U.S. Market for Interventional Cardiology 2009

Published: April 2009
No. of Pages: 312
  

In 2008, the U.S. market for interventional cardiology was valued at $US 4.6 billion. This value represents drug-eluting stents, PTCA balloons, coronary closure devices, bare-metal stents, embolic protection devices, interventional guidewires, diagnostic catheters, intravascular ultrasound (IVUS) catheters, and interventional catheters. Over the forecast period, the market is predicted to decrease in value due to limited sales of drug-eluting stents.

U.S. Market for Interventional Cardiology 2009

 

TABLE OF CONTENTS
TABLE OF CONTENTS.......................................................................................................I
LIST OF FIGURES.............................................................................................................XI
LIST OF CHARTS........................................................................................................ XVIII
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
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RESEARCH METHODOLOGY....................................................................................... 12
2.1 RESEARCH SCOPE ....................................................................................................... 12
2.2 IDATA’S 9-STEP METHODOLOGY ............................................................................... 12
2.2.1 Step 1: Project Initiation & Team Selection ...................................................... 13
2.2.2 Step 2: Prepare Data Systems and Perform Secondary Research..................... 14
2.2.3 Step 3: Preparation for Interviews & Questionnaire Design ............................ 15
2.2.4 Step 4: Performing Primary Research............................................................... 16
2.2.5 Step 5: Research Analysis: Establishing Baseline Estimates ............................ 18
2.2.6 Step 6: Market Forecast and Analysis ............................................................... 18
2.2.7 Step 7: Identify Strategic Opportunities ............................................................ 20
2.2.8 Step 8: Final Review and Market Release ......................................................... 21
2.2.9 Step 9: Customer Feedback and Market Monitoring......................................... 22
U.S. MARKET FOR INTERVENTIONAL CARDIOLOGY DEVICES ...................... 23
3.1 INTRODUCTION ........................................................................................................... 23
3.2 OVERVIEW OF THE MARKET....................................................................................... 23
3.3 MARKET SEGMENTED BY DEVICE TYPE..................................................................... 25
3.3.1 Effects of the Economic Crisis .............................................................................. 25
3.4 TREND ANALYSIS BY MARKET SEGMENT .................................................................. 30
3.5 MARKET DRIVERS ...................................................................................................... 34
3.6 MARKET LIMITERS ..................................................................................................... 35
3.7 COMPETITIVE ANALYSIS ............................................................................................ 36
3.8 MERGERS AND ACQUISITIONS .................................................................................... 40
BARE-METAL AND DRUG-ELUTING STENTS.......................................................... 43
4.1 INTRODUCTION ........................................................................................................... 43
4.2 POPULATION AT RISK ................................................................................................. 45
4.3 PROCEDURE NUMBERS ............................................................................................... 49
4.4 MARKET ANALYSIS & FORECAST .............................................................................. 51
4.4.1 Units Sold by Type ................................................................................................ 54
4.4.2 Bare-Metal Stent Market ...................................................................................... 56
4.4.2.1 Bare-Metal Stent Market Drivers ....................................................................58
4.4.2.2 Bare-Metal Stent Market Limiters ...................................................................58
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4.4.3 Drug-Eluting Stent Market ................................................................................... 60
4.4.3.1 Drug-Eluting Stent Market Drivers .................................................................63
4.4.3.2 Drug-Eluting Stent Market Limiters ................................................................64
4.4.4 Stents in Development........................................................................................... 66
4.4.4.1 Bioabsorbable Stents .......................................................................................67
4.4.4.2 Bifurcated Stents..............................................................................................69
4.5 STENT MARKET BY DELIVERY PLATFORM................................................................. 71
4.6 STENT MARKET BY SIZE............................................................................................. 73
4.7 COMPETITIVE ANALYSIS ............................................................................................ 75
4.7.1 Bare-Metal Stents ................................................................................................. 75
4.7.2 Drug-Eluting Stents .............................................................................................. 77
4.7.3 Potential New Market Participants ...................................................................... 81
PTCA AND CUTTING BALLOON CATHETERS......................................................... 84
5.1 INTRODUCTION ........................................................................................................... 84
5.1.1 The Problem of Restenosis.................................................................................... 84
5.1.2 Conventional and Cutting Balloons...................................................................... 84
5.2 MARKET OVERVIEW................................................................................................... 85
5.3 MARKET FOR PTCA BALLOONS................................................................................. 87
5.3.1 Units Sold.............................................................................................................. 87
5.3.2 Market Analysis & Forecast ................................................................................. 88
5.4 MARKET FOR CUTTING BALLOONS ............................................................................ 90
5.4.1 Device Penetration ............................................................................................... 90
5.4.2 Market Analysis & Forecast ................................................................................. 91
5.5 MARKET DRIVERS AND LIMITERS .............................................................................. 93
5.5.1 Market Drivers...................................................................................................... 93
5.5.2 Market Limiters..................................................................................................... 93
5.6 NEW TECHNOLOGIES – DRUG-COATED BALLOON CATHETERS................................. 94
5.7 COMPETITIVE ANALYSIS ............................................................................................ 95
5.7.1 PTCA Balloon Catheters ...................................................................................... 95
5.7.2 Cutting Balloon Catheters .................................................................................... 97
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BALLOON-INFLATION SYRINGES.............................................................................. 98
6.1 INTRODUCTION ........................................................................................................... 98
6.2 MARKET ANALYSIS & FORECAST .............................................................................. 99
6.3 MARKET DRIVERS AND LIMITERS ............................................................................ 101
6.3.1 Market Drivers.................................................................................................... 101
6.3.2 Market Limiters................................................................................................... 101
6.4 COMPETITIVE ANALYSIS .......................................................................................... 102
ANGIOPLASTY KITS ..................................................................................................... 104
7.1 INTRODUCTION ......................................................................................................... 104
7.2 MARKET ANALYSIS & FORECAST ............................................................................ 105
7.3 MARKET DRIVERS AND LIMITERS ............................................................................ 107
7.3.1 Market Drivers.................................................................................................... 107
7.3.2 Market Limiters................................................................................................... 107
7.4 COMPETITIVE ANALYSIS .......................................................................................... 108
INTERVENTIONAL CATHETERS............................................................................... 110
8.1 INTRODUCTION ......................................................................................................... 110
8.2 UNITS SOLD .............................................................................................................. 111
8.3 MARKET ANALYSIS & FORECAST ............................................................................ 112
8.3.1 Interventional Guiding Catheters Market........................................................... 114
8.3.2 Interventional Support Catheters Market ........................................................... 115
8.4 MARKET DRIVERS AND LIMITERS ............................................................................ 116
8.4.1 Market Drivers.................................................................................................... 116
8.4.2 Market Limiters................................................................................................... 116
8.5 COMPETITIVE ANALYSIS .......................................................................................... 118
INTERVENTIONAL GUIDEWIRES............................................................................. 120
9.1 INTRODUCTION ......................................................................................................... 120
9.1.1 Conventional and Specialty Guidewires............................................................. 120
9.1.2 Material and Fabrication ................................................................................... 120
9.2 UNITS SOLD .............................................................................................................. 121
9.3 MARKET ANALYSIS & FORECAST ............................................................................ 123
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9.3.1 Conventional Guidewires Market ....................................................................... 125
9.3.2 Specialized Guidewires Market .......................................................................... 126
9.4 MARKET DRIVER AND LIMITERS .............................................................................. 127
9.4.1 Market Drivers.................................................................................................... 127
9.4.2 Market Limiters................................................................................................... 127
9.5 COMPETITIVE ANALYSIS .......................................................................................... 128
EMBOLIC PROTECTION DEVICES ........................................................................... 130
10.1 INTRODUCTION ....................................................................................................... 130
10.1.1 Saphenous Vein Grafts...................................................................................... 130
10.1.2 Protection Mechanism ...................................................................................... 130
10.2 MARKET ANALYSIS & FORECAST .......................................................................... 132
10.3 PENETRATION RATE ............................................................................................... 134
10.4 MARKET DRIVERS AND LIMITERS .......................................................................... 136
10.4.1 Market Drivers.................................................................................................. 136
10.4.2 Market Limiters................................................................................................. 136
10.5 COMPETITIVE ANALYSIS ........................................................................................ 137
CORONARY ATHERECTOMY DEVICES.................................................................. 140
11.1 INTRODUCTION ....................................................................................................... 140
11.1.1 Atherectomy ...................................................................................................... 140
11.1.2 Technologies ..................................................................................................... 141
11.1.2.1 Mechanical ..................................................................................................141
11.1.2.2 Laser ............................................................................................................141
11.1.2.3 Directional Coronary Atherectomy (DCA)..................................................141
11.2 MARKET ANALYSIS & FORECAST .......................................................................... 142
11.3 PENETRATION RATE ............................................................................................... 144
11.4 MARKET DRIVERS AND LIMITERS .......................................................................... 145
11.4.1 Market Drivers.................................................................................................. 145
11.4.2 Market Limiters................................................................................................. 145
11.5 COMPETITIVE ANALYSIS ........................................................................................ 146
THROMBECTOMY DEVICES ...................................................................................... 149
12.1 INTRODUCTION ....................................................................................................... 149
12.1.1 Thrombosis and Drug-Eluting Stents................................................................ 149
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12.2 MARKET ANALYSIS & FORECAST .......................................................................... 150
12.3 PENETRATION RATE ............................................................................................... 152
12.4 MARKET DRIVERS AND LIMITERS .......................................................................... 153
12.4.1 Market Drivers.................................................................................................. 153
12.4.2 Market Limiters................................................................................................. 153
12.5 COMPETITIVE ANALYSIS ........................................................................................ 154
CHRONIC TOTAL OCCLUSION CROSSERS............................................................ 156
13.1 INTRODUCTION ....................................................................................................... 156
13.2 POTENTIAL MARKET............................................................................................... 157
13.3 MARKET ANALYSIS & FORECAST .......................................................................... 158
13.4 PENETRATION RATE ............................................................................................... 160
13.5 MARKET DRIVERS AND LIMITERS .......................................................................... 162
13.5.1 Market Drivers.................................................................................................. 162
13.5.2 Market Limiters................................................................................................. 162
13.6 COMPETITIVE ANALYSIS ........................................................................................ 163
INTRODUCER SHEATHS.............................................................................................. 166
14.1 INTRODUCTION ....................................................................................................... 166
14.2 MARKET ANALYSIS & FORECAST .......................................................................... 167
14.2.1 Units Sold.......................................................................................................... 167
14.2.2 Market Analysis & Forecast ............................................................................. 168
14.3 MARKET DRIVERS AND LIMITERS .......................................................................... 170
14.3.1 Market Drivers.................................................................................................. 170
14.3.2 Market Limiters................................................................................................. 170
14.4 COMPETITIVE ANALYSIS ........................................................................................ 171
VASCULAR CLOSURE DEVICES................................................................................ 173
15.1 INTRODUCTION ....................................................................................................... 173
15.1.1 Manual Compression........................................................................................ 173
15.1.2 Invasive and Non-Invasive Devices .................................................................. 173
15.2 MARKET ANALYSIS & FORECAST .......................................................................... 174
15.3 PENETRATION RATE ............................................................................................... 176
15.3.1 Diagnostic Procedures ..................................................................................... 176
15.3.2 Interventional Procedures ................................................................................ 176
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15.4 MARKET DRIVERS AND LIMITERS .......................................................................... 178
15.4.1 Market Drivers.................................................................................................. 178
15.4.2 Market Limiters................................................................................................. 179
15.5 COMPETITIVE ANALYSIS ........................................................................................ 180
DIAGNOSTIC CATHETERS AND GUIDEWIRES..................................................... 183
16.1 INTRODUCTION ....................................................................................................... 183
16.1.1 Coronary Angiography ..................................................................................... 183
16.2 MARKET ANALYSIS & FORECAST .......................................................................... 184
16.3 DIAGNOSTIC CATHETERS........................................................................................ 186
16.3.1 Market Analysis & Forecast ............................................................................. 186
16.3.2 Units Sold.......................................................................................................... 188
16.3.3 Units Sold Segmented by Size ........................................................................... 189
16.3.4 Competitive Analysis......................................................................................... 191
16.4 DIAGNOSTIC GUIDEWIRES ...................................................................................... 193
16.4.1 Market Analysis & Forecast ............................................................................. 193
16.4.2 Units Sold.......................................................................................................... 195
16.4.3 Competitive Analysis......................................................................................... 196
16.5 FRACTIONAL FLOW RESERVE (FFR) GUIDEWIRES................................................ 198
16.5.1 Market Analysis and Forecast .......................................................................... 198
16.5.2 Units Sold.......................................................................................................... 200
16.5.3 Competitive Analysis......................................................................................... 201
16.6 MARKET DRIVERS AND LIMITERS .......................................................................... 203
16.6.1 Market Drivers.................................................................................................. 203
16.6.2 Market Limiters................................................................................................. 203
IVUS CATHETERS.......................................................................................................... 204
17.1 INTRODUCTION ....................................................................................................... 204
17.1.1 Pre-Stenting Applications ................................................................................. 204
17.1.2 Post-Stenting Applications................................................................................ 204
17.1.3 IVUS Console Penetration................................................................................ 205
17.2 MARKET ANALYSIS & FORECAST .......................................................................... 206
17.3 PENETRATION RATE ............................................................................................... 208
17.4 MARKET DRIVERS AND LIMITERS .......................................................................... 209
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17.4.1 Market Drivers.................................................................................................. 209
17.4.2 Market Limiters................................................................................................. 210
17.5 COMPETITIVE ANALYSIS ........................................................................................ 211
OPTICAL COHERENCE TOMOGRAPHY (OCT) DEVICES .................................. 212
18.1 INTRODUCTION ....................................................................................................... 212
18.2 POTENTIAL MARKET............................................................................................... 214
18.3 MARKET ANALYSIS AND FORECAST ...................................................................... 215
18.4 MARKET DRIVERS AND LIMITERS .......................................................................... 218
18.4.1 Market Drivers.................................................................................................. 218
18.4.2 Market Limiters................................................................................................. 219
18.5 COMPETITIVE ANALYSIS ........................................................................................ 220
VULNERABLE PLAQUE DEVICES............................................................................. 222
19.1 INTRODUCTION ....................................................................................................... 222
19.1.1 Vulnerable Plaque Screening Technologies ..................................................... 223
19.1.1.1 Intravascular Ultrasound (IVUS) ................................................................223
19.1.1.2 Optical Coherence Tomography (OCT) ......................................................223
19.1.1.3 Raman Spectroscopy....................................................................................223
19.1.1.4 Near Infrared (NIR) Spectroscopy...............................................................224
19.1.1.5 Thermography..............................................................................................224
19.1.1.6 Intravascular Magnetic Resonance Imaging (IVMRI) ................................224
19.1.1.7 Computed Tomography (CT).......................................................................224
19.1.2 Potential Vulnerable Plaque Treatments.......................................................... 225
19.1.2.1 Stents............................................................................................................225
19.1.2.2 Pharmaceuticals ..........................................................................................225
19.1.2.3 Photodynamic Therapies .............................................................................225
19.1.2.4 Cryotherapy .................................................................................................226
19.2 TARGET POPULATION ............................................................................................. 226
19.3 MARKET ANALYSIS AND FORECAST ...................................................................... 228
19.3.1 Total Market Potential...................................................................................... 228
19.3.2 Market Forecast................................................................................................ 230
19.3.3 Screening Market.............................................................................................. 232
19.3.4 Treatment Market ............................................................................................. 234
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19.4 COMPETITIVE ANALYSIS ........................................................................................ 236
PFO DEVICES .................................................................................................................. 240
20.1 INTRODUCTION ....................................................................................................... 240
20.2 MARKET ANALYSIS AND FORECAST ...................................................................... 241
20.3 MARKET DRIVERS AND LIMITERS .......................................................................... 243
20.3.1 Market Drivers.................................................................................................. 243
20.3.2 Market Limiters................................................................................................. 243
20.4 COMPETITIVE ANALYSIS ........................................................................................ 244
ASD AND VSD DEVICES................................................................................................ 248
21.1 INTRODUCTION ....................................................................................................... 248
21.1.1.1 Atrial Septal Defect (ASD)...........................................................................248
21.1.1.2 Ventricular Septal Defect (VSD)..................................................................248
21.2 MARKET ANALYSIS AND FORECAST ...................................................................... 249
21.3 MARKET DRIVERS AND LIMITERS .......................................................................... 251
21.3.1 Market Drivers.................................................................................................. 251
21.3.2 Market Limiters................................................................................................. 251
21.4 COMPETITIVE ANALYSIS ........................................................................................ 252
PERCUTANEOUS MITRAL VALVE REPAIR DEVICES......................................... 255
22.1 INTRODUCTION ....................................................................................................... 255
22.1.1 Percutaneous Mitral Valve Repair (PMVR) ..................................................... 255
22.2 TARGET POPULATION ............................................................................................. 256
22.3 POTENTIAL MARKET............................................................................................... 257
22.4 MARKET DRIVERS AND LIMITERS .......................................................................... 259
22.4.1 Market Drivers.................................................................................................. 259
22.4.2 Limiters ............................................................................................................. 259
22.5 COMPETITIVE ANALYSIS ........................................................................................ 261
PERCUTANEOUS AORTIC HEART VALVE REPLACEMENT DEVICES .......... 263
23.1 INTRODUCTION ....................................................................................................... 263
23.2 MARKET ANALYSIS AND FORECAST ...................................................................... 264
23.2.1 Revenue Probability.......................................................................................... 265
23.3 MARKET DRIVERS AND LIMITERS .......................................................................... 268
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23.3.1 Market Drivers.................................................................................................. 268
23.3.2 Market Limiters................................................................................................. 269
23.4 COMPETITIVE ANALYSIS ........................................................................................ 270
ABBREVIATIONS............................................................................................................ 273
List of Figures
     xi
LIST OF FIGURES
EXECUTIVE SUMMARY.................................................................................... 1
RESEARCH METHODOLOGY.......................................................................... 12
U.S. MARKET FOR INTERVENTIONAL CARDIOLOGY DEVICES................. 23
Figure 3-1: Market for Interventional Cardiology Segmented by Device Type,
U.S., 2005 – 2015 .......................................................................................... 26
Figure 3-2: Trend Analysis by Market Segment, Growth Rates of the Market for
Interventional Cardiology, U.S., 2005 – 2015 ................................................. 31
Figure 3-3: Market Drivers, Market for Interventional Cardiology, U.S, 2008...... 34
Figure 3-4: Market Limiters, Market for Interventional Cardiology, U.S., 2008 ... 35
Figure 3-5: Leading Competitors by Market Segment, U.S. Market for
Interventional Cardiology, 2008..................................................................... 37
BARE-METAL AND DRUG-ELUTING STENTS............................................... 43
Figure 4-1: Population at Risk, Market for Interventional Cardiology, U.S., 2005
– 2015 ........................................................................................................... 46
Figure 4-2: Angiography and Angioplasty Procedures, U.S., 2005 – 2015............ 49
Figure 4-3: Market for Coronary Stents by Type, U.S., 2005 – 2015.................... 52
Figure 4-4: Units Sold, Market for Coronary Stents, U.S., 2005 – 2015 ............... 54
Figure 4-5: Coronary Stent Units by Type, U.S., 2005 – 2015 ............................. 55
Figure 4-6: Market for Bare-Metal Stents, U.S., 2005 – 2015 .............................. 56
Figure 4-7: Market Drivers and Limiters, Market for Bare-Metal Stents, U.S.,
2008 .............................................................................................................. 59
Figure 4-8: Market for Drug-Eluting Stents, U.S., 2005 – 2015 ........................... 61
Figure 4-9: Market Drivers and Limiters, Market for Drug-Eluting Stents, U.S.,
2008 .............................................................................................................. 65
Figure 4-10: Coronary Stent Platforms in Development Not Approved by the
FDA, 2008..................................................................................................... 66
Figure 4-11: Potential Market for Bioabsorbable Stents, U.S., 2013 – 2015 ......... 68
Figure 4-12: Potential Market for Bifurcated Stents, U.S., 2010 – 2015 ............... 70
List of Figures
     xii
Figure 4-13: Market for Coronary Stents by Delivery Platform, Units Sold, U.S.,
2005 – 2015................................................................................................... 71
Figure 4-14: Market for Coronary Stents by Size, U.S., 2008 .............................. 73
Figure 4-15: Leading Competitors, Market for Bare-Metal Stents, U.S., 2008 ...... 76
Figure 4-16: Leading Competitors, U.S. Market for Drug-Eluting Stents, 2008 .... 79
PTCA AND CUTTING BALLOON CATHETERS .............................................. 84
Figure 5-1: Market for PTCA and Cutting Balloon Catheters, U.S., 2005 – 2015 . 85
Figure 5-2: Units Sold, Market for PTCA Balloon Catheters, U.S., 2005 – 2015 .. 87
Figure 5-3: Market for PTCA Balloon Catheters, U.S., 2005 – 2015 .................... 88
Figure 5-4: Units Sold, Market for Cutting Balloon Catheters, U.S., 2005 – 2015 90
Figure 5-5: Market for Cutting Balloon Catheters, U.S., 2005 – 2015 .................. 91
Figure 5-6: Market Drivers and Limiters, U.S. Market for PTCA and Cutting
Balloon Catheters, 2008................................................................................. 94
Figure 5-7: Leading Competitors, Market for PTCA Balloon Catheters, U.S.,
2008 .............................................................................................................. 95
Figure 5-8: Leading Competitors, Market for PTCA Balloon Catheters, U.S.,
2008 .............................................................................................................. 97
BALLOON-INFLATION SYRINGES................................................................. 98
Figure 6-1: Market for Balloon-Inflation Syringes, U.S., 2005 – 2015 ................. 99
Figure 6-2: Market Drivers and Limiters, U.S. Market for Balloon-Inflation
Syringes, 2008............................................................................................. 101
Figure 6-3: Leading Competitors, Market for Balloon-Inflation Syringes, U.S.,
2008 ............................................................................................................ 102
ANGIOPLASTY KITS ..................................................................................... 104
Figure 7-1: Market for Angioplasty Accessory Kits, U.S., 2005 – 2015 ............. 105
Figure 7-2: Market Drivers and Limiters, Market for Angioplasty Accessory Kits,
U.S., 2005 – 2015 ........................................................................................ 107
Figure 7-3: Leading Competitors, Market for Angioplasty Accessory Kits, U.S.,
2005 – 2015................................................................................................. 108
INTERVENTIONAL CATHETERS .................................................................. 110
Figure 8-1: Units Sold, Market for Interventional Coronary Catheters, U.S., 2005
– 2015 ......................................................................................................... 111
Figure 8-2: Market for Interventional Coronary Catheters by Device Type, U.S.,
2005 – 2015................................................................................................. 112
List of Figures
     xiii
Figure 8-3: Market for Interventional Guiding Catheters, U.S., 2005 – 2015...... 114
Figure 8-4: Market for Interventional Support Catheters, U.S., 2005 – 2015 ...... 115
Figure 8-5: Market Drivers and Limiters, Market for Interventional Coronary
Catheters, U.S., 2008 ................................................................................... 117
Figure 8-6: Leading Competitors, Market for Interventional Coronary Catheters,
U.S., 2008 ................................................................................................... 118
INTERVENTIONAL GUIDEWIRES ................................................................ 120
Figure 9-1: Units Sold, Market for Interventional Coronary Guidewires, U.S.,
2005 – 2015................................................................................................. 121
Figure 9-2: Market for Interventional Coronary Guidewires by Device Type,
U.S., 2005 – 2015 ........................................................................................ 123
Figure 9-3: Market for Interventional Coronary Conventional Guidewires, U.S.,
2005 – 2015................................................................................................. 125
Figure 9-4: Market for Interventional Coronary Specialized Guidewires, U.S.,
2005 – 2015................................................................................................. 126
Figure 9-5: Market Drivers and Limiters, Market for Interventional Coronary
Guidewires, U.S., 2008 ................................................................................ 127
Figure 9-6: Leading Competitors, Market for Interventional Coronary
Guidewires, U.S., 2008 ................................................................................ 128
EMBOLIC PROTECTION DEVICES ............................................................... 130
Figure 10-1: Market for Coronary Embolic Protection Devices, U.S., 2005 – 2015132
Figure 10-2: Penetration Rate, Market for Coronary Embolic Protection Devices,
U.S., 2005 – 2015 ........................................................................................ 135
Figure 10-3: Market Drivers and Limiters, Market for Coronary Embolic
Protection Devices, U.S., 2008..................................................................... 137
Figure 10-4: Leading Competitors, Market for Coronary Embolic Protection
Devices, U.S., 2008 ..................................................................................... 138
CORONARY ATHERECTOMY DEVICES....................................................... 140
Figure 11-1: Market for Coronary Atherectomy Devices, U.S., 2005 – 2015 ...... 142
Figure 11-2: Penetration Rate, Market for Coronary Atherectomy Devices, U.S.,
2005 – 2015................................................................................................. 144
Figure 11-3: Market Drivers and Limiters, U.S. Market for Coronary
Atherectomy Devices, 2008 ......................................................................... 146
List of Figures
     xiv
Figure 11-4: Leading Competitors, Market for Coronary Atherectomy Devices,
U.S., 2008 ................................................................................................... 147
THROMBECTOMY DEVICES......................................................................... 149
Figure 12-1: Market for Coronary Thrombectomy Devices, U.S., 2005 – 2015... 150
Figure 12-2: Penetration Rate, Market for Coronary Thrombectomy Devices,
U.S., 2005 – 2015 ........................................................................................ 152
Figure 12-3: Market Drivers and Limiters, Market for Coronary Thrombectomy
Devices, U.S., 2008 ..................................................................................... 153
Figure 12-4: Leading Competitors, Market for Coronary Thrombectomy Devices,
U.S., 2008 ................................................................................................... 154
CHRONIC TOTAL OCCLUSION CROSSERS ................................................. 156
Figure 13-1: Potential Market for Chronic Total Occlusion Crossers, Market for
Interventional Cardiology, U.S., 2005 – 2015 ............................................... 157
Figure 13-2: Market for Coronary Chronic Total Occlusion Crossers, U.S., 2005
– 2015 ......................................................................................................... 158
Figure 13-3: Penetration Rate, Market for Coronary Chronic Total Occlusion
Crossers, U.S., 2005 – 2015 ......................................................................... 160
Figure 13-4 Market Drivers and Limiters, Market for Coronary Chronic Total
Occlusion Crossers, U.S., 2008 .................................................................... 163
Figure 13-5: Leading Competitors, Market for Coronary Chronic Total Occlusion
Crossers, U.S., 2008 .................................................................................... 164
INTRODUCER SHEATHS ............................................................................... 166
Figure 14-1: Units Sold, Coronary Market for Introducer Sheaths, U.S., 2005 –
2015 ............................................................................................................ 167
Figure 14-2: Coronary Market for Introducer Sheaths, U.S., 2005 – 2015 .......... 168
Figure 14-3: Market Drivers and Limiters, U.S. Market for Introducer Sheaths,
2008 ............................................................................................................ 170
Figure 14-4: Leading Competitors, Market for Introducer Sheaths, U.S., 2008... 171
VASCULAR CLOSURE DEVICES .................................................................. 173
Figure 15-1: Market for Coronary Vascular Closure Devices (Invasive and Non-
Invasive), U.S., 2005 – 2015 ........................................................................ 174
Figure 15-2: Penetration Rate, Market for Coronary Vascular Closure Devices
(Invasive and Non-Invasive), U.S., 2005 – 2015 ........................................... 177
List of Figures
     xv
Figure 15-3: Market Drivers and Limiters, Market for Coronary Vascular Closure
Devices, U.S., 2008 ..................................................................................... 179
Figure 15-4: Leading Competitors, Market for Coronary Vascular Closure
Devices, U.S., 2008 ..................................................................................... 181
DIAGNOSTIC CATHETERS AND GUIDEWIRES ........................................... 183
Figure 16-1: Market for Diagnostic Coronary Catheters and Guidewires, U.S.,
2005 – 2015................................................................................................. 184
Figure 16-2: Market for Diagnostic Coronary Catheters, U.S., 2005 – 2015 ....... 186
Figure 16-3: Units Sold, Market for Diagnostic Coronary Catheters, U.S., 2005 –
2015 ............................................................................................................ 188
Figure 16-4: Units Sold Segmented by Size, Market for Diagnostic Coronary
Catheters, U.S., 2005 – 2015........................................................................ 189
Figure 16-5: Leading Competitors, Market for Diagnostic Coronary Catheters,
U.S., 2008 ................................................................................................... 191
Figure 16-6: Market for Diagnostic Coronary Guidewires, U.S., 2005 – 2015 .... 193
Figure 16-7: Units Sold, Market for Diagnostic Coronary Guidewires, U.S., 2005
– 2015 ......................................................................................................... 195
Figure 16-8: Leading Competitors, Market for Diagnostic Coronary Guidewires,
U.S., 2008 ................................................................................................... 196
Figure 16-9: Market for FFR Guidewires, U.S., 2005 – 2015............................. 198
Figure 16-10: Units Sold, Market for FFR Guidewires, U.S., 2005 – 2015 ......... 200
Figure 16-11: Leading Competitors in the FFR Guidewire Market, U.S., 2008 ... 201
Figure 16-12: Market Drivers and Limiters, Market for Diagnostic Coronary
Catheters and Guidewires, U.S., 2008 .......................................................... 203
IVUS CATHETERS ......................................................................................... 204
Figure 17-1: IVUS Console Penetration Rate, U.S., 2005 – 2015 ....................... 205
Figure 17-2: Market for IVUS Catheters, U.S., 2005 – 2015.............................. 206
Figure 17-3: Penetration Rate, Market for IVUS Catheters, U.S., 2005 – 2015... 208
Figure 17-4: Market Drivers and Limiters, Market for IVUS Catheters, U.S., 2008210
Figure 17-5: Leading Competitors, Market for IVUS Catheters, U.S., 2005 – 2015211
OPTICAL COHERENCE TOMOGRAPHY (OCT) DEVICES............................ 212
Figure 18-1: Potential Market for OCT Catheters, U.S., 2010 – 2015................. 215
Figure 18-2: Potential Market for OCT Consoles, U.S., 2010 – 2015 ................. 217
Figure 18-3: Potential Market for Coronary OCT Devices, U.S., 2010 – 2015.... 217
List of Figures
     xvi
Figure 18-4: Market Drivers and Limiters in the OCT Market, U.S., 2008 ......... 219
VULNERABLE PLAQUE DEVICES................................................................ 222
Figure 19-1: Target Population, Potential Market for Vulnerable Plaque
Screening, U.S., 2005 – 2015 ....................................................................... 227
Figure 19-2: Maximum Potential Market for Vulnerable Plaque, U.S., 2010 –
2015 ............................................................................................................ 228
Figure 19-3: Forecasted Potential Market for Vulnerable Plaque, U.S., 2010 –
2015 ............................................................................................................ 230
Figure 19-4: Forecasted Potential Market for Vulnerable Plaque Screening, U.S.,
2010 – 2015................................................................................................. 233
Figure 19-5 : Forecasted Potential Market for Vulnerable Plaque Treatment, U.S.,
2010 – 2015................................................................................................. 235
Figure 19-6: Potential Competitors in the U.S. Market for Vulnerable Plaque
Devices ....................................................................................................... 239
PFO DEVICES................................................................................................. 240
Figure 20-1: Market for PFO Devices, U.S., 2005 – 2015.................................. 241
Figure 20-2: Market Drivers and Limiters in the PFO Devices Market, U.S., 2008244
Figure 20-3: Leading Competitors, Market for PFO Devices, U.S., 2008 ........... 246
ASD AND VSD DEVICES ............................................................................... 248
Figure 21-1: Market for ASD and VSD Devices, U.S., 2005 – 2015................... 249
Figure 21-2: Market Drivers and Limiters in the ASD and VSD Devices Market,
U.S., 2008 ................................................................................................... 251
Figure 21-3: Leading Competitors, Market for ASD and VSD Devices, U.S., 2008253
PERCUTANEOUS MITRAL VALVE REPAIR DEVICES ................................ 255
Figure 22-1: Target Population, Potential Market for PMVR Devices, U.S., 2010
– 2015 ......................................................................................................... 256
Figure 22-2: Potential Market for Percutaneous Mitral Valve Repair Devices,
U.S., 2010 – 2015 ........................................................................................ 257
Figure 22-3: Market Drivers and Limiters in the PVMR Market, U.S., 2008 ...... 260
Figure 22-4: Market Players, Potential Market for PMVR Devices, U.S., 2010 –
2015 ............................................................................................................ 262
PERCUTANEOUS AORTIC HEART VALVE REPLACEMENT DEVICES ...... 263
Figure 23-1: Potential Market for Aortic Valve Replacement Devices, Weighted
Average Scenario, U.S., 2008 – 2015 ........................................................... 265
List of Figures
     xvii
Figure 23-2: Total Revenue, Potential Market for Aortic Valve Replacement
Devices, Weighted Average Scenario, U.S., 2011 – 2015 .............................. 266
Figure 23-3: Market Drivers and Limiters in the Aortic Valve Replacement
Market, U.S., 2008 ...................................................................................... 269
Figure 23-4: Market Players, Potential Market for PAVR Devices, U.S., 2010 –
2015 ............................................................................................................ 272
ABBREVIATIONS .......................................................................................... 273
List of Charts
     xviii
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.......................................................................... 12
U.S. MARKET FOR INTERVENTIONAL CARDIOLOGY DEVICES................. 23
Chart 3-1: Market for Interventional Cardiology, U.S., 2005 – 2015 .................... 24
Chart 3-2: Market for Interventional Cardiology Segmented by Device Type,
U.S., 2008 ..................................................................................................... 28
Chart 3-3: Market for Interventional Cardiology Segmented by Device Type,
U.S., 2015 ..................................................................................................... 29
Chart 3-4: Trend Analysis for Selected Markets for Interventional Cardiology
Devices, U.S., 2005 – 2015 ............................................................................ 33
Chart 3-5: Leading Competitors, Market for Interventional Cardiology, U.S.,
2008 .............................................................................................................. 39
BARE-METAL AND DRUG-ELUTING STENTS............................................... 43
Chart 4-1: Population at Risk, Market for Interventional Cardiology, U.S., 2005
– 2015 ........................................................................................................... 47
List of Charts
     xix
Chart 4-2: Age Group Most Likely to Undergo Cardiac Intervention: 60 to 69
Years Old, U.S., 2005 – 2015......................................................................... 48
Chart 4-3: Angioplasty and Angiography Procedures, U.S., 2005 – 2015 ............. 50
Chart 4-4: Market for Coronary Stents by Type, U.S., 2005 – 2015 ..................... 53
Chart 4-5: Coronary Stent Units by Type, U.S., 2005 – 2015............................... 55
Chart 4-6: Market for Bare-Metal Stents, U.S., 2005 – 2015................................ 57
Chart 4-7: Market for Drug-Eluting Stents, U.S., 2005 – 2015............................. 62
Chart 4-8: Penetration Rate for Bioabsorbable Stents, U.S., 2013 – 2015............. 68
Chart 4-9: Penetration Rate for Bifurcated Stents, U.S., 2010 – 2015 .................. 70
Chart 4-10: Market for Coronary Stents by Delivery Platform, Units Sold, U.S.,
2005 – 2015................................................................................................... 72
Chart 4-11: Market for Coronary Stents by Size, U.S., 2008 ................................ 74
Chart 4-12: Leading Competitors, Market for Bare-Metal Stents, U.S., 2008 ....... 76
Chart 4-13: Leading Competitors, Market for Drug-Eluting Stents, U.S., 2008 .... 80
PTCA AND CUTTING BALLOON CATHETERS .............................................. 84
Chart 5-1: Market for PTCA and Cutting Balloon Catheters, U.S., 2005 – 2015 ... 86
Chart 5-2: Market for PTCA Balloon Catheters, U.S., 2005 – 2015 ..................... 89
Chart 5-3: Market for Cutting Balloon Catheters, U.S., 2005 – 2015.................... 92
Chart 5-4: Leading Competitors, Market for PTCA Balloon Catheters, U.S., 200896
BALLOON-INFLATION SYRINGES................................................................. 98
Chart 6-1: Market for Balloon-Inflation Syringes, U.S., 2005 – 2015................. 100
Chart 6-2: Leading Competitors, Market for Balloon-Inflation Syringes, U.S.,
2008 ............................................................................................................ 103
ANGIOPLASTY KITS ..................................................................................... 104
Chart 7-1: Market for Angioplasty Accessory Kits, U.S., 2005 – 2015............... 106
Chart 7-2: Leading Competitors, Market for Angioplasty Accessory Kits, U.S.,
2005 – 2015................................................................................................. 109
INTERVENTIONAL CATHETERS .................................................................. 110
Chart 8-1: Market for Interventional Coronary Catheters by Device Type, U.S.,
2005 – 2015................................................................................................. 113
Chart 8-2: Leading Competitors, Market for Interventional Coronary Catheters,
U.S., 2008 ................................................................................................... 119
INTERVENTIONAL GUIDEWIRES ................................................................ 120
List of Charts
     xx
Chart 9-1: Units Sold, Market for Interventional Coronary Guidewires, U.S.,
2005 – 2015................................................................................................. 122
Chart 9-2: Market for Interventional Coronary Guidewires by Device Type, U.S.,
2005 – 2015................................................................................................. 124
Chart 9-3: Leading Competitors, Market for Interventional Coronary Guidewires,
U.S., 2008 ................................................................................................... 129
EMBOLIC PROTECTION DEVICES ............................................................... 130
Chart 10-1: Market for Coronary Embolic Protection Devices, U.S., 2005 – 2015133
Chart 10-2: Leading Competitors, Market for Coronary Embolic Protection
Devices, U.S., 2008 ..................................................................................... 139
CORONARY ATHERECTOMY DEVICES....................................................... 140
Chart 11-1: Market for Coronary Atherectomy Devices, U.S., 2005 – 2015 ....... 143
Chart 11-2: Leading Competitors, U.S. Market for Coronary Atherectomy
Devices, 2008 .............................................................................................. 148
THROMBECTOMY DEVICES......................................................................... 149
Chart 12-1: Market for Coronary Thrombectomy Devices, U.S., 2005 – 2015 .... 151
Chart 12-2: Leading Competitors, Market for Coronary Thrombectomy Devices,
U.S., 2008 ................................................................................................... 155
CHRONIC TOTAL OCCLUSION CROSSERS ................................................. 156
Chart 13-1: Market for Coronary Chronic Total Occlusion Crossers, U.S., 2005 –
2015 ............................................................................................................ 159
Chart 13-2: Penetration Rate, Market for Coronary Chronic Total Occlusion
Crossers, U.S., 2005 – 2015 ......................................................................... 161
Chart 13-3: Leading Competitors, Market for Coronary Chronic Total Occlusion
Crossers, U.S., 2008 .................................................................................... 165
INTRODUCER SHEATHS ............................................................................... 166
Chart 14-1: Coronary Market for Introducer Sheaths, U.S., 2005 – 2015............ 169
Chart 14-2: Leading Competitors, U.S. Market for Introducer Sheaths, 2008 ..... 172
VASCULAR CLOSURE DEVICES .................................................................. 173
Chart 15-1: Market for Coronary Vascular Closure Devices (Invasive and Non-
Invasive), U.S., 2005 – 2015 ........................................................................ 175
Chart 15-2: Leading Competitors, Market for Coronary Vascular Closure
Devices, U.S., 2008 ..................................................................................... 182
DIAGNOSTIC CATHETERS AND GUIDEWIRES ........................................... 183
List of Charts
     xxi
Chart 16-1: Market for Diagnostic Coronary Catheters and Guidewires, U.S.,
2005 – 2015................................................................................................. 185
Chart 16-2: Market for Diagnostic Coronary Catheters, U.S., 2005 – 2015 ........ 187
Chart 16-3: Units Sold Segmented by Size, Market for Diagnostic Coronary
Catheters, U.S., 2005 – 2015........................................................................ 190
Chart 16-4: Leading Competitors, Market for Diagnostic Coronary Catheters,
U.S., 2008 ................................................................................................... 192
Chart 16-5: Market for Diagnostic Coronary Guidewires, U.S., 2005 – 2015 ..... 194
Chart 16-6: Leading Competitors, Market for Diagnostic Coronary Guidewires,
U.S., 2008 ................................................................................................... 197
Chart 16-7: Market for FFR Guidewires, U.S., 2005 – 2015 .............................. 199
Chart 16-8: Leading Competitors in the FFR Guidewire Market, U.S., 2008 ...... 202
IVUS CATHETERS ......................................................................................... 204
Chart 17-1: Market for IVUS Catheters, U.S., 2005 – 2015 ............................... 207
OPTICAL COHERENCE TOMOGRAPHY (OCT) DEVICES............................ 212
Chart 18-1: Potential Market for OCT Catheters, U.S., 2010 – 2015 .................. 216
VULNERABLE PLAQUE DEVICES................................................................ 222
Chart 19-1: Target Population, Potential Market for Vulnerable Plaque
Screening, U.S., 2005 – 2015 ....................................................................... 227
Chart 19-2: Maximum Potential Market for Vulnerable Plaque, U.S., 2010 – 2015229
Chart 19-3: Forecasted Potential Market for Vulnerable Plaque, U.S., 2010 –
2015 ............................................................................................................ 231
Chart 19-4: Forecasted Potential Market for Vulnerable Plaque Screening, U.S.,
2010 – 2015................................................................................................. 233
Chart 19-5: Forecasted Potential Market for Vulnerable Plaque Treatment, U.S.,
2010 – 2015................................................................................................. 235
PFO DEVICES................................................................................................. 240
Chart 20-1: Market for PFO Devices, U.S., 2005 – 2015 ................................... 242
Chart 20-2: Leading Competitors, Market for PFO Devices, U.S., 2008............. 247
ASD AND VSD DEVICES ............................................................................... 248
Chart 21-1: Market for ASD and VSD Devices, U.S., 2005 – 2015 .................... 250
Chart 21-2: Leading Competitors in the ASD and VSD Market, U.S., 2008 ....... 254
PERCUTANEOUS MITRAL VALVE REPAIR DEVICES ................................ 255
List of Charts
     xxii
Chart 22-1: Potential Market for Percutaneous Mitral Valve Repair Devices,
U.S., 2010 – 2015 ........................................................................................ 258
PERCUTANEOUS AORTIC HEART VALVE REPLACEMENT DEVICES ...... 263
Chart 23-1: Revenue Probability, Potential Market for Aortic Valve Replacement
Devices, U.S., 2008 – 2015 .......................................................................... 267
ABBREVIATIONS .......................................................................................... 273
Published By: iData Research
Product Code: iData Research1139


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