile PTA Balloon – Product Status 32

Zero-Profile PTA Balloon – Product Description 32

AnGes Inc Pipeline Products & Ongoing Clinical Trials Overview 33

NF-kB Decoy Oligo Coated PTA Balloon Catheter – Product Status 33

NF-kB Decoy Oligo Coated PTA Balloon Catheter – Product Description 33

AngioCure, Inc. Pipeline Products & Ongoing Clinical Trials Overview 34

AngioCure TOP-C Smart Balloon Catheter – Product Status 34

AngioCure TOP-C Smart Balloon Catheter – Product Description 34

APT Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 35

0.018″ PTA Balloon Dilatation Catheter – Product Status 35

0.018″ PTA Balloon Dilatation Catheter – Product Description 35

0.035″ PTA Balloon Dilatation Catheter – Product Status 36

0.035″ PTA Balloon Dilatation Catheter – Product Description 36

Ascenion GmbH Pipeline Products & Ongoing Clinical Trials Overview 37

Paclitaxel-Coated Balloon Catheter – Product Status 37

Paclitaxel-Coated Balloon Catheter – Product Description 37

Becton Dickinson and Co Pipeline Products & Ongoing Clinical Trials Overview 38

BD Sirolimus Drug Coated Balloon Catheter – Product Status 38

BD Sirolimus Drug Coated Balloon Catheter – Product Description 38

Becton Dickinson and Co – Ongoing Clinical Trials Overview 39

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 40

Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 41

Drug Coated Balloon – Below-The-Knee (BTK) – Product Status 41

Drug Coated Balloon – Below-The-Knee (BTK) – Product Description 41

High Pressure Balloon – Venous Disease – Product Status 42

High Pressure Balloon – Venous Disease – Product Description 42

Next Generation 0.018” Balloon – Product Status 42

Next Generation 0.018” Balloon – Product Description 42

Ranger Paclitaxel-Coated PTA Balloon Catheter – Product Status 43

Ranger Paclitaxel-Coated PTA Balloon Catheter – Product Description 43

Boston Scientific Corp – Ongoing Clinical Trials Overview 44

Ranger Paclitaxel-Coated PTA Balloon Catheter – A Prospective, Single-Centre Study Investigating the Clinical Use and Safety of the Jetstream Atherectomy With Drug Coated Balloon (Ranger) for the Treatment of Dysfunctional Arterio-Venous Graft Stenosis 45

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) 45

Ranger Paclitaxel-Coated PTA Balloon Catheter – Drug-eluting Registry: Real-world Treatment of Lesions in the Peripheral Vasculature (ELEGANCE) 45

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 46

Ranger Paclitaxel-Coated PTA Balloon Catheter – JETStream AtheRectomy with Adjunctive Paclitaxel-coated Balloon Angioplasty Versus Balloon Angioplasty Followed by Paclitaxel-coated Balloon in Treating Complex Denovo Femoropopliteal Arterial Disease: JET-RANGER 46

Ranger Paclitaxel-Coated PTA Balloon Catheter – Prospective, Randomized, Multi-center Study for the Treatment of Subjects with Symptomatic Femoropopliteal Artery Disease with the Ranger Paclitaxel Coated PTA Balloon Catheter (Study Arm) Versus the IN.PACT Drug Eluting Balloon (Control Arm) 46

Ranger Paclitaxel-Coated PTA Balloon Catheter – Ranger Drug-coated Balloon Catheters Post Market Surveillance 47

Ranger Paclitaxel-Coated PTA Balloon Catheter – RANGER II SFA: A 3:1 Randomized Trial Comparing the Boston Scientific RANGER Paclitaxel Coated Balloon Versus Standard Balloon Angioplasty for the Treatment of Superficial Femoral Arteries (SFA) and Proximal Popliteal Arteries (PPA) 47

BrosMed Medical Co., Ltd Pipeline Products & Ongoing Clinical Trials Overview 48

Tiche PTA Balloon Dilatation Catheter – Product Status 48

Tiche PTA Balloon Dilatation Catheter – Product Description 49

Cardionovum GmbH Pipeline Products & Ongoing Clinical Trials Overview 50

LEGFLOW OTW – Product Status 50

LEGFLOW OTW – Product Description 50

Cardionovum GmbH – Ongoing Clinical Trials Overview 51

LEGFLOW OTW – Evaluation of the Safety and Efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW) in Treatment of Stenosis or Occlusion in Femoral-popliteal Arteries: A Prospective, Multicenter, Randomized, Controlled Clinical Study 52

LEGFLOW OTW – Evaluation the Safety and Efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW) in Treatment of Stenosis or Occlusion in below the Knee Arteries: A Prospective, Multicenter, Randomized, Controlled Clinical Study 52

Cardiovascular Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 53

Peripheral PTA Balloon Catheter – Product Status 53

Peripheral PTA Balloon Catheter – Product Description 53

Chansu Vascular Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 54

Peripheral Everolimus Drug-Coated Balloon – Product Status 54

Peripheral Everolimus Drug-Coated Balloon – Product Description 54

Chansu Vascular Technologies LLC – Ongoing Clinical Trials Overview 55

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 56

Peripheral Everolimus Drug-Coated Balloon – Chansu Vascular Technologies Everolimus-Coated Balloon Percutaneous Transluminal Angioplasty Catheter First-in-Human Clinical Investigation 56

Concept Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 57

MagicTouch PTA Balloon Catheter – Product Status 57

MagicTouch PTA Balloon Catheter – Product Description 58

Concept Medical Inc – Ongoing Clinical Trials Overview 59

MagicTouch PTA Balloon Catheter – Comparison of Sirolimus Vs Paclitaxel Drug Eluting Balloon for Below-the-knee Angioplasty in Critical Limb Ischemia 60

MagicTouch PTA Balloon Catheter – Head-to-Head Comparison of Sirolimus Versus Paclitaxel Drug-Eluting Balloon Angioplasty in the Femoropopliteal Artery 60

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 60

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 61

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 61

Contego Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 62

Superficial Femoral Artery Balloon – Product Status 62

Superficial Femoral Artery Balloon – Product Description 62

Tibial Artery Drug Eluting Balloon – Product Status 63

Tibial Artery Drug Eluting Balloon – Product Description 63

Dingke Medical Technology (Suzhou) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 64

Dissolve AV – Product Status 64

Dissolve AV – Product Description 64

Endocor GmbH Pipeline Products & Ongoing Clinical Trials Overview 65

Endorenal – Product Status 65

Endorenal – Product Description 65

eucatech AG Pipeline Products & Ongoing Clinical Trials Overview 66

Support – Product Status 66

Support – Product Description 66

Hexacath SA Pipeline Products & Ongoing Clinical Trials Overview 67

MERAK PTA Dilatation Catheter – Product Status 67

MERAK PTA Dilatation Catheter – Product Description 67

InnoRa GmbH Pipeline Products & Ongoing Clinical Trials Overview 68

InnoCath AB Hyper-Compliant Balloon Catheter – Product Status 68

InnoCath AB Hyper-Compliant Balloon Catheter – Product Description 68

Lifetech Scientific (Shenzhen) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 69

FemFlow Drug-Eluting Peripheral Balloon Catheter (DEB) – Product Status 69

FemFlow Drug-Eluting Peripheral Balloon Catheter (DEB) – Product Description 69

Lifetech Scientific (Shenzhen) Co Ltd – Ongoing Clinical Trials Overview 70

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 71

Lutonix Inc Pipeline Products & Ongoing Clinical Trials Overview 72

Lutonix 014 Drug Coated Balloon PTA Catheter – Product Status 72

Lutonix 014 Drug Coated Balloon PTA Catheter – Product Description 72

M.A. Med Alliance SA Pipeline Products & Ongoing Clinical Trials Overview 73

SELUTION SLR 018 DEB – Peripheral Artery Disease – Product Status 73

SELUTION SLR 018 DEB – Peripheral Artery Disease – Product Description 73

M.A. Med Alliance SA – Ongoing Clinical Trials Overview 74

SELUTION SLR 018 DEB – Peripheral Artery Disease – A Prospective Multi-center Study to Assess the Safety and Efficacy of SELUTION SLR for the Treatment of Lesions of Superficial Femoral Arteries and/or Popliteal Arteries 75

SELUTION SLR 018 DEB – Peripheral Artery Disease – Intervention with Selution SLR Agent Balloon for Endovascular Latent Limus Therapy for Failing AV Fistulas (ISABELLA) Trial 75

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 75

SELUTION SLR 018 DEB – Peripheral Artery Disease – Prospective Registry to Investigate the Safety and Efficacy of the Treatment with the Selution Sirolimus Drug Coated Balloon in TASC C and D Atheroma-occlusive Infra-inguinal Disease in Patients with Chronic Limb Threatening Ischemia from Singapore 76

SELUTION SLR 018 DEB – Peripheral Artery Disease – SAVE Trial – Use of the Selution Sirolimus Eluting Balloon for Dysfunctional AV accEss Treatment Indications 76

SELUTION SLR 018 DEB – Peripheral Artery Disease – Scientific Proposal to Substantiate Vascular Effects Through Sirolimus vs. Paclitaxel DCB Implantation 76

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 77

SELUTION SLR 018 DEB – Peripheral Artery Disease – SUCCESS (Selution, Safety, Efficacy, Health Economics and Proms) PTA Study 77

Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 78

IN.PACT Admiral DEB – BTK – Product Status 78

IN.PACT Admiral DEB – BTK – Product Description 78

Medtronic Plc – Ongoing Clinical Trials Overview 79

IN.PACT Admiral DEB – BTK – Randomized Study of IN.PACT 014 Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter Versus Standard Percutaneous Transluminal Angioplasty for the Treatment of Chronic Total Occlusions in the Infrapopliteal Arteries 80

Micell Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 81

Drug-Coated Balloon – Product Status 81

Drug-Coated Balloon – Product Description 81

Neovasc Inc Pipeline Products & Ongoing Clinical Trials Overview 82

Ostial Flare – Product Status 82

Ostial Flare – Product Description 82

NuVascular Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 83

NuSpun DE Balloon – Product Status 83

NuSpun DE Balloon – Product Description 83

OrbusNeich Pipeline Products & Ongoing Clinical Trials Overview 84

JADE 14/18/35 OTW PTA Balloon Catheter – Product Status 84

JADE 14/18/35 OTW PTA Balloon Catheter – Product Description 84

JADE II PTA Balloon Catheter – Product Status 85

JADE II PTA Balloon Catheter – Product Description 85

Limus Drug Coated Balloon – Peripheral – Product Status 85

Limus Drug Coated Balloon – Peripheral – Product Description 86

Orchestra BioMed Inc Pipeline Products & Ongoing Clinical Trials Overview 87

Virtue Sirolimus-Eluting Balloon – BTK – Product Status 87

Virtue Sirolimus-Eluting Balloon – BTK – Product Description 87

Pulsus Medical LLC (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 88

Micro-Perforated Catheter Balloon Drug Delivery System – Product Status 88

Micro-Perforated Catheter Balloon Drug Delivery System – Product Description 88

QT Vascular Ltd Pipeline Products & Ongoing Clinical Trials Overview 89

Silk PTA Balloon Catheter – Product Status 89

Silk PTA Balloon Catheter – Product Description 89

QualiMed Innovative Medizinprodukte GmbH Pipeline Products & Ongoing Clinical Trials Overview 90

Kinesyx-Based Peripheral Drug Coated Balloon – Product Status 90

Kinesyx-Based Peripheral Drug Coated Balloon – Product Description 90

Shanghai Changde Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 91

Below-The-Knee Rapamycin Drug Coated Balloon – Product Status 91

Below-The-Knee Rapamycin Drug Coated Balloon – Product Description 91

Shanghai Changde Medical Technology Co Ltd – Ongoing Clinical Trials Overview 92

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 93

Shenzhen Salubris Pharmaceuticals Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 94

PTA Balloon Catheter – Product Status 94

PTA Balloon Catheter – Product Description 94

Rapamycin Drug-Eluting Peripheral Balloon Catheter – Product Status 95

Rapamycin Drug-Eluting Peripheral Balloon Catheter – Product Description 95

Shockwave Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 96

LX – Product Status 96

LX – Product Description 96

S4+ – Product Status 97

S4+ – Product Description 97

SiL Vascular Ltd Pipeline Products & Ongoing Clinical Trials Overview 98

Peripheral Vascular Balloon – Product Status 98

Peripheral Vascular Balloon – Product Description 98

Spectranetics Corp Pipeline Products & Ongoing Clinical Trials Overview 99

Stellarex 0.014″ Over-The-Wire Drug-Coated Angioplasty Balloon – Product Status 99

Stellarex 0.014″ Over-The-Wire Drug-Coated Angioplasty Balloon – Product Description 99

Spectranetics Corp – Ongoing Clinical Trials Overview 100

Stellarex 0.014″ Over-The-Wire Drug-Coated Angioplasty Balloon – Prospective, Multi-center Study to Evaluate Treatment of Subjects with Occlusive Disease with a Novel Paclitazel-coated Angioplasty Balloon in Below-the-knee (BTK) Arteries: A Post Market Clinical Study 101

Stemplant LLC Pipeline Products & Ongoing Clinical Trials Overview 102

Peripheral Vascular Angioplasty Delivery Device – Product Status 102

Peripheral Vascular Angioplasty Delivery Device – Product Description 102

SurModics Inc Pipeline Products & Ongoing Clinical Trials Overview 103

0.018” Radial PTA Balloon Catheter – Product Status 103

0.018” Radial PTA Balloon Catheter – Product Description 104

0.035” Next Generation Workhorse PTA Catheter – Product Status 104

0.035” Next Generation Workhorse PTA Catheter – Product Description 104

Advance Serenity 14 Hydrophilic PTA Balloon Dilation Catheter – Product Status 105

Advance Serenity 14 Hydrophilic PTA Balloon Dilation Catheter – Product Description 105

Advance Serenity 18 Hydrophilic PTA Balloon Dilation Catheter – Product Status 105

Advance Serenity 18 Hydrophilic PTA Balloon Dilation Catheter – Product Description 106

Avess Arteriovenous Access Drug Coated Balloon (DCB) – Product Status 106

Avess Arteriovenous Access Drug Coated Balloon (DCB) – Product Description 107

Sundance BTK DCB – Product Status 107

Sundance BTK DCB – Product Description 107

SurVeil Drug Coated Balloon – Peripheral Artery Disease – Product Status 108

SurVeil Drug Coated Balloon – Peripheral Artery Disease – Product Description 108

SurModics Inc – Ongoing Clinical Trials Overview 109

SurVeil Drug Coated Balloon – Peripheral Artery Disease – A Prospective, Multi-center, Single-arm Study to Assess the Safety and Performance of the Surmodics Drug Coated Balloon in the Treatment of Subjects with Obstructive Lesions of Arteriovenous Fistulae for Hemodialysis, Including Native or Synthetic Grafts 110

SurVeil Drug Coated Balloon – Peripheral Artery Disease – The Randomized and Controlled Noninferiority Trial to Evaluate Safety and Clinical Efficacy of the SurVeil Drug-coated Balloon in the Treatment of Subjects with Stenotic Lesions of the Femoropopliteal Artery Compared to the Medtronic IN.PACT Admiral Drug-coated Balloon 110

Sundance BTK DCB – A Prospective, Multi-center, Single-arm, Feasibility Study to Assess the Safety and Performance with the SUNDANCE DruG Coated Balloon for the Treatment of De Novo or Restenotic Lesions in Infra-popliteal Arteries 111

Suzhou Zhonghui Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 112

C-wave Peripheral Shock Wave Catheter System – Product Status 112

C-wave Peripheral Shock Wave Catheter System – Product Description 112

Tailored Medical Devices Inc Pipeline Products & Ongoing Clinical Trials Overview 113

MR-PEO-DCB – Product Status 113

MR-PEO-DCB – Product Description 113

Transit Scientific LLC Pipeline Products & Ongoing Clinical Trials Overview 114

XO Score – 3F – Product Status 114

XO Score – 3F – Product Description 114

XO Score – 4F – Product Status 115

XO Score – 4F – Product Description 115

XO Score – 5F – Product Status 115

XO Score – 5F – Product Description 116

TransMed7 LLC Pipeline Products & Ongoing Clinical Trials Overview 117

Zeppelin II – Product Status 117

Zeppelin II – Product Description 117

Vascular Nanotransfer Technologies Pipeline Products & Ongoing Clinical Trials Overview 118

Mitomycin-Based Drug Coated Balloon – Peripheral – Product Status 118

Mitomycin-Based Drug Coated Balloon – Peripheral – Product Description 118

Paclitaxel-Based Drug Coated Balloon – Peripheral – Product Status 119

Paclitaxel-Based Drug Coated Balloon – Peripheral – Product Description 119

Zylox-Tonbridge Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 120

PTA Scoring Balloon Catheter – Product Status 120

PTA Scoring Balloon Catheter – Product Description 121

Second Generation PTA Balloon Catheter – Product Status 121

Second Generation PTA Balloon Catheter – Product Description 121

Second Generation UltraFree Drug Coated PTA Balloon Catheter – Product Status 122

Second Generation UltraFree Drug Coated PTA Balloon Catheter – Product Description 122

Ultrafree Drug Coated PTA Balloon Catheter – BTK – Product Status 122

Ultrafree Drug Coated PTA Balloon Catheter – BTK – Product Description 123

Ultrafree Drug Coated PTA Balloon Catheter – Dialysis Access – Product Status 123

Ultrafree Drug Coated PTA Balloon Catheter – Dialysis Access – Product Description 123

Ultrafree Drug Coated PTA Balloon Catheter – Vertebral Artery Stenosis – Product Status 124

Ultrafree Drug Coated PTA Balloon Catheter – Vertebral Artery Stenosis – Product Description 124

Zylox-Tonbridge Medical Technology Co Ltd – Ongoing Clinical Trials Overview 125

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 126

Ultrafree Drug Coated PTA Balloon Catheter – BTK – Study to Evaluate the Safety and Efficacy of Ultrafree Drug Coated PTA Balloon Catheter for the Treatment of Stenosis or Occlusion in Below-the-knee 126

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 127

Ultrafree Drug Coated PTA Balloon Catheter – Vertebral Artery Stenosis – Study to Evaluate the Safety and Efficacy of Ultrafree Drug Coated PTA Balloon Catheter for Vertebral Artery Stenosis 128

Glossary 174

Figures

PTA Balloon Catheters – Pipeline Products by Stage of Development 15

PTA Balloon Catheters – Pipeline Products by Segment 16

PTA Balloon Catheters – Pipeline Products by Territory 17

PTA Balloon Catheters – Pipeline Products by Regulatory Path 18

PTA Balloon Catheters – Pipeline Products by Estimated Approval Date 19

PTA Balloon Catheters – Ongoing Clinical Trials 20

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