Percutaneous Transluminal Angioplasty (PTA) Balloons - Medical Devices Pipeline Assessment, 2017

Published : Mar-2017

No. of Pages : 109

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Table of Contents

1 Table of Contents 2
1.1 List of Tables 5
1.2 List of Figures 6

2 Introduction 7
2.1 Percutaneous Transluminal Angioplasty (PTA) Balloons Overview 7

3 Products under Development 8
3.1 Percutaneous Transluminal Angioplasty (PTA) Balloons - Pipeline Products by Stage of Development 8
3.2 Percutaneous Transluminal Angioplasty (PTA) Balloons - Pipeline Products by Territory 9
3.3 Percutaneous Transluminal Angioplasty (PTA) Balloons - Pipeline Products by Regulatory Path 10
3.4 Percutaneous Transluminal Angioplasty (PTA) Balloons - Pipeline Products by Estimated Approval Date 11
3.5 Percutaneous Transluminal Angioplasty (PTA) Balloons - Ongoing Clinical Trials 12

4 Percutaneous Transluminal Angioplasty (PTA) Balloons - Pipeline Products under Development by Companies 13
4.1 Percutaneous Transluminal Angioplasty (PTA) Balloons Companies - Pipeline Products by Stage of Development 13
4.2 Percutaneous Transluminal Angioplasty (PTA) Balloons - Pipeline Products by Stage of Development 14

5 Percutaneous Transluminal Angioplasty (PTA) Balloons Companies and Product Overview 15
5.1 Andramed GmbH Company Overview 15
5.1.1 Andramed GmbH Pipeline Products & Ongoing Clinical Trials Overview 15
5.2 Boston Scientific Corp Company Overview 16
5.2.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 16
5.3 C. R. Bard Inc Company Overview 17
5.3.1 C. R. Bard Inc Pipeline Products & Ongoing Clinical Trials Overview 17
5.4 Cagent Vascular LLC Company Overview 21
5.4.1 Cagent Vascular LLC Pipeline Products & Ongoing Clinical Trials Overview 21
5.5 Contego Medical, LLC Company Overview 22
5.5.1 Contego Medical, LLC Pipeline Products & Ongoing Clinical Trials Overview 22
5.6 Hexacath SA Company Overview 26
5.6.1 Hexacath SA Pipeline Products & Ongoing Clinical Trials Overview 26
5.7 MicroPort Scientific Corp Company Overview 27
5.7.1 MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 27
5.8 NuVascular Technologies Inc Company Overview 29
5.8.1 NuVascular Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 29
5.9 Occlutech International AB Company Overview 30
5.9.1 Occlutech International AB Pipeline Products & Ongoing Clinical Trials Overview 30
5.10 QT Vascular Ltd Company Overview 31
5.10.1 QT Vascular Ltd Pipeline Products & Ongoing Clinical Trials Overview 31
5.11 SurModics Inc Company Overview 34
5.11.1 SurModics Inc Pipeline Products & Ongoing Clinical Trials Overview 34

6 Percutaneous Transluminal Angioplasty (PTA) Balloons- Recent Developments 38
6.1 Mar 13, 2017: Cook Medical Announces Umesh Patel as President of Cook Biotech 38
6.2 Mar 07, 2017: Anteo Technologies Announces Verification Study With Cook Medical Australia 38
6.3 Feb 27, 2017: AV Medical's Chameleon Receives Expanded Indication to Include Infusion of Diagnostic or Therapeutic Fluids 39
6.4 Feb 23, 2017: Teleflex Announces Benson Smith to Retire as Chief Executive Officer at End of 2017; Liam Kelly to Succeed Smith as Chief Executive Officer 40
6.5 Feb 23, 2017: Teleflex Reports Fourth Quarter and Full Year 2016 Results; Provides 2017 Guidance 40
6.6 Feb 23, 2017: Spectranetics Reports Fourth Quarter 2016 Revenue of $71.9 million 42
6.7 Feb 21, 2017: Medtronic Reports Third Quarter Financial Results 43
6.8 Feb 09, 2017: Terumo Announces Change of Executive Officers 45
6.9 Feb 08, 2017: AV Medical's Chameleon PTA Balloon Catheter to be Featured at Upcoming ASDIN Scientific Meeting 46
6.10 Feb 06, 2017: Medtronic Awarded U.S. Department of Veterans Affairs National Contracts for Home Telehealth Technologies, with Three Other Vendors 47
6.11 Feb 02, 2017: Boston Scientific Announces Results For Fourth Quarter And Full Year Ended December 31, 2016 47
6.12 Feb 02, 2017: Surmodics Reports First Quarter Fiscal 2017 Results 49
6.13 Feb 01, 2017: Edwards Lifesciences Reports Fourth Quarter Results 50
6.14 Jan 31, 2017: Terumo Opens a Branch in Yangon 52
6.15 Jan 26, 2017: Bard Announces Fourth Quarter Results 52
6.16 Jan 19, 2017: Terumo to Acquire Bolton Medical from Werfen Life 53
6.17 Jan 12, 2017: STENTYS: 2016 Annual Revenues up 20% at 7.3 Million 53
6.18 Jan 11, 2017: Spectranetics Names Scott Hutton as General Manager, Vascular Intervention 54
6.19 Dec 19, 2016: MicroPort Endovascular Received CE Mark Approval for Reewarm Peripheral Balloon Dilation Catheter 54
6.20 Dec 12, 2016: Terumo Formulates 5-Year Mid- to Long-term Growth Strategy 55
6.21 Dec 08, 2016: Edwards Lifesciences Outlines Growth Strategy At Annual Investor Conference 55
6.22 Dec 01, 2016: Teleflex Acquires Vascular Solutions for up to USD1 Billion 57
6.23 Nov 22, 2016: Medtronic Reports Second Quarter Financial Results 58
6.24 Nov 16, 2016: Medtronic Releases FY16 Integrated Performance Report 61
6.25 Nov 16, 2016: Surmodics Reports Fourth Quarter Fiscal 2016 Results 61
6.26 Nov 15, 2016: CEVA to work with Medtronic for distribution facility construction 63
6.27 Oct 31, 2016: Surmodics Announces Launch of Serene Single-Coat (SC) Solutions Offering Unmatched Lubricity and Durability to a Broader Range of Device Applications 63
6.28 Oct 27, 2016: Svelte Medical receives CE Mark for new treatment of coronary artery disease 64
6.29 Oct 27, 2016: Teleflex Reports Third Quarter 2016 Results 64
6.30 Oct 27, 2016: Spectranetics Reports Third Quarter 2016 Revenue of $68.3 million 67
6.31 Oct 26, 2016: Boston Scientific Announces Results For Third Quarter 2016 67
6.32 Oct 25, 2016: Edwards Lifesciences Reports Third Quarter Results 69
6.33 Oct 25, 2016: Bard Announces Third Quarter Results 71
6.34 Oct 24, 2016: Vascular Solutions Reports Third Quarter Results 71
6.35 Oct 10, 2016: Professor Ian Meredith To Join Boston Scientific As Executive Vice President And Global Chief Medical Officer 74
6.36 Sep 22, 2016: LUTONIX Global Real-World Registry 24-Month Outcomes Presented at VIVA 2016 75
6.37 Sep 21, 2016: AV Medical's Chameleon PTA Balloon Catheter Featured in Radiation Protection Pavilion at CIRSE Conference 75
6.38 Sep 15, 2016: STENTYS Reports 2016 First-Half Results 76
6.39 Sep 15, 2016: Medtronic Names Mark Ploof Senior Vice President of Global Operations and Business Services 77
6.40 Aug 31, 2016: Cook Medical Names Jean-Marc Creissel Vice President of Operations in Greater China 78
6.41 Aug 30, 2016: MPSC Announces 2016 Interim Results 79
6.42 Aug 25, 2016: Medtronic Reports First Quarter Financial Results 80
6.43 Jul 28, 2016: Spectranetics Reports Second Quarter 2016 Revenue of $67.7 million 83
6.44 Jul 28, 2016: Surmodics Reports Third Quarter Fiscal 2016 Results 84
6.45 Jul 28, 2016: Boston Scientific Announces Results For Second Quarter 2016 85
6.46 Jul 28, 2016: Teleflex Reports Second Quarter 2016 Results 87
6.47 Jul 26, 2016: Edwards Lifesciences Reports Second Quarter Results 88
6.48 Jul 26, 2016: Bard Announces Second Quarter Results 90
6.49 Jul 25, 2016: QT Vascular Announces Federal Circuit Reversal of Adverse AngioScore / Spectranetics Judgment 91
6.50 Jul 25, 2016: QT Vascular Announces Federal Circuit Reversal of Adverse AngioScore / Spectranetics Judgment 91
6.51 Jul 25, 2016: Vascular Solutions Reports Second Quarter Results 92
6.52 Jul 21, 2016: Federal Circuit Court Rules in Appeal 94
6.53 Jul 20, 2016: Contego Medical Completes Enrollment of Paladin Clinical Registry 95
6.54 Jul 18, 2016: AV Medical Announces Initial Experience in the US with Its Chameleon PTA Balloon Catheter 95
6.55 Jul 13, 2016: Boston Scientific Elects Yoshiaki Fujimori to Board of Directors 96
6.56 Jul 12, 2016: STENTYS: 41% Increase in Revenues in the Second Quarter of 2016 96
6.57 Jul 04, 2016: STENTYS: Appointment of Cardiolovascular Device Veteran as New CEO 97
6.58 Jun 30, 2016: NuVasive Agrees to Settle Patent Litigation With Medtronic 97
6.59 Jun 08, 2016: Boston Scientific Announces Restructuring Program to Support Long-Term Growth and Innovation 98
6.60 Jun 06, 2016: Medtronic Outlines Future Growth Vision at Investor Day 98
6.61 Jun 03, 2016: LEPUCARE established in India 99
6.62 May 31, 2016: Medtronic Reports Fourth Quarter and Fiscal Year 2016 Financial Results 99
6.63 May 24, 2016: OrbusNeich Introduces News JADE catheter to Treat Peripheral Disease 102
6.64 May 24, 2016: OrbusNeich Expands Portfolio To Include Scoreflex PTA balloon Catheter 103
6.65 May 11, 2016: Teleflex Raises USD400 Million in Public Offering of 4.875% Notes Due 2026 103
6.66 Apr 21, 2016: AV Medical Announces Successful Completion of 30 Patient Study with its Innovative Angioplasty Balloon Catheter, Chameleon 104
6.67 Apr 13, 2016: STENTYS Reports 38% Increase in Revenues in First Quarter 2016 104
6.68 Mar 23, 2016: MicroPort Signs Cooperation Agreement with Beijing Weimai Medical Device 104

7 Appendix 106
7.1 Methodology 106
7.2 About GlobalData 109
7.3 Contact Us 109
7.4 Disclaimer 109

List of Tables

Table 1: Percutaneous Transluminal Angioplasty (PTA) Balloons - Pipeline Products by Stage of Development 8
Table 2: Percutaneous Transluminal Angioplasty (PTA) Balloons - Pipeline Products by Territory 9
Table 3: Percutaneous Transluminal Angioplasty (PTA) Balloons - Pipeline Products by Regulatory Path 10
Table 4: Percutaneous Transluminal Angioplasty (PTA) Balloons - Pipeline Products by Estimated Approval Date 11
Table 5: Percutaneous Transluminal Angioplasty (PTA) Balloons - Ongoing Clinical Trials 12
Table 6: Percutaneous Transluminal Angioplasty (PTA) Balloons Companies - Pipeline Products by Stage of Development 13
Table 7: Percutaneous Transluminal Angioplasty (PTA) Balloons - Pipeline Products by Stage of Development 14
Table 8: Andramed GmbH Pipeline Products & Ongoing Clinical Trials Overview 15
Table 9: Zero-Profile PTA Balloon - Product Status 15
Table 10: Zero-Profile PTA Balloon - Product Description 15
Table 11: Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 16
Table 12: Next Generation 0.018" Balloon - Product Status 16
Table 13: Next Generation 0.018" Balloon - Product Description 16
Table 14: C. R. Bard Inc Pipeline Products & Ongoing Clinical Trials Overview 17
Table 15: LUTONIX 035 Drug Coated Balloon PTA Catheter - Long Femoropopliteal Lesions - Product Status 17
Table 16: LUTONIX 035 Drug Coated Balloon PTA Catheter - Long Femoropopliteal Lesions - Product Description 18
Table 17: Ultrascore - Product Status 18
Table 18: Ultrascore - Product Description 18
Table 19: C. R. Bard Inc - Ongoing Clinical Trials Overview 19
Table 20: LUTONIX 035 Drug Coated Balloon PTA Catheter - Long Femoropopliteal Lesions - A Randomized Trial to Confirm the Safety and Effectiveness of Chocolate Touch Paclitaxel Coated Balloon Catheter, in Above the Knee Lesions 20
Table 21: Cagent Vascular LLC Pipeline Products & Ongoing Clinical Trials Overview 21
Table 22: Serranator Bass - Product Status 21
Table 23: Serranator Bass - Product Description 21
Table 24: Contego Medical, LLC Pipeline Products & Ongoing Clinical Trials Overview 22
Table 25: PALADIN - Product Status 22
Table 26: PALADIN - Product Description 22
Table 27: Superficial Femoral Artery Balloon - Product Status 23
Table 28: Superficial Femoral Artery Balloon - Product Description 23
Table 29: Contego Medical, LLC - Ongoing Clinical Trials Overview 24
Table 30: PALADIN - Multi-center Study to Evaluate Acute Safety and Clinical Performance of Paladin Carotid Post-dilation Balloon with Integrated Embolic Protection 25
Table 31: Hexacath SA Pipeline Products & Ongoing Clinical Trials Overview 26
Table 32: MERAK PTA Dilatation Catheter - Product Status 26
Table 33: MERAK PTA Dilatation Catheter - Product Description 26
Table 34: MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 27
Table 35: Reewarm14 - Product Status 27
Table 36: Reewarm14 - Product Description 27
Table 37: Reewarm18 Peripheral Balloon Dilation Catheter - Product Status 28
Table 38: Reewarm18 Peripheral Balloon Dilation Catheter - Product Description 28
Table 39: NuVascular Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 29
Table 40: NuSpun DE Balloon - Product Status 29
Table 41: NuSpun DE Balloon - Product Description 29
Table 42: Occlutech International AB Pipeline Products & Ongoing Clinical Trials Overview 30
Table 43: Occlutech Sizing Balloon - Product Status 30
Table 44: Occlutech Sizing Balloon - Product Description 30
Table 45: QT Vascular Ltd Pipeline Products & Ongoing Clinical Trials Overview 31
Table 46: Chocolate PTA Balloon Catheter - Product Status 31
Table 47: Chocolate PTA Balloon Catheter - Product Description 31
Table 48: QT Vascular Ltd - Ongoing Clinical Trials Overview 32
Table 49: Chocolate PTA Balloon Catheter - Procedural Success Assessment After Treatment With Drug Coated Chocolate Balloon 33
Table 50: SurModics Inc Pipeline Products & Ongoing Clinical Trials Overview 34
Table 51: 0.018" OTW Dual Lumen PTA Catheter - Product Status 34
Table 52: 0.018" OTW Dual Lumen PTA Catheter - Product Description 35
Table 53: 0.018" RX Dual Lumen PTA Catheter - Product Status 35
Table 54: 0.018" RX Dual Lumen PTA Catheter - Product Description 35
Table 55: 0.035" Large Diameter OTW PTA Catheter - Product Status 36
Table 56: 0.035" Large Diameter OTW PTA Catheter - Product Description 36
Table 57: 0.035" Next Generation Workhorse PTA Catheter - Product Status 36
Table 58: 0.035" Next Generation Workhorse PTA Catheter - Product Description 37
Table 59: Glossary 108

List of Figures

Figure 1: Percutaneous Transluminal Angioplasty (PTA) Balloons - Pipeline Products by Stage of Development 8
Figure 2: Percutaneous Transluminal Angioplasty (PTA) Balloons - Pipeline Products by Territory 9
Figure 3: Percutaneous Transluminal Angioplasty (PTA) Balloons - Pipeline Products by Regulatory Path 10
Figure 4: Percutaneous Transluminal Angioplasty (PTA) Balloons - Pipeline Products by Estimated Approval Date 11
Figure 5: Percutaneous Transluminal Angioplasty (PTA) Balloons - Ongoing Clinical Trials 12

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