U.S. Markets for Interventional Cardiology Products

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2 U.S. Markets for Interventional Cardiology Products Table of Contents EXECUTIVE SUMMARY... ES-1 i. Diagnostic Interventional Cardiology Products... ES-2 ii. Therapeutic Interventional Cardiology Products... ES-3 iii. Methodology... ES-5 Exhibit ES-1: Diagnostic Interventional Cardiology Systems Market Share, by Product Segment, 2015 and ES-4 Exhibit ES-2: Therapeutic Interventional Systems Market Share, by Product Segment, 2015 and ES-6 1. HEART DISEASE OVERVIEW Coronary Heart Disease Atherosclerosis Angina Pectoris Myocardial Infarction Hypertension Cardiomyopathy Congenital Heart Defects Heart Failure Disease Development Exhibit 1-1: Statistics for Selected Coronary Heart Disease Risk Factors Exhibit 1-2: Angina Pectoris, Selected Statistics Exhibit 1-3: Clinical Classification of AMI Exhibit 1-4: Myocardial Infarction, Selected Statistics Exhibit 1-5: Hypertension, Selected Statistics Exhibit 1-6: Cardiomyopathy, Selected Statistics Exhibit 1-7: Congenital Heart Defects, Selected Statistics Exhibit 1-8: Summary, American College of Cardiology/American Heart Association Heart Failure Staging System Exhibit 1-9: Heart Failure, Selected Statistics DIAGNOSTIC INTERVENTIONAL CARDIOLOGY PROCEDURES AND PRODUCTS Coronary Angiography Procedure Volumes Products Medtech Insight i #A209

3 U.S. Markets for Interventional Cardiology Products Table of Contents Market Forecast Competitors Guidewire-Based Physiologic Intravascular Stenosis Assessment Procedure Volumes Products Market Forecast Competitors Intracardiac Echocardiography Procedure Volumes Products Market Forecast Competitors Intravascular Ultrasound Procedure Volumes Products Market Forecast Competitors Optical Coherence Tomography Procedure Volumes Products Market Forecast Competitors Exhibit 2-1: Diagnostic Interventional Cardiology, Combined Procedure Volumes Forecast, Exhibit 2-2: Diagnostic Interventional Cardiology Products, Combined Market Forecast, Exhibit 2-3: Coronary Angiography, Procedure Volumes Forecast, Exhibit 2-4: Coronary Angiography Devices, Market Forecast, Exhibit 2-5: 2015, Coronary Angiography Devices Market, Share by Supplier Exhibit 2-6: Guidewire-Based Physiologic Intravascular Stenosis Assessment, Procedure Volumes Forecast, Exhibit 2-7: Physiologic Intravascular Stenosis Assessment Guidewires, Market Forecast, Exhibit 2-8: 2015, Physiologic Intravascular Stenosis Assessment Guidewire Systems Market, Share by Supplier Medtech Insight ii #A209

4 U.S. Markets for Interventional Cardiology Products Table of Contents Exhibit 2-9: Intracardiac Echocardiography, Procedure Volumes Forecast, Exhibit 2-10: Intracardiac Echocardiography Catheters, Market Forecast, Exhibit 2-11: 2015, Intracardiac Echocardiography Catheters Market, Share by Supplier Exhibit 2-12: Intravascular Ultrasound, Procedure Volumes Forecast, Exhibit 2-13: Intravascular Ultrasound Products, Market Forecast, Exhibit 2-14: 2015, Intravascular Ultrasound Products Market, Share by Supplier Exhibit 2-15: Cardiovascular Optical Coherence Tomography, Procedure Volumes Forecast, Exhibit 2-16: Cardiovascular Optical Coherence Tomography Systems, Market Forecast, THERAPEUTIC INTERVENTIONAL CARDIOLOGY PROCEDURES AND PRODUCTS Percutaneous Transluminal Coronary Angioplasty Procedure Volumes Forecast Products Market Forecast Competitors Coronary Stenting Procedure Volumes Forecast Products Market Forecast Competitors Coronary Atherectomy Procedure Volumes Forecast Products Market Forecast Competitors Coronary Thrombectomy Procedures Volumes Forecast Products Market Forecast Medtech Insight iii #A209

5 U.S. Markets for Interventional Cardiology Products Table of Contents Competitors Transcatheter Septal Defect Repair Procedure Volumes Forecast Products Market Forecast Competitors Exhibit 3-1: Therapeutic Interventional Cardiology, Combined Procedure Volumes Forecast, Exhibit 3-2: Therapeutic Interventional Cardiology Products, Combined Market Forecast, Exhibit 3-3: Percutaneous Transluminal Coronary Angioplasty, Procedure Volumes Forecast, Exhibit 3-4: Percutaneous Transluminal Coronary Angioplasty Devices, Market Forecast, Exhibit 3-5: 2015, Percutaneous Transluminary Coronary Angioplasty Devices Market, Share by Supplier Exhibit 3-6: 2016, Selected Anti-Restenosis Agents Exhibit 3-7: Coronary Stenting, Procedure Volumes Forecast, Exhibit 3-8: Coronary Stent Systems, Market Forecast, Exhibit 3-9: 2015, Coronary Stent Systems Market, Share by Supplier Exhibit 3-10: Coronary Atherectomy, Procedure Volumes Forecast, Exhibit 3-11: Coronary Atherectomy Systems, Market Forecast, Exhibit 3-12: 2015, Coronary Atherectomy Devices Market, Share by Supplier Exhibit 3-13: Coronary Thrombectomy, Procedure Volumes Forecast, Exhibit 3-14: Coronary Thrombectomy Systems, Market Forecast, Exhibit 3-15: 2015, Coronary Thrombectomy Systems Market, Share by Supplier Exhibit 3-16: Transcatheter Septal Defect Repair, Procedure Volumes Forecast, Exhibit 3-17: Transcatheter Septal Defect Repair Devices, Market Forecast, Exhibit 3-18: 2015, Transcatheter Coronary Septal Defects Repair Devices Market, Share by Supplier Medtech Insight iv #A209

6 U.S. Markets for Interventional Cardiology Products Table of Contents APPENDIX: COMPANY LISTING... A-1 BIBLIOGRAPHY... B Medtech Insight v #A209

7 U.S. Markets for Interventional Cardiology Products Executive Summary EXECUTIVE SUMMARY In the United States (U.S.), approximately 85.6 million adults have at least one type of cardiovascular disease (CVD), a broad group of disorders that affect the heart and circulatory system. Cardiovascular disease in all its forms accounts for more deaths than any other major cause in the U.S., including cancer, with one of every three deaths in the country due to CVD and over 2,200 people dying from the disease each day (or an average of one death from CVD every 40 seconds). Coronary heart disease (CHD), also known as ischemic heart disease, is a form of CVD that is associated with a reduction in blood flow through the vasculature of the heart. Classified under the umbrella of CHD are acute and chronic conditions such as atherosclerosis, angina pectoris, and myocardial infarction (MI). Approximately 15.5 million adults age 20 or older in the U.S. suffer from CHD, which is the single largest cause of death in the U.S. and also is the greatest cause of premature and permanent disability in the labor force (AHA, 2016). This report will cover: interventional diagnostic and therapeutic products for the treatment of CVD; procedure and market forecasts for the years 2015 to 2020; key market drivers and limiters; estimated revenues and market shares for major U.S. competitors; and, analysis of lead products and emerging products/technologies. Diseases/disorders of the heart are managed using a variety of methods including noninvasive imaging, open surgery, and catheter-based modalities. Interventional cardiology is a continually evolving area of medicine that involves the use of catheter-based, or transcatheter, tools and techniques to diagnose and treat coronary vascular and structural disorders. Today, interventional techniques are a mainstay for the diagnosis and treatment of patients with CHD and certain other types of CVD, as the transcatheter procedures typically are more cost-effective and less traumatic to patients than open surgical methods Medtech Insight ES-1 #A209

8 Heart Disease Overview Chapter 1 Exhibit 1-1: Statistics for Selected Coronary Heart Disease Risk Factors Risk Factor Number of Affected Adults Share of Total Population Total Cholesterol 200mg/dL Total Cholesterol 240mg/dL LDL Cholesterol 130mg/dL HDL Cholesterol 40mg/dL 100.1M 42.8% Overweight ( 25.0 BMI) Obesity ( 30.0 BMI) Physician-Diagnosed Diabetes Mellitus Regular Leisure-Time Physical Activity Tobacco Smoking Notes: BMI = body mass index. HDL = high-density lipoprotein. LDL = low-density lipoprotein. Cholesterol, diabetes mellitus, and overweight and obesity figures are for adults age 20 or older. Physical activity and tobacco smoking figures are for adults age 18 or older. Regular leisure-time physical activity = light-moderate activity for 150 minutes/week; or vigorous activity for 75 minutes/week. Figures are for 2009 to 2012, except the regular leisure-time physical activity and tobacco smoking figures, which are for 2014 and 2011 to 2013, respectively. Sources: American Heart Association, 2016 Heart and Stroke Statistical Update; Centers for Disease Control and Prevention; Medtech Insight 2016 Medtech Insight 1-3 #A209

9 Heart Disease Overview Chapter 1 Exhibit 1-3: Clinical Classification of AMI Class Description Class I Class II Class III Class IVa Class IVb Class V Spontaneous AMI related to atherosclerotic plaque dissection, erosion, fissuring, rupture, or ulceration with resulting intraluminal thrombus in one or multiple coronary arteries resulting in decreased myocardial blood flow or distal platelet emboli with consequent myocyte necrosis AMI secondary to ischemia resulting from myocardial injury with necrosis that creates an imbalance between myocardial oxygen supply and/or demand, e.g. anemia, coronary artery spasm, coronary embolism, coronary endothelial dysfunction, hypertension with or without left ventricular hypertrophy, hypotension, respiratory failure, and tachy-/brady-arrhythmias Sudden unexpected cardiac death, including cardiac arrest, often with symptoms suggestion ischemia with a new ST-segment elevation, new left bundle branch block, or pathologic or angiographic evidence of fresh coronary thrombus in the absence of reliable biomarker findings AMI associated with percutaneous coronary intervention AMI associated with documented in-stent thrombosis AMI associated with coronary artery bypass graft surgery Note: AMI = acute myocardial infarction. Sources: ACC/AHA Publications; Medtech Insight 2016 Medtech Insight 1-7 #A209

10 Diagnostic Interventional Cardiology Procedures and Products Chapter 2 Exhibit 2-1: (Continued) Diagnostic Interventional Cardiology, Combined Procedure Volumes Forecast ,000 Procedure Volumes, in Thousands 2,500 2,000 1,500 1, Coronary Angiography Intravascular Ultrasound Guidewire-Based Physiologic Intravascular Stenosis Assessment Optical Coherence Tomography Intracardiac Echocardiography Total Notes: Figures for coronary angiography include standard transcatheter coronary angiography procedures. Figures for intravascular ultrasound (IVUS) include IVUS procedures performed for coronary indications. Source: Medtech Insight 2016 Medtech Insight 2-4 #A209

11 Diagnostic Interventional Cardiology Procedures and Products Chapter 2 1 year. In addition, using FFR to guide treatment of the study patients significantly reduced procedural costs, hospital lengths of stay, and the number of DESs required per patient, and importantly, the use of FFR did not significantly increase multivessel PCI procedure time (Tonino et al, 2009) Procedure Volumes In 2015, approximately 231,200 procedures utilizing blood flow/pressure wires for functional lesion assessment in patients with intravascular blockages were performed in the U.S. During the forecast period covered by this report, the volume of assessment procedures is projected to grow at a compound annual rate of 3.6%, reaching an estimated 275,800 procedures in the year This forecast takes into account the fact that interventional cardiologists utilized FFR guidance in only a small minority of interventional procedures in the past, but since the publication of the positive results from the FAME, FAME II, and DEFER study results, there has been a steady adoption of the use of FFR guidance in the management of CAD patients, particularly those with multivessel disease. Exhibit 2-6 presents the U.S. procedure volumes forecast for guidewire-based physiologic vascular stenosis assessment for the years 2015 through Products Products used in physiologic intravascular stenoses assessment include blood pressure and flow velocity guidewires along with consoles with monitors that display the guidewire readings and calculations such as FFR values (some systems measure both blood pressure and flow across the lesion using a single guidewire). Companies offering products for the functional assessment of intravascular stenoses in the U.S. include Boston Scientific, St. Jude Medical and Volcano/Royal Philips Market Forecast Findings from the FAME study indicate that compared to the control group, the group in which FFR was used to determine cardiac stenting strategies had a significantly lower incidence of major adverse cardiac events (repeat revascularization, MI, or death) with the implication being that the placement of stents to open blockages not causing ischemia is unnecessary and may actually 2016 Medtech Insight 2-16 #A209

12 Therapeutic Interventional Cardiology Procedures and Products Chapter 3 1,500 Exhibit 3-1: (Continued) Therapeutic Interventional Cardiology, Combined Procedure Volumes Forecast, Procedure Volumes, in Thousands 1,350 1,200 1, Coronary Stenting PTCA Coronary Atherectomy Coronary Thrombectomy Transcatheter Septal Defect Repair Total Procedures Notes: PTCA = percutaneous transluminal coronary angioplasty. Coronary stenting procedures include those performed using drug-eluting and non-drug-eluting stents. Figures for PTCA assume approval of drug-eluting balloon angioplasty for at least one coronary indication in the United States by the year Coronary atherectomy figures include laser and mechanical procedures. Coronary thrombectomy figures include aspiration and mechanical procedures. Transcathter septal defect repair figures include procedures for the repair of atrial septal defects (including patent foramen ovale), patent ductus arteriosus, and ventricular septal defects. Source: Medtech Insight 2016 Medtech Insight 3-4 #A209

13 Company Listing Appendix COMPANY LISTING Abbott Laboratories Abbott Vascular/ Abbott Laboratories ACIST Medical Systems Alvimedica AngioDynamics Arrow International, Inc./ Teleflex, Inc. ASAHI INTECC Company LTD Atrium Medical Corporation/ Maquet Holding/ Getinge Group Bayer AG Bayer HealthCare AG/ Bayer AG BioCardia Biosense Webster/ Johnson & Johnson Biosensors International Group LTD BIOTRONIK SE & Co, KG Blue Medical Boston Scientific Corporation Bracco Group B. Braun Melsungen AG Capture Vascular Systems Cardinal Health Cardia, Inc. Cardiovascular Systems, Inc. CeloNova Biosciences, Inc. Control Medical Technology Cook Group, Inc. Cook Medical/ Cook Group Medtech Insight A-1 #A209

14 Company Listing Appendix Cordis Corporation/ Cardinal Health Covidien/ Medtronic DISA Vascular PTY LTD Edwards Lifesciences Corporation Elixir Medical Corporation eucatech AG Eurocor GmbH/ Opto Circuits India LTD General Electric Healthcare/ General Electric Company W.L. Gore & Associates, Inc. Hexacath IberHospiTex Infraredx/ Nipro Corporation InSitu Technologies, Inc. Johnson & Johnson Kaneka Medical Products/ Kaneka Medix Corporation Kyoto Medical Planning Corporation LTD Maquet Holding/ Getinge Group Maxcor/ Opto Circuits India LTD Medtronic, Inc. Merit Medical Systems, Inc. Micell Technologies, Inc. MicroPort Scientific Corporation Opsens OrbusNeich Philips Healthcare/ Royal Philips REVA Medical, Inc. Siemens AG Siemens Healthcare/ Siemens AG Medtech Insight A-2 #A209

15 Company Listing Appendix Spectranetics Corporation STENTYS St. Jude Medical, Inc. Terumo Interventional Systems/ Terumo Corporation Translumina GmbH Vascular Concepts/ Vascular Concepts Group Vascular Solutions, Inc. Volcano Corporation/ Royal Philips Medtech Insight A-3 #A209