| TABLE OF CONTENTS |
| U.S. MARKET FOR DRUG-ELUTING AND BARE METAL STENTS 2009................I |
| TABLE OF CONTENTS..................................................................................................... II |
| LIST OF FIGURES...............................................................................................................V |
| LIST OF CHARTS..............................................................................................................VI |
| EXECUTIVE SUMMARY................................................................................................... 1 |
| 1.1 MARKET FOR INTERVENTIONAL CARDIOLOGY DEVICES ............................................. 1 |
| 1.2 BARE-METAL AND DRUG-ELUTING STENTS ................................................................ 1 |
| 1.3 PTCA AND CUTTING BALLOONS.................................................................................. 1 |
| 1.4 BALLOON-INFLATION SYRINGES AND ANGIOPLASTY KITS ......................................... 2 |
| 1.5 INTERVENTIONAL CATHETERS ..................................................................................... 2 |
| 1.6 INTERVENTIONAL GUIDEWIRES.................................................................................... 2 |
| 1.7 EMBOLIC PROTECTION DEVICES .................................................................................. 3 |
| 1.8 ATHERECTOMY DEVICES.............................................................................................. 3 |
| 1.9 THROMBECTOMY DEVICES........................................................................................... 4 |
| 1.10 CHRONIC TOTAL OCCLUSION CROSSERS ................................................................... 4 |
| 1.11 INTRODUCER SHEATHS............................................................................................... 5 |
| 1.12 VASCULAR CLOSURE DEVICES................................................................................... 5 |
| 1.13 DIAGNOSTIC CORONARY CATHETERS AND GUIDEWIRES .......................................... 6 |
| 1.14 FRACTIONAL FLOW RESERVE GUIDEWIRES ............................................................... 7 |
| 1.15 IVUS CATHETERS....................................................................................................... 8 |
| 1.16 OPTICAL COHERENCE TOMOGRAPHY (OCT) DEVICES .............................................. 9 |
| 1.17 VULNERABLE PLAQUE DEVICES............................................................................... 10 |
| 1.18 PFO, ASD AND VSD DEVICES ................................................................................. 10 |
| 1.19 PERCUTANEOUS MITRAL VALVE REPAIR DEVICES.................................................. 10 |
| 1.20 AORTIC HEART VALVE REPLACEMENT DEVICES..................................................... 10 |
| 1.21 LEADING COMPETITORS ........................................................................................... 11 |
| Table of Contents |
| iii |
| RESEARCH METHODOLOGY....................................................................................... 13 |
| 2.1 RESEARCH SCOPE ....................................................................................................... 13 |
| 2.2 IDATA’S 9-STEP METHODOLOGY ............................................................................... 13 |
| 2.2.1 Step 1: Project Initiation & Team Selection ...................................................... 14 |
| 2.2.2 Step 2: Prepare Data Systems and Perform Secondary Research..................... 15 |
| 2.2.3 Step 3: Preparation for Interviews & Questionnaire Design ............................ 16 |
| 2.2.4 Step 4: Performing Primary Research............................................................... 17 |
| 2.2.5 Step 5: Research Analysis: Establishing Baseline Estimates ............................ 19 |
| 2.2.6 Step 6: Market Forecast and Analysis ............................................................... 19 |
| 2.2.7 Step 7: Identify Strategic Opportunities ............................................................ 21 |
| 2.2.8 Step 8: Final Review and Market Release ......................................................... 22 |
| 2.2.9 Step 9: Customer Feedback and Market Monitoring......................................... 23 |
| BARE-METAL AND DRUG-ELUTING STENTS.......................................................... 24 |
| 3.1 INTRODUCTION ........................................................................................................... 24 |
| 3.2 POPULATION AT RISK ................................................................................................. 26 |
| 3.3 PROCEDURE NUMBERS ............................................................................................... 30 |
| 3.4 MARKET ANALYSIS & FORECAST .............................................................................. 32 |
| 3.4.1 Units Sold by Type ................................................................................................ 35 |
| 3.4.2 Bare-Metal Stent Market ...................................................................................... 37 |
| 3.4.2.1 Bare-Metal Stent Market Drivers ....................................................................39 |
| 3.4.2.2 Bare-Metal Stent Market Limiters ...................................................................39 |
| 3.4.3 Drug-Eluting Stent Market ................................................................................... 41 |
| 3.4.3.1 Drug-Eluting Stent Market Drivers .................................................................44 |
| 3.4.3.2 Drug-Eluting Stent Market Limiters ................................................................45 |
| 3.4.4 Stents in Development........................................................................................... 47 |
| 3.4.4.1 Bioabsorbable Stents .......................................................................................48 |
| 3.4.4.2 Bifurcated Stents..............................................................................................50 |
| 3.5 STENT MARKET BY DELIVERY PLATFORM................................................................. 52 |
| 3.6 STENT MARKET BY SIZE............................................................................................. 54 |
| 3.7 COMPETITIVE ANALYSIS ............................................................................................ 56 |
| 3.7.1 Bare-Metal Stents ................................................................................................. 56 |
| 3.7.2 Drug-Eluting Stents .............................................................................................. 58 |
| 3.7.3 Potential New Market Participants ...................................................................... 62 |
| Table of Contents |
| iv |
| ABBREVIATIONS.............................................................................................................. 65 |
| List of Figures |
| v |
| LIST OF FIGURES |
| EXECUTIVE SUMMARY.................................................................................... 1 |
| RESEARCH METHODOLOGY.......................................................................... 13 |
| BARE-METAL AND DRUG-ELUTING STENTS............................................... 24 |
| Figure 4-1: Population at Risk, Market for Interventional Cardiology, U.S., 2005 |
| – 2015 ........................................................................................................... 27 |
| Figure 4-2: Angiography and Angioplasty Procedures, U.S., 2005 – 2015............ 30 |
| Figure 4-3: Market for Coronary Stents by Type, U.S., 2005 – 2015.................... 33 |
| Figure 4-4: Units Sold, Market for Coronary Stents, U.S., 2005 – 2015 ............... 35 |
| Figure 4-5: Coronary Stent Units by Type, U.S., 2005 – 2015 ............................. 36 |
| Figure 4-6: Market for Bare-Metal Stents, U.S., 2005 – 2015 .............................. 37 |
| Figure 4-7: Market Drivers and Limiters, Market for Bare-Metal Stents, U.S., |
| 2008 .............................................................................................................. 40 |
| Figure 4-8: Market for Drug-Eluting Stents, U.S., 2005 – 2015 ........................... 42 |
| Figure 4-9: Market Drivers and Limiters, Market for Drug-Eluting Stents, U.S., |
| 2008 .............................................................................................................. 46 |
| Figure 4-10: Coronary Stent Platforms in Development Not Approved by the |
| FDA, 2008..................................................................................................... 47 |
| Figure 4-11: Potential Market for Bioabsorbable Stents, U.S., 2013 – 2015 ......... 49 |
| Figure 4-12: Potential Market for Bifurcated Stents, U.S., 2010 – 2015 ............... 51 |
| Figure 4-13: Market for Coronary Stents by Delivery Platform, Units Sold, U.S., |
| 2005 – 2015................................................................................................... 52 |
| Figure 4-14: Market for Coronary Stents by Size, U.S., 2008 .............................. 54 |
| Figure 4-15: Leading Competitors, Market for Bare-Metal Stents, U.S., 2008 ...... 57 |
| Figure 4-16: Leading Competitors, U.S. Market for Drug-Eluting Stents, 2008 .... 60 |
| ABBREVIATIONS ............................................................................................ 65 |
| List of Charts |
| vi |
| LIST OF CHART S |
| EXECUTIVE SUMMARY.................................................................................... 1 |
| Chart 1-1: Market for Interventional Cardiology Devices, U.S., 2008 .................... 1 |
| Chart 1-2: Market for Coronary Stents, U.S., 2005 – 2015..................................... 1 |
| Chart 1-3: Coronary Atherectomy Devices Market, U.S., 2005 – 2015................... 3 |
| Chart 1-4: Coronary CTO Crosser Market, U.S., 2005 – 2015 ............................... 4 |
| Chart 1-5: Coronary Vascular Closure Devices, U.S., 2005 – 2015 ........................ 5 |
| Chart 1-6: Market for Diagnostic Coronary Catheters and Guidewires, U.S., 2005 |
| – 2015 ............................................................................................................. 6 |
| Chart 1-7: Penetration Rate of FFR Guidewires in PCI Procedures, U.S., 2005 - |
| 2015 ................................................................................................................ 7 |
| Chart 1-8: Number of IVUS Catheter Units Sold, U.S., 2005 – 2015...................... 8 |
| Chart 1-9: Optical Coherence Tomography Catheter Market, U.S., 2010 – 2015 .... 9 |
| Chart 1-10: Leading Competitors, Market for Interventional Cardiology, U.S., |
| 2008 .............................................................................................................. 11 |
| RESEARCH METHODOLOGY.......................................................................... 13 |
| BARE-METAL AND DRUG-ELUTING STENTS............................................... 24 |
| Chart 4-1: Population at Risk, Market for Interventional Cardiology, U.S., 2005 |
| – 2015 ........................................................................................................... 28 |
| Chart 4-2: Age Group Most Likely to Undergo Cardiac Intervention: 60 to 69 |
| Years Old, U.S., 2005 – 2015......................................................................... 29 |
| Chart 4-3: Angioplasty and Angiography Procedures, U.S., 2005 – 2015 ............. 31 |
| Chart 4-4: Market for Coronary Stents by Type, U.S., 2005 – 2015 ..................... 34 |
| Chart 4-5: Coronary Stent Units by Type, U.S., 2005 – 2015............................... 36 |
| Chart 4-6: Market for Bare-Metal Stents, U.S., 2005 – 2015................................ 38 |
| Chart 4-7: Market for Drug-Eluting Stents, U.S., 2005 – 2015............................. 43 |
| Chart 4-8: Penetration Rate for Bioabsorbable Stents, U.S., 2013 – 2015............. 49 |
| Chart 4-9: Penetration Rate for Bifurcated Stents, U.S., 2010 – 2015 .................. 51 |
| List of Charts |
| vii |
| Chart 4-10: Market for Coronary Stents by Delivery Platform, Units Sold, U.S., |
| 2005 – 2015................................................................................................... 53 |
| Chart 4-11: Market for Coronary Stents by Size, U.S., 2008 ................................ 55 |
| Chart 4-12: Leading Competitors, Market for Bare-Metal Stents, U.S., 2008 ....... 57 |
| Chart 4-13: Leading Competitors, Market for Drug-Eluting Stents, U.S., 2008 .... 61 |
| ABBREVIATIONS ............................................................................................ 65 |