Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Medical Devices Pipeline Assessment, 2017

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Product Code:GDME0377EPD

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August 2017

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About the Report

About the Report

Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Medical Devices Pipeline Assessment, 2017

Summary

GlobalData's Medical Devices sector report, "Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Medical Devices Pipeline Assessment, 2017" provides an overview of Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB) currently in pipeline stage.

The report provides comprehensive information on the pipeline products with comparative analysis of the products at various stages of development. The report reviews major players involved in the pipeline product development. It also provides information about clinical trials in progress, which includes trial phase, trial status, trial start and end dates, and, the number of trials for the key Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB) pipeline products.

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

*Note: Certain sections in the report may be removed or altered based on the availability and relevance of data in relation to the equipment type.

Scope

Extensive coverage of the Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB) 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 Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB) and list all their pipeline projects

The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage

The report provides key clinical trial data of ongoing trials specific to pipeline products

Recent developments in the segment / industry

Reasons to buy

The report enables you to

Formulate significant competitor information, analysis, and insights to improve R D strategies

Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

Identify and understand important and diverse types of Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB) 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

Products

Products

AnGes MG Inc, NF-kB Decoy Oligo Coated PTA Balloon Catheter; AngioCure, Inc., AngioCure TOP-C Smart Balloon Catheter; C. R. Bard Inc, Lutonix-AV; C. R. Bard Inc, Lutonix-ISR; C. R. Bard Inc, Lutonix 014 DCB Catheter; Contego Medical, LLC, Tibial Artery Drug Eluting Balloon; eucatech AG, Support; M.A. Med Alliance SA, SELUTION Sirolimus Coated Balloon; Medtronic plc, IN.PACT Admiral DEB-BTK; Medtronic plc, IN.PACT AV Access Drug-Coated Balloon-4-7mm; Medtronic plc, IN.PACT AV Access Drug-Coated Balloon-8-12mm; Micell Technologies Inc, Drug-Coated Balloon; QT Vascular Ltd, Chocolate Touch; QualiMed Innovative Medizinprodukte GmbH, Kinesyx-Based Peripheral Drug Coated Balloon; SiL Vascular Ltd, Peripheral Vascular Balloon; SurModics Inc, SurVeil Drug Coated Balloon-Arterio Venous (AV) Fistulas; SurModics Inc, SurVeil Drug Coated Balloon-Below The Knee (BTK); SurModics Inc, SurVeil Drug Coated Balloon-SFA; The Spectranetics Corp, Stellarex 0.014" Drug-Coated Balloon-Below The Knee (BTK); The Spectranetics Corp, Stellarex Drug Coated Balloon-Above-Knee; Vascular Nanotransfer Technologies, Mitomycin-Based Drug Coated Balloon-Peripheral; Vascular Nanotransfer Technologies, Paclitaxel-Based Drug Coated Balloon-Peripheral


Companies

AnGes MG Inc

AngioCure, Inc.

C. R. Bard Inc

Contego Medical, LLC

eucatech AG

M.A. Med Alliance SA

Medtronic plc

Micell Technologies Inc

QT Vascular Ltd

QualiMed Innovative Medizinprodukte GmbH

SiL Vascular Ltd

SurModics Inc

The Spectranetics Corp

Vascular Nanotransfer Technologies

Table of Contents

Table of Contents

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 6

1.2 List of Figures 8

2 Introduction 9

2.1 Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB) Overview 9

3 Products under Development 10

3.1 Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Pipeline Products by Stage of Development 10

3.2 Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Pipeline Products by Territory 11

3.3 Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Pipeline Products by Regulatory Path 12

3.4 Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Pipeline Products by Estimated Approval Date 13

3.5 Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Ongoing Clinical Trials 14

4 Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Pipeline Products under Development by Companies 15

4.1 Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB) Companies-Pipeline Products by Stage of Development 15

4.2 Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Pipeline Products by Stage of Development 16

5 Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB) Companies and Product Overview 17

5.1 AnGes MG Inc Company Overview 17

5.1.1 AnGes MG Inc Pipeline Products Ongoing Clinical Trials Overview 17

5.2 AngioCure, Inc. Company Overview 19

5.2.1 AngioCure, Inc. Pipeline Products Ongoing Clinical Trials Overview 19

5.3 C. R. Bard Inc Company Overview 20

5.3.1 C. R. Bard Inc Pipeline Products Ongoing Clinical Trials Overview 20

5.4 Contego Medical, LLC Company Overview 26

5.4.1 Contego Medical, LLC Pipeline Products Ongoing Clinical Trials Overview 26

5.5 eucatech AG Company Overview 27

5.5.1 eucatech AG Pipeline Products Ongoing Clinical Trials Overview 27

5.6 M.A. Med Alliance SA Company Overview 28

5.6.1 M.A. Med Alliance SA Pipeline Products Ongoing Clinical Trials Overview 28

5.7 Medtronic plc Company Overview 31

5.7.1 Medtronic plc Pipeline Products Ongoing Clinical Trials Overview 31

5.8 Micell Technologies Inc Company Overview 37

5.8.1 Micell Technologies Inc Pipeline Products Ongoing Clinical Trials Overview 37

5.9 QT Vascular Ltd Company Overview 38

5.9.1 QT Vascular Ltd Pipeline Products Ongoing Clinical Trials Overview 38

5.10 QualiMed Innovative Medizinprodukte GmbH Company Overview 41

5.10.1 QualiMed Innovative Medizinprodukte GmbH Pipeline Products Ongoing Clinical Trials Overview 41

5.11 SiL Vascular Ltd Company Overview 42

5.11.1 SiL Vascular Ltd Pipeline Products Ongoing Clinical Trials Overview 42

5.12 SurModics Inc Company Overview 43

5.12.1 SurModics Inc Pipeline Products Ongoing Clinical Trials Overview 43

5.13 The Spectranetics Corp Company Overview 48

5.13.1 The Spectranetics Corp Pipeline Products Ongoing Clinical Trials Overview 48

5.14 Vascular Nanotransfer Technologies Company Overview 53

5.14.1 Vascular Nanotransfer Technologies Pipeline Products Ongoing Clinical Trials Overview 53

6 Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Recent Developments 55

6.1 Jul 11, 2017: Daiichi Sankyo Selected for Ninth Consecutive Year as Constituent of FTSE4Good Global Index by FTSE Russell 55

6.2 Jul 03, 2017: 15th Takamine Memorial Daiichi Sankyo Prize Winner Announced 55

6.3 Jun 27, 2017: Boston Scientific Outlines Strategy for Sustained Growth at 2017 Investor Day 55

6.4 Jun 14, 2017: Spectranetics Announces Election of New Chairperson of the Board of Directors 57

6.5 Jun 08, 2017: B. Braun is participating in the third edition of the High-Tech Founders Fund 58

6.6 May 25, 2017: Medtronic Reports Fourth Quarter and Fiscal Year 2017 Financial Results 58

6.7 May 24, 2017: Medtronic Enrolls First Patient in Study of IN.PACT AV Access Drug-Coated Balloon in Patients with End-Stage Renal Disease 61

6.8 May 03, 2017: Cardiovascular Systems Reports Fiscal 2017 Third-Quarter Financial Results 62

6.9 Apr 27, 2017: Daiichi Sankyo Announces 15 Billion Yen Manufacturing Investment to Support Acceleration of Antibody Drug Conjugate Portfolio 64

6.10 Apr 27, 2017: Boston Scientific Announces Results For First Quarter 2017 65

6.11 Apr 27, 2017: Surmodics Reports Second Quarter Fiscal 2017 Results, Updates Fiscal 2017 Financial Guidance 66

6.12 Apr 27, 2017: Spectranetics Reports First Quarter 2017 Revenue of $69.7 million 67

6.13 Apr 25, 2017: Medtronic Drug-Coated Balloon Demonstrates Consistent Results in Two New Analyses of Complex PAD Patients 67

6.14 Apr 23, 2017: Bard Announces First Quarter Results 68

6.15 Apr 17, 2017: Surmodics Appoints Lisa Wipperman Heine to Its Board of Directors 69

6.16 Apr 12, 2017: Change in the B. Braun Management Board and the Aesculap Management Board 70

6.17 Mar 31, 2017: B. Braun continues its sales and earnings growth 70

6.18 Mar 24, 2017: LifeTech Announces 2016 Annual Results 72

6.19 Mar 13, 2017: Cook Medical Announces Umesh Patel as President of Cook Biotech 74

6.20 Mar 09, 2017: Medtronic Launches Below-The-Knee Clinical Study In Europe For Treatment Of PAD Using New Drug-Coated Balloon Technology 75

6.21 Mar 07, 2017: Anteo Technologies Announces Verification Study With Cook Medical Australia 76

6.22 Feb 24, 2017: Daiichi Sankyo Announces Organizational Restructuring Effective as of April 1, 2017 76

6.23 Feb 24, 2017: Daiichi Sankyo Appoints New Group Corporate Officers 78

6.24 Feb 23, 2017: Spectranetics Reports Fourth Quarter 2016 Revenue of $71.9 million 79

6.25 Feb 22, 2017: Change in the B. Braun Management Board 79

6.26 Feb 21, 2017: Medtronic Reports Third Quarter Financial Results 80

6.27 Feb 21, 2017: Cardiovascular Systems Announces Healthcare Veteran Martha Goldberg Aronson Joins Board of Directors 82

6.28 Feb 20, 2017: LUMINOR Registry may help "reopen the door" for drug-coated balloons below the knee 83

6.29 Feb 15, 2017: Daiichi Sankyo Strengthens Authorized Generic Business through Daiichi Sankyo Espha 83

6.30 Feb 10, 2017: Daiichi Sankyo Announces Further Reorganization of its Research Development Structure 84

6.31 Feb 09, 2017: Medtronic Announces Health Canada Licence for Drug-Coated Balloon 85

6.32 Feb 09, 2017: First Drug-Coated Balloon Study Results in Japan Demonstrate Consistent Clinical Outcomes with Other Medtronic DCB Studies 85

6.33 Feb 09, 2017: Terumo Announces Change of Executive Officers 86

6.34 Feb 06, 2017: Medtronic Awarded U.S. Department of Veterans Affairs National Contracts for Home Telehealth Technologies, with Three Other Vendors 87

6.35 Feb 02, 2017: Boston Scientific Announces Results For Fourth Quarter And Full Year Ended December 31, 2016 88

6.36 Feb 02, 2017: Surmodics Reports First Quarter Fiscal 2017 Results 89

6.37 Jan 31, 2017: Daiichi Sankyo Announces New Chairman and President 91

6.38 Jan 31, 2017: Terumo Opens a Branch in Yangon 91

6.41 Jan 25, 2017: Medtronic IN.PACT Admiral Drug-Coated Balloon Demonstrates Consistent Results in Asia and Belgium According to New Data Presented at LINC 2017 93

6.42 Jan 25, 2017: LINC 2017: Physicians Discuss Lesion Response-Adapted Therapies for Lower Limb Interventions 94

6.43 Jan 25, 2017: iVascular Official Program Activities at LINC 2017 95

6.44 Jan 25, 2017: Cardiovascular Systems Reports Fiscal 2017 Second-Quarter Financial Results 96

6.45 Jan 24, 2017: ILLUMENATE Global 12-month Results Validate Stellarex's Top-tier Performance in Complex Patient Populations 98

6.46 Jan 11, 2017: Spectranetics Names Scott Hutton as General Manager, Vascular Intervention 99

6.47 Jan 10, 2017: Daiichi Sankyo Announces Reorganization of Research Development System 99

6.48 Dec 16, 2016: FDA Grants QT Vascular Full IDE Approval to Begin Pivotal Trial Of Its Drug-Coated Balloon, Chocolate Touch 100

6.49 Dec 12, 2016: Terumo Formulates 5-Year Mid-to Long-term Growth Strategy 100

6.50 Nov 22, 2016: Medtronic Reports Second Quarter Financial Results 101

6.51 Nov 21, 2016: Spectranetics Receives CE Mark for Stellarex 0.014" Drug-Coated Balloon 104

6.52 Nov 16, 2016: Medtronic Releases FY16 Integrated Performance Report 104

6.53 Nov 16, 2016: Surmodics Reports Fourth Quarter Fiscal 2016 Results 105

6.54 Nov 15, 2016: CEVA to work with Medtronic for distribution facility construction 106

6.55 Nov 02, 2016: Spectranetics Files PMA Application for FDA Approval of the Stellarex Drug-Coated Balloon 107

6.56 Nov 02, 2016: Stellarex ILLUMENATE Pivotal Results Are Top-tier in the Most Complex Patient Group Studied in DCB IDE Trials 108

6.57 Oct 31, 2016: Surmodics Announces Launch of Serene Single-Coat (SC) Solutions Offering Unmatched Lubricity and Durability to a Broader Range of Device Applications 109

6.58 Oct 27, 2016: Spectranetics Reports Third Quarter 2016 Revenue of $68.3 million 110

6.59 Oct 26, 2016: Boston Scientific Announces Results For Third Quarter 2016 110

6.60 Oct 26, 2016: Cardiovascular Systems Reports Fiscal 2017 First-Quarter Financial Results 112

6.61 Oct 25, 2016: Bard Announces Third Quarter Results 113

6.62 Oct 10, 2016: Professor Ian Meredith To Join Boston Scientific As Executive Vice President And Global Chief Medical Officer 114

6.63 Sep 19, 2016: QT Vascular Announces FDA Has Granted Approval To Initiate The Pivotal Trial Of Its Novel Drug-Coated Balloon 115

6.64 Sep 19, 2016: New Data Presented in VIVA Late Breaking Clinical Trials Demonstrate Durability, Safety and Efficacy for the Medtronic In.Pact Admiral DCB 116

6.65 Sep 19, 2016: FDA Approves 6-Month Primary End Point For The Lutonix Below-the-Knee Drug Coated Balloon 117

6.66 Sep 15, 2016: Eurocor enters the market with their FREEWAY COATED SHUNT BALLOON CATHETER 118

6.67 Sep 15, 2016: Medtronic Names Mark Ploof Senior Vice President of Global Operations and Business Services 119

6.68 Sep 13, 2016: Medtronic Receives FDA Approval of First Drug-Coated Balloon for Treatment of In-Stent Restenosis 120

6.69 Sep 06, 2016: Daiichi Sankyo Announces New Global Head of Development 121

6.70 Aug 31, 2016: Cook Medical Names Jean-Marc Creissel Vice President of Operations in Greater China 121

6.71 Aug 25, 2016: Medtronic Reports First Quarter Financial Results 122

6.72 Aug 16, 2016: Cardiovascular Systems Names Scott Ward as CEO 125

6.73 Aug 10, 2016: First Randomized Trial of the Stellarex Drug-coated Balloon Presented at the Amputation Prevention Symposium 125

6.74 Aug 03, 2016: Cardiovascular Systems Reports Fiscal 2016 Fourth-Quarter Financial Results 126

6.75 Jul 28, 2016: Spectranetics Reports Second Quarter 2016 Revenue of $67.7 million 128

6.76 Jul 28, 2016: Surmodics Reports Third Quarter Fiscal 2016 Results 128

6.77 Jul 28, 2016: Boston Scientific Announces Results For Second Quarter 2016 130

6.78 Jul 26, 2016: Bard Announces Second Quarter Results 131

6.79 Jul 25, 2016: QT Vascular Announces Federal Circuit Reversal of Adverse AngioScore / Spectranetics Judgment 132

6.80 Jul 21, 2016: Federal Circuit Court Rules in Appeal 133

6.81 Jul 20, 2016: 12-month Results of the ILLUMENATE European Randomized Clinical Trial to be Presented at the Amputation Prevention Symposium 133

7 Appendix 134

7.1 Methodology 134

7.2 About GlobalData 137

7.3 Contact Us 137

7.4 Disclaimer 137


List of Figure

1.2 List of Figures

Figure 1: Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Pipeline Products by Stage of Development 10

Figure 2: Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Pipeline Products by Territory 11

Figure 3: PTA Peripheral Drug Eluting Balloons (DEB)-Pipeline Products by Regulatory Path 12

Figure 4: Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Pipeline Products by Estimated Approval Date 13

Figure 5: Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Ongoing Clinical Trials 14


List of Table

1.1 List of Tables

Table 1: Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Pipeline Products by Stage of Development 10

Table 2: Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Pipeline Products by Territory 11

Table 3: Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Pipeline Products by Regulatory Path 12

Table 4: PTA Peripheral Drug Eluting Balloons (DEB)-Pipeline Products by Estimated Approval Date 13

Table 5: Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Ongoing Clinical Trials 14

Table 6: PTA Peripheral Drug Eluting Balloons (DEB) Companies-Pipeline Products by Stage of Development 15

Table 7: PTA Peripheral Drug Eluting Balloons (DEB)-Pipeline Products by Stage of Development 16

Table 8: AnGes MG Inc Pipeline Products Ongoing Clinical Trials Overview 17

Table 9: NF-kB Decoy Oligo Coated PTA Balloon Catheter-Product Status 17

Table 10: NF-kB Decoy Oligo Coated PTA Balloon Catheter-Product Description 18

Table 11: AngioCure, Inc. Pipeline Products Ongoing Clinical Trials Overview 19

Table 12: AngioCure TOP-C Smart Balloon Catheter-Product Status 19

Table 13: AngioCure TOP-C Smart Balloon Catheter-Product Description 19

Table 14: C. R. Bard Inc Pipeline Products Ongoing Clinical Trials Overview 20

Table 15: Lutonix-AV-Product Status 20

Table 16: Lutonix-AV-Product Description 21

Table 17: Lutonix-ISR-Product Status 21

Table 18: Lutonix-ISR-Product Description 21

Table 19: Lutonix 014 DCB Catheter-Product Status 22

Table 20: Lutonix 014 DCB Catheter-Product Description 22

Table 21: C. R. Bard Inc-Ongoing Clinical Trials Overview 23

Table 22: Lutonix 014 DCB Catheter-A Prospective, Multicenter, Registry of the Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries (LEVANT 2 Safety Registry) 24

Table 23: Lutonix 014 DCB Catheter-A Prospective, Multicenter, Single Arm Real-world Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon Percutaneous Transluminal Angioplasty (PTA) Catheter for Treatment of Below-the-Knee (BTK) Arteries 24

Table 24: Lutonix 014 DCB Catheter-A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Lutonix Drug Coated Balloon Versus Standard Balloon Angioplasty for Treatment of Below-the-knee (BTK) Arteries (Lutonix BTK Trial) 24

Table 25: Lutonix 014 DCB Catheter-Drug Eluting Balloon in Peripheral Intervention for Below-the-knee Arteries with Freeway and Lutonix 25

Table 26: Lutonix 014 DCB Catheter-Evaluation of Paclitaxel in Patients with CLI (Critical Limb Ischemia) and Femoropopliteal Occlusive Disease Treated with DCB Angioplasty 25

Table 27: Lutonix 014 DCB Catheter-Tack Optimized Balloon Angioplasty Study for Superficial Femoral and Proximal Popliteal Arteries Using the Tack Endovascular System 25

Table 28: Contego Medical, LLC Pipeline Products Ongoing Clinical Trials Overview 26

Table 29: Tibial Artery Drug Eluting Balloon-Product Status 26

Table 30: Tibial Artery Drug Eluting Balloon-Product Description 26

Table 31: eucatech AG Pipeline Products Ongoing Clinical Trials Overview 27

Table 32: Support-Product Status 27

Table 33: Support-Product Description 27

Table 34: M.A. Med Alliance SA Pipeline Products Ongoing Clinical Trials Overview 28

Table 35: SELUTION Sirolimus Coated Balloon-Product Status 28

Table 36: SELUTION Sirolimus Coated Balloon-Product Description 28

Table 37: M.A. Med Alliance SA-Ongoing Clinical Trials Overview 29

Table 38: SELUTION Sirolimus Coated Balloon-SELUTION Sirolimus Coated PTA Balloon Catheter Prospective, Controlled, Multi-center, Open, Single-arm Clinical Investigation for the Treatment of Patients with Femoropopliteal Artery Lesions with a Novel Drug Coated Balloon 30

Table 39: Medtronic plc Pipeline Products Ongoing Clinical Trials Overview 31

Table 40: IN.PACT Admiral DEB-BTK-Product Status 31

Table 41: IN.PACT Admiral DEB-BTK-Product Description 31

Table 42: IN.PACT AV Access Drug-Coated Balloon-4-7mm-Product Status 32

Table 43: IN.PACT AV Access Drug-Coated Balloon-4-7mm-Product Description 32

Table 44: IN.PACT AV Access Drug-Coated Balloon-8-12mm-Product Status 32

Table 45: IN.PACT AV Access Drug-Coated Balloon-8-12mm-Product Description 33

Table 46: Medtronic plc-Ongoing Clinical Trials Overview 34

Table 47: IN.PACT AV Access Drug-Coated Balloon-4-7mm-Study of IN.PACT Admiral Drug-coated Balloon for a New Indication in Subjects with End-stage Renal Disease 35

Table 48: 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 36

Table 49: Micell Technologies Inc Pipeline Products Ongoing Clinical Trials Overview 37

Table 50: Drug-Coated Balloon-Product Status 37

Table 51: Drug-Coated Balloon-Product Description 37

Table 52: QT Vascular Ltd Pipeline Products Ongoing Clinical Trials Overview 38

Table 53: Chocolate Touch-Product Status 38

Table 54: Chocolate Touch-Product Description 38

Table 55: QT Vascular Ltd-Ongoing Clinical Trials Overview 39

Table 56: Chocolate Touch-A Randomized Trial to Confirm the Safety and Effectiveness of Chocolate Touch Paclitaxel Coated Balloon Catheter, in Above the Knee Lesions 40

Table 57: QualiMed Innovative Medizinprodukte GmbH Pipeline Products Ongoing Clinical Trials Overview 41

Table 58: Kinesyx-Based Peripheral Drug Coated Balloon-Product Status 41

Table 59: Kinesyx-Based Peripheral Drug Coated Balloon-Product Description 41

Table 60: SiL Vascular Ltd Pipeline Products Ongoing Clinical Trials Overview 42

Table 61: Peripheral Vascular Balloon-Product Status 42

Table 62: Peripheral Vascular Balloon-Product Description 42

Table 63: SurModics Inc Pipeline Products Ongoing Clinical Trials Overview 43

Table 64: SurVeil Drug Coated Balloon-Arterio Venous (AV) Fistulas-Product Status 43

Table 65: SurVeil Drug Coated Balloon-Arterio Venous (AV) Fistulas-Product Description 44

Table 66: SurVeil Drug Coated Balloon-Below The Knee (BTK)-Product Status 44

Table 67: SurVeil Drug Coated Balloon-Below The Knee (BTK)-Product Description 44

Table 68: SurVeil Drug Coated Balloon-SFA-Product Status 45

Table 69: SurVeil Drug Coated Balloon-SFA-Product Description 45

Table 70: SurModics Inc-Ongoing Clinical Trials Overview 46

Table 71: SurVeil Drug Coated Balloon-SFA-A Prospective, Multi-center, Single-arm Trial to Assess the Safety and Feasibility of the SurModics Drug Coated Balloon in the Treatment of Subjects with De Novo Lesions of the Femoropopliteal Artery 47

Table 72: The Spectranetics Corp Pipeline Products Ongoing Clinical Trials Overview 48

Table 73: Stellarex 0.014" Drug-Coated Balloon-Below The Knee (BTK)-Product Status 48

Table 74: Stellarex 0.014" Drug-Coated Balloon-Below The Knee (BTK)-Product Description 49

Table 75: Stellarex Drug Coated Balloon-Above-The-Knee-Product Status 49

Table 76: Stellarex Drug Coated Balloon-Above-The-Knee-Product Description 49

Table 77: The Spectranetics Corp-Ongoing Clinical Trials Overview 50

Table 78: Stellarex Drug Coated Balloon-Above-The-Knee-Economic Evaluation Comparing Standard Balloon Angioplasty Versus Drug-eluted Balloon or Laser-excimer in Association with Drug-eluted Balloon in the Treatment of Femoropopliteal Artery In-stent Restenosis 51

Table 79: Stellarex Drug Coated Balloon-Above-The-Knee-Prospective, Randomized, Multi-center, Single-blinded Study for the Treatment of Subjects Presenting with De Novo Occluded/Stenotic or Re-occluded/Restenotic Lesions of the Superficial Femoral or Popliteal Arteries Using Paclitaxel or Bare Percutaneous Transluminal Angioplasty Balloon Catheter 51

Table 80: Stellarex Drug Coated Balloon-Above-The-Knee-Prospective, Single-arm, Global Multi-center Study to Evaluate Treatment of Obstructive Superficial Femoral Artery (SFA) and/or Popliteal Lesions with a Novel Paclitaxel-coated Percutaneous Angioplasty (PTA) Balloon and in In-Stent Restenosis (ILLUMENATE GLOBAL and ISR) 52

Table 81: Stellarex Drug Coated Balloon-Above-The-Knee-Prospective, Single-arm, Multi-center, Pharmacokinetic Study to Evaluate Treatment of Obstructive Superficial Femoral Artery or Popliteal Lesions with a Novel Paclitaxel-coated Percutaneous Angioplasty Balloon 52

Table 82: Stellarex Drug Coated Balloon-Above-The-Knee-Stellarex Vascular E-Registry 52

Table 83: Vascular Nanotransfer Technologies Pipeline Products Ongoing Clinical Trials Overview 53

Table 84: Mitomycin-Based Drug Coated Balloon-Peripheral-Product Status 53

Table 85: Mitomycin-Based Drug Coated Balloon-Peripheral-Product Description 53

Table 86: Paclitaxel-Based Drug Coated Balloon-Peripheral-Product Status 54

Table 87: Paclitaxel-Based Drug Coated Balloon-Peripheral-Product Description 54

Table 88: Glossary 136

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