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Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB) - Medical Devices Pipeline Assessment, 2018

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Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Medical Devices Pipeline Assessment, 2018

Summary

GlobalData's Medical Devices sector report, Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Medical Devices Pipeline Assessment, 2018 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

READ MORE

Table Of Content

Scope

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 5

1.2 List of Figures 7

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 Inc Company Overview 17

5.2 AngioCure, Inc. Company Overview 19

5.3 Becton Dickinson and Co Company Overview 20

5.4 Boston Scientific Corp Company Overview 21

5.5 C. R. Bard Inc Company Overview 25

5.6 Contego Medical, LLC Company Overview 30

5.7 eucatech AG Company Overview 31

5.8 Lifetech Scientific (Shenzhen) Co Ltd Company Overview 32

5.9 M.A. Med Alliance SA Company Overview 33

5.10 Medtronic plc Company Overview 36

5.11 Micell Technologies Inc Company Overview 43

5.12 Pulsus Medical LLC (Inactive) Company Overview 44

5.13 QT Vascular Ltd Company Overview 45

5.14 QualiMed Innovative Medizinprodukte GmbH Company Overview 48

5.15 SiL Vascular Ltd Company Overview 49

5.16 Spectranetics Corp Company Overview 50

5.17 SurModics Inc Company Overview 55

5.18 TransMed7 LLC Company Overview 60

5.19 Vascular Nanotransfer Technologies Company Overview 61

6 Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Recent Developments 63

6.1 May 24, 2018: Medtronic Reports Fourth Quarter And Fiscal Year 2018 Financial Results 63

6.2 May 16, 2018: Surmodics Announces Leadership Change and Appointment of Interim CFO 65

6.3 May 11, 2018: Terumo Appoints its U.S.-based Subsidiary's Associate as the Fifth Terumo Fellow 66

6.4 May 11, 2018: Daiichi Sankyo Announces Changes to Representative Directors and Members of the Audit and Supervisory Board 66

6.5 May 07, 2018: Medtronic Appoints Mike Weinstein As Senior Vice President Of Strategy 67

6.6 May 02, 2018: Surmodics Reports Second Quarter Fiscal 2018 Results, Increases Fiscal 2018 Guidance 67

6.7 May 02, 2018: CORRECTING and REPLACING Surmodics Reports Second Quarter Fiscal 2018 Results, Increases Fiscal 2018 Guidance 68

6.8 May 02, 2018: Cardiovascular Systems Reports Fiscal 2018 Third-Quarter Financial Results 69

6.9 Apr 26, 2018: Charing Cross Symposium 2018: Real World DCB Registry BIOLUX P-III Shows Excellent 12-Month Results in the Full Cohort and BTK Subgroup 71

6.10 Apr 25, 2018: Boston Scientific Reports Financial Results For First Quarter 2018 72

6.11 Apr 25, 2018: Xianjian Technology Receives the Most Attention from Institutional Investors 74

6.12 Apr 23, 2018: Medtronic IN.PACT Admiral Drug Coated Balloon Receives FDA Approval to Treat Long SFA Lesions 74

6.13 Apr 20, 2018: Cook Medical Appoints Christina Anne Vice President of Distribution Channel Management 75

6.14 Apr 05, 2018: Dr. Laura Mauri to Join Medtronic as Vice President, Global Clinical Research & Analytics 76

6.15 Mar 23, 2018: 2017 fiscal year: B. Braun increases sales and earnings, with investments of one billion euros 76

6.16 Feb 28, 2018: Daiichi Sankyo Aligns U.S. Commercial Operations to Current Portfolio and Upcoming Cancer Pipeline 79

6.17 Feb 23, 2018: Daiichi Sankyo Announces Organizational Restructuring Effective as of April 1, 2018 79

6.18 Feb 21, 2018: Daiichi Sankyo Selected for 2018 Certified Health and Productivity Management Organization (White 500) 80

6.19 Feb 13, 2018: Four start-ups chosen for the B. Braun Accelerator Program 81

6.20 Feb 08, 2018: Terumo Revises the Full-Year Results Forecast for FY 2017 81

6.21 Feb 08, 2018: Surmodics Reports First Quarter Fiscal 2018 Results, Updates Fiscal 2018 Guidance 82

6.22 Feb 07, 2018: Cardiovascular Systems Reports Fiscal 2018 Second-Quarter Financial Results 82

6.23 Feb 02, 2018: Daiichi Sankyo Selected for Silver Class of RobecoSAM Sustainability Award 2018 84

6.24 Feb 02, 2018: Cardiovascular Systems Appoints Jeff Points as Chief Financial Officer 84

6.25 Feb 01, 2018: Boston Scientific Announces Results for Fourth Quarter and Full Year 2017 85

6.26 Jan 30, 2018: United Health Products Issues Update on HemoStyp South Korea MFDS Application 87

6.27 Jan 30, 2018: IN.PACT Admiral Demonstrates Consistent and Durable Outcomes in New Two-Year Japan Data and IN.PACT Global Critical Limb Ischemia Cohort Analysis 87

6.28 Jan 30, 2018: Alex Gu Named Senior Vice President and President of Medtronic's Greater China Region 88

6.29 Jan 25, 2018: Terumo Announces Change of Directors and Executive Officers 89

6.30 Jan 24, 2018: Cardiovascular Systems Appoints Rhonda Robb as New Chief Operating Officer 91

6.31 Jan 18, 2018: BD Announces Completion of Enrollment in the Lutonix 014 Drug Coated Balloon Below-The-Knee Trial 92

6.32 Jan 09, 2018: Boston Scientific Announces Preliminary Unaudited Sales For The Fourth Quarter And Full Year Ended December 31, 2017 92

6.33 Jan 07, 2018: LifeTech Scientific and Ally Bridge Group Form China-Global Medtech Investment and Operating Partnership 92

6.34 Dec 19, 2017: Bob White Named Executive Vice President and President of Medtronic's Minimally Invasive Therapies Group; Chris Lee to Assume Leadership of Medtronic's Asia Pacific Region 93

6.35 Dec 13, 2017: Terumo Constructs a New Building in Yamaguchi, Japan To Strengthen Production Operations in Interventional Systems 94

6.36 Dec 12, 2017: B. Braun establishes a subsidiary in Zambia 94

6.37 Nov 30, 2017: Daiichi Sankyo to Convert Kitasato Daiichi Sankyo Vaccine into Wholly Owned Subsidiary 95

6.38 Nov 21, 2017: Medtronic Reports Second Quarter Financial Results 95

6.39 Nov 15, 2017: Heiko Schipper is the new CEO and Head of the Consumer Health Division at Bayer 98

6.40 Nov 13, 2017: Philips showcases integrated vascular solutions at VEITH 2017 99

6.41 Nov 08, 2017: Surmodics Reports Fourth Quarter Fiscal 2017 Results and Provides Fiscal 2018 Guidance 100

6.42 Nov 08, 2017: Medtronic Announces Preliminary Second Quarter Revenue 101

6.43 Nov 02, 2017: Medtronic Releases Fiscal Year 2017 Integrated Performance Report 102

6.44 Oct 26, 2017: Boston Scientific Announces Results For Third Quarter 2017 103

6.45 Oct 25, 2017: Cardiovascular Systems Reports Fiscal 2018 First-Quarter Financial Results 104

6.46 Oct 25, 2017: Bard Announces Third Quarter Results 106

6.47 Oct 23, 2017: Surmodics Announces First Patient Enrolled in TRANSCEND Pivotal Clinical Trial for SurVeil Drug-Coated Balloon 107

6.48 Oct 17, 2017: Bayer Appoints Brenda L. Raphael Senior Vice President and General Manager of Therapeutics Business Unit for Consumer Health 108

6.49 Oct 10, 2017: Terumo Provides Update on Impact from Hurricane Maria 108

6.50 Oct 06, 2017: Medtronic Provides Update on Impact from Hurricane Maria 109

6.51 Oct 04, 2017: Boston Scientific Appoints Desiree Ralls-Morrison General Counsel and Corporate Secretary 110

6.52 Sep 26, 2017: MicroVention Celebrates Grand Opening of New Worldwide Innovation Center in Aliso Viejo, California 110

6.53 Sep 25, 2017: The T.I.N.T.I.N. trial evaluating the combined therapy of Luminor DCB and iVolution SX stent 111

6.54 Sep 21, 2017: Luminor 14m has received the Canadian Medical Device License 111

6.55 Sep 18, 2017: CIRSE 2017: BIOTRONIK Studies Demonstrate Efficacy of Minimizing Metal Burden in SFA Therapy 112

6.56 Sep 18, 2017: Eurocor announces the presentation of the 12 months data of the Freeway Stent Study at CIRSE in Copenhagen on Sept. 18, 2017 113

6.57 Sep 18, 2017: Cardiovascular Systems Announces Anticipated Revenue Impact from Hurricanes Harvey and Irma 114

6.58 Sep 15, 2017: Daiichi Sankyo Listed on the Dow Jones Sustainability Indices World Index 114

6.59 Sep 14, 2017: Efficacy of Philips' Stellarex .035" low-dose drug-coated balloon demonstrated in clinical trial at two years 115

6.60 Sep 13, 2017: Six-Month Data from the Surmodics SurVeil Drug-Coated Balloon Early Feasibility Study Presented at VIVA 2017 115

6.61 Sep 13, 2017: New Unpublished Clinical Trial Results of Stellarex DCB Announced At VIVA 17 117

6.62 Sep 12, 2017: Medtronic IN.PACT Admiral DCB Global Two Year Data and IN.PACT SFA Four Year Data Presented in VIVA Late Breaking Clinical Trials 117

6.63 Sep 08, 2017: Medtronic Announces Japanese Regulatory Approval for the IN.PACT Admiral Drug-Coated Balloon 119

6.64 Sep 07, 2017: Daiichi Sankyo Announces Organizational Restructuring Effective as of October 1, 2017 119

6.65 Aug 28, 2017: C. R. Bard Receives FDA Premarket Approval of the LUTONIX 035 Drug Coated Balloon as the First and Only DCB for the Treatment of Patients with Dysfunctional AV Fistulae 120

6.66 Aug 22, 2017: Medtronic Reports First Quarter Financial Results 121

6.67 Aug 03, 2017: Surmodics Reports Third Quarter Fiscal 2017 Results and Updates Fiscal 2017 Guidance 123

6.68 Aug 03, 2017: Spectranetics Reports Second Quarter 2017 Revenue of $74.7 million 124

6.69 Aug 02, 2017: Cardiovascular Systems Reports Fiscal 2017 Fourth-Quarter Financial Results 125

6.70 Jul 31, 2017: QT Vascular begins enrollment in US pivotal study of its drug-coated peripheral balloon 127

6.71 Jul 31, 2017: Dr. Joachim Schulz joins the Management Board of B. Braun Melsungen 127

6.72 Jul 28, 2017: Indonesian Minister of Health Launches New German Pharmaceutical Factory in Karawang 128

6.73 Jul 27, 2017: Boston Scientific Announces Results for Second Quarter 2017 128

6.74 Jul 26, 2017: Spectranetics Announces FDA Approval of Stellarex Drug-Coated Balloon 130

6.75 Jul 26, 2017: Surmodics Receives IDE Approval to Initiate Pivotal Trial of the SurVeil Drug-Coated Balloon 131

6.76 Jul 11, 2017: Daiichi Sankyo Selected for Ninth Consecutive Year as Constituent of FTSE4Good Global Index by FTSE Russell 133

6.77 Jul 03, 2017: 15th Takamine Memorial Daiichi Sankyo Prize Winner Announced 133

6.78 Jun 27, 2017: Boston Scientific Outlines Strategy for Sustained Growth at 2017 Investor Day 133

6.79 Jun 14, 2017: Spectranetics Announces Election of New Chairperson of the Board of Directors 135

7 Appendix 137

7.1 Methodology 137

7.2 About GlobalData 140

7.3 Contact Us 140

7.4 Disclaimer 140


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 11

Figure 2: Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Pipeline Products by Territory 12

Figure 3: Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Pipeline Products by Regulatory Path 13

Figure 4: Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Pipeline Products by Estimated Approval Date 14

Figure 5: Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Ongoing Clinical Trials 15


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 11

Table 2: Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Pipeline Products by Territory 12

Table 3: Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Pipeline Products by Regulatory Path 13

Table 4: Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Pipeline Products by Estimated Approval Date 14

Table 5: Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Ongoing Clinical Trials 15

Table 6: Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB) Companies-Pipeline Products by Stage of Development 16

Table 7: Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Pipeline Products by Stage of Development 17

Table 8: AnGes Inc Pipeline Products & Ongoing Clinical Trials Overview 18

Table 9: NF-kB Decoy Oligo Coated PTA Balloon Catheter-Product Status 18

Table 10: NF-kB Decoy Oligo Coated PTA Balloon Catheter-Product Description 19

Table 11: AngioCure, Inc. Pipeline Products & Ongoing Clinical Trials Overview 20

Table 12: AngioCure TOP-C Smart Balloon Catheter-Product Status 20

Table 13: AngioCure TOP-C Smart Balloon Catheter-Product Description 20

Table 14: Becton Dickinson and Co Pipeline Products & Ongoing Clinical Trials Overview 21

Table 15: Lutonix Drug Coated Balloon Catheter-Long Lesion-Product Status 21

Table 16: Lutonix Drug Coated Balloon Catheter-Long Lesion-Product Description 21

Table 17: Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 22

Table 18: Ranger Drug-Coated Balloon-Product Status 22

Table 19: Ranger Drug-Coated Balloon-Product Description 22

Table 20: Boston Scientific Corp-Ongoing Clinical Trials Overview 23

Table 21: Ranger Drug-Coated Balloon-A Randomized Trial Comparing Drug-coated Balloon and Regular Balloon for Dialysis Access Stent Graft Restenosis 24

Table 22: Ranger Drug-Coated Balloon-Clinical Study of the Boston Scientific Paclitaxel-coated PTA (Percutaneous Transluminal Angioplasty) Balloon Catheter (Ranger and Ranger SL (OTW) DCB) in China 24

Table 23: Ranger Drug-Coated Balloon-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 24

Table 24: Ranger Drug-Coated Balloon-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) 25

Table 25: Ranger Drug-Coated Balloon-Prospective, Randomized, Multicenter Clinical Study of the Hemoteq Ranger Paclitaxel-coated PTA Balloon Catheter (Ranger DCB) in Comparison to Uncoated PTA Balloons in Femoropopliteal Lesions 25

Table 26: Ranger Drug-Coated Balloon-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) 25

Table 27: C. R. Bard Inc Pipeline Products & Ongoing Clinical Trials Overview 26

Table 28: Lutonix-ISR-Product Status 26

Table 29: Lutonix-ISR-Product Description 26

Table 30: Lutonix 014 DCB Catheter-Product Status 27

Table 31: Lutonix 014 DCB Catheter-Product Description 27

Table 32: C. R. Bard Inc-Ongoing Clinical Trials Overview 28

Table 33: Lutonix 014 DCB Catheter-A Prospective, Multicenter, Registry of the Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries (LEVANT 2 Safety Registry) 29

Table 34: 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 29

Table 35: 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 29

Table 36: Lutonix 014 DCB Catheter-Drug Eluting Balloon in Peripheral Intervention for Below-the-knee Arteries with Freeway and Lutonix 30

Table 37: Lutonix 014 DCB Catheter-Evaluation of Paclitaxel in Patients with CLI (Critical Limb Ischemia) and Femoropopliteal Occlusive Disease Treated with DCB Angioplasty 30

Table 38: Lutonix 014 DCB Catheter-Tack Optimized Balloon Angioplasty Study for Superficial Femoral and Proximal Popliteal Arteries Using the Tack Endovascular System 30

Table 39: Contego Medical, LLC Pipeline Products & Ongoing Clinical Trials Overview 31

Table 40: Tibial Artery Drug Eluting Balloon-Product Status 31

Table 41: Tibial Artery Drug Eluting Balloon-Product Description 31

Table 42: eucatech AG Pipeline Products & Ongoing Clinical Trials Overview 32

Table 43: Support-Product Status 32

Table 44: Support-Product Description 32

Table 45: Lifetech Scientific (Shenzhen) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 33

Table 46: FemFlow Drug-Eluting Peripheral Balloon Catheter (DEB)-Product Status 33

Table 47: FemFlow Drug-Eluting Peripheral Balloon Catheter (DEB)-Product Description 33

Table 48: M.A. Med Alliance SA Pipeline Products & Ongoing Clinical Trials Overview 34

Table 49: SELUTION Sirolimus Coated Balloon-Product Status 34

Table 50: SELUTION Sirolimus Coated Balloon-Product Description 34

Table 51: M.A. Med Alliance SA-Ongoing Clinical Trials Overview 35

Table 52: 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 36

Table 53: Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 37

Table 54: IN.PACT Admiral DEB-BTK-Product Status 37

Table 55: IN.PACT Admiral DEB-BTK-Product Description 37

Table 56: IN.PACT AV Access Drug-Coated Balloon-4-7mm-Product Status 38

Table 57: IN.PACT AV Access Drug-Coated Balloon-4-7mm-Product Description 38

Table 58: IN.PACT AV Access Drug-Coated Balloon-8 -12mm-Product Status 38

Table 59: IN.PACT AV Access Drug-Coated Balloon-8 -12mm-Product Description 39

Table 60: Medtronic plc-Ongoing Clinical Trials Overview 40

Table 61: IN.PACT AV Access Drug-Coated Balloon-4-7mm-A Randomized Controlled Trial of Drug-Eluting Balloon Angioplasty in Venous Anastomotic Stenosis of Dialysis Arteriovenous Graft 41

Table 62: 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 41

Table 63: 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 42

Table 64: IN.PACT AV Access Drug-Coated Balloon-8 -12mm-A Randomized Controlled Trial of Drug-Eluting Balloon Angioplasty in Venous Anastomotic Stenosis of Dialysis Arteriovenous Graft 43

Table 65: Micell Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 44

Table 66: Drug-Coated Balloon-Product Status 44

Table 67: Drug-Coated Balloon-Product Description 44

Table 68: Pulsus Medical LLC (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 45

Table 69: Micro-Perforated Catheter Balloon Drug Delivery System-Product Status 45

Table 70: Micro-Perforated Catheter Balloon Drug Delivery System-Product Description 45

Table 71: QT Vascular Ltd Pipeline Products & Ongoing Clinical Trials Overview 46

Table 72: Chocolate Touch-Product Status 46

Table 73: Chocolate Touch-Product Description 46

Table 74: QT Vascular Ltd-Ongoing Clinical Trials Overview 47

Table 75: Chocolate Touch-A Randomized Trial to Confirm the Safety and Effectiveness of Chocolate Touch Paclitaxel Coated Balloon Catheter, in Above the Knee Lesions 48

Table 76: QualiMed Innovative Medizinprodukte GmbH Pipeline Products & Ongoing Clinical Trials Overview 49

Table 77: Kinesyx-Based Peripheral Drug Coated Balloon-Product Status 49

Table 78: Kinesyx-Based Peripheral Drug Coated Balloon-Product Description 49

Table 79: SiL Vascular Ltd Pipeline Products & Ongoing Clinical Trials Overview 50

Table 80: Peripheral Vascular Balloon-Product Status 50

Table 81: Peripheral Vascular Balloon-Product Description 50

Table 82: Spectranetics Corp Pipeline Products & Ongoing Clinical Trials Overview 51

Table 83: Stellarex 0.014 Drug-Coated Balloon-Below The Knee (BTK)-Product Status 51

Table 84: Stellarex 0.014 Drug-Coated Balloon-Below The Knee (BTK)-Product Description 52

Table 85: Stellarex Drug Coated Balloon-Above-The-Knee-Product Status 52

Table 86: Stellarex Drug Coated Balloon-Above-The-Knee-Product Description 52

Table 87: Spectranetics Corp-Ongoing Clinical Trials Overview 53

Table 88: 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 54

Table 89: Stellarex Drug Coated Balloon-Above-The-Knee-Prospective, Randomized, Single-blind, U.S. Multi-center Study to Evaluate Treatment of Obstructive Superficial Femoral Artery or Popliteal Lesions with a Novel Paclitaxel-coated Percutaneous Angioplasty Balloon: ILLUMENATE Pivotal 54

Table 90: 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 55

Table 91: Stellarex Drug Coated Balloon-Above-The-Knee-Stellarex Vascular E-Registry 55

Table 92: SurModics Inc Pipeline Products & Ongoing Clinical Trials Overview 56

Table 93: Drug Coated Balloon-Arterio Venous (AV) Fistulas-Product Status 56

Table 94: Drug Coated Balloon-Arterio Venous (AV) Fistulas-Product Description 57

Table 95: Drug Coated Balloon-Below The Knee (BTK)-Product Status 57

Table 96: Drug Coated Balloon-Below The Knee (BTK)-Product Description 57

Table 97: SurVeil Drug Coated Balloon-Peripheral Artery Disease-Product Status 58

Table 98: SurVeil Drug Coated Balloon-Peripheral Artery Disease-Product Description 58

Table 99: SurModics Inc-Ongoing Clinical Trials Overview 59

Table 100: SurVeil Drug Coated Balloon-Peripheral Artery Disease-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 60

Table 101: 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 60

Table 102: TransMed7 LLC Pipeline Products & Ongoing Clinical Trials Overview 61

Table 103: Zeppelin II-Product Status 61

Table 104: Zeppelin II-Product Description 61

Table 105: Vascular Nanotransfer Technologies Pipeline Products & Ongoing Clinical Trials Overview 62

Table 106: Mitomycin-Based Drug Coated Balloon-Peripheral-Product Status 62

Table 107: Mitomycin-Based Drug Coated Balloon-Peripheral-Product Description 62

Table 108: Paclitaxel-Based Drug Coated Balloon-Peripheral-Product Status 63

Table 109: Paclitaxel-Based Drug Coated Balloon-Peripheral-Product Description 63

Table 110: Glossary 140

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Products and Companies

Products

AnGes Inc, NF-kB Decoy Oligo Coated PTA Balloon Catheter; AngioCure, Inc., AngioCure TOP-C Smart Balloon Catheter; Becton Dickinson and Co, Lutonix Drug Coated Balloon Catheter - Long Lesion; Boston Scientific Corp, Ranger Drug-Coated Balloon; 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; Lifetech Scientific (Shenzhen) Co Ltd, FemFlow Drug-Eluting Peripheral Balloon Catheter (DEB); 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; Pulsus Medical LLC (Inactive), Micro-Perforated Catheter Balloon Drug Delivery System; QT Vascular Ltd, Chocolate Touch; QualiMed Innovative Medizinprodukte GmbH, Kinesyx-Based Peripheral Drug Coated Balloon; SiL Vascular Ltd, Peripheral Vascular Balloon; Spectranetics Corp, Stellarex 0.014 Drug-Coated Balloon - Below The Knee (BTK); Spectranetics Corp, Stellarex Drug Coated Balloon - Above-The-Knee; SurModics Inc, Drug Coated Balloon - Arterio Venous (AV) Fistulas; SurModics Inc, Drug Coated Balloon - Below The Knee (BTK); SurModics Inc, SurVeil Drug Coated Balloon - Peripheral Artery Disease; TransMed7 LLC, Zeppelin II; Vascular Nanotransfer Technologies, Mitomycin-Based Drug Coated Balloon - Peripheral; Vascular Nanotransfer Technologies, Paclitaxel-Based Drug Coated Balloon - Peripheral


Companies

AnGes Inc

AngioCure, Inc.

Becton Dickinson and Co

Boston Scientific Corp

C. R. Bard Inc

Contego Medical, LLC

eucatech AG

Lifetech Scientific (Shenzhen) Co Ltd

M.A. Med Alliance SA

Medtronic plc

Micell Technologies Inc

Pulsus Medical LLC

QT Vascular Ltd

QualiMed Innovative Medizinprodukte GmbH

SiL Vascular Ltd

Spectranetics Corp

SurModics Inc

TransMed7 LLC

Vascular Nanotransfer Technologies

Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Medical Devices Pipeline Assessment, 2018

Summary

GlobalData's Medical Devices sector report, Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Medical Devices Pipeline Assessment, 2018 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

READ MORE

Scope

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 5

1.2 List of Figures 7

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 Inc Company Overview 17

5.2 AngioCure, Inc. Company Overview 19

5.3 Becton Dickinson and Co Company Overview 20

5.4 Boston Scientific Corp Company Overview 21

5.5 C. R. Bard Inc Company Overview 25

5.6 Contego Medical, LLC Company Overview 30

5.7 eucatech AG Company Overview 31

5.8 Lifetech Scientific (Shenzhen) Co Ltd Company Overview 32

5.9 M.A. Med Alliance SA Company Overview 33

5.10 Medtronic plc Company Overview 36

5.11 Micell Technologies Inc Company Overview 43

5.12 Pulsus Medical LLC (Inactive) Company Overview 44

5.13 QT Vascular Ltd Company Overview 45

5.14 QualiMed Innovative Medizinprodukte GmbH Company Overview 48

5.15 SiL Vascular Ltd Company Overview 49

5.16 Spectranetics Corp Company Overview 50

5.17 SurModics Inc Company Overview 55

5.18 TransMed7 LLC Company Overview 60

5.19 Vascular Nanotransfer Technologies Company Overview 61

6 Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Recent Developments 63

6.1 May 24, 2018: Medtronic Reports Fourth Quarter And Fiscal Year 2018 Financial Results 63

6.2 May 16, 2018: Surmodics Announces Leadership Change and Appointment of Interim CFO 65

6.3 May 11, 2018: Terumo Appoints its U.S.-based Subsidiary's Associate as the Fifth Terumo Fellow 66

6.4 May 11, 2018: Daiichi Sankyo Announces Changes to Representative Directors and Members of the Audit and Supervisory Board 66

6.5 May 07, 2018: Medtronic Appoints Mike Weinstein As Senior Vice President Of Strategy 67

6.6 May 02, 2018: Surmodics Reports Second Quarter Fiscal 2018 Results, Increases Fiscal 2018 Guidance 67

6.7 May 02, 2018: CORRECTING and REPLACING Surmodics Reports Second Quarter Fiscal 2018 Results, Increases Fiscal 2018 Guidance 68

6.8 May 02, 2018: Cardiovascular Systems Reports Fiscal 2018 Third-Quarter Financial Results 69

6.9 Apr 26, 2018: Charing Cross Symposium 2018: Real World DCB Registry BIOLUX P-III Shows Excellent 12-Month Results in the Full Cohort and BTK Subgroup 71

6.10 Apr 25, 2018: Boston Scientific Reports Financial Results For First Quarter 2018 72

6.11 Apr 25, 2018: Xianjian Technology Receives the Most Attention from Institutional Investors 74

6.12 Apr 23, 2018: Medtronic IN.PACT Admiral Drug Coated Balloon Receives FDA Approval to Treat Long SFA Lesions 74

6.13 Apr 20, 2018: Cook Medical Appoints Christina Anne Vice President of Distribution Channel Management 75

6.14 Apr 05, 2018: Dr. Laura Mauri to Join Medtronic as Vice President, Global Clinical Research & Analytics 76

6.15 Mar 23, 2018: 2017 fiscal year: B. Braun increases sales and earnings, with investments of one billion euros 76

6.16 Feb 28, 2018: Daiichi Sankyo Aligns U.S. Commercial Operations to Current Portfolio and Upcoming Cancer Pipeline 79

6.17 Feb 23, 2018: Daiichi Sankyo Announces Organizational Restructuring Effective as of April 1, 2018 79

6.18 Feb 21, 2018: Daiichi Sankyo Selected for 2018 Certified Health and Productivity Management Organization (White 500) 80

6.19 Feb 13, 2018: Four start-ups chosen for the B. Braun Accelerator Program 81

6.20 Feb 08, 2018: Terumo Revises the Full-Year Results Forecast for FY 2017 81

6.21 Feb 08, 2018: Surmodics Reports First Quarter Fiscal 2018 Results, Updates Fiscal 2018 Guidance 82

6.22 Feb 07, 2018: Cardiovascular Systems Reports Fiscal 2018 Second-Quarter Financial Results 82

6.23 Feb 02, 2018: Daiichi Sankyo Selected for Silver Class of RobecoSAM Sustainability Award 2018 84

6.24 Feb 02, 2018: Cardiovascular Systems Appoints Jeff Points as Chief Financial Officer 84

6.25 Feb 01, 2018: Boston Scientific Announces Results for Fourth Quarter and Full Year 2017 85

6.26 Jan 30, 2018: United Health Products Issues Update on HemoStyp South Korea MFDS Application 87

6.27 Jan 30, 2018: IN.PACT Admiral Demonstrates Consistent and Durable Outcomes in New Two-Year Japan Data and IN.PACT Global Critical Limb Ischemia Cohort Analysis 87

6.28 Jan 30, 2018: Alex Gu Named Senior Vice President and President of Medtronic's Greater China Region 88

6.29 Jan 25, 2018: Terumo Announces Change of Directors and Executive Officers 89

6.30 Jan 24, 2018: Cardiovascular Systems Appoints Rhonda Robb as New Chief Operating Officer 91

6.31 Jan 18, 2018: BD Announces Completion of Enrollment in the Lutonix 014 Drug Coated Balloon Below-The-Knee Trial 92

6.32 Jan 09, 2018: Boston Scientific Announces Preliminary Unaudited Sales For The Fourth Quarter And Full Year Ended December 31, 2017 92

6.33 Jan 07, 2018: LifeTech Scientific and Ally Bridge Group Form China-Global Medtech Investment and Operating Partnership 92

6.34 Dec 19, 2017: Bob White Named Executive Vice President and President of Medtronic's Minimally Invasive Therapies Group; Chris Lee to Assume Leadership of Medtronic's Asia Pacific Region 93

6.35 Dec 13, 2017: Terumo Constructs a New Building in Yamaguchi, Japan To Strengthen Production Operations in Interventional Systems 94

6.36 Dec 12, 2017: B. Braun establishes a subsidiary in Zambia 94

6.37 Nov 30, 2017: Daiichi Sankyo to Convert Kitasato Daiichi Sankyo Vaccine into Wholly Owned Subsidiary 95

6.38 Nov 21, 2017: Medtronic Reports Second Quarter Financial Results 95

6.39 Nov 15, 2017: Heiko Schipper is the new CEO and Head of the Consumer Health Division at Bayer 98

6.40 Nov 13, 2017: Philips showcases integrated vascular solutions at VEITH 2017 99

6.41 Nov 08, 2017: Surmodics Reports Fourth Quarter Fiscal 2017 Results and Provides Fiscal 2018 Guidance 100

6.42 Nov 08, 2017: Medtronic Announces Preliminary Second Quarter Revenue 101

6.43 Nov 02, 2017: Medtronic Releases Fiscal Year 2017 Integrated Performance Report 102

6.44 Oct 26, 2017: Boston Scientific Announces Results For Third Quarter 2017 103

6.45 Oct 25, 2017: Cardiovascular Systems Reports Fiscal 2018 First-Quarter Financial Results 104

6.46 Oct 25, 2017: Bard Announces Third Quarter Results 106

6.47 Oct 23, 2017: Surmodics Announces First Patient Enrolled in TRANSCEND Pivotal Clinical Trial for SurVeil Drug-Coated Balloon 107

6.48 Oct 17, 2017: Bayer Appoints Brenda L. Raphael Senior Vice President and General Manager of Therapeutics Business Unit for Consumer Health 108

6.49 Oct 10, 2017: Terumo Provides Update on Impact from Hurricane Maria 108

6.50 Oct 06, 2017: Medtronic Provides Update on Impact from Hurricane Maria 109

6.51 Oct 04, 2017: Boston Scientific Appoints Desiree Ralls-Morrison General Counsel and Corporate Secretary 110

6.52 Sep 26, 2017: MicroVention Celebrates Grand Opening of New Worldwide Innovation Center in Aliso Viejo, California 110

6.53 Sep 25, 2017: The T.I.N.T.I.N. trial evaluating the combined therapy of Luminor DCB and iVolution SX stent 111

6.54 Sep 21, 2017: Luminor 14m has received the Canadian Medical Device License 111

6.55 Sep 18, 2017: CIRSE 2017: BIOTRONIK Studies Demonstrate Efficacy of Minimizing Metal Burden in SFA Therapy 112

6.56 Sep 18, 2017: Eurocor announces the presentation of the 12 months data of the Freeway Stent Study at CIRSE in Copenhagen on Sept. 18, 2017 113

6.57 Sep 18, 2017: Cardiovascular Systems Announces Anticipated Revenue Impact from Hurricanes Harvey and Irma 114

6.58 Sep 15, 2017: Daiichi Sankyo Listed on the Dow Jones Sustainability Indices World Index 114

6.59 Sep 14, 2017: Efficacy of Philips' Stellarex .035" low-dose drug-coated balloon demonstrated in clinical trial at two years 115

6.60 Sep 13, 2017: Six-Month Data from the Surmodics SurVeil Drug-Coated Balloon Early Feasibility Study Presented at VIVA 2017 115

6.61 Sep 13, 2017: New Unpublished Clinical Trial Results of Stellarex DCB Announced At VIVA 17 117

6.62 Sep 12, 2017: Medtronic IN.PACT Admiral DCB Global Two Year Data and IN.PACT SFA Four Year Data Presented in VIVA Late Breaking Clinical Trials 117

6.63 Sep 08, 2017: Medtronic Announces Japanese Regulatory Approval for the IN.PACT Admiral Drug-Coated Balloon 119

6.64 Sep 07, 2017: Daiichi Sankyo Announces Organizational Restructuring Effective as of October 1, 2017 119

6.65 Aug 28, 2017: C. R. Bard Receives FDA Premarket Approval of the LUTONIX 035 Drug Coated Balloon as the First and Only DCB for the Treatment of Patients with Dysfunctional AV Fistulae 120

6.66 Aug 22, 2017: Medtronic Reports First Quarter Financial Results 121

6.67 Aug 03, 2017: Surmodics Reports Third Quarter Fiscal 2017 Results and Updates Fiscal 2017 Guidance 123

6.68 Aug 03, 2017: Spectranetics Reports Second Quarter 2017 Revenue of $74.7 million 124

6.69 Aug 02, 2017: Cardiovascular Systems Reports Fiscal 2017 Fourth-Quarter Financial Results 125

6.70 Jul 31, 2017: QT Vascular begins enrollment in US pivotal study of its drug-coated peripheral balloon 127

6.71 Jul 31, 2017: Dr. Joachim Schulz joins the Management Board of B. Braun Melsungen 127

6.72 Jul 28, 2017: Indonesian Minister of Health Launches New German Pharmaceutical Factory in Karawang 128

6.73 Jul 27, 2017: Boston Scientific Announces Results for Second Quarter 2017 128

6.74 Jul 26, 2017: Spectranetics Announces FDA Approval of Stellarex Drug-Coated Balloon 130

6.75 Jul 26, 2017: Surmodics Receives IDE Approval to Initiate Pivotal Trial of the SurVeil Drug-Coated Balloon 131

6.76 Jul 11, 2017: Daiichi Sankyo Selected for Ninth Consecutive Year as Constituent of FTSE4Good Global Index by FTSE Russell 133

6.77 Jul 03, 2017: 15th Takamine Memorial Daiichi Sankyo Prize Winner Announced 133

6.78 Jun 27, 2017: Boston Scientific Outlines Strategy for Sustained Growth at 2017 Investor Day 133

6.79 Jun 14, 2017: Spectranetics Announces Election of New Chairperson of the Board of Directors 135

7 Appendix 137

7.1 Methodology 137

7.2 About GlobalData 140

7.3 Contact Us 140

7.4 Disclaimer 140


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 11

Figure 2: Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Pipeline Products by Territory 12

Figure 3: Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Pipeline Products by Regulatory Path 13

Figure 4: Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Pipeline Products by Estimated Approval Date 14

Figure 5: Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Ongoing Clinical Trials 15


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 11

Table 2: Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Pipeline Products by Territory 12

Table 3: Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Pipeline Products by Regulatory Path 13

Table 4: Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Pipeline Products by Estimated Approval Date 14

Table 5: Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Ongoing Clinical Trials 15

Table 6: Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB) Companies-Pipeline Products by Stage of Development 16

Table 7: Percutaneous Transluminal Angioplasty (PTA) Peripheral Drug Eluting Balloons (DEB)-Pipeline Products by Stage of Development 17

Table 8: AnGes Inc Pipeline Products & Ongoing Clinical Trials Overview 18

Table 9: NF-kB Decoy Oligo Coated PTA Balloon Catheter-Product Status 18

Table 10: NF-kB Decoy Oligo Coated PTA Balloon Catheter-Product Description 19

Table 11: AngioCure, Inc. Pipeline Products & Ongoing Clinical Trials Overview 20

Table 12: AngioCure TOP-C Smart Balloon Catheter-Product Status 20

Table 13: AngioCure TOP-C Smart Balloon Catheter-Product Description 20

Table 14: Becton Dickinson and Co Pipeline Products & Ongoing Clinical Trials Overview 21

Table 15: Lutonix Drug Coated Balloon Catheter-Long Lesion-Product Status 21

Table 16: Lutonix Drug Coated Balloon Catheter-Long Lesion-Product Description 21

Table 17: Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 22

Table 18: Ranger Drug-Coated Balloon-Product Status 22

Table 19: Ranger Drug-Coated Balloon-Product Description 22

Table 20: Boston Scientific Corp-Ongoing Clinical Trials Overview 23

Table 21: Ranger Drug-Coated Balloon-A Randomized Trial Comparing Drug-coated Balloon and Regular Balloon for Dialysis Access Stent Graft Restenosis 24

Table 22: Ranger Drug-Coated Balloon-Clinical Study of the Boston Scientific Paclitaxel-coated PTA (Percutaneous Transluminal Angioplasty) Balloon Catheter (Ranger and Ranger SL (OTW) DCB) in China 24

Table 23: Ranger Drug-Coated Balloon-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 24

Table 24: Ranger Drug-Coated Balloon-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) 25

Table 25: Ranger Drug-Coated Balloon-Prospective, Randomized, Multicenter Clinical Study of the Hemoteq Ranger Paclitaxel-coated PTA Balloon Catheter (Ranger DCB) in Comparison to Uncoated PTA Balloons in Femoropopliteal Lesions 25

Table 26: Ranger Drug-Coated Balloon-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) 25

Table 27: C. R. Bard Inc Pipeline Products & Ongoing Clinical Trials Overview 26

Table 28: Lutonix-ISR-Product Status 26

Table 29: Lutonix-ISR-Product Description 26

Table 30: Lutonix 014 DCB Catheter-Product Status 27

Table 31: Lutonix 014 DCB Catheter-Product Description 27

Table 32: C. R. Bard Inc-Ongoing Clinical Trials Overview 28

Table 33: Lutonix 014 DCB Catheter-A Prospective, Multicenter, Registry of the Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries (LEVANT 2 Safety Registry) 29

Table 34: 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 29

Table 35: 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 29

Table 36: Lutonix 014 DCB Catheter-Drug Eluting Balloon in Peripheral Intervention for Below-the-knee Arteries with Freeway and Lutonix 30

Table 37: Lutonix 014 DCB Catheter-Evaluation of Paclitaxel in Patients with CLI (Critical Limb Ischemia) and Femoropopliteal Occlusive Disease Treated with DCB Angioplasty 30

Table 38: Lutonix 014 DCB Catheter-Tack Optimized Balloon Angioplasty Study for Superficial Femoral and Proximal Popliteal Arteries Using the Tack Endovascular System 30

Table 39: Contego Medical, LLC Pipeline Products & Ongoing Clinical Trials Overview 31

Table 40: Tibial Artery Drug Eluting Balloon-Product Status 31

Table 41: Tibial Artery Drug Eluting Balloon-Product Description 31

Table 42: eucatech AG Pipeline Products & Ongoing Clinical Trials Overview 32

Table 43: Support-Product Status 32

Table 44: Support-Product Description 32

Table 45: Lifetech Scientific (Shenzhen) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 33

Table 46: FemFlow Drug-Eluting Peripheral Balloon Catheter (DEB)-Product Status 33

Table 47: FemFlow Drug-Eluting Peripheral Balloon Catheter (DEB)-Product Description 33

Table 48: M.A. Med Alliance SA Pipeline Products & Ongoing Clinical Trials Overview 34

Table 49: SELUTION Sirolimus Coated Balloon-Product Status 34

Table 50: SELUTION Sirolimus Coated Balloon-Product Description 34

Table 51: M.A. Med Alliance SA-Ongoing Clinical Trials Overview 35

Table 52: 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 36

Table 53: Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 37

Table 54: IN.PACT Admiral DEB-BTK-Product Status 37

Table 55: IN.PACT Admiral DEB-BTK-Product Description 37

Table 56: IN.PACT AV Access Drug-Coated Balloon-4-7mm-Product Status 38

Table 57: IN.PACT AV Access Drug-Coated Balloon-4-7mm-Product Description 38

Table 58: IN.PACT AV Access Drug-Coated Balloon-8 -12mm-Product Status 38

Table 59: IN.PACT AV Access Drug-Coated Balloon-8 -12mm-Product Description 39

Table 60: Medtronic plc-Ongoing Clinical Trials Overview 40

Table 61: IN.PACT AV Access Drug-Coated Balloon-4-7mm-A Randomized Controlled Trial of Drug-Eluting Balloon Angioplasty in Venous Anastomotic Stenosis of Dialysis Arteriovenous Graft 41

Table 62: 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 41

Table 63: 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 42

Table 64: IN.PACT AV Access Drug-Coated Balloon-8 -12mm-A Randomized Controlled Trial of Drug-Eluting Balloon Angioplasty in Venous Anastomotic Stenosis of Dialysis Arteriovenous Graft 43

Table 65: Micell Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 44

Table 66: Drug-Coated Balloon-Product Status 44

Table 67: Drug-Coated Balloon-Product Description 44

Table 68: Pulsus Medical LLC (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 45

Table 69: Micro-Perforated Catheter Balloon Drug Delivery System-Product Status 45

Table 70: Micro-Perforated Catheter Balloon Drug Delivery System-Product Description 45

Table 71: QT Vascular Ltd Pipeline Products & Ongoing Clinical Trials Overview 46

Table 72: Chocolate Touch-Product Status 46

Table 73: Chocolate Touch-Product Description 46

Table 74: QT Vascular Ltd-Ongoing Clinical Trials Overview 47

Table 75: Chocolate Touch-A Randomized Trial to Confirm the Safety and Effectiveness of Chocolate Touch Paclitaxel Coated Balloon Catheter, in Above the Knee Lesions 48

Table 76: QualiMed Innovative Medizinprodukte GmbH Pipeline Products & Ongoing Clinical Trials Overview 49

Table 77: Kinesyx-Based Peripheral Drug Coated Balloon-Product Status 49

Table 78: Kinesyx-Based Peripheral Drug Coated Balloon-Product Description 49

Table 79: SiL Vascular Ltd Pipeline Products & Ongoing Clinical Trials Overview 50

Table 80: Peripheral Vascular Balloon-Product Status 50

Table 81: Peripheral Vascular Balloon-Product Description 50

Table 82: Spectranetics Corp Pipeline Products & Ongoing Clinical Trials Overview 51

Table 83: Stellarex 0.014 Drug-Coated Balloon-Below The Knee (BTK)-Product Status 51

Table 84: Stellarex 0.014 Drug-Coated Balloon-Below The Knee (BTK)-Product Description 52

Table 85: Stellarex Drug Coated Balloon-Above-The-Knee-Product Status 52

Table 86: Stellarex Drug Coated Balloon-Above-The-Knee-Product Description 52

Table 87: Spectranetics Corp-Ongoing Clinical Trials Overview 53

Table 88: 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 54

Table 89: Stellarex Drug Coated Balloon-Above-The-Knee-Prospective, Randomized, Single-blind, U.S. Multi-center Study to Evaluate Treatment of Obstructive Superficial Femoral Artery or Popliteal Lesions with a Novel Paclitaxel-coated Percutaneous Angioplasty Balloon: ILLUMENATE Pivotal 54

Table 90: 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 55

Table 91: Stellarex Drug Coated Balloon-Above-The-Knee-Stellarex Vascular E-Registry 55

Table 92: SurModics Inc Pipeline Products & Ongoing Clinical Trials Overview 56

Table 93: Drug Coated Balloon-Arterio Venous (AV) Fistulas-Product Status 56

Table 94: Drug Coated Balloon-Arterio Venous (AV) Fistulas-Product Description 57

Table 95: Drug Coated Balloon-Below The Knee (BTK)-Product Status 57

Table 96: Drug Coated Balloon-Below The Knee (BTK)-Product Description 57

Table 97: SurVeil Drug Coated Balloon-Peripheral Artery Disease-Product Status 58

Table 98: SurVeil Drug Coated Balloon-Peripheral Artery Disease-Product Description 58

Table 99: SurModics Inc-Ongoing Clinical Trials Overview 59

Table 100: SurVeil Drug Coated Balloon-Peripheral Artery Disease-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 60

Table 101: 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 60

Table 102: TransMed7 LLC Pipeline Products & Ongoing Clinical Trials Overview 61

Table 103: Zeppelin II-Product Status 61

Table 104: Zeppelin II-Product Description 61

Table 105: Vascular Nanotransfer Technologies Pipeline Products & Ongoing Clinical Trials Overview 62

Table 106: Mitomycin-Based Drug Coated Balloon-Peripheral-Product Status 62

Table 107: Mitomycin-Based Drug Coated Balloon-Peripheral-Product Description 62

Table 108: Paclitaxel-Based Drug Coated Balloon-Peripheral-Product Status 63

Table 109: Paclitaxel-Based Drug Coated Balloon-Peripheral-Product Description 63

Table 110: Glossary 140

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Products

AnGes Inc, NF-kB Decoy Oligo Coated PTA Balloon Catheter; AngioCure, Inc., AngioCure TOP-C Smart Balloon Catheter; Becton Dickinson and Co, Lutonix Drug Coated Balloon Catheter - Long Lesion; Boston Scientific Corp, Ranger Drug-Coated Balloon; 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; Lifetech Scientific (Shenzhen) Co Ltd, FemFlow Drug-Eluting Peripheral Balloon Catheter (DEB); 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; Pulsus Medical LLC (Inactive), Micro-Perforated Catheter Balloon Drug Delivery System; QT Vascular Ltd, Chocolate Touch; QualiMed Innovative Medizinprodukte GmbH, Kinesyx-Based Peripheral Drug Coated Balloon; SiL Vascular Ltd, Peripheral Vascular Balloon; Spectranetics Corp, Stellarex 0.014 Drug-Coated Balloon - Below The Knee (BTK); Spectranetics Corp, Stellarex Drug Coated Balloon - Above-The-Knee; SurModics Inc, Drug Coated Balloon - Arterio Venous (AV) Fistulas; SurModics Inc, Drug Coated Balloon - Below The Knee (BTK); SurModics Inc, SurVeil Drug Coated Balloon - Peripheral Artery Disease; TransMed7 LLC, Zeppelin II; Vascular Nanotransfer Technologies, Mitomycin-Based Drug Coated Balloon - Peripheral; Vascular Nanotransfer Technologies, Paclitaxel-Based Drug Coated Balloon - Peripheral


Companies

AnGes Inc

AngioCure, Inc.

Becton Dickinson and Co

Boston Scientific Corp

C. R. Bard Inc

Contego Medical, LLC

eucatech AG

Lifetech Scientific (Shenzhen) Co Ltd

M.A. Med Alliance SA

Medtronic plc

Micell Technologies Inc

Pulsus Medical LLC

QT Vascular Ltd

QualiMed Innovative Medizinprodukte GmbH

SiL Vascular Ltd

Spectranetics Corp

SurModics Inc

TransMed7 LLC

Vascular Nanotransfer Technologies