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United States Peripheral Vascular Devices Market Outlook to 2020 GDMECC0339DB/ Published May 2014

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United States Peripheral Vascular

Devices Market Outlook to 2020

Reference Code: GDMECC0339DB

Publication Date: May 2014

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1 Table of Contents

1 Table of Contents .............................................................................................................................................. 2

1.1 List of Tables .............................................................................................................................................. 9

1.2 List of Figures ........................................................................................................................................... 11

2 Introduction...................................................................................................................................................... 13

2.1 What Is This Report About? ...................................................................................................................... 13

2.2 Peripheral Vascular Devices Market Segmentation ................................................................................... 13

2.3 Definitions of Markets Covered in the Report ............................................................................................ 14

3 Peripheral Vascular Devices Market, United States ....................................................................................... 19

3.1 Peripheral Vascular Devices Market, United States, Revenue ($m), 2005-2012 ........................................ 19

3.2 Peripheral Vascular Devices Market, United States, Revenue ($m), 2012-2020 ........................................ 21

3.2.1 Aortic Stent Grafts Market, United States, Revenue ($m), by Segment, 2005-2012 ............................... 23

3.2.2 Inferior Vena Cava Filters (IVCF) Market, United States, Revenue ($m), by Segment, 2005-2012 ......... 24

3.2.3 Peripheral Embolic Protection Devices Market, United States, Revenue ($m), by Segment, 2005-2012 . 25

3.2.4 Peripheral Guidewires Market, United States, Revenue ($m), by Segment, 2005-2012 .......................... 27

3.2.5 Peripheral Vascular Stents Market, United States, Revenue ($m), by Segment, 2005-2012................... 28

3.2.6 Peripheral Venous Thrombectomy Devices Market, United States, Revenue ($m), by Segment, 2005-2012 33

3.2.7 Aortic Stent Grafts Market, United States, Revenue ($m), by Segment, 2012-2020 ............................... 35

3.2.8 Inferior Vena Cava Filters (IVCF) Market, United States, Revenue ($m), by Segment, 2012-2020 ......... 37

3.2.9 Peripheral Embolic Protection Devices Market, United States, Revenue ($m), by Segment, 2012-2020 . 39

3.2.10 Peripheral Guidewires Market, United States, Revenue ($m), by Segment, 2012-2020 ...................... 41

3.2.11 Peripheral Vascular Stents Market, United States, Revenue ($m), by Segment, 2012-2020 ............... 43

3.2.12 Peripheral Venous Thrombectomy Devices Market, United States, Revenue ($m), by Segment, 2012-2020 49

3.3 Peripheral Vascular Devices Market, United States, Volume (Units), 2005-2012 ....................................... 51

3.4 Peripheral Vascular Devices Market, United States, Volume (Units), 2012-2020 ....................................... 53

3.4.1 Aortic Stent Grafts Market, United States, Volume (Units), by Segment, 2005-2012 .............................. 56

3.4.2 Inferior Vena Cava Filters (IVCF) Market, United States, Volume (Units), by Segment, 2005-2012 ........ 58

3.4.3 Peripheral Embolic Protection Devices Market, United States, Volume (Units), by Segment, 2005-2012 60

3.4.4 Peripheral Guidewires Market, United States, Volume (Units), by Segment, 2005-2012......................... 62

3.4.5 Peripheral Vascular Stents Market, United States, Volume (Units), by Segment, 2005-2012 .................. 64

3.4.6 Peripheral Venous Thrombectomy Devices Market, United States, Volume (Units), by Segment, 2005-2012 69

3.4.7 Aortic Stent Grafts Market, United States, Volume (Units), by Segment, 2012-2020 .............................. 71

3.4.8 Inferior Vena Cava Filters (IVCF) Market, United States, Volume (Units), by Segment, 2012-2020 ........ 73

3.4.9 Peripheral Embolic Protection Devices Market, United States, Volume (Units), by Segment, 2012-2020 75

3.4.10 Peripheral Guidewires Market, United States, Volume (Units), by Segment, 2012-2020 ..................... 77

3.4.11 Peripheral Vascular Stents Market, United States, Volume (Units), by Segment, 2012-2020 .............. 79

3.4.12 Peripheral Venous Thrombectomy Devices Market, United States, Volume (Units), by Segment, 2012-2020 87

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3.5 Peripheral Vascular Devices Market, United States, Average Price ($), 2005-2020 ................................... 89

3.6 Peripheral Vascular Devices Market, United States, Distribution Share by Revenue ($m), 2011-2012 ....... 94

3.7 Peripheral Vascular Devices Market, United States, Company Share by Revenue ($m), 2011-2012 .......... 95

4 Overview of Key Companies in United States, Peripheral Vascular Devices Market ................................... 97

4.1 C. R. Bard, Inc. ......................................................................................................................................... 97

4.1.1 Company Overview ............................................................................................................................... 97

4.2 Boston Scientific Corporation .................................................................................................................... 97


4.3 Abbott Laboratories .................................................................................................................................. 97


4.4 Medtronic, Inc. .......................................................................................................................................... 98


4.5 Covidien plc .............................................................................................................................................. 98


4.6 Cordis Corporation .................................................................................................................................... 98


4.7 AngioDynamics, Inc. ................................................................................................................................. 99


4.8 Cook Medical Incorporated ....................................................................................................................... 99


4.9 Terumo Corporation .................................................................................................................................. 99


5 Peripheral Vascular Devices Market Pipeline Products ............................................................................... 100

6 Financial Deals Landscape ........................................................................................................................... 102

6.1 Acquisition .............................................................................................................................................. 102

6.1.1 Boston Scientific Completes Acquisition Of Vessix Vascular, Developer Of Catheter-Based Renal Denervation System, For Up to US$425 Million ................................................................................................ 102

6.1.2 AngioDynamics Completes Acquisition Of Vortex Medical, Endomechanical Device Developer ........... 105

6.1.3 Boston Scientific Completes Acquisition Of BridgePoint Medical, Cardiovascular Device Maker .......... 107

6.2 Asset Transactions ................................................................................................................................. 109

6.2.1 LeMaitre Vascular To Acquire Assets Of InaVein For US$2.5 Million ................................................... 109

6.2.2 Acacia Acquires Seven Patent Portfolios From Medical Device Company ........................................... 111

6.2.3 Acacia Research Acquires Patent For Intraluminal Device Technology ................................................ 112

6.3 Debt Offerings ........................................................................................................................................ 113

6.3.1 Teleflex Medical Prices Private Placement of Notes Due 2024 for USD250 Million .............................. 113

6.3.2 Medtronic Completes Public Offering Of Notes Due 2017 For US$250 Million ..................................... 114

6.3.3 Medtronic Completes Public Offering Of 0.875% Notes Due 2017 For US$250 Million ........................ 116



6.3.6 Edwards Lifesciences Completes Public Offering Of Notes Due 2018 For US$600 Million ................... 122

6.3.7 Medtronic Completes Public Offering Of Notes Due 2018 For US$1 Billion .......................................... 124

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6.3.9 Medtronic Completes Public Offering Of Notes Due 2023 For US$1.25 Billion ..................................... 128

6.4 Equity Offerings ...................................................................................................................................... 130

6.4.1 Vermillion Completes Private Placement Of Shares US$18 Million Upon Exercise Of Warrants ........... 130

6.4.2 Vermillion Completes Private Placement Of Shares For US$13.2 Million ............................................. 131

6.5 Partnerships ........................................................................................................................................... 133

6.5.1 ReFlow Medical Enters Into Distribution Agreement With MicroPort Scientific ...................................... 133

6.5.2 Cordis Enters Into Distribution Agreement With TriReme Medical ........................................................ 134

6.6 Private Equity ......................................................................................................................................... 135

6.6.1 Endeavour Capital Acquires Access Scientific, Maker Of Vascular Access Devices ............................. 135

6.7 Venture Financing ................................................................................................................................... 136

6.7.1 Shockwave Medical Raises US$12.5 Million In Series A Financing Round .......................................... 136

6.7.2 Avinger Raises Funds Through Venture Financing Round ................................................................... 137

6.7.3 AtheroMed Raises US$4.3 Million In Venture Financing ...................................................................... 138

6.7.4 Avinger Raises US$10.5 Million In Venture Financing ......................................................................... 139

6.7.5 CardioFocus Raises US$11 Million In Venture Financing .................................................................... 140

6.7.6 AtheroMed Raises US$6 Million In Series D Financing ........................................................................ 141

6.7.7 480 Biomedical Raises US$18 Million In Venture Financing ................................................................ 142

6.7.8 Cheetah Medical Raises US$14.4 Million In Extended Series C Financing .......................................... 143

6.7.9 480 Biomedical Raises US$5 Million In Venture Financing .................................................................. 144

6.7.10 Sapheon Raises US$20 Million In Series B Financing ..................................................................... 146

6.7.11 NexGen Medical Systems Plans To Raise US$10 Million In Series B Financing .............................. 147

6.7.12 Avinger Raises US$33 Million In Series D Financing ....................................................................... 148

6.7.13 NexGen Medical Systems Raises US$0.5 Million In Venture Financing ........................................... 149

6.7.14 Aptus Endosystems Raises US$25 Million In Series BB Financing .................................................. 150

6.7.15 Access Scientific Raises US$4 Million In Venture Financing ............................................................ 152

7 Recent Developments.................................................................................................................................... 153

7.1 Corporate Communications..................................................................................................................... 153

7.1.1 May 19, 2014: Medtronic Appoints Brad Lerman to Serve as Senior Vice President, General Counsel and Corporate Secretary......................................................................................................................................... 153

7.1.2 Apr 23, 2014: Vermillion Appoints Chairman of Board James LaFrance as President and Chief Executive Officer 153

7.1.3 Apr 01, 2014: Aptus Endosystems Appoints Dr. Bart E. Muhs as Chief Medical Officer........................ 154

7.1.4 Mar 13, 2014: CytoSorbents to Sponsor CytoSorb Research Symposium at ISICEM 2014 .................. 154

7.1.5 Feb 10, 2014: REVA Hires Vice President, General Counsel ............................................................... 155

7.1.6 Jan 20, 2014: Cardiva Medical Announces Appointment of Randy Hubbell, Chief Commercial Officer . 155

7.1.7 Dec 17, 2013: Vermillion Appoints Marian E. Sacco as SVP of Sales and Marketing and Chief Commercial Officer .......................................................................................................................................... 156

7.1.8 Dec 13, 2013: Vermillion Board of Directors Elects James T. LaFrance as Chairman .......................... 157

7.1.9 Dec 07, 2013: Novartis highlights research on investigational, personalized T cell therapy CTL019 in patients with forms of acute and chronic leukemia ............................................................................................ 157

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7.1.10 Dec 05, 2013: Anxious Patient Group Calls on NICE to Approve Only Drug Treatment for Ultra-Rare Disease 159

7.1.11 Dec 05, 2013: Edwards Lifesciences Announces Appointment of CFO ............................................ 162

7.1.12 Dec 04, 2013: Cook Medical Names Rob Lyles Executive Vice President ........................................ 162

7.1.13 Dec 04, 2013: Mark Breedlove Named Vice President of Cook Medical‘s Peripheral Intervention Clinical Division ............................................................................................................................................... 163

7.1.14 Nov 11, 2013: LeMaitre Vascular Announces Appointment of Michael Thomas to Its Board of Directors 163

7.1.15 Nov 04, 2013: Canbex Therapeutics Commences Phase I Clinical Trial of Lead Product VSN16R as a Potential Treatment for Spasticity in Multiple Sclerosis ..................................................................................... 164

7.1.16 Oct 01, 2013: Gretchen Gutman Named Vice President of Public Policy for Cook Group ................. 165

7.1.17 Sep 25, 2013: Accellent Announces the Promotion of Jeremy Friedman to President and Chief Operating Officer for the Cardio & Vascular Business and the Appointment of Richard Johnson as Interim CFO 165

7.1.18 Sep 16, 2013: Vermillion Appoints Dr. Eric Varma to its Board of Directors ...................................... 166

7.1.19 Aug 22, 2013: Nicky James Named Vice President and Global Leader of Cook Medical Aortic Intervention Clinical Division ............................................................................................................................ 166

7.1.20 Aug 13, 2013: Covidien launches Barrx Channel RFA Endoscopic Catheter .................................... 166

7.1.21 Aug 02, 2013: China CDC Enters Into R&D Agreement With Aeras Global For TB Vaccine ............. 167

7.1.22 Jul 23, 2013: Dean Schauer, Executive Vice President, Cardio & Vascular Group, Announces Resignation ..................................................................................................................................................... 168

7.1.23 Jul 03, 2013: Noted Interventional Radiologists Join Surefire Medical‘s Scientific Advisory Board .... 169

7.1.24 Jun 04, 2013: Cheetah Medical Appoints Chris Hutchison As CEO .................................................. 169

7.2 Financial Announcements ....................................................................................................................... 170

7.2.1 May 20, 2014: Medtronic Reports Fourth Quarter and Fiscal Year 2014 Earnings ............................... 170

7.2.2 May 15, 2014: Vermillion Reports First Quarter 2014 Results .............................................................. 172

7.2.3 Apr 24, 2014: Edwards Lifesciences Reports Strong First Quarter Results .......................................... 173

7.2.4 Apr 22, 2014: Bard Announces First Quarter Results .......................................................................... 174

7.2.5 Mar 06, 2014: Vermillion Reports Fourth Quarter and Full Year 2013 Results ...................................... 175

7.2.6 Feb 25, 2014: LeMaitre Q4 2013 Record Sales of $17.9mm ................................................................ 176

7.2.7 Feb 18, 2014: Medtronic Reports Third Quarter Earnings .................................................................... 177

7.2.8 Feb 03, 2014: Edwards Lifesciences Reports Strong Fourth Quarter Results ...................................... 179

7.2.9 Jan 30, 2014: Bard Announces Fourth Quarter Results ....................................................................... 181

7.2.10 Dec 11, 2013: Bard Declares Quarterly Dividend ............................................................................. 181

7.2.11 Nov 26, 2013: FDA approves Varithena (polidocanol injectable foam) for the treatment of patients with varicose veins .................................................................................................................................................. 181

7.2.12 Nov 19, 2013: Medtronic Reports Second Quarter Earnings ............................................................ 182

7.2.13 Nov 14, 2013: Vermillion reports third quarter 2013 results .............................................................. 184

7.2.14 Nov 11, 2013: Medtronic to Announce Financial Results for Its Second Quarter of Fiscal Year 2014 185

7.2.15 Nov 07, 2013: Accellent Announces Third Quarter 2013 Results ..................................................... 186

7.2.16 Nov 05, 2013: REVA to Hold Briefing Call on Q3 2013 Financial Results ......................................... 187

7.2.17 Oct 31, 2013: Vermillion Sets Third Quarter 2013 Conference Call for Thursday, November 14, 2013 187

7.2.18 Oct 29, 2013: LeMaitre Q3 2013 sales $15.3mm (+12%) ................................................................. 187

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7.2.19 Oct 28, 2013: Edwards Lifesciences Reports Solid Third Quarter Results ........................................ 189

7.2.20 Oct 22, 2013: Bard Announces Third Quarter Results ..................................................................... 190

7.2.21 Oct 09, 2013: Bard Declares Quarterly Dividend .............................................................................. 191

7.2.22 Oct 02, 2013: LeMaitre Vascular Will Announce Third Quarter 2013 Earnings Results on October 29, 2013 191

7.2.23 Oct 01, 2013: Bard to Host Earnings Conference Call on October 22, 2013 ..................................... 191

7.2.24 Aug 20, 2013: Medtronic Reports First Quarter Earnings ................................................................. 191

7.2.25 Aug 14, 2013: Vermillion Reports Second Quarter 2013 Results...................................................... 193

7.2.26 Aug 13, 2013: Accellent Announces Second Quarter 2013 Results ................................................. 195

7.2.27 Aug 12, 2013: Medtronic to Announce Financial Results for Its First Quarter of Fiscal Year 2014..... 196

7.2.28 Aug 06, 2013: Accellent Announces Timing of Second Quarter 2013 Earnings Release and Conference Call ............................................................................................................................................... 196

7.2.29 Aug 06, 2013: REVA Medical to Hold Briefing Call on Q2 2013 Financial Results ............................ 196

7.2.30 Jul 31, 2013: Vermillion Sets Second Quarter 2013 Conference Call for Wednesday, August 14, 2013 197

7.2.31 Jul 30, 2013: LeMaitre Q2 2013 Record Sales $16mm (+12% Organic), Op. Income $1.4mm ......... 197

7.2.32 Jul 25, 2013: Edwards Lifesciences Reports Solid Second Quarter Results ..................................... 198

7.2.33 Jul 24, 2013: Bard Announces Second Quarter Results ................................................................... 200

7.2.34 Jul 12, 2013: LeMaitre Vascular Will Announce Second Quarter 2013 Earnings Results on July 30, 2013 200

7.2.35 Jul 11, 2013: Edwards Lifesciences to Host Earnings Conference Call on July 25, 2013 .................. 201

7.3 Government and Public Interest .............................................................................................................. 201

7.3.1 Jan 31, 2014: Vermillion to Present at Leerink Global Healthcare Conference on February 13............. 201

7.3.2 Jan 06, 2014: Medtronic CEO Omar Ishrak to Speak at J.P. Morgan Healthcare Conference .............. 201

7.3.3 Jan 06, 2014: Bard to Host Earnings Conference Call on January 30, 2014 ........................................ 201

7.3.4 Dec 20, 2013: Bard to Present at J.P. Morgan Healthcare Conference ................................................ 201

7.3.5 Dec 04, 2013: Medtronic CFO Gary Ellis to Speak at Oppenheimer Healthcare Conference ................ 202

7.3.6 Nov 27, 2013: LeMaitre Vascular to Present at the Benchmark Company Micro Cap Discovery Conference on Wednesday, December 11, 2013 ............................................................................................. 202

7.3.7 Nov 26, 2013: Medtronic EVP & President Mike Coyle to Speak at Piper Jaffray Healthcare Conference 202

7.3.8 Nov 20, 2013: Bard to Present at Piper Jaffray Healthcare Conference ............................................... 202

7.3.9 Nov 08, 2013: LeMaitre Vascular to Participate in Two Investor Conferences in November 2013 ......... 202

7.3.10 Nov 06, 2013: LeMaitre Vascular Announces Details for Its November 12th & 13th Investor and Analyst Days.................................................................................................................................................... 202

7.3.11 Oct 29, 2013: Bard to Present at Credit Suisse Healthcare Conference ........................................... 203

7.3.12 Oct 28, 2013: Edwards Lifesciences to Webcast Analyst Meeting at TCT 25 ................................... 203

7.3.13 Oct 25, 2013: LeMaitre Vascular to Present at the Canaccord Genuity Medical Technology & Diagnostics Forum on Thursday, November 14, 2013 ...................................................................................... 203

7.3.14 Oct 14, 2013: Edwards Lifesciences to Host Earnings Conference Call on October 28, 2013 ........... 203

7.3.15 Sep 11, 2013: LeMaitre Vascular to Host Two Investor and Analyst Days: November 12 & 13, 2013203

7.3.16 Sep 06, 2013: Medtronic CFO Gary Ellis to Speak at Morgan Stanley Healthcare Conference ......... 204

7.3.17 Sep 03, 2013: Bard to Host Conference Call on September 4, 2013 ................................................ 204

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7.3.18 Sep 03, 2013: LeMaitre Vascular to Present at the Stifel Healthcare Conference 2013 on Thursday, September 12, 2013 ........................................................................................................................................ 204

7.3.19 Aug 23, 2013: LeMaitre Vascular to Present at the 6th Annual Barrington Research Growth Conference on Wednesday, September 4, 2013 .............................................................................................. 204

7.3.20 Aug 20, 2013: Bard to Present at Morgan Stanley Global Healthcare Conference ............................ 204

7.3.21 Aug 14, 2013: LeMaitre Vascular to Present at the Three Part Advisors Midwest IDEAS Investor Conference on Tuesday, August 27, 2013........................................................................................................ 205

7.3.22 Aug 12, 2013: Edwards Lifesciences to Present at the Canaccord Genuity Growth Conference ....... 205

7.3.23 Jul 26, 2013: LeMaitre Vascular to Present at the Canaccord Genuity 33rd Annual Growth Conference on Thursday, August 15, 2013 ......................................................................................................................... 205

7.4 Legal And Regulatory ............................................................................................................................. 205

7.4.1 May 20, 2014: Edwards Lifesciences, Medtronic Agree to Global Transcatheter Valve Litigation Settlement ....................................................................................................................................................... 205

7.4.2 Apr 11, 2014: Federal Court Orders Preliminary Injunction on U.S. Sales of Medtronic's Infringing Transcatheter Valve ......................................................................................................................................... 206

7.4.3 Mar 12, 2014: Venaxis to Discuss Top-Line Results from Pivotal Study of APPY1 Test ....................... 206

7.4.4 Jan 22, 2014: Medtronic Statement on U.S. Supreme Court Ruling in Medtronic, Inc. v. Mirowski Family Ventures .......................................................................................................................................................... 207

7.4.5 Dec 27, 2013: Abbott Laboratories Pays U.S. $5.475 Million to Settle Claims That Company Paid Kickbacks to Physicians ................................................................................................................................... 207

7.4.6 Nov 14, 2013: Edwards Comments on German Appellate Court Ruling ............................................... 208

7.4.7 Nov 07, 2013: Law Office of Brodsky & Smith Announces Investigation of Edwards Lifescience .......... 208

7.4.8 Oct 19, 2013: Medtronic Statement on Medical Device Security .......................................................... 208

7.4.9 Oct 18, 2013: Law Offices of Howard G. Smith Announces Lead Plaintiff Deadline In The Class Action Lawsuit Against Edwards Lifesciences Corporation .......................................................................................... 209

7.4.10 Aug 01, 2013: Medtronic Notifies More Than 2,700 Patients Of Lost Records .................................. 210

7.4.11 Jul 01, 2013: Bronstein, Gewirtz & Grossman, LLC Announces that a Securities Class Action has been Filed Against Medtronic, Inc. ............................................................................................................................ 210

7.5 Other Significant Developments .............................................................................................................. 210

7.5.1 Apr 16, 2014: Bard Declares Quarterly Dividend ................................................................................. 210

7.5.2 Feb 24, 2014: Cesca Therapeutics and Cook Medical Enter Supply Agreement for a Phase 1b Clinical Trial 211

7.5.3 Feb 13, 2014: Medtronic Announces Cash Dividend for Fourth Quarter of Fiscal Year 2014 ................ 211

7.5.4 Jan 28, 2014: Medtronic Relocates Its Regional Headquarters to Dubai .............................................. 211

7.5.5 Jan 13, 2014: AUXILIO Signs Five-Year Managed Print Services Contract with University of California at San Diego (UCSD) Health System ................................................................................................................... 212

7.5.6 Dec 16, 2013: Vermillion Reports Results of 2013 Annual Meeting ...................................................... 212

7.5.7 Dec 09, 2013: Edwards Lifesciences Outlines Growth Strategy at Annual Investor Conference ........... 213

7.5.8 Dec 06, 2013: The Edwards Lifesciences Fund to Grant ~$5.6 Million to 450+ Non-Profit Organizations in 2013 215

7.5.9 Dec 04, 2013: Medtronic Issues $500,000 in Health Access Grants to Support Diabetes Services for the Underserved of Greater Los Angeles ............................................................................................................... 215

7.5.10 Aug 22, 2013: Medtronic Announces Cash Dividend for Second Quarter of Fiscal Year 2014 .......... 216

7.6 Product News ......................................................................................................................................... 216

7.6.1 Jan 02, 2014: LeMaitre to Sell Direct-to-Hospital in Australia and Norway ........................................... 216

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7.6.2 Nov 15, 2013: FDA Classifies Medtronic's Worldwide Voluntary Field Action on Guidewires as Class I Recall 217

7.6.3 Aug 19, 2013: Spectranetics Broadens Laser Catheter Portfolio to Treat Complex Lesions and Chronic Total Occlusions .............................................................................................................................................. 217

7.6.4 Jun 19, 2013: LeMaitre Vascular Launches 1.5mm Valvulotome, MultiTASC And AlboSure Patch....... 218

7.6.5 May 30, 2013: Cardiovascular Systems Enrolls First Patient In Liberty 360° Study .............................. 219

7.7 Research And Development ................................................................................................................... 220

7.7.1 May 30, 2013: Cook Medical Joins With Indiana Life Science Businesses, Academia And Government To Help Launch Bioscience Research Center ....................................................................................................... 220

7.8 Strategy And Business Planning ............................................................................................................. 221

7.8.1 Feb 04, 2014: Purdue Research Foundation, Cook Medical partner on $12 million project to support life sciences startup opportunities .......................................................................................................................... 221

7.8.2 Dec 19, 2013: Tryton Medical Establishes Bifurcation Institute ............................................................ 221

7.8.3 Nov 14, 2013: Cook Medical Opens New Innovation Centre in Limerick, Ireland .................................. 222

7.8.4 Nov 13, 2013: Edwards Lifesciences Expands Singapore Manufacturing Facility ................................. 223

7.8.5 Sep 17, 2013: Medtronic Opens New Customer Innovation Centre in Galway, Ireland ......................... 223

7.8.6 Sep 02, 2013: Medtronic announces formation of hospital solutions business aimed at driving efficiencies 224

7.8.7 Aug 29, 2013: Medtronic To Set Up Global Center Of Excellence In Singapore For Business Model Innovation ........................................................................................................................................................ 225

8 Appendix ........................................................................................................................................................ 226

8.1 Research Methodology ........................................................................................................................... 227

8.1.1 Coverage ............................................................................................................................................ 227

8.1.2 Secondary Research........................................................................................................................... 227

8.1.3 Primary Research ............................................................................................................................... 228

8.1.4 Market Modeling and Forecasting ....................................................................................................... 229

8.1.5 Company Share Analysis .................................................................................................................... 232

8.1.6 Distribution Share Analysis ................................................................................................................. 233

8.2 Expert Panel ........................................................................................................................................... 233

8.3 GlobalData Consulting ............................................................................................................................ 234

8.5 Disclaimer ............................................................................................................................................... 234

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1.1 List of Tables

Table 1: Peripheral Vascular Devices Market, United States, Revenue ($m), USD Constant, Historic, 2005-2012 ...................... 20

Table 2: Peripheral Vascular Devices Market, United States, Revenue ($m), USD Constant, Forecast, 2012-2020 .................... 22

Table 3: Aortic Stent Grafts Market, United States, Revenue ($m), USD Constant, Historic, 2005-2012..................................... 23

Table 4: Inferior Vena Cava Filters (IVCF) Market, United States, Revenue ($m), USD Constant, Historic, 2005-2012 ............... 24

Table 5: Peripheral Embolic Protection Devices Market, United States, Revenue ($m), USD Constant, Historic, 2005-2012 ...... 26

Table 6: Peripheral Guidewires Market, United States, Revenue ($m), USD Constant, Historic, 2005-2012 ............................... 27

Table 7: Peripheral Vascular Stents Market, United States, Revenue ($m), USD Constant, Historic, 2005-2012 ........................ 29

Table 8: Fem-pop Artery Stents Market, United States, Revenue ($m), by Sub Segment, USD Constant, Historic, 2005-2012 ... 30

Table 9: Iliac Artery Stents Market, United States, Revenue ($m), by Sub Segment, USD Constant, Historic, 2005-2012........... 31

Table 10: Infrapop Artery Stents Market, United States, Revenue ($m), by Sub Segment, USD Constant, Historic, 2005-2012 .. 32

Table 11: Peripheral Venous Thrombectomy Devices Market, United States, Revenue ($m), USD Constant, Historic, 2005-2012

................................................................................................................................................................................................ 34

Table 12: Aortic Stent Grafts Market, United States, Revenue ($m), USD Constant, Forecast, 2012-2020 ................................. 36

Table 13: Inferior Vena Cava Filters (IVCF) Market, United States, Revenue ($m), USD Constant, Forecast, 2012-2020 ........... 38

Table 14: Peripheral Embolic Protection Devices Market, United States, Revenue ($m), USD Constant, Forecast, 2012-2020 ... 40

Table 15: Peripheral Guidewires Market, United States, Revenue ($m), USD Constant, Forecast, 2012-2020 ........................... 42

Table 16: Peripheral Vascular Stents Market, United States, Revenue ($m), USD Constant, Forecast, 2012-2020 .................... 44

Table 17: Fem-pop Artery Stents Market, United States, Revenue ($m), by Sub Segment, USD Constant, Forecast, 2012-2020 46

Table 18: Iliac Artery Stents Market, United States, Revenue ($m), by Sub Segment, USD Constant, Forecast, 2012-2020 ....... 47

Table 19: Infrapop Artery Stents Market, United States, Revenue ($m), by Sub Segment, USD Constant, Forecast, 2012-2020 48

Table 20: Peripheral Venous Thrombectomy Devices Market, United States, Revenue ($m), USD Constant, Forecast, 2012-2020

................................................................................................................................................................................................ 50

Table 21: Peripheral Vascular Devices Market, United States, Volume (Units), Historic, 2005-2012 .......................................... 52

Table 22: Peripheral Vascular Devices Market, United States, Volume (Units), Forecast, 2012-2020......................................... 54

Table 23: Aortic Stent Grafts Market, United States, Volume (Units), Historic, 2005-2012 ......................................................... 57

Table 24: Inferior Vena Cava Filters (IVCF) Market, United States, Volume (Units), Historic, 2005-2012 .................................... 59

Table 25: Peripheral Embolic Protection Devices Market, United States, Volume (Units), Historic, 2005-2012 ........................... 61

Table 26: Peripheral Guidewires Market, United States, Volume (Units), Historic, 2005-2012 .................................................... 63

Table 27: Peripheral Vascular Stents Market, United States, Volume (Units), Historic, 2005-2012 ............................................. 65

Table 28: Fem-pop Artery Stents Market, United States, Volume (Units), by Sub Segment, Historic, 2005-2012 ........................ 66

Table 29: Iliac Artery Stents Market, United States, Volume (Units), by Sub Segment, Historic, 2005-2012 ............................... 67

Table 30: Infrapop Artery Stents Market, United States, Volume (Units), by Sub Segment, Historic, 2005-2012 ......................... 68

Table 31: Peripheral Venous Thrombectomy Devices Market, United States, Volume (Units), Historic, 2005-2012 .................... 70

Table 32: Aortic Stent Grafts Market, United States, Volume (Units), Forecast, 2012-2020........................................................ 72

Table 33: Inferior Vena Cava Filters (IVCF) Market, United States, Volume (Units), Forecast, 2012-2020 .................................. 74

Table 34: Peripheral Embolic Protection Devices Market, United States, Volume (Units), Forecast, 2012-2020 ......................... 76

Table 35: Peripheral Guidewires Market, United States, Volume (Units), Forecast, 2012-2020 .................................................. 78

Table 36: Peripheral Vascular Stents Market, United States, Volume (Units), Forecast, 2012-2020 ........................................... 80

Table 37: Fem-pop Artery Stents Market, United States, Volume (Units), by Sub Segment, Forecast, 2012-2020 ...................... 82

Table 38: Iliac Artery Stents Market, United States, Volume (Units), by Sub Segment, Forecast, 2012-2020.............................. 84

Table 39: Infrapop Artery Stents Market, United States, Volume (Units), by Sub Segment, Forecast, 2012-2020 ....................... 86

Table 40: Peripheral Venous Thrombectomy Devices Market, United States, Volume (Units), Forecast, 2012-2020................... 88

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Table 41: Peripheral Vascular Devices Market, United States, Average Price ($), Historic, 2005-2012 ...................................... 89

Table 42: Peripheral Vascular Devices Market, United States, Average Price ($), Forecast, 2012-2020..................................... 91

Table 43: Peripheral Vascular Devices Market, United States, Distribution Share by Revenue ($m), USD Constant, 2011-2012 94

Table 44: Peripheral Vascular Devices Market, United States, Company Share by Revenue ($m), USD Constant, 2011-2012 ... 96

Table 45: Peripheral Vascular Devices Market Pipeline Products ............................................................................................ 100

Table 46: Boston Scientific Completes Acquisition Of Vessix Vascular, Developer Of Catheter-Based Renal Denervation System,

For Up to US$425 Million ........................................................................................................................................................ 102

Table 47: AngioDynamics Completes Acquisition Of Vortex Medical, Endomechanical Device Developer ................................ 105

Table 48: Boston Scientific Completes Acquisition Of BridgePoint Medical, Cardiovascular Device Maker ................................ 107

Table 49: LeMaitre Vascular To Acquire Assets Of InaVein For US$2.5 Million ........................................................................ 109

Table 50: Acacia Acquires Seven Patent Portfolios From Medical Device Company ................................................................ 111

Table 51: Acacia Research Acquires Patent For Intraluminal Device Technology .................................................................... 112

Table 52: Teleflex Medical Prices Private Placement of Notes Due 2024 for USD250 Million ................................................... 113

Table 53: Medtronic Completes Public Offering Of Notes Due 2017 For US$250 Million .......................................................... 114

Table 54: Medtronic Completes Public Offering Of 0.875% Notes Due 2017 For US$250 Million .............................................. 116



Table 57: Edwards Lifesciences Completes Public Offering Of Notes Due 2018 For US$600 Million ........................................ 122

Table 58: Medtronic Completes Public Offering Of Notes Due 2018 For US$1 Billion ............................................................... 124


Table 60: Medtronic Completes Public Offering Of Notes Due 2023 For US$1.25 Billion .......................................................... 128

Table 61: Vermillion Completes Private Placement Of Shares US$18 Million Upon Exercise Of Warrants ................................ 130

Table 62: Vermillion Completes Private Placement Of Shares For US$13.2 Million .................................................................. 131

Table 63: ReFlow Medical Enters Into Distribution Agreement With MicroPort Scientific ........................................................... 133

Table 64: Cordis Enters Into Distribution Agreement With TriReme Medical ............................................................................ 134

Table 65: Endeavour Capital Acquires Access Scientific, Maker Of Vascular Access Devices .................................................. 135

Table 66: Shockwave Medical Raises US$12.5 Million In Series A Financing Round ............................................................... 136

Table 67: Avinger Raises Funds Through Venture Financing Round ....................................................................................... 137

Table 68: AtheroMed Raises US$4.3 Million In Venture Financing .......................................................................................... 138

Table 69: Avinger Raises US$10.5 Million In Venture Financing .............................................................................................. 139

Table 70: CardioFocus Raises US$11 Million In Venture Financing ......................................................................................... 140

Table 71: AtheroMed Raises US$6 Million In Series D Financing ............................................................................................ 141

Table 72: 480 Biomedical Raises US$18 Million In Venture Financing ..................................................................................... 142

Table 73: Cheetah Medical Raises US$14.4 Million In Extended Series C Financing ............................................................... 143

Table 74: 480 Biomedical Raises US$5 Million In Venture Financing ....................................................................................... 144

Table 75: Sapheon Raises US$20 Million In Series B Financing ............................................................................................. 146

Table 76: NexGen Medical Systems Plans To Raise US$10 Million In Series B Financing ....................................................... 147

Table 77: Avinger Raises US$33 Million In Series D Financing ............................................................................................... 148

Table 78: NexGen Medical Systems Raises US$0.5 Million In Venture Financing .................................................................... 149

Table 79: Aptus Endosystems Raises US$25 Million In Series BB Financing ........................................................................... 150

Table 80: Access Scientific Raises US$4 Million In Venture Financing .................................................................................... 152

Table 81: Total Number of Primary Research Participants, Cardiovascular Devices Market, by Country .................................. 229

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1.2 List of Figures

Figure 1: Peripheral Vascular Devices Market, United States, Revenue ($m), USD Constant, Historic, 2005-2012 .................... 19

Figure 2: Peripheral Vascular Devices Market, United States, Revenue ($m), USD Constant, Forecast, 2012-2020................... 21

Figure 3: Aortic Stent Grafts Market, United States, Revenue ($m), USD Constant, Historic, 2005-2012 ................................... 23

Figure 4: Inferior Vena Cava Filters (IVCF) Market, United States, Revenue ($m), USD Constant, Historic, 2005-2012 .............. 24

Figure 5: Peripheral Embolic Protection Devices Market, United States, Revenue ($m), USD Constant, Historic, 2005-2012 ..... 25

Figure 6: Peripheral Guidewires Market, United States, Revenue ($m), USD Constant, Historic, 2005-2012 .............................. 27

Figure 7: Peripheral Vascular Stents Market, United States, Revenue ($m), USD Constant, Historic, 2005-2012 ....................... 28

Figure 8: Fem-pop Artery Stents Market, United States, Revenue ($m), by Sub Segment, USD Constant, Historic, 2005-2012 .. 30

Figure 9: Iliac Artery Stents Market, United States, Revenue ($m), by Sub Segment, USD Constant, Historic, 2005-2012 ......... 31

Figure 10: Infrapop Artery Stents Market, United States, Revenue ($m), by Sub Segment, USD Constant, Historic, 2005-2012 . 32

Figure 11: Peripheral Venous Thrombectomy Devices Market, United States, Revenue ($m), USD Constant, Historic, 2005-2012

................................................................................................................................................................................................ 33

Figure 12: Aortic Stent Grafts Market, United States, Revenue ($m), USD Constant, Forecast, 2012-2020 ................................ 35

Figure 13: Inferior Vena Cava Filters (IVCF) Market, United States, Revenue ($m), USD Constant, Forecast, 2012-2020 .......... 37

Figure 14: Peripheral Embolic Protection Devices Market, United States, Revenue ($m), USD Constant, Forecast, 2012-2020 . 39

Figure 15: Peripheral Guidewires Market, United States, Revenue ($m), USD Constant, Forecast, 2012-2020 .......................... 41

Figure 16: Peripheral Vascular Stents Market, United States, Revenue ($m), USD Constant, Forecast, 2012-2020 ................... 43

Figure 17: Fem-pop Artery Stents Market, United States, Revenue ($m), by Sub Segment, USD Constant, Forecast, 2012-2020

................................................................................................................................................................................................ 45

Figure 18: Iliac Artery Stents Market, United States, Revenue ($m), by Sub Segment, USD Constant, Forecast, 2012-2020 ...... 47

Figure 19: Infrapop Artery Stents Market, United States, Revenue ($m), by Sub Segment, USD Constant, Forecast, 2012-2020 48

Figure 20: Peripheral Venous Thrombectomy Devices Market, United States, Revenue ($m), USD Constant, Forecast, 2012-

2020 ........................................................................................................................................................................................ 49

Figure 21: Peripheral Vascular Devices Market, United States, Volume (Units), Historic, 2005-2012 ......................................... 51

Figure 22: Peripheral Vascular Devices Market, United States, Volume (Units), Forecast, 2012-2020 ....................................... 53

Figure 23: Aortic Stent Grafts Market, United States, Volume (Units), Historic, 2005-2012 ........................................................ 56

Figure 24: Inferior Vena Cava Filters (IVCF) Market, United States, Volume (Units), Historic, 2005-2012 .................................. 58

Figure 25 Peripheral Embolic Protection Devices Market, United States, Volume (Units), Historic, 2005-2012 ........................... 60

Figure 26: Peripheral Guidewires Market, United States, Volume (Units), Historic, 2005-2012................................................... 62

Figure 27: Peripheral Vascular Stents Market, United States, Volume (Units), Historic, 2005-2012 ............................................ 64

Figure 28: Fem-pop Artery Stents Market, United States, Volume (Units), by Sub Segment, Historic, 2005-2012 ....................... 66

Figure 29: Iliac Artery Stents Market, United States, Volume (Units), by Sub Segment, Historic, 2005-2012 .............................. 67

Figure 30: Infrapop Artery Stents Market, United States, Volume (Units), by Sub Segment, Historic, 2005-2012 ........................ 68

Figure 31: Peripheral Venous Thrombectomy Devices Market, United States, Volume (Units), Historic, 2005-2012 ................... 69

Figure 32: Aortic Stent Grafts Market, United States, Volume (Units), Forecast, 2012-2020 ...................................................... 71

Figure 33: Inferior Vena Cava Filters (IVCF) Market, United States, Volume (Units), Forecast, 2012-2020................................. 73

Figure 34: Peripheral Embolic Protection Devices Market, United States, Volume (Units), Forecast, 2012-2020 ........................ 75

Figure 35: Peripheral Guidewires Market, United States, Volume (Units), Forecast, 2012-2020 ................................................. 77

Figure 36: Peripheral Vascular Stents Market, United States, Volume (Units), Forecast, 2012-2020 .......................................... 79

Figure 37: Fem-pop Artery Stents Market, United States, Volume (Units), by Sub Segment, Forecast, 2012-2020 ..................... 81

Figure 38: Iliac Artery Stents Market, United States, Volume (Units), by Sub Segment, Forecast, 2012-2020 ............................ 83

Figure 39: Infrapop Artery Stents Market, United States, Volume (Units), by Sub Segment, Forecast, 2012-2020 ...................... 85

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Figure 40: Peripheral Venous Thrombectomy Devices Market, United States, Volume (Units), Forecast, 2012-2020 ................. 87

Figure 41: Peripheral Vascular Devices Market, United States, Company Share (%) 2012 ........................................................ 95

Figure 42: GlobalData Epidemiology-Based Forecasting Model ............................................................................................. 231

Figure 43: GlobalData Capital Equipment-Based Forecasting Model ...................................................................................... 232

Figure 44: Primary Interviews by Participant Type (%) ........................................................................................................... 233

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2 Introduction

Medical Equipment Market Reports are the ideal guide for anyone wishing to understand their market better in terms

of revenues, unit sales, distributors and competitors.

2.1 What Is This Report About?

This report provides an overview and the following information related to the country, various categories, distribution

share and competitive landscape in the market:

1. Comprehensive data related to the market revenue, unit sale, average price, company share and

distribution share.

2. Corporate-level profiles of key companies operating in the Peripheral Vascular Devices market, which

includes a brief overview of the company. The selection of the companies is based on their operational

presence.

3. A list of key products under development by different companies. The selection of this list is based on

the territory in which these products are being clinically investigated.

4. Key news and deals related to the Peripheral Vascular Devices market.

2.2 Peripheral Vascular Devices Market Segmentation

Peripheral Vascular Devices market is segmented as described below, in this report:

1. Renal Denervation Disposable Catheters

2. PTA Balloons

3. PTA Peripheral Drug Eluting Balloons (DEB)

4. Inferior Vena Cava Filters (IVCF)

Inferior Vena Cava Filters (IVCF) includes sub-segments such as Permanent IVCF and Retrievable

IVCF

5. Peripheral Embolic Protection Devices

Peripheral Embolic Protection Devices includes sub-segments such as Carotid Embolic Protection

Devices, Lower Extremity Embolic Protection Devices and Renal Embolic Protection Devices

6. Peripheral Guidewires

Peripheral Guidewires includes sub-segments such as Hydrophilic Peripheral Guidewires and Non-

Hydrophilic Peripheral Guidewires

7. Peripheral Vascular Stents

Peripheral Vascular Stents includes sub-segments such as Carotid Artery Bare Metal Stents, Fem-

pop Artery Stents (Fem-pop Artery Bare Metal Stents, Fem-pop Artery Bioabsorbable Stents, Fem-

pop Artery Covered Stents and Fem-pop Artery Drug Eluting Stents), Iliac Artery Stents (Iliac Artery

Bare Metal Stents, Iliac Artery Bioabsorbable Stents, Iliac Artery Covered Stents and Iliac Artery

Drug Eluting Stents), Infrapop Artery Stents (Infrapop Artery Bare Metal Stents, Infrapop Artery

Bioabsorbable Stents, Infrapop Artery Covered Stents and Infrapop Artery Drug Eluting Stents) and

Renal Artery Bare Metal Stents

8. Aortic Stent Grafts

Aortic Stent Grafts includes sub-segments such as Abdominal Aortic Stent Grafts and Thoracic

Aortic Stent Grafts

9. Vascular Grafts

10. Peripheral Venous Thrombectomy Devices

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Peripheral Venous Thrombectomy Devices includes sub-segments such as Mechanical

Thrombectomy Devices and Aspiration Thrombectomy Devices

2.3 Definitions of Markets Covered in the Report

Peripheral Vascular Devices

Peripheral vascular devices include devices used to treat peripheral vascular disease (PVD). These include

peripheral vascular stents, peripheral non vascular stents, peripheral guidewires, percutaneous transluminal

angioplasty (PTA) balloons, grafts (allograft and artificial) and embolic protection devices.

Inferior Vena Cava Filter (IVCF)

Inferior Vena Cava Filter (IVCF) is used to prevent emboli from reaching lungs which results in Pulmonary Embolism

(PE). It includes Retrievable IVCF and Permanent IVCF.

Permanent IVCF

Permanent IVCF are the one's which cannot be removed or repositioned. One unit refers to one Permanent IVCF.

Retrievable IVCF

Temporary or retrievable IVCF are the one‘s which can be retrieved or repositioned up to a certain point of time. It

includes both temporary filters that must be retrieved and retrievable filters where retrieval is optional. One unit refers

to one Retrievable IVCF.

Peripheral Embolic Protection Devices

Peripheral Embolic Protection devices prevent the emboli or other debris from blocking and disrupting blood flow in

the body. Carotid, renal and lower extremity embolic protection devices have been tracked under this segment.

Carotid Embolic Protection Devices

Carotid embolic protection devices are used to prevent the debris from reaching the brain during carotid angioplasty.

One unit refers to one embolic protection device used in carotid angioplasty.

Renal Embolic Protection Devices

Renal embolic protection devices are used to prevent the debris from reaching the kidney while placing a stent in the

renal artery. One unit refers to one renal embolic protection device.

Lower Extremity Embolic Protection Devices

Lower extremity embolic protection devices are used during lower extremity interventions. One unit refers to one

lower extremity embolic protection device.

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Peripheral Guidewires

Peripheral Guidewires are used during the percutaneous transluminal angioplasty and angiography for guiding the

stents or catheters to the site of action in the peripheral vasculature. Hydrophilic and Non-hydrophilic peripheral

guidewires are tracked under this segment.

Hydrophilic Peripheral Guidewires

Hydrophilic peripheral guidewires are coated with hydrophilic coating which provides maximum lubricity and helps to

facilitate catheter navigation. One unit refers to one hydrophilic peripheral guidewire.

Non-Hydrophilic Peripheral Guidewires

Non-hydrophilic peripheral guidewires are peripheral guidewires which do not have a hydrophilic coating and may

include other coatings such as PTFE, silicone etc. One unit refers to one peripheral guidewire.

Peripheral Vascular Stents

Peripheral Vascular Stent is an expandable perforated tube that is inserted into a peripheral vessel to prevent blood

flow constriction. Carotid artery stents, Iliac Artery Stents, Infrapop Artery Stents, Renal Artery stents and Fem-pop

Artery stents, are covered under this segment.

Carotid Artery Bare Metal Stents

A carotid artery stent is the tube that is inserted in the Carotid artery, to increase the flow of blood blocked by plaque.

It is generally recommended for people who are unable to undergo an endarterectomy. Only Bare Metal Stents are

tracked under this sub-segment, as majority of the surgeries use Bare Metal Stents for Carotid Artery Stenting. One

unit refers to one Carotid Artery Bare Metal Stent.

Renal Artery Bare Metal Stents

Renal stent is a tube that is inserted in the renal arteries to increase blood flow to kidneys. Only Bare Metal Stents are

tracked under this sub-segment, as majority of the surgeries use Bare Metal Stents for the Renal Artery Stenting. One

unit refers to one Renal Artery Bare Metal Stent.

Fem-pop Artery Stents

A Fem-pop Stent is a tiny, expandable metal coil that is inserted into the femoral and popliteal arteries located in thigh

and knee during the femoropopliteal artery stenting devices. Fem-pop Artery Stents are further segmented into;

Fem-pop Artery Bare Metal Stents

Fem-pop Artery Bare-metal stent is a stent without a coating. It is a mesh-like tube of thin wire. One unit refers to one

Fem-pop Artery Bare Metal Stent.

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Fem-pop Artery Drug Eluting Stents

Fem-pop Artery Drug-Eluting stent is coated with a medicine or drug that helps further prevent the arteries from re-

closing. One unit refers to one Fem-pop Artery Drug Eluting Stent.

Fem-pop Artery Covered Stents

Fem-pop Artery Covered Stent is a flexible tube used to repair or support a damaged section of an artery. These

stents are made up of a metallic frame which is covered by durable fabric. One unit refers to one Fem-pop Artery

Covered Stent.

Iliac Artery Stents

An Iliac artery stent is the tube that is inserted in the Iliac artery to increase the flow of blood in the narrowed iliac

arteries. Iliac Artery Stents are further segmented into;

Iliac Artery Bare Metal Stents

Iliac Artery Bare-metal stent is a stent without a coating. It is a mesh-like tube of thin wire. One unit refers to one Iliac

Artery Bare Metal Stent.

Iliac Artery Drug Eluting Stents

Iliac Artery Drug-Eluting stent is coated with a medicine or drug that helps further prevent the arteries from re-

closing. One unit refers to one Iliac Artery Drug Eluting Stent.

Iliac Artery Covered Stents

Iliac Artery Covered Stent is a flexible tube used to repair or support a damaged section of an artery. These stents

are made up of a metallic frame which is covered by durable fabric. One unit refers to one Iliac Artery Covered Stent.

Infrapop Artery Stents

An Infrapop Stent is a tiny, expandable metal coil that is inserted to establish flow in the tibial, peroneal or pedal

arteries. Infrapop Artery Stents are further classified into;

Infrapop Artery Bare Metal Stents

Infrapop Artery Bare-metal stent is a stent without a coating. It is a mesh-like tube of thin wire. One unit refers to one

Infrapop Artery Bare Metal Stent.

Infrapop Artery Drug Eluting Stents

Infrapop Artery Drug-Eluting stent is coated with a medicine or drug that helps further prevent the arteries from re-

closing. One unit refers to one Infrapop Artery Drug Eluting Stent.

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Infrapop Artery Covered Stents

Infrapop Artery Covered Stent is a flexible tube used to repair or support a damaged section of an artery. These

stents are made up of a metallic frame which is covered by durable fabric. One unit refers to one Infrapop Artery

Covered Stent.

Renal Denervation Disposable Catheters

Renal Denervation is a catheter based specialized ablation procedure used to reduce blood pressure in patients with

hypertension, or who are resistant to medical therapy. During this procedure, Radio Frequency (RF) energy is

delivered to the renal artery using a catheter with a RF energy electrode tip. This ablation delivered to the renal artery

disrupts the renal nerves resulting in reduction of blood pressure. One unit refers to one Renal Denervation

Disposable Catheter.

PTA Balloons

Percutaneous Transluminal Angioplasty (PTA) balloon catheters are used to compress plaque and dilate the arterial

wall to restore normal blood flow through the vessel. A PTA balloon catheter has a small folded balloon at the end of

the catheter. One unit refers to one PTA balloon catheter.

PTA Peripheral Drug Eluting Balloons (DEB)

A Drug Eluting Balloon (DEB) is an anti-restenotic drug coated PTA (percutaneous transluminal angioplasty) balloon

intended to prevent re-narrowing of the peripheral arteries. DEBs provide fast, short-term, homogenous, local drug

delivery, preserve the anatomy of the vessel, promote enhanced vessel healing, and reduce the need for prolonged

dual antiplatelet therapy without leaving any metal behind. One unit refers to one PTA peripheral DEB.

Aortic Stent Grafts

Aortic Stent grafts are used to surgically reinforce a part of the diseased aorta such as blood filled dilation and are

used in cases that cannot be treated with intervention. It can be an allograft or a poly tetra fluro ethylene (PTFE) type.

These include thoracic aortic stent grafts and abdominal aortic stent grafts.

Abdominal Aortic Stent Grafts

Abdominal aortic stent grafts are used to treat abdominal aortic aneurysms by reinforcing a part of the aorta using a

minimally invasive procedure. One unit refers to one abdominal stent graft.

Thoracic Aortic Stent Grafts

Thoracic aortic stent grafts are used to treat thoracic aortic aneurysms by reinforcing a part of the aorta using a

minimally invasive procedure. One unit refers to one thoracic aortic stent graft.

Vascular Grafts

Vascular grafts are used to repair or replace blood vessels in surgical devices. They are made up of Dacron or

polytetrafluroethylene (PTFE). It is also used to patch injured or diseased areas of arteries, for replacement of whole

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segments of larger arteries such as the aorta. One unit refers to one vascular graft. In the taxonomy only synthetic

vascular grafts are tracked, thus preserved autologous grafts from other veins and arteries, cryo-preserved veins,

xenografts, arterial homograft are excluded from the analysis.

Peripheral Venous Thrombectomy Devices

Peripheral venous thrombectomy devices are the type of clot busting devices that are used to treat thrombus

containing lesions developed due to peripheral insufficiency. Mechanical Thrombectomy devices and Aspiration

Thrombectomy devices are tracked under this category:

Mechanical Thrombectomy Devices

Mechanical thrombectomy device involves the use of rotating coil which mechanically breaks the clot, sucking the

debris out through the catheter from the peripheral vasculature by negative pressure. One unit of mechanical

thrombectomy device consists of a catheter and a driving unit with a rotating coil to which the catheter is attached.

Aspiration Thrombectomy Devices

This type of thrombectomy device involves the application of negative pressure for the removal of thrombus from the

peripheral vasculature. The pressure is applied at the distal end of the catheter which leads to aspiration of the clot

into the catheter. One unit of aspiration thrombectomy device consists of a catheter and a driving unit to which the

catheter is attached.

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3 Peripheral Vascular Devices Market, United States

3.1 Peripheral Vascular Devices Market, United States, Revenue ($m), 2005-2012

Figure 1: Peripheral Vascular Devices Market, United States, Revenue ($m), USD Constant, Historic, 2005-2012

Source: GlobalData

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Table 1: Peripheral Vascular Devices Market, United States, Revenue ($m), USD Constant, Historic, 2005-2012

Category 2005 2006 2007 2008 2009 2010 2011 2012 CAGR 05-12


% Growth

Aortic Stent Grafts

% Growth

Peripheral Embolic Protection Devices

% Growth

Inferior Vena Cava Filters (IVCF)

% Growth

PTA Balloons

% Growth


% Growth

Vascular Grafts

% Growth

Peripheral Venous Thrombectomy Devices

% Growth

Total

% Growth

Source: GlobalData

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3.2 Peripheral Vascular Devices Market, United States, Revenue ($m), 2012-2020

Figure 2: Peripheral Vascular Devices Market, United States, Revenue ($m), USD Constant, Forecast, 2012-2020

Source: GlobalData

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Table 2: Peripheral Vascular Devices Market, United States, Revenue ($m), USD Constant, Forecast, 2012-2020

Category 2012 2013 2014 2015 2016 2017 2018 2019 2020 CAGR 12-

20


% Growth

Aortic Stent Grafts

% Growth

Peripheral Embolic Protection

Devices

% Growth

Inferior Vena Cava Filters (IVCF)

% Growth

PTA Balloons

% Growth


% Growth

Vascular Grafts

% Growth

Peripheral Venous Thrombectomy

Devices

% Growth

PTA Peripheral Drug Eluting

Balloons (DEB)

% Growth

Renal Denervation Disposable

Catheters

% Growth

Total

% Growth

Source: GlobalData

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3.2.1 Aortic Stent Grafts Market, United States, Revenue ($m), by Segment, 2005-2012

Figure 3: Aortic Stent Grafts Market, United States, Revenue ($m), USD Constant, Historic, 2005-2012

Source: GlobalData

Table 3: Aortic Stent Grafts Market, United States, Revenue ($m), USD Constant, Historic, 2005-2012

Segment 2005 2006 2007 2008 2009 2010 2011 2012 CAGR 05-12

Abdominal Aortic Stent Grafts

% Growth

Thoracic Aortic Stent Grafts

% Growth

Total

% Growth

Source: GlobalData

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8 Appendix

The data and analysis within this report are driven by Medical eTrack. Medical eTrack gives you the key information

required to drive sales, investment and deal-making activity in your business. It includes the following:

15,000+ data tables showing market size across more than 780 medical equipment segments and 15 countries,

from 2005 and forecast to 2020

6,000+ primary expert interviews, conducted annually to ensure data and report quality

1,100+ medical equipment conference reports

1,000+ industry-leading reports per annum, covering growing sectors, market trends, investment opportunities

and competitive landscape

600+ analysis reports, covering market and pipeline product analysis, by indication; medical equipment trends

and issues, and investment and M&A trends worth over $3m

50,000+ medical equipment company profiles

2,000+ private, emerging and technology start-up company profiles

4,000+ company profiles of medical equipment manufacturers in China and India

2,000+ company profiles of medical equipment manufacturers in Japan

825+ companies‘ revenue splits and market shares

1,100+ quarterly and annual medical equipment company financials

700+ medical equipment company SWOTs

11,700+ pipeline product profiles

14,000+ marketed product profiles

16,900+ clinical trials

17,000+ trial investigators

18,000+ new product patents

3,700+ reports on companies with products in development

21,500+ reports on deals in the medical equipment industry

1,300+ surgical and diagnostic procedures by therapy area

50+ key healthcare indicators by country

For more information or to receive a free demonstration of the service, please visit:

http://www.medicaletrack.com/ContactUs.aspx?Id=RequestDemo

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8.1 Research Methodology

GlobalData‘s dedicated research and analysis teams consist of experienced professionals with advanced statistical

expertise and marketing, market research and consulting backgrounds in the medical devices industry.

GlobalData adheres to the codes of practice of the European Pharmaceutical Marketing Research Association

(http://www.ephmra.org/).

All GlobalData databases are continuously updated and revised.

8.1.1 Coverage

The objective of updating GlobalData‘s coverage is to ensure that it represents the most up-to-date vision of the

industry possible.

Changes to the industry taxonomy are built on the basis of extensive research of company, association and

competitor sources.

Company coverage is based on three key factors: revenue; product and media attention; and innovation and market

potential.

The estimated revenue of all major companies, both private and public, are gathered and used to prioritize coverage.

GlobalData aims to cover all major news events and deals in the medical devices industry, updated on a daily basis.

The coverage is further streamlined and strengthened with additional input from GlobalData‘s expert panel.

8.1.2 Secondary Research

The research process begins with extensive secondary research using internal and external sources to gather all

relevant data and information pertaining to a particular market model for a particular country. The secondary research

sources that are typically referred to include, but are not limited to:

Company websites, annual reports, financial reports, broker reports, investor presentations and SEC filings

Industry trade journals, scientific journals and other technical literature

Association and healthcare organization websites

PubMed, Medscape and other relevant services which compile extensive reviews of clinical literature

Internal proprietary databases

Relevant patent and regulatory databases

National government documents, statistical databases and market reports

Procedure registries

News articles, press releases and web-casts specific to the companies operating in the market

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8.1.3 Primary Research

GlobalData conducts interviews with industry participants and commentators in order to validate its data and analysis.

A typical research interview fulfills the following functions:

Provides first-hand information on market size, market trends, growth trends, competitive landscape and

future outlook

Helps to validate and strengthen secondary research findings

Further develops the analysis team‘s expertise and market understanding

Primary research involves email correspondence, telephone interviews and face-to-face interviews for each market,

category, segment and sub-segment across a range of geographies.

The participants who typically take part in such a process include, but are not limited to:

o Industry participants: CEOs, VPs, marketing/product managers, market intelligence managers and

national sales managers

o Distributors, paramedics and representatives from hospital stores, laboratories and pharmacies

o Outside experts: investment bankers, valuation experts and research analysts that specialize in specific

medical equipment markets

o Key opinion leaders: physicians and surgeons that specialize in the therapeutic areas in which the

medical device is used

The market data was validated based on the inputs from 1,771 primary research participants. The primary research

participants included stakeholders from demand side such as the cardiovascular surgeons, as well as participants

from the supply side such as the marketing managers, sales managers and product managers of companies

manufacturing/marketing cardiovascular devices.

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Table 81: Total Number of Primary Research Participants, Cardiovascular Devices Market, by Country

Country Total Number of Primary Research Participants

United States 136

United Kingdom 120

Germany 128

France 153

Italy 121

Spain 134

Brazil 128

China 79

India 173

Russia 89

Japan 88

Australia 122

Canada 111

Mexico 90

South Korea 99

Total 1,771

Source: GlobalData

8.1.4 Market Modeling and Forecasting

GlobalData uses an epidemiology-based treatment flow model and capital equipment-based model to estimate and

forecast market size.

Epidemiology-Based Market Model and Forecasting

The epidemiology-based forecasting model uses epidemiology data gathered from research publications and primary

interviews with physicians to establish the target patient population and treatment flow pattern for individual diseases

and therapies. The data covers prevalence, incidence, diseased population, diagnosed population, and treatment

population.

The market forecast begins with the general population, the size of which varies depending on the indication.

Prevalence is the percentage of the total population that suffers from a particular disease or condition.

Incidence is the number of new cases of a condition, symptom, death or injury that develop during a specific

time period, such as one year.

The diseased population is the population suffering from a particular disease or condition.

The diagnosed population is the population that has been diagnosed with a particular disease or condition,

expressed as a percentage of the prevalence population.

The treatment population is the percentage of the population that has been diagnosed with a particular

disease or condition.

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Device uptake is the percentage of the treatment population using a particular device, determined based on

the primary responses and the information available in secondary sources.

The epidemiology-based forecasting model for a medical device is used to:

Determine the patient segment using a particular device or procedure

Determine the frequency of usage of a particular device depending on the patient type, which further helps to

determine the absolute unit sales of a device in a year

The market for any medical device is directly proportional to the volume of units sold and the price per unit.

Market size = volumes of units sold X ASP (Average Selling Price)

The volume of units sold is calculated from the number of patients using or that has been implanted with the device.

Data on treatment rate, diagnosis and surgical treatment rate, if unavailable from research publications, is gathered

from interviews with physicians and used to estimate the patient volume for the disease under consideration.

The ASP of a device is mostly gathered from primary and secondary sources. ASP is the price at which a device is

available in a target country to an end-user. For capital equipment, the end-user is typically considered to be the

healthcare setting. For implants and consumables purchased by patients, the end-user is the patient.

Factors such as company share, reimbursement, company type (local/domestic or multinational) are taken into

consideration during ASP analysis, which uses the following sources:

Company websites

Annual reports/industry reports

Press releases

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Epidemiology-Based Forecasting Model

Capital Equipment-Based Market Model and Forecasting

The capital equipment-based forecasting model is based on the installed base, replacements and new sales of a

specific type of capital equipment in healthcare facilities such as hospitals, clinics and diagnostic centers. The

installed base is calculated from the average number of units per facility. Sales for a particular year are arrived at by

calculating the number of replacement units and new units (additional and first-time purchases). Secondary sources

and interviews with supply-side participants and key opinion leaders from healthcare facilities are used to arrive at

installed base and unit sales for a particular year. The factors typically affecting the forecast growth rates are:

Growth in the number of healthcare facilities

Healthcare spending and government programs and initiatives

Migration from low-end equipment to high-end equipment

Growth in the diagnosed population and treatment population

Figure 42: GlobalData Epidemiology-Based Forecasting Model

Source: GlobalData

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Capital Equipment-Based Forecasting Model

8.1.5 Company Share Analysis

Company shares are calculated by analyzing a company‘s sales in a particular market. In the case of public

companies, annual reports and regulatory filings, investor presentations, earnings call transcripts and broker reports

are used to determine a company‘s revenue in a particular market and in a particular geography.

In the case of the private companies, company share data is gathered mostly from primary interviews and secondary

sources. Company share analysis is based on primary interviews with:

Supply side (manufacturers)

Procurement side

Distributors

Hospital purchasing groups

Demand side (surgeons/specialists)

Figure 43: GlobalData Capital Equipment-Based Forecasting Model

Source: GlobalData

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The benefits of this approach are:

High number of respondents to validate and from which to derive accurate company shares

Broad view from the supply, demand, and procurement side

Prevents biased opinions being reproduced

Demand-side interviews with key opinion leaders help to understand their preferences for the devices of

specific companies, strengthening company share estimates

Primary Interviews by Participant Type

Figure 44: Primary Interviews by Participant Type (%)

The final company share data is based on input from the supply side, the procurement side and the demand side, as

well as secondary sources. Please note that market share for companies that are included under the ‗Others‘

category is not tracked on an individual basis.

8.1.6 Distribution Share Analysis

Distribution share information is gathered using a combination of secondary and primary research. It is supported by

primary interviews because the availability of secondary data is limited in most cases.

8.2 Expert Panel

GlobalData uses a panel of experts to cross-verify its databases and forecasts.

GlobalData‘s expert panel comprises marketing managers, product specialists, international sales managers from

medical device companies, academics from research universities, key opinion leaders from hospitals, consultants

from venture capital funds and distributors/suppliers of medical equipment and supplies.

Historic data and forecasts are relayed to GlobalData‘s expert panel for feedback and adjusted accordingly.

50

25

25

Procurement side Supply side Demand side

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8.3 GlobalData Consulting

We hope that the data and analysis in this brief will help you to make informed and imaginative business decisions. If

you have further requirements, GlobalData‘s consulting team may be able to help you. GlobalData offers tailor-made

analytical and advisory services to drive your key strategic decisions.

8.5 Disclaimer

All Rights Reserved.

No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means,

electronic, mechanical, photocopying, recording or otherwise without the prior permission of the publisher,

GlobalData.

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