GlobalData has released its medical devices report, “MediPoint: Drug-Eluting Balloons US Analysis and Market Forecasts”. The report is an essential source of information and analysis on the drug-eluting balloons (DEB) market in the US. The report provides in-depth insight into the use of DEB for coronary and peripheral applications in the lower extremity including in-stent restenosis, bifurcation lesions, small vessel disease, femoropopliteal artery and below-the-knee lesions, chronic total occlusions, acute myocardial infarction and lesions in diabetics.

The DEB market in the US was assessed to identify the unmet needs in the market, understand the regulatory challenges DEB manufacturers will encounter in the US, identify the challenges to adoption in clinical practice and evaluate future adoption of DEB for select coronary and peripheral indications. The US sales expectations are discussed through careful analysis of adoption patterns of using DEB.

Clients can use this report to better understand the scope of this technology and for strategic planning to explore opportunities in this dynamic market. The report provides insights into the competitive landscape, the marketed and pipeline DEB products, the current and emerging players and comparative market analysis of different types of interventional techniques used to treat coronary and peripheral artery disease. This report is built using data and information sourced from secondary sources and primary research interviews and survey with leading Interventional Cardiologists and Interventional Radiologists, with in-house analysis conducted by GlobalData’s team of industry experts.

Scope

• An overview of coronary artery disease and peripheral artery disease in the lower extremity, which includes epidemiology, pathophysiology, symptoms, diagnosis, and treatment guidelines and modalities.

 

• Annualized total drug-eluting balloon market revenue by type of disease, annual cost of disease and drug-eluting balloons adoption pattern and procedure data in the US from 2010-2012 and forecast for seven years to 2019.

 

• Key topics covered include strategic competitor assessment, market characterization, identification of unmet needs, reimbursement and regulatory considerations, evaluating market access and implications of the drug-eluting balloon market.

 

• Pipeline analysis: comprehensive data split across different stages of development, emerging trends and DEB designs in development, including investigation of DEB coating technology, antiproliferative agent used, balloon and catheter design and durability.

 

• Analysis of the current and future market competition in the US drug-eluting balloon market. Insightful review of the key industry drivers, opportunities, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

 

Reasons to buy

• Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.

 

• Develop business strategies by understanding the trends that will shape and drive the DEB market in the US.

 

• Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the US DEB market in the future.

 

• Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.

 

• Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.

 

• Track device sales in the US DEB market by disease and indication from 2010-2019.

 

• Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

 

Table of Contents

 

1 Table of Contents 8

1.1 List of Tables 16

1.2 List of Figures 22

 

2 Introduction 25

2.1 Catalyst 26

 

3 Disease Overview 27

3.1 Overview 27

3.1.1 Coronary Artery Disease 27

3.1.2 Peripheral Artery Disease 27

3.2 Anatomy and Physiology 28

3.2.1 Coronary Arteries 28

3.2.2 Peripheral Arteries of the Lower Extremity 29

3.3 Pathophysiology 31

3.3.1 Coronary Artery Disease 31

3.3.2 Peripheral Artery Disease 32

3.4 Clinical Presentation 33

3.4.1 Symptoms 33

3.4.2 Risk Factors 36

3.4.3 Disease Classification 37

3.4.4 Diagnosis 39

3.4.5 Clinical Outcomes 42

3.5 Epidemiology 76

3.5.1 Coronary Artery Disease 76

3.5.2 Peripheral Artery Disease 78

3.6 Economic Impact of Coronary and Peripheral Artery Disease 80

3.6.1 Cost of Coronary Artery Disease 81

3.6.2 Cost of Peripheral Artery Disease 82

3.6.3 Treatment Costs of Coronary and Peripheral Artery Disease 84

 

4 Competitive Assessment 86

4.1 Overview 86

4.2 Product Profiles by Company 87

4.2.1 Aachen Resonance 88

4.2.2 B. Braun 91

4.2.3 Biotronik 97

4.2.4 Blue Medical 100

4.2.5 Cardionovum 106

4.2.6 C.R. Bard 112

4.2.7 Concept Medical Research 118

4.2.8 Cook Medical 122

4.2.9 Eurocor 124

4.2.10 Medrad (Bayer Healthcare) 138

4.2.11 Medtronic 141

4.2.12 Minvasys 149

 

5 Unmet Needs 152

5.1 Need for Better Clinical Outcomes in Specific Lesions 152

5.1.1 Chronic Total Occlusions 152

5.1.2 Small-Vessel Coronary Lesions 153

5.1.3 Long Lesions 153

5.1.4 Heavily-Calcified and Uncrossable/Undilatable Lesions 154

5.1.5 Bifurcation Lesions 154

5.2 Need for Better Revascularization of the Femoropopliteal Artery 155

5.3 Difficulty in Treating the Infrapopliteal Artery 157

5.4 Eliminating Mechanisms of Failure with Balloon Angioplasty 158

5.5 Addressing Challenges of Stenting 160

5.5.1 Risk of Post-Procedural Complications 160

5.5.2 In-Stent Restenosis 161

5.5.3 Stent-In-Stent Procedures 163

5.5.4 Prolonged Dual Antiplatelet Therapy 164

5.5.5 Lack of Homogenous Drug Distribution 165

5.5.6 Delayed Healing 165

5.5.7 Stent Fracture 166

5.5.8 Negative Vessel Remodeling 167

5.5.9 Long-Term Vessel Patency 167

5.6 Need for Effective Therapy for Specific Patient Populations 168

5.7 Lack of Clinical Data 169

5.8 Addressing the Complications of Bypass Surgery 169

5.9 Need to Improve Medical Therapy 170

5.10 Comparative Studies on Exercise Therapy for PAD 171

 

6 Pipeline Products 172

6.1 Overview 172

6.2 Pipeline by Stage of Development 173

6.3 Pipeline Product Profiles 175

6.3.1 NF-?B Decoy Oligo DEB 175

6.3.2 Drug-Coated AngioSculpt 177

6.3.3 BioPath 180

6.3.4 BioStream 181

6.3.5 Boston Scientific Drug-Coated Balloon 182

6.3.6 Coroflex DEBlue 183

6.3.7 Covidien Drug-Coated Balloon 185

6.3.8 Caliber Therapeutics DEB 187

6.3.9 Elixir Medical Corporation DCB 188

6.3.10 LifeTech Scientific Corporation DEB 188

6.3.11 Micell Technologies Drug-Coated Balloon 188

6.3.12 Drug-Coated Chocolate DEB 190

6.3.13 Passeo-18 Lux 192

6.3.14 Vascular Nanotransfer Technologies Drug-Coated Balloon 193

6.3.15 WOMBAT DCB 194

 

7 Clinical Trial Analysis 196

7.1 Overview 196

7.2 Clinical Trials to Watch 197

7.2.1 Drug-Eluting Balloons 197

7.2.2 Vascular Stents 210

 

8 Industry Overview 215

8.1 Procedure Trends 215

8.1.1 Factors Contributing to the Rise of Coronary and Peripheral Interventions 215

8.1.2 Coronary Artery Disease 216

8.1.3 Peripheral Artery Disease 217

8.2 Physician Decision-Making Process 220

8.3 Market Access 222

8.3.1 Regulatory Process 222

8.3.2 Adoption 223

8.3.3 Reimbursement Trends in US 228

8.4 Regulatory Issues/Recalls 231

8.4.1 Product Recalls 231

8.5 Mergers and Acquisitions/Partnerships 231

8.5.1 Biosensors International and Eurocor 231

8.5.2 Boston Scientific Corporation and Guidant Corporation 232

8.5.3 Covidien and ev3, CV Ingenuity 232

8.5.4 C.R. Bard and Lutonix 233

8.5.5 Micell Technologies and Maxcor Lifescience 233

8.5.6 Medrad and Bayer 234

8.5.7 Medtronic and Invatec 234

 

9 Current and Future Players 235

9.1 Overview 235

9.2 Trends in Corporate Strategy 236

9.3 Company Profiles 239

9.3.1 Aachen Resonance 239

9.3.2 AnGes MG 240

9.3.3 AngioScore 242

9.3.4 AVIDAL Vascular 244

9.3.5 B. Braun 246

9.3.6 Biosensors International 248

9.3.7 Biotronik 250

9.3.8 Blue Medical 252

9.3.9 Boston Scientific Corporation 254

9.3.10 Caliber Therapeutics 256

9.3.11 Cardionovum 258

9.3.12 Concept Medical Research 260

9.3.13 Cook Medical 262

9.3.14 Covidien 264

9.3.15 C.R. Bard 266

9.3.16 DSM Biomedical 268

9.3.17 Elixir Medical Corporation 270

9.3.18 Eurocor 272

9.3.19 LifeTech Scientific Corporation 274

9.3.20 Medtronic 276

9.3.21 Micell Technologies 278

9.3.22 Minvasys 279

9.3.23 TriReme Medical 281

9.3.24 Vascular Nanotransfer Technologies 283

 

10 Market Drivers, Opportunities, Barriers and Substitutes 285

10.1 Market Drivers 285

10.1.1 Rising Prevalence of Disease 286

10.1.2 Viable Treatment for Select Indications 287

10.1.3 No Metal Left Behind 292

10.1.4 Avoid Stent-in-Stent Procedures 293

10.1.5 Reduce the Need for Prolonged Dual Antiplatelet Therapy 294

10.1.6 Enhanced Vessel Healing and Better Patency 294

10.1.7 Technical Feasibility of Future Interventions 295

10.1.8 DEB as an Adjunctive Therapy 296

10.1.9 Limb Amputation 296

10.1.10 Cost Savings 297

10.1.11 Availability of Long-Term and Cost-Effective Data 298

10.1.12 Launch of DEB in the US 298

10.2 Opportunities 299

10.2.1 Improve DEB Design 299

10.2.2 DEB Hybrid Systems (DEB + Stent) 303

10.2.3 Target Indications Where Stenting is Not Satisfactory 303

10.2.4 Challenges in Treating the Femoropopliteal and Infrapopliteal Arteries 306

10.2.5 Target Challenging Patient Populations 308

10.2.6 Launch DEB in the Japanese Market 309

10.2.7 Emerging Markets 309

10.3 Market Barriers 310

10.3.1 Slow Adoption 310

10.3.2 High Selling Prices 314

10.3.3 Lack of Reimbursement 315

10.3.4 US FDA Regulatory Challenges 316

10.3.5 Healthcare Cost-Cutting and Reimbursement 317

10.3.6 Availability of Venture Capital 318

10.3.7 Medical Device Excise Tax 319

10.4 Market Substitutes 319

10.4.1 Vascular Stents 319

10.4.2 Liquid Drug Delivery Catheter 323

 

11 Drug-Eluting Balloon Market Analysis 326

11.1 Market Distribution by Indication 326

11.2 Primary Versus Adjunctive Therapy 328

11.3 Comparative Market Analysis 330

11.3.1 Coronary Artery Disease 330

11.3.2 Peripheral Artery Disease in the Lower Extremity 332

 

12 Country Outlooks & Forecasts 334

12.1 United States 334

12.1.1 Overview 334

12.1.2 Market Analysis 334

 

13 Appendix 339

13.1 Bibliography 339

13.2 Abbreviations 363

13.3 Report Methodology 367

13.3.1 Overview 367

13.3.2 Coverage 367

13.3.3 Secondary Research 367

13.3.4 Forecasting Methodology 368

13.4 Physicians and Specialists Included in this Study 370

13.5 Physician Survey 373

13.6 About the Authors 374

13.6.1 Analysts 374

13.6.2 Global Head of Healthcare 375

13.7 About MediPoint 376

13.8 About GlobalData 376

13.9 Disclaimer 376

 

List of Tables

 

Table 1: Classification Systems for Determining the Severity of PAD Symptoms 35

Table 2: Risk Factors Associated with CAD and PAD 36

Table 3: Types of Atherosclerotic Lesions 38

Table 4: Treatment Guidelines to Improve the Symptoms of CAD* 43

Table 5: TASC II Classification of Iliac Artery Lesions 45

Table 6: TASC II Classification of Femoropopliteal Artery Lesions 46

Table 7: TASC II Classification of Infrapopliteal Artery Lesions 47

Table 8: Types of Coronary Artery Bypass Grafting 59

Table 9: Complications of Coronary/Peripheral Artery Bypass Surgery 60

Table 10: Indications for Using Drug-Eluting Balloons 63

Table 11: Drug-Eluting Balloon Coating Characteristics 66

Table 12: Drugs Incorporated Into Drug-Eluting Stents 69

Table 13: Types of Lesions Treated Using Atherectomy 72

Table 14: Prevalence of CAD in the Population Age ?65 Years in the US (millions), 2010-2019 77

Table 15: Prevalence of PAD in the Population Age ?65 Years in the US (millions), 2010-2019 79

Table 16: Direct and Indirect Healthcare Costs 80

Table 17: Healthcare Expenditures ($bn, 2008$) for CAD in the US 81

Table 18: Healthcare Expenditures ($bn) for PAD in the US 82

Table 19: US Mean Hospital Costs* for Coronary and Peripheral Revascularization Procedures, 2010-2019 ($US) 84

Table 20: Marketed DEB Products 87

Table 21: Elutax SV Product Portfolio 88

Table 22: Elutax SV SWOT Analysis, 2013 90

Table 23: SeQuent Please Product Portfolio 91

Table 24: SeQuent Please SWOT Analysis, 2013 96

Table 25: Pantera Lux Product Portfolio 97

Table 26: Pantera Lux SWOT Analysis, 2013 99

Table 27: Pioneer Product Portfolio 100

Table 28: Pioneer SWOT Analysis, 2013 102

Table 29: Protégé Product Portfolio 103

Table 30: Protégé SWOT Analysis, 2013 106

Table 31: Restore DEB Product Portfolio 107

Table 32: Restore DEB SWOT Analysis, 2013 108

Table 33: Legflow DEB Product Portfolio 109

Table 34: Legflow DEB SWOT Analysis, 2013 111

Table 35: Other DEB Products Developed by Cardionovum 112

Table 36: Lutonix Product Portfolio 113

Table 37: Lutonix SWOT Analysis, 2013 118

Table 38: Magic Touch Product Portfolio 119

Table 39: Magic Touch SWOT Analysis, 2013 121

Table 40: Advance 18 PTX Product Portfolio 122

Table 41: Advance 18 PTX SWOT Analysis, 2013 124

Table 42: Dior Product Portfolio 125

Table 43: Dior SWOT Analysis, 2013 131

Table 44: Freeway Family of DEB Product Portfolio 132

Table 45: Freeway Family of DEB SWOT Analysis, 2013 135

Table 46: Magical Product Portfolio 136

Table 47: Magical SWOT Analysis, 2013 138

Table 48: Cotavance Product Portfolio 139

Table 49: Cotavance SWOT Analysis, 2013 141

Table 50: IN.PACT Family DEB Product Portfolio 142

Table 51: IN.PACT SWOT Analysis, 2013 149

Table 52: Danubio Product Portfolio 150

Table 53: Danubio SWOT Analysis, 2013 151

Table 54: Global DEB Pipeline Products 174

Table 55: NF-?B Decoy Oligo DEB SWOT Analysis, 2013 177

Table 56: AngioSculpt SWOT Analysis, 2013 179

Table 57: BioPath SWOT Analysis, 2013 181

Table 58: BioStream SWOT Analysis, 2013 182

Table 59: Boston Scientific DEB SWOT Analysis, 2013 183

Table 60: Coroflex DEBlue SWOT Analysis, 2013 185

Table 61: Covidien DCB SWOT Analysis, 2013 187

Table 62: Micell Technologies' DCB SWOT Analysis, 2013 189

Table 63: Drug-Coated Chocolate DEB SWOT Analysis, 2013 191

Table 64: Passeo-18 Lux SWOT Analysis, 2013 193

Table 65: Vascular Nanotransfer Technologies DCB SWOT Analysis, 2013 194

Table 66: WOMBAT DCB SWOT Analysis, 2013 195

Table 67: Medicare National Average of Inpatient Hospital Payment for Coronary and Peripheral Interventions, 2012-2013 229

Table 68: Aachen Resonance Company Profile 239

Table 69: Aachen Resonance, Marketed DEB Product 240

Table 70: Aachen Resonance SWOT Analysis, 2013 240

Table 71: AnGes MG Company Profile 241

Table 72: AnGes MG, Pipeline DEB Product 242

Table 73: AnGes MG SWOT Analysis, 2013 242

Table 74: AngioScore Company Profile 243

Table 75: AngioScore, Pipeline DEB Product 243

Table 76: AngioScore SWOT Analysis, 2013 244

Table 77: AVIDAL Vascular Company Profile 244

Table 78: AVIDAL Vascular, Pipeline DEB Product 245

Table 79: AVIDAL Vascular SWOT Analysis, 2013 246

Table 80: B. Braun Company Profile 246

Table 81: B. Braun, Marketed and Pipeline DEB Products 247

Table 82: B. Braun SWOT Analysis, 2013 248

Table 83: Biosensors International Company Profile 249

Table 84: Biosensors International, Pipeline DEB Products 249

Table 85: Biosensors International SWOT Analysis, 2013 250

Table 86: Biotronik Company Profile 251

Table 87: Biotronik, Marketed and Pipeline DEB Products 251

Table 88: Biotronik SWOT Analysis, 2013 252

Table 89: Blue Medical Company Profile 253

Table 90: Blue Medical, Marketed DEB Products 254

Table 91: Blue Medical SWOT Analysis, 2013 254

Table 92: Boston Scientific Corporation Company Profile 255

Table 93: Boston Scientific Corporation, Pipeline DEB Product 255

Table 94: Boston Scientific Corporation SWOT Analysis, 2013 256

Table 95: Caliber Therapeutics Company Profile 256

Table 96: Caliber Therapeutics, Pipeline DEB Product 257

Table 97: Caliber Therapeutics SWOT Analysis, 2013 258

Table 98: Cardionovum Company Profile 258

Table 99: Cardionovum, Marketed and Pipeline DEB Products 259

Table 100: Cardionovum SWOT Analysis, 2013 260

Table 101: Concept Medical Research Company Profile 260

Table 102: Concept Medical Research, Marketed DEB Product 261

Table 103: Concept Medical Research SWOT Analysis, 2013 262

Table 104: Cook Medical Company Profile 262

Table 105: Cook Medical, Marketed DEB Product 263

Table 106: Cook Medical SWOT Analysis, 2013 264

Table 107: Covidien Company Profile 265

Table 108: Covidien, Pipeline DEB Product 265

Table 109: Covidien SWOT Analysis, 2013 266

Table 110: C.R. Bard Company Profile 266

Table 111: C.R. Bard, Marketed DEB Products 267

Table 112: C.R. Bard SWOT Analysis, 2013 268

Table 113: DSM Biomedical Company Profile 269

Table 114: DSM Biomedical, Pipeline DEB Product 269

Table 115: DSM Biomedical SWOT Analysis, 2013 270

Table 116: Elixir Medical Corporation Company Profile 270

Table 117: Elixir Medical Corporation, Pipeline DEB Product 271

Table 118: Elixir Medical Corporation SWOT Analysis, 2013 271

Table 119: Eurocor Company Profile 272

Table 120: Eurocor, Marketed DEB Products 273

Table 121: Eurocor SWOT Analysis, 2013 273

Table 122: LifeTech Scientific Corporation Company Profile 274

Table 123: LifeTech Scientific, Pipeline DEB Product 275

Table 124: LifeTech Scientific SWOT Analysis, 2013 275

Table 125: Medtronic Company Profile 276

Table 126: Medtronic, Marketed DEB Products 277

Table 127: Medtronic SWOT Analysis, 2013 277

Table 128: Micell Technologies Company Profile 278

Table 129: Micell Technologies, Pipeline DEB Product 279

Table 130: Micell Technologies SWOT Analysis, 2013 279

Table 131: Minvasys Company Profile 280

Table 132: Minvasys, Marketed DEB Product 280

Table 133: Minvasys SWOT Analysis, 2013 281

Table 134: TriReme Medical Company Profile 281

Table 135: TriReme Medical, Pipeline DEB Product 282

Table 136: TriReme Medical SWOT Analysis, 2013 283

Table 137: Vascular Nanotransfer Technologies Company Profile 283

Table 138: Vascular Nanotransfer Technologies, Pipeline DEB Product 284

Table 139: Vascular Nanotransfer Technologies SWOT Analysis, 2013 284

Table 140: Percent of Patients with CAD or PAD Expected to Receive Stenting with DEB Angioplasty, US, 2018 (N=12) 328

Table 141: DEB Sales ($m) Forecast for the United States, 2010-2019 335

Table 142: Physicians Surveyed, By Country 373

 

List of Figures

 

Figure 1: Coronary Arteries of the Human Heart 28

Figure 2: Peripheral Arteries of the Lower Extremity 29

Figure 3: Pathophysiology of Coronary Artery Disease 31

Figure 4: Pathophysiology of Peripheral Artery Disease 32

Figure 5: Treatment Modalities - Coronary Artery Disease 49

Figure 6: Percent of Patients with CAD Who Receive Each Therapy Option Only, US, 2012 and 2019 (N=5) 50

Figure 7: Treatment Modalities - Peripheral Artery Disease 51

Figure 8: Percent of Patients with PAD Who Receive Each Therapy Option Only, US, 2012 (N=7) 52

Figure 9: Percent of Patients with PAD Who Receive Each Therapy Option Only, US, 2012 (N=7) 53

Figure 10: Drug-Eluting Balloon 62

Figure 11: Types of Stents Used to Treat CAD and PAD 68

Figure 12: Bare Metal Stent 68

Figure 13: Drug-Eluting Stent 69

Figure 14: Covered Stents 70

Figure 15: Bioabsorbable Stent - Remedy 71

Figure 16: Types of Atherectomy 73

Figure 17: Prevalence of CAD in the Population Age ?65 Years in the US (millions), 2010-2019 78

Figure 18: Prevalence of PAD in the Population Age ?65 Years in the US (millions), 2010-2019 80

Figure 19: Healthcare Expenditures ($bn, 2008$) for CAD in the US 82

Figure 20: Healthcare Expenditures ($bn) for PAD in the US 83

Figure 21: US Mean Hospital Costs* for Coronary and Peripheral Revascularization Procedures, 2010-2019 ($US) 85

Figure 22: Image of the Protégé DEB 104

Figure 23: Percent of CAD and PAD Patients with Acute Vessel Recoil After Standard Balloon Angioplasty, US, 2012 and 2018 (N=12) 159

Figure 24: Percent of CAD and PAD Patients with Thrombosis After Stenting, US, 2012 and 2018 (N=12) 161

Figure 25: Percent of CAD and PAD Patients with ISR, US, 2012 and 2018 (N=12) 162

Figure 26: Percent of CAD and PAD Patients Who Receive Stent-In-Stent Procedures, US, 2012 and 2018 (N=12) 163

Figure 27: Percent of CAD and PAD Patients with Stent Fracture, US, 2012 and 2018 (N=12) 166

Figure 28: Global DEB Pipeline Products by Stage of Development, 2013 173

Figure 29: AngioSculpt Scoring Balloon Expansion Profile 178

Figure 30: Drug-Coated Chocolate DEB 190

Figure 31: Population (? 65 years) of CAD Patients Receiving Interventional Procedures, US, 2010-2019 216

Figure 32: Population (? 65 years) of PAD Patients Receiving Interventional Procedures for the Peripheral Arteries in the Lower Extremity, US, 2010-2019 218

Figure 33: Population (? 65 years) of PAD Patients Receiving DEB Angioplasty for the Peripheral Arteries in the Lower Extremity, US, 2010-2019 219

Figure 34: Medicare National Average of Outpatient Hospitalization Payment for PCI and Endovascular Procedures, 2012-2013 230

Figure 35: DEB Market for Treating CAD and PAD in the Lower Extremity, Company Share (%), 2012 235

Figure 36: DEB Market for Each Type of Disease, Company Share (%), 2012 237

Figure 37: Importance of Each Therapy Attribute in Adopting DEB for the Treatment of CAD and PAD, Global, 2012 (N=112) 300

Figure 38: Projected US DEB Market Distribution (%) by Indication, 2018 (N=12) 327

Figure 39: Percent of Patients with CAD Receiving Each Type of Interventional Technique Only, US, 2018 (N=5) 331

Figure 40: Percent of Patients with Lower Limb PAD Receiving Each Type of Interventional Technique Only, US, 2018 (N=7) 332

Figure 41: US DEB Market ($m) for Coronary and Peripheral Applications, 2010-2019 336