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

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PTA Balloon Catheters Pipeline Market Report Overview

A PTA balloon catheter is a type of balloon that is inserted into the affected artery and inflated to push the plaque against the walls of the artery thereby widening the artery and improving blood flow. The catheter is inserted into the artery through a small incision in the skin and guided to the site of the blockage using imaging techniques such as X-ray or ultrasound. The segment includes PTA Standard balloon catheters and PTA peripheral DCB catheters.

The PTA balloon catheters pipeline market research report provides a comprehensive understanding of the pipeline products along with their comparative analysis at various stages of development. The report also includes information about the territories wherein the clinical trials are in progress, the regulatory paths followed by the trials, and the companies associated with the trials.

Key Segments ·       PTA Peripheral DCB Catheters

·       PTA Standard Balloon Catheters

Key Territories ·       United States

·       China

·       Europe

·       Global

·       Japan

Key Regulatory Paths ·       NMPA

·       PMA

·       CE

·       510(k)

·       Shonin

Leading Companies ·       Acotec Scientific Co Ltd

·       Acotec Scientific Holdings Ltd

·       Andramed GmbH

·       AnGes Inc

·       AngioCure, Inc.

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PTA Balloon Catheters Pipeline Market Segments

PTA Peripheral DCB Catheters and PTA Standard Balloon Catheters are the two segments of the PTA Balloon Catheters Pipeline market. The PTA Peripheral DCB Catheters segment accounted for the highest share of the PTA Balloon Catheters Pipeline market as of May 2024.

PTA Balloon Catheters Pipeline Market Analysis by Segments, 2024 (%)

PTA Balloon Catheters Pipeline Market Analysis by Segments, 2024 (%)

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PTA Balloon Catheters Pipeline Market Segmentation by Territories

A few of the key territories for PTA balloon catheters pipeline products are the United States, China, Europe, Global, and Japan among others. As of May 2024, the US accounted for the highest number of pipeline products.

PTA Balloon Catheters Pipeline Market Analysis by Territories, 2024 (%)

PTA Balloon Catheters Pipeline Market Analysis by Territories, 2024 (%)

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PTA Balloon Catheters Pipeline Market Segmentation by Regulatory Paths

A few of the key regulatory paths followed by the PTA balloon catheters pipeline market are NMPA, PMA, CE, 510(k), Shonin among others. As of May 2024, NMPA was the most followed pathway for pipeline products in the market.

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

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

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PTA Balloon Catheters Pipeline Market – Competitive Landscape

A few of the key companies associated with the PTA balloon catheters pipeline market are Acotec Scientific Co Ltd, Acotec Scientific Holdings Ltd, Andramed GmbH, AnGes Inc, AngioCure, Inc.among others.

Acotec Scientific Co Ltd: It is a subsidiary of Acotec Scientific Holdings Ltd, which is a research and development firm that offers medical devices such as electro physiologic catheter, drug coated balloon, percutaneous transluminal angioplasty, and vascular interventional treatments.

Andramed GmbH: It 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 Analysis by Companies, 2024

PTA Balloon Catheters Pipeline Market Analysis by Companies, 2024

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Segments Covered in the Report

PTA Balloon Catheters Pipeline Market Segments

  • PTA Peripheral DCB Catheters
  • PTA Standard Balloon Catheters

PTA Balloon Catheters Pipeline Market Territories Outlook

  • United States
  • China
  • Europe
  • Global
  • Japan

PTA Balloon Catheters Pipeline Market Regulatory Paths Outlook

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

Scope

This report provides:

  • Extensive coverage of the PTA balloon catheters 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 PTA balloon catheters 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

  • Formulate significant competitor information, analysis, and insights to improve R&D strategies.
  • Identify emerging players with potentially strong product portfolios and create effective counter strategies to gain a competitive advantage.
  • Identify and understand important and diverse types of PTA 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.
  • Carry out 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
Cardionovum GmbH
Cardiovascular Systems Inc
Chansu Vascular Technologies LLC
Concept Medical Inc
Contego Medical LLC
Cordis US Corp
Dingke Medical Technology (Suzhou) Co Ltd
Dongguan TT Medical Inc
Endocor GmbH
eucatech AG
Hexacath SA
InnoRa GmbH
Lifetech Scientific (Shenzhen) Co Ltd
Lutonix Inc
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 Easy-Flow Medical Tech Co Ltd
Shenzhen Salubris Pharmaceuticals Co Ltd
Shockwave Medical Inc
SiL Vascular Ltd
Stemplant LLC
SurModics Inc
Tailored Medical Devices Inc
Transit Scientific LLC
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 7

1.2 List of Figures 12

2 Introduction 13

2.1 PTA Balloon Catheters Overview 13

3 Products under Development 14

3.1 PTA Balloon Catheters – Pipeline Products by Stage of Development 14

3.2 PTA Balloon Catheters – Pipeline Products by Segment 15

3.3 PTA Balloon Catheters – Pipeline Products by Territory 16

3.4 PTA Balloon Catheters – Pipeline Products by Regulatory Path 17

3.5 PTA Balloon Catheters – Pipeline Products by Estimated Approval Date 18

3.6 PTA Balloon Catheters – Ongoing Clinical Trials 19

4 PTA Balloon Catheters – Pipeline Products under Development by Companies 20

4.1 PTA Balloon Catheters Companies – Pipeline Products by Stage of Development 20

4.2 PTA Balloon Catheters – Pipeline Products by Stage of Development 22

5 PTA Balloon Catheters Companies and Product Overview 24

5.1 Acotec Scientific Co Ltd Company Overview 24

5.1.1 Acotec Scientific Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 24

5.2 Acotec Scientific Holdings Ltd Company Overview 29

5.2.1 Acotec Scientific Holdings Ltd Pipeline Products & Ongoing Clinical Trials Overview 29

5.3 Andramed GmbH Company Overview 30

5.3.1 Andramed GmbH Pipeline Products & Ongoing Clinical Trials Overview 30

5.4 AnGes Inc Company Overview 31

5.4.1 AnGes Inc Pipeline Products & Ongoing Clinical Trials Overview 31

5.5 AngioCure, Inc. Company Overview 32

5.5.1 AngioCure, Inc. Pipeline Products & Ongoing Clinical Trials Overview 32

5.6 APT Medical Inc Company Overview 33

5.6.1 APT Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 33

5.7 Ascenion GmbH Company Overview 35

5.7.1 Ascenion GmbH Pipeline Products & Ongoing Clinical Trials Overview 35

5.8 Becton Dickinson and Co Company Overview 36

5.8.1 Becton Dickinson and Co Pipeline Products & Ongoing Clinical Trials Overview 36

5.9 Boston Scientific Corp Company Overview 40

5.9.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 40

5.10 Cardionovum GmbH Company Overview 46

5.10.1 Cardionovum GmbH Pipeline Products & Ongoing Clinical Trials Overview 46

5.11 Cardiovascular Systems Inc Company Overview 47

5.11.1 Cardiovascular Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 47

5.12 Chansu Vascular Technologies LLC Company Overview 48

5.12.1 Chansu Vascular Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 48

5.13 Concept Medical Inc Company Overview 51

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

5.14 Contego Medical LLC Company Overview 57

5.14.1 Contego Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 57

5.15 Cordis US Corp Company Overview 59

5.15.1 Cordis US Corp Pipeline Products & Ongoing Clinical Trials Overview 59

5.16 Dingke Medical Technology (Suzhou) Co Ltd Company Overview 63

5.16.1 Dingke Medical Technology (Suzhou) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 63

5.17 Dongguan TT Medical Inc Company Overview 64

5.17.1 Dongguan TT Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 64

5.18 Endocor GmbH Company Overview 65

5.18.1 Endocor GmbH Pipeline Products & Ongoing Clinical Trials Overview 65

5.19 eucatech AG Company Overview 66

5.19.1 eucatech AG Pipeline Products & Ongoing Clinical Trials Overview 66

5.20 Hexacath SA Company Overview 67

5.20.1 Hexacath SA Pipeline Products & Ongoing Clinical Trials Overview 67

5.21 InnoRa GmbH Company Overview 68

5.21.1 InnoRa GmbH Pipeline Products & Ongoing Clinical Trials Overview 68

5.22 Lifetech Scientific (Shenzhen) Co Ltd Company Overview 69

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

5.23 Lutonix Inc Company Overview 72

5.23.1 Lutonix Inc Pipeline Products & Ongoing Clinical Trials Overview 72

5.24 Medtronic Plc Company Overview 73

5.24.1 Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 73

5.25 Micell Technologies Inc Company Overview 74

5.25.1 Micell Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 74

5.26 Neovasc Inc Company Overview 75

5.26.1 Neovasc Inc Pipeline Products & Ongoing Clinical Trials Overview 75

5.27 NuVascular Technologies Inc Company Overview 76

5.27.1 NuVascular Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 76

5.28 OrbusNeich Company Overview 77

5.28.1 OrbusNeich Pipeline Products & Ongoing Clinical Trials Overview 77

5.29 Orchestra BioMed Inc Company Overview 80

5.29.1 Orchestra BioMed Inc Pipeline Products & Ongoing Clinical Trials Overview 80

5.30 Pulsus Medical LLC (Inactive) Company Overview 81

5.30.1 Pulsus Medical LLC (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 81

5.31 QT Vascular Ltd Company Overview 82

5.31.1 QT Vascular Ltd Pipeline Products & Ongoing Clinical Trials Overview 82

5.32 QualiMed Innovative Medizinprodukte GmbH Company Overview 83

5.32.1 QualiMed Innovative Medizinprodukte GmbH Pipeline Products & Ongoing Clinical Trials Overview 83

5.33 Shanghai Easy-Flow Medical Tech Co Ltd Company Overview 84

5.33.1 Shanghai Easy-Flow Medical Tech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 84

5.34 Shenzhen Salubris Pharmaceuticals Co Ltd Company Overview 87

5.34.1 Shenzhen Salubris Pharmaceuticals Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 87

5.35 Shockwave Medical Inc Company Overview 89

5.35.1 Shockwave Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 89

5.36 SiL Vascular Ltd Company Overview 91

5.36.1 SiL Vascular Ltd Pipeline Products & Ongoing Clinical Trials Overview 91

5.37 Stemplant LLC Company Overview 92

5.37.1 Stemplant LLC Pipeline Products & Ongoing Clinical Trials Overview 92

5.38 SurModics Inc Company Overview 93

5.38.1 SurModics Inc Pipeline Products & Ongoing Clinical Trials Overview 93

5.39 Tailored Medical Devices Inc Company Overview 98

5.39.1 Tailored Medical Devices Inc Pipeline Products & Ongoing Clinical Trials Overview 98

5.40 Transit Scientific LLC Company Overview 99

5.40.1 Transit Scientific LLC Pipeline Products & Ongoing Clinical Trials Overview 99

5.41 TransMed7 LLC Company Overview 101

5.41.1 TransMed7 LLC Pipeline Products & Ongoing Clinical Trials Overview 101

5.42 Vascular Nanotransfer Technologies Company Overview 102

5.42.1 Vascular Nanotransfer Technologies Pipeline Products & Ongoing Clinical Trials Overview 102

5.43 Zhejiang Batai Medical Technology Co Ltd Company Overview 104

5.43.1 Zhejiang Batai Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 104

5.44 Zylox-Tonbridge Medical Technology Co Ltd Company Overview 106

5.44.1 Zylox-Tonbridge Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 106

6 PTA Balloon Catheters- Recent Developments 114

6.1 May 09, 2024: Zylox-Tonbridge Announces Retirement and Proposed Appointment of Independent Non-Executive Directors 114

6.2 Apr 25, 2024: Edwards Lifesciences Reports First Quarter Results 115

6.3 Apr 24, 2024: Medtronic Names Yarmela Pavlovic as Chief Regulatory Officer 116

6.4 Apr 15, 2024: Edwards Lifesciences Appoints New China Head 116

6.5 Apr 10, 2024: Goodman Receives FDA 510(k) Clearance for Aperta NSE PTA Balloon Dilatation Catheter 117

6.6 Apr 02, 2024: Concept wins another IDE from FDA for MagicTouch range 117

6.7 Mar 29, 2024: MicroPort CardioFlow Medtech Full Year 2023 Earnings 117

6.8 Mar 21, 2024: Zylox-Tonbridge Announces Annual Financial Results for 2023, Demonstrating Robust Growth and Improved Profitability 118

6.9 Mar 12, 2024: Medtronic To Present At Barclays Global Healthcare Conference 119

6.10 Feb 28, 2024: Boston Scientific Raises $2.2B to Support Purchase of California Medical Device Company 119

6.11 Feb 23, 2024: Edwards Lifesciences to Present at the 44th Annual TD Cowen Healthcare Conference 119

6.12 Feb 23, 2024: Medical Tech Leader, Boston Scientific (BSX), Announces Notes Offering 119

6.13 Feb 21, 2024: Zylox-Tonbridge Receives Marketing Approvals for Multiple Products in the Uae 120

6.14 Feb 19, 2024: Boston Scientific Appoints Madan Krishnan to Lead India Subcontinent 120

6.15 Feb 08, 2024: Teleflex Announces Fourth Quarter 2023 Earnings Conference Call Information 120

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

232.27 KB) 120

6.17 Jan 31, 2024: Boston Scientific Announces Results for Fourth Quarter and Full Year 2023 120

6.18 Jan 17, 2024: Injectable Angioplasty Balloon Catheter Transforms Peripheral Procedures, Users Report Reduced Equipment and Contrast Needs 122

6.19 Jan 16, 2024: Surmodics to Report First Quarter of Fiscal 2024 Financial Results on February 1 123

6.20 Jan 11, 2024: Biblios Study Full Cohort Results on BTK Lesions Presented at PVI 123

6.21 Jan 05, 2024: Boston Scientific Announces Conference Call Discussing Fourth Quarter 2023 Results 124

6.22 Jan 04, 2024: Kossel Medtech Suzhou Receives 510(k) Clearance for Falexpand HP PTA Balloon Dilatation Catheter 124

6.23 Dec 20, 2023: AnGes Laying Off 110 EmendoBio Employees Three Years After $250 million Acquisition 124

6.24 Nov 16, 2023: Surmodics Announces TRANSCEND Trial 36-Month Data Presented at 50th Annual VEITH Symposium 125

6.25 Nov 16, 2023: Surmodics Announces 24-Month Data from the SWING Trial Presented at VEITHsymposium 126

6.26 Nov 10, 2023: Microport Appointment of Director 127

6.27 Nov 05, 2023: Teleflex Reports Third Quarter Financial Results, Full Year 2023 Outlook 127

6.28 Nov 01, 2023: BD Registry Underscores Value of the Lutonix Drug Coated Balloon (DCB) Technology in Treating Femoropopliteal Disease 127

6.29 Oct 31, 2023: Second Round of Late-Breaking Clinical Trial Results Announced at VIVA23 128

6.30 Oct 26, 2023: Boston Scientific Announces Results for Third Quarter 2023 130

6.31 Oct 18, 2023: Edwards Lifesciences to Host Earnings Conference Call on October 25, 2023 132

6.32 Oct 15, 2023: Shanghai Kindly Medical Instruments Co. Notice of 2023 First Extraordinary General Meeting 132

6.33 Oct 05, 2023: Shanghai Kindly Medical Instruments Co. Announces 2022 Annual Report 132

6.34 Oct 04, 2023: Medtronic Names Paolo Di Vincenzo President of the Neuromodulation Business 133

6.35 Sep 29, 2023: Barry Slowey Named Vice President and Chief Sustainability Officer 133

6.36 Sep 21, 2023: Microport Scientific Corp. Announces 2023 Interim Report 134

6.37 Sep 15, 2023: Amber Beauchamp Named Vice President of Global Human Resources 136

6.38 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 136

6.39 Sep 01, 2023: MicroPort Endovastec Achieves Its First Clinical Implantation of Reewarm PTX DCB Catheter in Brazil 137

6.40 Aug 30, 2023: Zylox-Tonbridge’s ZENFlow Tiger LD PTA Dilatation Catheter Receives ANVISA Marketing Approval 137

6.41 Aug 29, 2023: MicroPort CardioFlow Medtech Corp. Announces Change of Directors and Chairman 138

6.42 Aug 29, 2023: Microport Cardioflow Medtech Announces Change of Directors and Chairman 140

6.43 Aug 28, 2023: Edwards Lifesciences to Present at the 2023 Wells Fargo Healthcare Conference 140

6.44 Aug 27, 2023: Zylox-Tonbridge Reveals 2023 Interim Financial Results: Revenue Surges

50.7% YOY to 230 Million Yuan, Gross Profit Climbs to 171 Million Yuan 141

6.45 Aug 26, 2023: Medtronic Q2 2024 Earnings Estimates Increased by William Blair 142

6.46 Aug 23, 2023: Zylox-tonbridge Medical Technology Co. Announces Interim Results for the Six Months Ended June 30, 2023 142

6.47 Aug 08, 2023: Medtronic to Announce Financial Results for its First Quarter of Fiscal Year 2024 143

6.48 Aug 07, 2023: MCRA Aids Surmodics in Obtaining FDA Pre-market Approval for Cardiovascular Drug-Coated Balloon 144

6.49 Aug 03, 2023: Teleflex Reports Second Quarter Financial Results and Full Year 2023 Outlook 144

6.50 Jul 21, 2023: Medtronic Statement on the Safety of Paclitaxel Coated Devices to Treat Peripheral Arterial Disease 147

6.51 Jul 19, 2023: Boston Scientific lays off 52 workers as it closes another Silicon Valley facility 148

6.52 Jul 13, 2023: BIOPACT RCT Subgroup Analyses Show Consistently Great Results for Passeo-18 Lux Drug-Coated Balloon 148

6.53 Jul 11, 2023: Cagent Vascular Announces Initial Recoil Study Results: Serranator Demonstrates 49% Less Recoil Than Poba in BTK Arteries 149

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

6.55 Jun 29, 2023: Advance Serenity PTA Balloon Now Available in More Sizes and Locations 150

6.56 Jun 15, 2023: Summa Therapeutics Receives 510(k) Clearance for Finesse Injectable PTA Balloon Dilatation Catheter 150

6.57 Jun 07, 2023: Endovastec Participates in the Congresso International de Cirurgia Endovascular 151

6.58 Jun 06, 2023: Zylox-tonbridge Medical Technology Co. Announces Poll Results of the 2022 Annual General Meeting 152

6.59 May 30, 2023: Excellent 12-Month Results from SELUTION SFA Trial Presented at JET 153

7 Appendix 154

7.1 Methodology 154

7.2 About GlobalData 157

7.3 Contact Us 157

7.4 Disclaimer 157

Table

PTA Balloon Catheters – Pipeline Products by Stage of Development 14

PTA Balloon Catheters – Pipeline Products by Segment 15

PTA Balloon Catheters – Pipeline Products by Territory 16

PTA Balloon Catheters – Pipeline Products by Regulatory Path 17

PTA Balloon Catheters – Pipeline Products by Estimated Approval Date 18

PTA Balloon Catheters – Ongoing Clinical Trials 19

PTA Balloon Catheters Companies – Pipeline Products by Stage of Development 20

PTA Balloon Catheters – Pipeline Products by Stage of Development 22

Acotec Scientific Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 24

AcoArt-Litos Drug-Eluting Balloon – Product Status 24

AcoArt-Litos Drug-Eluting Balloon – Product Description 24

AcoArt-Tulip – Product Status 25

AcoArt-Tulip – Product Description 25

Acotec Scientific Co Ltd – Ongoing Clinical Trials Overview 26

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 27

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 27

AcoArt-Litos Drug-Eluting Balloon – Comparison of Sirolimus Vs Paclitaxel Drug Eluting Balloon for Below-the-knee Angioplasty in Critical Limb Ischemia 27

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 28

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 28

Acotec Scientific Holdings Ltd Pipeline Products & Ongoing Clinical Trials Overview 29

Below-The-Knee PTA Balloon – Product Status 29

Below-The-Knee PTA Balloon – Product Description 29

Andramed GmbH Pipeline Products & Ongoing Clinical Trials Overview 30

Zero-Profile PTA Balloon – Product Status 30

Zero-Profile PTA Balloon – Product Description 30

AnGes Inc Pipeline Products & Ongoing Clinical Trials Overview 31

NF-kB Decoy Oligo Coated PTA Balloon Catheter – Product Status 31

NF-kB Decoy Oligo Coated PTA Balloon Catheter – Product Description 31

AngioCure, Inc. Pipeline Products & Ongoing Clinical Trials Overview 32

AngioCure TOP-C Smart Balloon Catheter – Product Status 32

AngioCure TOP-C Smart Balloon Catheter – Product Description 32

APT Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 33

0.018″” PTA Balloon Dilatation Catheter – Product Status 33

0.018″” PTA Balloon Dilatation Catheter – Product Description 33

0.035″” PTA Balloon Dilatation Catheter – Product Status 34

0.035″” PTA Balloon Dilatation Catheter – Product Description 34

Ascenion GmbH Pipeline Products & Ongoing Clinical Trials Overview 35

Paclitaxel-Coated Balloon Catheter – Product Status 35

Paclitaxel-Coated Balloon Catheter – Product Description 35

Becton Dickinson and Co Pipeline Products & Ongoing Clinical Trials Overview 36

BD Sirolimus Drug Coated Balloon Catheter – Product Status 36

BD Sirolimus Drug Coated Balloon Catheter – Product Description 37

Becton Dickinson and Co – Ongoing Clinical Trials Overview 38

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 39

Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 40

Drug Coated Balloon – Below-The-Knee (BTK) – Product Status 40

Drug Coated Balloon – Below-The-Knee (BTK) – Product Description 40

High Pressure Balloon – Venous Disease – Product Status 41

High Pressure Balloon – Venous Disease – Product Description 41

Next Generation 0.018” Balloon – Product Status 41

Next Generation 0.018” Balloon – Product Description 41

Ranger Paclitaxel-Coated PTA Balloon Catheter – Product Status 42

Ranger Paclitaxel-Coated PTA Balloon Catheter – Product Description 42

Boston Scientific Corp – Ongoing Clinical Trials Overview 43

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) 44

Ranger Paclitaxel-Coated PTA Balloon Catheter – Drug-eluting Registry: Real-world Treatment of Lesions in the Peripheral Vasculature (ELEGANCE) 44

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 44

Ranger Paclitaxel-Coated PTA Balloon Catheter – Ranger Drug-coated Balloon Catheters Post Market Surveillance 45

Cardionovum GmbH Pipeline Products & Ongoing Clinical Trials Overview 46

LEGFLOW OTW – Product Status 46

LEGFLOW OTW – Product Description 46

Cardiovascular Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 47

Peripheral PTA Balloon Catheter – Product Status 47

Peripheral PTA Balloon Catheter – Product Description 47

Chansu Vascular Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 48

Peripheral Everolimus Drug-Coated Balloon – Product Status 48

Peripheral Everolimus Drug-Coated Balloon – Product Description 48

Chansu Vascular Technologies LLC – Ongoing Clinical Trials Overview 49

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 50

Peripheral Everolimus Drug-Coated Balloon – Chansu Vascular Technologies Everolimus-Coated Balloon Percutaneous Transluminal Angioplasty Catheter First-in-Human Clinical Investigation 50

Concept Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 51

MagicTouch AVF Balloon Catheter – Product Status 51

MagicTouch AVF Balloon Catheter – Product Description 51

MagicTouch PTA Balloon Catheter – Product Status 52

MagicTouch PTA Balloon Catheter – Product Description 52

Concept Medical Inc – Ongoing Clinical Trials Overview 53

MagicTouch AVF Balloon Catheter – A Study to Evaluate the Efficacy of MagicTouch AVF in the Treatment of Stenotic Lesions of Arteriovenous Fistula for the Hemodialysis Management of Chronic Renal Failure 54

MagicTouch AVF Balloon Catheter – Sirolimus Coated Angioplasty Versus Plain Balloon Angioplasty in the Treatment of Dialysis Access Dysfunction 54

MagicTouch PTA Balloon Catheter – Comparison of Sirolimus Vs Paclitaxel Drug Eluting Balloon for Below-the-knee Angioplasty in Critical Limb Ischemia 55

MagicTouch PTA Balloon Catheter – Head-to-Head Comparison of Sirolimus Versus Paclitaxel Drug-Eluting Balloon Angioplasty in the Femoropopliteal Artery 55

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 55

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 56

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 56

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 56

Contego Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 57

Superficial Femoral Artery Balloon – Product Status 57

Superficial Femoral Artery Balloon – Product Description 57

Tibial Artery Drug Eluting Balloon – Product Status 58

Tibial Artery Drug Eluting Balloon – Product Description 58

Cordis US Corp Pipeline Products & Ongoing Clinical Trials Overview 59

SELUTION SLR 018 DEB – Peripheral Artery Disease – Product Status 59

SELUTION SLR 018 DEB – Peripheral Artery Disease – Product Description 59

Cordis US Corp – Ongoing Clinical Trials Overview 60

SELUTION SLR 018 DEB – Peripheral Artery Disease – Intervention with Selution SLR Agent Balloon for Endovascular Latent Limus Therapy for Failing AV Fistulas (ISABELLA) Trial 61

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 61

SELUTION SLR 018 DEB – Peripheral Artery Disease – SAVE Trial – Use of the Selution Sirolimus Eluting Balloon for Dysfunctional AV accEss Treatment Indications 61

SELUTION SLR 018 DEB – Peripheral Artery Disease – Scientific Proposal to Substantiate Vascular Effects Through Sirolimus vs. Paclitaxel DCB Implantation 62

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 62

SELUTION SLR 018 DEB – Peripheral Artery Disease – SUCCESS (Selution, Safety, Efficacy, Health Economics and Proms) PTA Study 62

Dingke Medical Technology (Suzhou) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 63

Dissolve AV – Product Status 63

Dissolve AV – Product Description 63

Dongguan TT Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 64

Score PTA – Product Status 64

Score PTA – 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

Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 73

IN.PACT Admiral DEB – BTK – Product Status 73

IN.PACT Admiral DEB – BTK – Product Description 73

Micell Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 74

Drug-Coated Balloon – Product Status 74

Drug-Coated Balloon – Product Description 74

Neovasc Inc Pipeline Products & Ongoing Clinical Trials Overview 75

Ostial Flare – Product Status 75

Ostial Flare – Product Description 75

NuVascular Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 76

NuSpun DE Balloon – Product Status 76

NuSpun DE Balloon – Product Description 76

OrbusNeich Pipeline Products & Ongoing Clinical Trials Overview 77

JADE 14/18/35 OTW PTA Balloon Catheter – Product Status 77

JADE 14/18/35 OTW PTA Balloon Catheter – Product Description 77

JADE II PTA Balloon Catheter – Product Status 78

JADE II PTA Balloon Catheter – Product Description 78

Limus Drug Coated Balloon – Peripheral – Product Status 78

Limus Drug Coated Balloon – Peripheral – Product Description 79

Orchestra BioMed Inc Pipeline Products & Ongoing Clinical Trials Overview 80

Virtue Sirolimus-Eluting Balloon – BTK – Product Status 80

Virtue Sirolimus-Eluting Balloon – BTK – Product Description 80

Pulsus Medical LLC (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 81

Micro-Perforated Catheter Balloon Drug Delivery System – Product Status 81

Micro-Perforated Catheter Balloon Drug Delivery System – Product Description 81

QT Vascular Ltd Pipeline Products & Ongoing Clinical Trials Overview 82

Silk PTA Balloon Catheter – Product Status 82

Silk PTA Balloon Catheter – Product Description 82

QualiMed Innovative Medizinprodukte GmbH Pipeline Products & Ongoing Clinical Trials Overview 83

Kinesyx-Based Peripheral Drug Coated Balloon – Product Status 83

Kinesyx-Based Peripheral Drug Coated Balloon – Product Description 83

Shanghai Easy-Flow Medical Tech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 84

Below-The-Knee Rapamycin Drug Coated Balloon – Product Status 84

Below-The-Knee Rapamycin Drug Coated Balloon – Product Description 84

Shanghai Easy-Flow Medical Tech Co Ltd – Ongoing Clinical Trials Overview 85

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 86

Shenzhen Salubris Pharmaceuticals Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 87

PTA Balloon Catheter – Product Status 87

PTA Balloon Catheter – Product Description 87

Rapamycin Drug-Eluting Peripheral Balloon Catheter – Product Status 88

Rapamycin Drug-Eluting Peripheral Balloon Catheter – Product Description 88

Shockwave Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 89

LX – Product Status 89

LX – Product Description 89

S4+ – Product Status 90

S4+ – Product Description 90

SiL Vascular Ltd Pipeline Products & Ongoing Clinical Trials Overview 91

Peripheral Vascular Balloon – Product Status 91

Peripheral Vascular Balloon – Product Description 91

Stemplant LLC Pipeline Products & Ongoing Clinical Trials Overview 92

Peripheral Vascular Angioplasty Delivery Device – Product Status 92

Peripheral Vascular Angioplasty Delivery Device – Product Description 92

SurModics Inc Pipeline Products & Ongoing Clinical Trials Overview 93

0.018” Radial PTA Balloon Catheter – Product Status 93

0.018” Radial PTA Balloon Catheter – Product Description 94

0.035” Next Generation Workhorse PTA Catheter – Product Status 94

0.035” Next Generation Workhorse PTA Catheter – Product Description 94

Advance Serenity 14 Hydrophilic PTA Balloon Dilation Catheter – Product Status 95

Advance Serenity 14 Hydrophilic PTA Balloon Dilation Catheter – Product Description 95

Advance Serenity 18 Hydrophilic PTA Balloon Dilation Catheter – Product Status 95

Advance Serenity 18 Hydrophilic PTA Balloon Dilation Catheter – Product Description 96

Avess Arteriovenous Access Drug Coated Balloon (DCB) – Product Status 96

Avess Arteriovenous Access Drug Coated Balloon (DCB) – Product Description 96

Sundance BTK DCB – Product Status 97

Sundance BTK DCB – Product Description 97

Tailored Medical Devices Inc Pipeline Products & Ongoing Clinical Trials Overview 98

MR-PEO-DCB – Product Status 98

MR-PEO-DCB – Product Description 98

Transit Scientific LLC Pipeline Products & Ongoing Clinical Trials Overview 99

XO Score – 3F – Product Status 99

XO Score – 3F – Product Description 99

XO Score – 4F – Product Status 100

XO Score – 4F – Product Description 100

XO Score – 5F – Product Status 100

XO Score – 5F – Product Description 100

TransMed7 LLC Pipeline Products & Ongoing Clinical Trials Overview 101

Zeppelin II – Product Status 101

Zeppelin II – Product Description 101

Vascular Nanotransfer Technologies Pipeline Products & Ongoing Clinical Trials Overview 102

Mitomycin-Based Drug Coated Balloon – Peripheral – Product Status 102

Mitomycin-Based Drug Coated Balloon – Peripheral – Product Description 102

Paclitaxel-Based Drug Coated Balloon – Peripheral – Product Status 103

Paclitaxel-Based Drug Coated Balloon – Peripheral – Product Description 103

Zhejiang Batai Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 104

Coronary Artery Constrained Drug Balloon – Product Status 104

Coronary Artery Constrained Drug Balloon – Product Description 104

Peripherally Constrained Drug Balloon – Product Status 105

Peripherally Constrained Drug Balloon – Product Description 105

Zylox-Tonbridge Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 106

PTA Scoring Balloon Catheter – Product Status 106

PTA Scoring Balloon Catheter – Product Description 107

Second Generation PTA Balloon Catheter – Product Status 107

Second Generation PTA Balloon Catheter – Product Description 107

Second Generation UltraFree Drug Coated PTA Balloon Catheter – Product Status 108

Second Generation UltraFree Drug Coated PTA Balloon Catheter – Product Description 108

Ultrafree Drug Coated PTA Balloon Catheter – BTK – Product Status 108

Ultrafree Drug Coated PTA Balloon Catheter – BTK – Product Description 109

Ultrafree Drug Coated PTA Balloon Catheter – Dialysis Access – Product Status 109

Ultrafree Drug Coated PTA Balloon Catheter – Dialysis Access – Product Description 109

Ultrafree Drug Coated PTA Balloon Catheter – Vertebral Artery Stenosis – Product Status 110

Ultrafree Drug Coated PTA Balloon Catheter – Vertebral Artery Stenosis – Product Description 110

Zylox-Tonbridge Medical Technology Co Ltd – Ongoing Clinical Trials Overview 111

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 112

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 113

Glossary 156

Figures

PTA Balloon Catheters – Pipeline Products by Stage of Development 14

PTA Balloon Catheters – Pipeline Products by Segment 15

PTA Balloon Catheters – Pipeline Products by Territory 16

PTA Balloon Catheters – Pipeline Products by Regulatory Path 17

PTA Balloon Catheters – Pipeline Products by Estimated Approval Date 18

PTA Balloon Catheters – Ongoing Clinical Trials 19

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