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

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
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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