GlobalData has released its medical devices report, “MediPoint: Drug-Eluting Balloons Global Analysis and Market Forecasts”. The report is an essential source of information and analysis on the global drug-eluting balloons (DEB) market. 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, France, Germany, Italy, Spain, UK, Japan, Brazil, China and India was assessed to identify and determine whether the current unmet needs are addressed, understand the challenges of DEB angioplasty and evaluate the current and future adoption of DEB for select coronary and peripheral indications.

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 also 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. It quantifies the unmet need in the global DEB market as well as in the individual markets of the US, the five major countries in the European Union, Japan, Brazil, China and India, highlighting the opportunity for future players. 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.

Highlights

Key Questions Answered

• What is the current perception and adoption of DEB for treating select coronary and peripheral indications, such as ISR, small vessel disease, bifurcations and peripheral arteries in the lower extremity?

 

• Bare metal and drug-eluting stents have been on the market for many years; however, unmet needs still exist with respect to patency, restenosis and the need for prolonged dual anti-platelet therapy. (Q).How will DEB fulfill the unmet needs of the vascular stent market for treating coronary and peripheral artery disease?

 

• What is the current and future adoption of DEB in the major markets? (Q).How will adoption of DEB affect the adoption of stents such as drug-eluting, bare metal and bioabsorbable stents?

 

• What are the challenges and complications of DEB angioplasty that have hindered widespread adoption?

 

• Currently, the majority of marketed DEB use the antiproliferative drug Paclitaxel. (Q).As the next-generation of DEB with limus-based antiproliferative drugs and innovative coating technologies receive approval, how will new entrants impact the DEB market for coronary and peripheral applications?

 

• (Q).What are the key factors and opportunities that will drive the DEB market in terms of future adoption rates leading to a mature market?

 

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 from 2010-2012 and forecast to 2019

 

• Key topics covered include strategic competitor assessment, market characterization, identification of unmet needs, reimbursement and regulatory considerations, evaluating market access in each of the regions covered in the report, 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 global 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

“What Do Physicians Think” quotes provide a unique insight into how healthcare professionals are reacting to events within the industry, and what their responses could mean for industry strategists. This information is essential for all strategic decision makers in every organization allowing them to act on high quality information.

Table of Contents

 

1 Table of Contents 9

1.1 List of Tables 18

1.2 List of Figures 25

 

2 Introduction 29

2.1 Catalyst 30

2.2 Related Reports 31

 

3 Disease Overview 32

3.1 Overview 32

3.1.1 Coronary Artery Disease 32

3.1.2 Peripheral Artery Disease 32

3.2 Anatomy and Physiology 33

3.2.1 Coronary Arteries 33

3.2.2 Peripheral Arteries of the Lower Extremity 34

3.3 Pathophysiology 36

3.3.1 Coronary Artery Disease 36

3.3.2 Peripheral Artery Disease 37

3.4 Clinical Presentation 38

3.4.1 Symptoms 38

3.4.2 Risk Factors 41

3.4.3 Disease Classification 42

3.4.4 Diagnosis 43

3.4.5 Clinical Outcomes 46

3.5 Epidemiology 79

3.5.1 Coronary Artery Disease 79

3.5.2 Peripheral Artery Disease 84

3.6 Economic Impact of Coronary and Peripheral Artery Disease 90

3.6.1 Cost of Coronary Artery Disease 90

3.6.2 Cost of Peripheral Artery Disease 94

3.6.3 Treatment Costs of Coronary and Peripheral Artery Disease 96

 

4 Competitive Assessment 99

4.1 Overview 99

4.2 Product Profiles by Company 101

4.2.1 Aachen Resonance 102

4.2.2 B. Braun 104

4.2.3 Biotronik 111

4.2.4 Blue Medical 114

4.2.5 Cardionovum 120

4.2.6 C.R. Bard 126

4.2.7 Concept Medical Research 132

4.2.8 Cook Medical 136

4.2.9 Eurocor 138

4.2.10 Medrad (Bayer Healthcare) 153

4.2.11 Medtronic 155

4.2.12 Minvasys 163

 

5 Unmet Needs 166

5.1 Need for Better Clinical Outcomes in Specific Lesions 166

5.1.1 Chronic Total Occlusions 166

5.1.2 Small-Vessel Coronary Lesions 167

5.1.3 Long Lesions 167

5.1.4 Heavily-Calcified and Uncrossable/Undilatable Lesions 168

5.1.5 Bifurcation Lesions 168

5.2 Need for Better Revascularization of the Femoropopliteal Artery 169

5.3 Difficulty in Treating the Infrapopliteal Artery 171

5.4 Eliminating Mechanisms of Failure with Balloon Angioplasty 172

5.5 Addressing Challenges of Stenting 174

5.5.1 Risk of Post-Procedural Complications 174

5.5.2 In-Stent Restenosis 176

5.5.3 Stent-In-Stent Procedures 177

5.5.4 Prolonged Dual Antiplatelet Therapy 178

5.5.5 Lack of Homogenous Drug Distribution 179

5.5.6 Delayed Healing 179

5.5.7 Stent Fracture 180

5.5.8 Negative Vessel Remodeling 181

5.5.9 Long-Term Vessel Patency 182

5.6 Need for Effective Therapy for Specific Patient Populations 182

5.7 Lack of Clinical Data 183

5.8 Addressing the Complications of Bypass Surgery 183

5.9 Need to Improve Medical Therapy 184

5.10 Comparative Studies on Exercise Therapy for PAD 185

 

6 Pipeline Products 186

6.1 Overview 186

6.2 Pipeline by Stage of Development 187

6.3 Pipeline Product Profiles 189

6.3.1 NF-?B Decoy Oligo DEB 189

6.3.2 Drug-Coated AngioSculpt 191

6.3.3 BioPath 194

6.3.4 BioStream 195

6.3.5 Boston Scientific Drug-Coated Balloon 196

6.3.6 Coroflex DEBlue 197

6.3.7 Covidien Drug-Coated Balloon 199

6.3.8 Caliber Therapeutics DEB 201

6.3.9 Elixir Medical Corporation DCB 202

6.3.10 LifeTech Scientific Corporation DEB 202

6.3.11 Micell Technologies Drug-Coated Balloon 202

6.3.12 Drug-Coated Chocolate DEB 204

6.3.13 Passeo-18 Lux 206

6.3.14 Vascular Nanotransfer Technologies Drug-Coated Balloon 207

6.3.15 WOMBAT DCB 208

 

7 Clinical Trial Analysis 210

7.1 Overview 210

7.2 Clinical Trials to Watch 210

7.2.1 Drug-Eluting Balloons 210

7.2.2 Vascular Stents 224

 

8 Industry Overview 229

8.1 Procedure Trends 229

8.1.1 Factors Contributing to the Rise of Coronary and Peripheral Interventions 229

8.1.2 Coronary Artery Disease 230

8.1.3 Peripheral Artery Disease 235

8.2 Physician Decision-Making Process 243

8.3 Market Access 245

8.3.1 United States 246

8.3.2 European Union 253

8.3.3 Asia-Pacific Region 262

8.3.4 South America 271

8.4 Regulatory Issues/Recalls 275

8.4.1 Regulatory Issues 275

8.4.2 Product Recalls 276

8.5 Mergers and Acquisitions/Partnerships 276

8.5.1 Biosensors International and Eurocor 276

8.5.2 Boston Scientific Corporation and Guidant Corporation 277

8.5.3 Covidien and ev3, CV Ingenuity 277

8.5.4 C.R. Bard and Lutonix 278

8.5.5 Micell Technologies and Maxcor Lifescience 278

8.5.6 Medrad and Bayer 279

8.5.7 Medtronic and Invatec 279

 

9 Current and Future Players 280

9.1 Overview 280

9.2 Trends in Corporate Strategy 281

9.3 Company Profiles 284

9.3.1 Aachen Resonance 284

9.3.2 AnGes MG 285

9.3.3 AngioScore 287

9.3.4 AVIDAL Vascular 289

9.3.5 B. Braun 291

9.3.6 Biosensors International 293

9.3.7 Biotronik 295

9.3.8 Blue Medical 297

9.3.9 Boston Scientific Corporation 299

9.3.10 Caliber Therapeutics 301

9.3.11 Cardionovum 303

9.3.12 Concept Medical Research 305

9.3.13 Cook Medical 307

9.3.14 Covidien 308

9.3.15 C.R. Bard 310

9.3.16 Elixir Medical Corporation 312

9.3.17 Eurocor 314

9.3.18 LifeTech Scientific Corporation 316

9.3.19 Medtronic 318

9.3.20 Micell Technologies 320

9.3.21 Minvasys 321

9.3.22 TriReme Medical 323

9.3.23 Vascular Nanotransfer Technologies 325

 

10 Market Drivers, Opportunities, Barriers and Substitutes 327

10.1 Market Drivers 327

10.1.1 Rising Prevalence of Disease 328

10.1.2 Viable Treatment for Select Indications 329

10.1.3 No Metal Left Behind 334

10.1.4 Avoid Stent-in-Stent Procedures 335

10.1.5 Reduce the Need for Prolonged Dual Antiplatelet Therapy 336

10.1.6 Enhanced Vessel Healing and Better Patency 336

10.1.7 Technical Feasibility of Future Interventions 337

10.1.8 DEB as an Adjunctive Therapy 338

10.1.9 Limb Amputation 338

10.1.10 Cost Savings 339

10.1.11 Availability of Long-Term and Cost-Effective Data 340

10.1.12 Launch of DEB in the US 340

10.2 Opportunities 341

10.2.1 Improve DEB Design 341

10.2.2 DEB Hybrid Systems (DEB + Stent) 345

10.2.3 Target Indications Where Stenting is Not Satisfactory 345

10.2.4 Challenges in Treating the Femoropopliteal and Infrapopliteal Arteries 348

10.2.5 Target Challenging Patient Populations 350

10.2.6 Launch DEB in the Japanese Market 351

10.2.7 Emerging Markets 351

10.3 Market Barriers 352

10.3.1 Slow Adoption 352

10.3.2 High Selling Prices 356

10.3.3 Lack of Reimbursement 357

10.3.4 US FDA Regulatory Challenges 358

10.3.5 Healthcare Cost-Cutting and Reimbursement 359

10.3.6 Availability of Venture Capital 360

10.3.7 Medical Device Excise Tax 361

10.4 Market Substitutes 361

10.4.1 Vascular Stents 361

10.4.2 Liquid Drug Delivery Catheter 365

 

11 Drug-Eluting Balloon Market Analysis 368

11.1 Global Market Overview 368

11.2 Market Analysis by Type of Disease 369

11.2.1 Coronary Artery Disease 369

11.2.2 Peripheral Artery Disease in the Lower Extremity 370

11.3 Market Distribution by Indication 373

11.4 Primary Versus Adjunctive Therapy 375

11.5 Comparative Market Analysis 377

11.5.1 Coronary Artery Disease 377

11.5.2 Peripheral Artery Disease in the Lower Extremity 379

 

12 Country Outlooks & Forecasts 381

12.1 Overview 381

12.2 United States 383

12.2.1 Overview 383

12.2.2 Market Analysis 383

12.3 France 386

12.3.1 Overview 386

12.3.2 Market Analysis 386

12.4 Germany 389

12.4.1 Overview 389

12.4.2 Market Analysis 389

12.5 Italy 393

12.5.1 Overview 393

12.5.2 Market Analysis 393

12.6 Spain 396

12.6.1 Overview 396

12.6.2 Market Analysis 396

12.7 United Kingdom 398

12.7.1 Overview 398

12.7.2 Market Analysis 398

12.8 Japan 401

12.8.1 Overview 401

12.8.2 Market Analysis 401

12.9 Brazil 404

12.9.1 Overview 404

12.9.2 Market Analysis 404

12.10 China 406

12.10.1 Overview 406

12.10.2 Market Analysis 406

12.11 India 409

12.11.1 Overview 409

12.11.2 Market Analysis 409

 

13 Appendix 413

13.1 Bibliography 413

13.2 Abbreviations 445

13.3 Report Methodology 449

13.3.1 Overview 449

13.3.2 Coverage 449

13.3.3 Secondary Research 449

13.3.4 Forecasting Methodology 450

13.4 Physicians and Specialists Included in this Study 452

13.5 Physician Survey 455

13.6 About the Authors 456

13.6.1 Analysts 456

13.6.2 Global Head of Healthcare 457

13.7 About MediPoint 458

13.8 About GlobalData 458

13.9 Disclaimer 458

 

List of Tables

 

Table 1: Classification Systems for Determining the Severity of PAD Symptoms 40

Table 2: Risk Factors Associated with CAD and PAD 41

Table 3: Types of Atherosclerotic Lesions 43

Table 4: Treatment Guidelines to Improve the Symptoms of CAD* 48

Table 5: TASC II Classification of Iliac Artery Lesions 49

Table 6: TASC II Classification of Femoropopliteal Artery Lesions 50

Table 7: TASC II Classification of Infrapopliteal Artery Lesions 51

Table 8: Types of Coronary Artery Bypass Grafting 62

Table 9: Complications of Coronary/Peripheral Artery Bypass Surgery 63

Table 10: Indications for Using Drug-Eluting Balloons 67

Table 11: Drug-Eluting Balloon Coating Characteristics 69

Table 12: Drugs Incorporated Into Drug-Eluting Stents 72

Table 13: Types of Lesions Treated Using Atherectomy 75

Table 14: Global Prevalence of CAD in the Population Age ?65 Years in the Major Markets (millions), 2010-2019 80

Table 15: Global Prevalence of PAD in the Population Age ?65 Years in the Major Markets (millions), 2010-2019 85

Table 16: Direct and Indirect Healthcare Costs 90

Table 17: Healthcare Expenditures ($bn, 2008$) for CAD in the US 91

Table 18: Healthcare Expenditures ($bn) for CAD in the Five Major EU Countries, 2006 92

Table 19: Healthcare Expenditures ($bn) for PAD in the US and EU 94

Table 20: US Mean Hospital Costs* for Coronary and Peripheral Revascularization Procedures, 2010-2019 ($US) 97

Table 21: Global DEB Market ($m) for Treating Coronary and Peripheral Artery Disease, 2012 99

Table 22: Marketed DEB Products 101

Table 23: Elutax SV Product Portfolio 102

Table 24: Elutax SV SWOT Analysis, 2013 104

Table 25: SeQuent Please Product Portfolio 105

Table 26: SeQuent Please SWOT Analysis, 2013 110

Table 27: Pantera Lux Product Portfolio 111

Table 28: Pantera Lux SWOT Analysis, 2013 113

Table 29: Pioneer Product Portfolio 114

Table 30: Pioneer SWOT Analysis, 2013 116

Table 31: Protégé Product Portfolio 117

Table 32: Protégé SWOT Analysis, 2013 120

Table 33: Restore DEB Product Portfolio 121

Table 34: Restore DEB SWOT Analysis, 2013 122

Table 35: Legflow DEB Product Portfolio 123

Table 36: Legflow DEB SWOT Analysis, 2013 125

Table 37: Other DEB Products Developed by Cardionovum 126

Table 38: Lutonix Product Portfolio 127

Table 39: Lutonix SWOT Analysis, 2013 132

Table 40: Magic Touch Product Portfolio 133

Table 41: Magic Touch SWOT Analysis, 2013 135

Table 42: Advance 18 PTX Product Portfolio 136

Table 43: Advance 18 PTX SWOT Analysis, 2013 138

Table 44: Dior Product Portfolio 139

Table 45: Dior SWOT Analysis, 2013 145

Table 46: Freeway Family of DEB Product Portfolio 146

Table 47: Freeway Family of DEB SWOT Analysis, 2013 149

Table 48: Magical Product Portfolio 150

Table 49: Magical SWOT Analysis, 2013 152

Table 50: Cotavance Product Portfolio 153

Table 51: Cotavance SWOT Analysis, 2013 155

Table 52: IN.PACT Family DEB Product Portfolio 156

Table 53: IN.PACT SWOT Analysis, 2013 163

Table 54: Danubio Product Portfolio 164

Table 55: Danubio SWOT Analysis, 2013 165

Table 56: Global DEB Pipeline Products 188

Table 57: NF-?B Decoy Oligo DEB SWOT Analysis, 2013 191

Table 58: AngioSculpt SWOT Analysis, 2013 193

Table 59: BioPath SWOT Analysis, 2013 195

Table 60: BioStream SWOT Analysis, 2013 196

Table 61: Boston Scientific DEB SWOT Analysis, 2013 197

Table 62: Coroflex DEBlue SWOT Analysis, 2013 199

Table 63: Covidien DCB SWOT Analysis, 2013 201

Table 64: Micell Technologies' DCB SWOT Analysis, 2013 203

Table 65: Drug-Coated Chocolate DEB SWOT Analysis, 2013 205

Table 66: Passeo-18 Lux SWOT Analysis, 2013 207

Table 67: Vascular Nanotransfer Technologies DCB SWOT Analysis, 2013 208

Table 68: WOMBAT DCB SWOT Analysis, 2013 209

Table 69: Medicare National Average of Inpatient Hospital Payment for Coronary and Peripheral Interventions, 2012-2013 252

Table 70: Reimbursement Classification of Medical Devices in Japan 269

Table 71: Aachen Resonance Company Profile 284

Table 72: Aachen Resonance, Marketed DEB Product 285

Table 73: Aachen Resonance SWOT Analysis, 2013 285

Table 74: AnGes MG Company Profile 286

Table 75: AnGes MG, Pipeline DEB Product 287

Table 76: AnGes MG SWOT Analysis, 2013 287

Table 77: AngioScore Company Profile 288

Table 78: AngioScore, Pipeline DEB Product 288

Table 79: AngioScore SWOT Analysis, 2013 289

Table 80: AVIDAL Vascular Company Profile 289

Table 81: AVIDAL Vascular, Pipeline DEB Product 290

Table 82: AVIDAL Vascular SWOT Analysis, 2013 291

Table 83: B. Braun Company Profile 291

Table 84: B. Braun, Marketed and Pipeline DEB Products 292

Table 85: B. Braun SWOT Analysis, 2013 293

Table 86: Biosensors International Company Profile 294

Table 87: Biosensors International, Pipeline DEB Products 294

Table 88: Biosensors International SWOT Analysis, 2013 295

Table 89: Biotronik Company Profile 296

Table 90: Biotronik, Marketed and Pipeline DEB Products 296

Table 91: Biotronik SWOT Analysis, 2013 297

Table 92: Blue Medical Company Profile 298

Table 93: Blue Medical, Marketed DEB Products 299

Table 94: Blue Medical SWOT Analysis, 2013 299

Table 95: Boston Scientific Corporation Company Profile 300

Table 96: Boston Scientific Corporation, Pipeline DEB Product 300

Table 97: Boston Scientific Corporation SWOT Analysis, 2013 301

Table 98: Caliber Therapeutics Company Profile 301

Table 99: Caliber Therapeutics, Pipeline DEB Product 302

Table 100: Caliber Therapeutics SWOT Analysis, 2013 302

Table 101: Cardionovum Company Profile 303

Table 102: Cardionovum, Marketed and Pipeline DEB Products 304

Table 103: Cardionovum SWOT Analysis, 2013 304

Table 104: Concept Medical Research Company Profile 305

Table 105: Concept Medical Research, Marketed DEB Product 306

Table 106: Concept Medical Research SWOT Analysis, 2013 306

Table 107: Cook Medical Company Profile 307

Table 108: Cook Medical, Marketed DEB Product 308

Table 109: Cook Medical SWOT Analysis, 2013 308

Table 110: Covidien Company Profile 309

Table 111: Covidien, Pipeline DEB Product 309

Table 112: Covidien SWOT Analysis, 2013 310

Table 113: C.R. Bard Company Profile 310

Table 114: C.R. Bard, Marketed DEB Products 311

Table 115: C.R. Bard SWOT Analysis, 2013 312

Table 116: Elixir Medical Corporation Company Profile 312

Table 117: Elixir Medical Corporation, Pipeline DEB Product 313

Table 118: Elixir Medical Corporation SWOT Analysis, 2013 313

Table 119: Eurocor Company Profile 314

Table 120: Eurocor, Marketed DEB Products 315

Table 121: Eurocor SWOT Analysis, 2013 315

Table 122: LifeTech Scientific Corporation Company Profile 316

Table 123: LifeTech Scientific, Pipeline DEB Product 317

Table 124: LifeTech Scientific SWOT Analysis, 2013 317

Table 125: Medtronic Company Profile 318

Table 126: Medtronic, Marketed DEB Products 319

Table 127: Medtronic SWOT Analysis, 2013 319

Table 128: Micell Technologies Company Profile 320

Table 129: Micell Technologies, Pipeline DEB Product 321

Table 130: Micell Technologies SWOT Analysis, 2013 321

Table 131: Minvasys Company Profile 322

Table 132: Minvasys, Marketed DEB Product 322

Table 133: Minvasys SWOT Analysis, 2013 323

Table 134: TriReme Medical Company Profile 323

Table 135: TriReme Medical, Pipeline DEB Product 324

Table 136: TriReme Medical SWOT Analysis, 2013 325

Table 137: Vascular Nanotransfer Technologies Company Profile 325

Table 138: Vascular Nanotransfer Technologies, Pipeline DEB Product 326

Table 139: Vascular Nanotransfer Technologies SWOT Analysis, 2013 326

Table 140: Global Coronary and Peripheral DEB Market ($m) Forecast, 2010-2019 369

Table 141: Global DEB Market ($m) for Treating PAD in the Lower Extremity, 2010-2019 370

Table 142: Percent of Patients with CAD or PAD Receiving Stenting with DEB Angioplasty, Global, 2012 and 2018 (N=112) 375

Table 143: DEB Sales ($m) Forecast for the United States, 2010-2019 384

Table 144: DEB Sales ($m) Forecast for France, 2010-2019 387

Table 145: DEB Sales ($m) Forecast for Germany, 2010-2019 390

Table 146: DEB Sales ($m) Forecast for Italy, 2010-2019 393

Table 147: DEB Sales ($m) Forecast for Spain, 2010-2019 397

Table 148: DEB Sales ($m) Forecast for UK, 2010-2019 399

Table 149: DEB Sales ($m) Forecast for Japan, 2010-2019 402

Table 150: DEB Sales ($m) Forecast for Brazil, 2010-2019 404

Table 151: DEB Sales ($m) Forecast for China, 2010-2019 407

Table 152: DEB Sales ($m) Forecast for India, 2010-2019 409

Table 153: Physicians Surveyed, By Country 45

 

List of Figures

 

Figure 1: Coronary Arteries of the Human Heart 33

Figure 2: Peripheral Arteries of the Lower Extremity 34

Figure 3: Pathophysiology of Coronary Artery Disease 36

Figure 4: Pathophysiology of Peripheral Artery Disease 37

Figure 5: Treatment Modalities - Coronary Artery Disease 53

Figure 6: Percent of Patients with CAD Who Receive Each Therapy Option Only, Global, 2012 and 2019 (N=58) 54

Figure 7: Treatment Modalities - Peripheral Artery Disease 55

Figure 8: Percent of Patients with PAD Who Receive Each Therapy Option Only, Global, 2012 (N=54) 56

Figure 9: Percent of Patients with PAD Who Receive Each Therapy Option Only, Global, 2012 (N=54) 57

Figure 10: Drug-Eluting Balloon 65

Figure 11: Types of Stents Used to Treat CAD and PAD 71

Figure 12: Bare Metal Stent 71

Figure 13: Drug-Eluting Stent 72

Figure 14: Covered Stents 73

Figure 15: Bioabsorbable Stent - Remedy 74

Figure 16: Types of Atherectomy 76

Figure 17: Global Prevalence of CAD in the Population Age ?65 Years in the Major Markets (millions), 2010-2019 81

Figure 18: Global Prevalence of PAD in the Population Age ?65 Years in the Major Markets (millions), 2010-2019 86

Figure 19: Healthcare Expenditures ($bn, 2008$) for CAD in the US 91

Figure 20: Healthcare Expenditures ($bn) for PAD in the US and EU 94

Figure 21: US Mean Hospital Costs* for Coronary and Peripheral Revascularization Procedures, 2010-2019 ($US) 98

Figure 22: Global DEB Market Share for Treating Peripheral Artery Disease in the Lower Extremity, 2012 100

Figure 23: Image of the Protégé DEB 118

Figure 24: Percent of CAD and PAD Patients with Acute Vessel Recoil After Standard Balloon Angioplasty, Global, 2012 and 2018 (N=112) 173

Figure 25: Percent of CAD and PAD Patients with Thrombosis After Stenting, Global, 2012 and 2018 (N=112) 175

Figure 26: Percent of CAD and PAD Patients with ISR, Global, 2012 and 2018 (N=112) 176

Figure 27: Percent of CAD and PAD Patients Who Receive Stent-In-Stent Procedures, Global, 2012 and 2018 (N=112) 178

Figure 28: Percent of CAD and PAD Patients with Stent Fracture, Global, 2012 and 2018 (N=112) 181

Figure 29: Global DEB Pipeline Products by Stage of Development, 2013 187

Figure 30: AngioSculpt Scoring Balloon Expansion Profile 192

Figure 31: Drug-Coated Chocolate DEB 204

Figure 32: Population (? 65 years) of CAD Patients Receiving Interventional Procedures, US, 2010-2019 230

Figure 33: Population (? 65 years) of CAD Patients Receiving Interventional Procedures, EU*, 2010-2019 232

Figure 34: Population (? 65 years) of CAD Patients Receiving Interventional Procedures, APAC*, 2010-2019 233

Figure 35: Population (? 65 years) of CAD Patients Receiving Interventional Procedures, South America*, 2010-2019 234

Figure 36: Population (? 65 years) of PAD Patients Receiving Interventional Procedures for the Peripheral Arteries in the Lower Extremity, US, 2010-2019 236

Figure 37: Population (? 65 years) of PAD Patients Receiving DEB Angioplasty for the Peripheral Arteries in the Lower Extremity, US, 2010-2019 237

Figure 38: Population (? 65 years) with PAD Receiving Interventional Procedures for the Peripheral Arteries in the Lower Extremity, EU*, 2010-2019 238

Figure 39: Population (? 65 years) with PAD Receiving DEB Angioplasty in the Peripheral Arteries in the Lower Extremity, EU*, 2010-2019 239

Figure 40: Population (? 65 years) with PAD Receiving Interventional Procedures for the Peripheral Arteries in the Lower Extremity, APAC*, 2010-2019 240

Figure 41: Population (? 65 years) with PAD Receiving DEB Angioplasty for the Peripheral Arteries in the Lower Extremity, APAC*, 2010-2019 241

Figure 42: Population (? 65 years) with PAD Receiving Interventional Procedures for the Peripheral Arteries in the Lower Extremity, South America*, 2010-2019 242

Figure 43: Population (? 65 years) with PAD Receiving DEB Angioplasty for the Peripheral Arteries in the Lower Extremity, South America*, 2010-2019 243

Figure 44: Medicare National Average of Outpatient Hospitalization Payment for PCI and Endovascular Procedures, 2012-2013 253

Figure 45: DEB Market for Treating CAD and PAD in the Lower Extremity, Company Share (%), 2012 280

Figure 46: DEB Market for Each Type of Disease, Company Share (%), 2012 282

Figure 47: Importance of Each Therapy Attribute in Adopting DEB for the Treatment of CAD and PAD, Global, 2012 (N=112) 342

Figure 48: Global DEB Market ($m) for Treating Coronary Artery Disease and Peripheral Artery Disease in the Lower Extremity, 2010-2019 368

Figure 49: Global DEB Market ($m) for Treating PAD in the Lower Extremity, 2010-2019 371

Figure 50: Global DEB Market Share for Peripheral Artery Revascularization in the Lower Extremity , 2012 and 2019 372

Figure 51: Global DEB Market Distribution (%) by Indication, 2012 and 2018 (N=112) 374

Figure 52: Percent of Patients with CAD Receiving Each Type of Interventional Technique Only, Global, 2018 (N=58) 378

Figure 53: Percent of Patients with Lower Limb PAD Receiving Each Type of Interventional Technique Only, Global, 2018 (N=54) 379

Figure 54: Global DEB Market Revenue ($m), 2012 and 2019 382

Figure 55: US DEB Market ($m) for Coronary and Peripheral Applications, 2010-2019 384

Figure 56: French DEB Market ($m) for Coronary and Peripheral Applications, 2010-2019 388

Figure 57: German DEB Market ($m) for Coronary and Peripheral Applications, 2010-2019 390

Figure 58: Italian DEB Market ($m) for Coronary and Peripheral Applications, 2010-2019 394

Figure 59: Spanish DEB Market ($m) for Coronary and Peripheral Applications, 2010-2019 397

Figure 60: UK DEB Market ($m) for Coronary and Peripheral Applications, 2010-2019 400

Figure 61: Japanese DEB Market ($m) for Coronary and Peripheral Applications, 2010-2019 402

Figure 62: Brazilian DEB Balloons Market ($m) for Coronary and Peripheral Applications, 2010-2019 405

Figure 63: Chinese DEB Market ($m) for Coronary and Peripheral Applications, 2010-2019 407

Figure 64: Indian DEB Market ($m) for Coronary and Peripheral Applications, 2010-2019 410