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Catheter Markets

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June 2012; Pages: 381
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Catheters are used in a number of processes, such as: cardiovascular, urological, intravenous, oximetry, thermodilution, suction and wound drainage processes, that involve the administration or drainage of fluids from the body. The global market for catheters is vibrant and continually evolving with significant investments to improve the capabilities of existing catheters, improve safety features and identify new medical applications. The growing number of aged people undergoing diagnostic and therapeutic procedures is driving increases in catheter sales. Government regulations also play a key role, mainly in the urological catheter segment, as regulations attempt to promote fewer infections among hospitalized patients through more frequent use of catheterization. This TriMark Publications report provides a detailed analysis of the global market for catheters, including central venous catheters (CVC), peripheral venous catheters (PVC), midline catheters (MC), hemodialysis catheters, pulmonary artery catheters, peripheral artery catheters and umbilical catheters. The study also analyzes almost all of the companies known to be marketing, manufacturing or developing catheter products in the U.S. and worldwide. Detailed tables, charts and figures are included with projected sales data by geographic region for the Americas, EMRA (Europe, the Middle East, Russia, Africa) and Asia-Pacific regions.

 

TABLE OF CONTENTS


1. Introduction 16
1.1 Scope of this Report 16
1.2 Methodology 16
1.3 Executive Summary 17
2. Catheter Uses and Types 19
2.1 Scope of this Chapter 19
2.2 Catheter Uses 19
2.3 Types of Catheters 20
2.3.1 Cardiovascular Catheters 20
2.3.1.1 Cardiac Catheterization Procedures 21
2.3.1.2 Indications for Cardiac Catheterization 22
2.3.2 Percutaneous Coranary Intervention (PCI) 22
2.3.3 Athrectomy 22
2.3.4 Ventricular Angiogram 23
2.3.5 Coronary Flow Reserve Measurements 24
2.3.6 Intravascular Ultrasound Imaging 24
2.3.7 Pericardiocentesis 25
2.3.8 Heart Biopsy Catheters 25
2.3.9 Atrial Fibrillation Catheters 25
2.3.10 Ablation Electrophysiology Catheters 26
2.3.10.1 New Cardiac Ablation Technology Trends 26
2.3.10.2 Next Generation Atrial Fibrillation Ablation Catheters 27
2.4 Urological Applications of Catheters 28
2.4.1 Condom Catheters 28
2.4.2 Indwelling Urethral Catheters 29
2.4.3 Intermittent Catheters 29
2.4.4 Dialysis Catheters 30
2.4.4.1 Advances in Urinary Catheter Technology 30
2.4.4.2 Biocompatibility 30
2.4.4.3 Biofilms and Encrustation 31
2.4.4.4 Issues in Intermittent Self-Catheterization 31
2.4.4.5 Coatings for Urinary Catheters 31
2.5 Neurovascular Applications of Catheters 31
2.6 Venous Access Applications of Catheters 32
2.6.1 Central Venous Catheters (CVC) 32
2.6.2 Short Peripheral Inserted Catheters (PIC) 33
2.6.3 Midline Catheters (MC) 33
2.6.4 Peripherally Inserted Central Catheter (PICC) 33
2.6.5 Pulmonary Artery Catheters (PAC) 34
2.6.6 Tunneled Central Catheters 34
2.6.7 Implanted Ports for Central Catheters 34
2.7 Oximetric Catheter 35
2.8 Thermodilution Catheters 35
2.9 Suction Catheters 35
2.10 Wound Drainage Catheters 36
2.11 Umbilical Catheters 36
2.12 Catheter Coating 36
2.13 Comparison of Three Common Catheter Materials 36
2.13.1 Silicones 37
2.13.2 Polyvinyl Chloride 37
2.13.3 Latex Rubber 37
2.14 Comparison of Silicone, PVC and Latex 37
2.15 The Making of Catheters 38
2.15.1 History 38
2.15.2 Raw Materials and Design 39
3. Disease Conditions that Fuel the Growth of Catheter Market 40
3.1 Scope of this Chapter 40
3.1 Cardiovascular Diseases 40
3.1.1 Mortality from Heart Disease and Stroke in Selected OECD Countries 45
3.1.2 Market for Cardiovascular Devices 48
3.1.3 Market Leaders in Cardiovascular Devices 49
3.2 Catheters and Ports in Cancer Treatment 49
3.2.1 Cancer in the U.S. 50
3.2.2 Mortality from Cancer in OECD Countries 53
3.2.3 Global Oncology Market 57
3.3 Renal Failure 57
3.3.2 Renal Failure in OECD Countries 58
3.3.3 Global Dialysis Market 60
3.3.4 Number of Dialysis Patients Globally 60
3.3.5 Number of U.S. Dialysis Patients 61
3.3.6 U.S. Dialysis Market 62
3.3.7 U.S. Dialysis Procedures by Segment 62
4. Trends in Overall Medical Device Industry 64
4.1 Scope of this Chapter 64
4.1.1 Global Medical Device Market 64
4.1.2 Market for Medical Devices in Americas 65
4.1.3 Medical Device Market in Western Europe 65
4.1.4 Medical Device Market in Central and Eastern Europe 66
4.1.5 Medical Device Market in Asia/Pacific 67
4.1.6 Medical Device Market in Middle East/Africa 67
4.1.7 Medical Device Market in China and India 68
5. Catheter Market: Overview 69
5.1 Scope of this Chapter 69
5.2 Segmentation of Catheter market 69
5.2.1 Global Market for Catheters 70
5.2.2 Market for Catheters in Americas 71
5.2.3 Catheter Market in Europe, Middle East, Russia and Africa, 2011-2018 72
5.2.4 Asia/Pacific Market for Catheters 72
5.2.5 Catheter Market in Japan 73
5.2.6 Global Catheter Market by Region 74
5.2.7 Global Catheter Market by Disease Segment 74
5.3 Market for Cardiovascular Catheters 75
5.3.1 Global Market for Diagnostic Catheters by Type 76
5.3.2 Global Market for Balloon Catheters 77
5.3.3 The Rise of Balloon Catheters in the U.S. 78
5.3.4 Fast Changing DEBs Market 78
5.3.5 Global Market for Electrophysiology Ablation Catheters 79
5.3.6 North American Market for Electrophysiology Ablation Catheters 80
5.3.7 European Market for Electrophysiology Ablation Catheters 80
5.3.8 Asia/Pacific Market for Electrophysiology Ablation Catheters 81
5.3.9 Single-Use Cardiac Catheter market 82
5.3.9.1 Global Market for Single-Use Catheters in Conventional Diagnostics 82
5.3.9.2 Global Market for Single-Use Catheters Used in Standard Ablation 83
5.3.9.3 Global Market for Single-Use Catheters Used in Advanced Diagnostics 84
5.3.9.4 Global Market for SUD Catheters Used in Irrigated Ablation 84
5.4 Global Market for Urological Catheters 85
5.4.1 FDA-Approved Urological Catheters 86
5.4.2 U.S. Urology Devices Market 87
5.4.3 U.S. Intermittent Catheters Market 87
5.4.4 Market Leaders in Intermittent Catheters 88
5.4.5 Market Leaders in Foley Catheters 89
5.4.6 U.S. Market for Urinary Incontinence Products by Type 89
5.4.7 U.S. Urinary Incontinence Market by Segment 90
5.4.8 Market Leaders in Male External Catheters 90
5.5 Global Market for Central Venous Catheters 91
5.5.1 Global Central Venous Catheter (CVC) Market by Region 91
5.5.2 Market Leaders in Central Venous Catheter Market 92
5.5.3 Market Leaders in Implantable Catheter Ports 92
6. Global Market for Tissue Ablation Devices 94
6.1 Scope of this Chapter 94
6.1.1 Share of the Ablation Technologies by Clinical Specialty 94
6.1.2 Global Ablation Devices Market by Type 95
6.1.3 Electrical and Electrocautery Devices 96
6.1.4 Radiation Devices 97
6.1.5 Light-Based Ablation Devices 97
6.1.6 Radiofrequency (RF) Energy 98
6.1.7 Market Leaders in RF Ablation Devices 99
6.1.8 Ultrasound Energy 99
6.1.9 Cryotherapy 100
6.1.10 Thermal Ablation 101
6.1.11 Microwave Hyperthermia 101
6.1.12 Hydromechanical Ablation 102
6.2 U.S. Market for Tissue Ablation Devices 103
6.2.1 Cryoablation in the U.S. 103
6.2.2 Hydromechanical Ablation Therapy in the U.S. 104
6.2.3 `Ultrasound Tissue Ablation in the U.S. 105
6.2.4 Radiofrequency Ablation Therapy in the U.S. 105
6.2.5 Market for Tissue Ablation Devices in Asia/Pacific 106
6.2.5.1 Market for Tissue Ablation Devices in Japan 107
6.2.5.2 Chinese Market for Tissue Ablation Devices 107
6.2.5.3 Australian Market for Tissue Ablation Devices 108
6.2.5.4 Market for Tissue Ablation in India 109
6.3 Share of the Ablation Technologies by Clinical Specialty 109
6.3.1 Cancer Ablation Market by Type of Cancer 110
6.3.2 Global Ablation Technologies Market by Modality 111
7. Free Standing Diagnostic Cath Lab Market in the U.S. 112
7.1 Reimbursement Trends 112
7.2 Joint Venture Options 113
7.3 Payer Mix and Volume 113
7.4 Overhead Expenses 114
7.5 Space Requirements and Costs 114
7.6 Personnel Staffing 115
7.7 Credentialing Requirements and Responsible Oversight 116
7.8 Considering Structural Alternatives 116
8. Coding and Payment Information for Catheters, 2012 119
8.1 Medicare Coverage Policy 119
8.2 Private Insurance Coverage 119
8.3 Documentation 119
8.4 Codes and Payments for Hospitals for Procedures Performed in Outpatient Setting 119
8.4.1 Codes and Payments for Inpatient Procedures 120
8.4.2 Codes and Payments for ASC Outpatient Procedures 120
8.5 Physician Payments 120
8.5.1 Physician Payment for Procedures Performed at a Facility 120
8.5.2 Physician Payment Performed in a Non-Facility Setting 120
8.6 Supplies 120
8.7 Appeals 121
9. Selected Company Profiles 125
9.1 Abbott Laboratories 125
9.1.1 Agiltrac 018 Peripheral Dilatation Catheter 125
9.1.2 Fox Plus PTA Catheter 125
9.1.3 Fox sv PTA Catheter 126
9.1.4 FoxCross 035 PTA Catheter 126
9.1.5 Veripath Peripheral Guiding Catheter 126
9.1.6 Powersail Coronary Dilatation Catheter 126
9.1.7 Rx Viatrac 14 Plus Peripheral Dilatation Catheter 127
9.1.8 Trek & Mini Trek Coronary Dilatation Catheter 127
9.2 Abiomed, Inc. 127
9.2.1 Impella 2.5 128
9.2.2 Impella 5.0 128
9.2.3 Impella LD 129
9.3 AngioDynamics, Inc. 129
9.3.1 Selected Products from AngioDynamics 130
9.3.1.1 UniFuse Infusion Catheter 130
9.3.1.2 NeoStar™ Triple Lumen Catheter 130
9.3.1.3 Soft-Vu 4 French High Flow 131
9.3.1.4 Omni Flush Angiographic Catheter 131
9.3.1.5 SOS Omni Selective Catheter 131
9.3.1.6 Mariner™ Hydrophilic Coated Angiographic Catheter 132
9.3.1.7 Total Abscession Drainage Catheter 132
9.3.1.8 Accu-Vu Sizing Catheter 132
9.3.1.9 AngiOptic Flush and Selective Catheters 133
9.3.1.10 Profiler Balloon Dilation Catheter 133
9.3.1.11 WorkHorse II PTA Balloon Catheter 134
9.3.1.12 DuraMax Chronic HemoDialysis Catheter 134
9.3.1.13 Dura-Flow Chronic Hemodialysis Catheter 134
9.3.1.14 SCHON XL Acute Hemodialysis Catheter 135
9.3.1.15 LifeJet VP VascPak 135
9.3.1.16 EVENMORE Chronic Dialysis Catheter 135
9.3.1.17 Schon Chronic Hemodialysis Catheter 136
9.3.1.18 EMBOSAFE Valved, Splittable Sheath Dialtor 136
9.4 Astra Tech AB 137
9.4.1 LoFric Primo 137
9.4.2 LoFric 137
9.4.3 LoFric Hydro-Kit 137
9.4.4 LoFric Dila Cath 137
9.5 AtriCure, Inc. 138
9.6 B. Braun Melsungen AG 138
9.6.1 B. Braun’s Intermittent Catheters 138
9.6.1.1 Actreen® Lite Mini (Female Self Intermittent Catheter) 139
9.6.1.2 Actreen® Lite Cath Tiemann Male 139
9.6.1.3 Actreen® Lite Cath Nelaton Male 139
9.6.1.4 Actreen® Lite Cath Nelaton Female 140
9.6.1.5 Actreen® SafeCath Tiemann Male 140
9.6.1.6 Actreen® SafeCath Nelaton Female 141
9.6.1.7 Actreen® Glys Cath Tiemann Male 141
9.6.1.8 Actreen® Glys Cath Nelaton Male 141
9.6.1.9 Actreen® Glys Cath Nelaton Female 142
9.6.2 Vesical Instillation Catheters 142
9.6.2.1 Actreen® Glys Luer Lock Tiemann Male 142
9.6.2.2 Actreen® Glys Luer Lock Nelaton Male 143
9.6.2.3 Actreen® Glys Luer Lock Nelaton Female 143
9.6.3 Male External Catheters 143
9.6.3.1 Urimed® Vision Standard 143
9.6.3.2 Urimed® Vision Short 144
9.6.4 Urological Catheters 144
9.6.4.1 Transurethral Balloon Catheter, Nelaton Tip 144
9.6.4.2 Transurethral Balloon Catheter, Tiemann Tip 145
9.6.4.3 Nelaton Catheter 145
9.6.4.4 Tiemann Catheter 145
9.6.4.5 Tiemann-Katheter with lubricant 146
9.6.5 Female Catheter 146
9.6.5.1 Cystofix® Basic Set (acute and medium term care) 146
9.6.5.2 Cystofix® Replacement Set 147
9.6.5.3 Cystofix® Dilation Replacement Set with Balloon Catheter 147
9.6.5.4 Cystofix® Basic Set with Balloon Catheter (long term care) 147
9.6.5.5 Cystofix® TUR 148
9.6.5.6 Cystofix® Paed Basic Set 148
9.6.5.7 Cystofix® Paediatrics and Neonatalogy Replacement Set 148
9.6.5.8 Nephrofix® 149
9.6.5.9 Nephrofix® Certo 149
9.7 Becton, Dickinson & Co. 149
9.8 Boston Scientific 152
9.8.1 Boston’s Advanced Mapping Catheters 152
9.8.1.1 AFocus™ Steerable Diagnostic Catheters 152
9.8.1.2 Constellation® Full Contact Mapping Catheter 153
9.8.1.3 Inquiry® H-Curve™ Steerable Diagnostic Catheters 153
9.8.1.4 Luma-Cath™ Fixed & Steerable Curve Diagnostic Catheters 154
9.8.1.5 Ten-Ten™ Duodecapolar Diagnostic Catheters 154
9.8.2 Boston’s Diagnostic Catheters 154
9.8.2.1 Blazer® Dx-20 Bidirectional Duodecapolar Diagnostic Catheter 154
9.8.2.2 Explorer 360™ and 360 Jr™ Diagnostic Catheters 155
9.8.2.3 Inquiry® Fixed Curve Diagnostic Catheters 155
9.8.2.4 Inquiry® HIS Diagnostic Catheters 155
9.8.2.5 Inquiry® Steerable Diagnostic Catheters 156
9.8.2.6 Polaris Dx™ Steerable Diagnostic Catheter 156
9.8.2.7 Polaris X™ Steerable Diagnostic Catheters 156
9.8.2.8 SteeroCath-Dx™ Bi-Directional Steerable Diagnostic Catheters 157
9.8.3 Boston’s Therapeutic Catheters 157
9.8.3.1 Blazer Prime® HTD and Blazer Prime® XP Temperature Catheters 157
9.8.3.2 Blazer® II XP Temperature Ablation Catheter 158
9.8.3.3 Blazer® Temperature Ablation Catheters 158
9.8.3.4 Chilli II® Cooled Ablation Catheters 159
9.8.4 Boston’s Catheters in Gasteroenterology 160
9.8.4.1 Gold Probe™ Electrohemostasis Catheter 160
9.8.4.2 Injection Gold Probe™ Hemostasis Catheter 160
9.8.5 Angiographic Catheter in Interventional Radiology 161
9.8.5.1 iCross™ Coronary Imaging Catheter 161
9.8.6 Selected Balloon Catheter in Interventional Radiology 161
9.8.6.1 Berenstein Large Lumen Occlusion Balloon Catheter 161
9.8.6.2 Charger™ 0.035” Balloon Dilatation Catheter 162
9.8.6.3 Coyote™ Balloon Dilatation Catheter 162
9.8.6.4 Sterling® ES Balloon Dilatation Catheters 163
9.8.6.5 Sterling® SL Balloon Dilatation Catheter 163
9.8.6.6 Sterling™ Monorail® Balloon Dilatation Catheters 164
9.8.7 Urology Balloon Catheters 164
9.8.7.1 NephroMax™ High Pressure Nephrostomy Balloon Catheter 164
9.8.7.2 UroMax Ultra™ High Pressure Balloon Catheter 165
9.9 Coloplast A/S 165
9.9.1 SpeediCath Control 165
9.9.2 SpeediCath Compact 166
9.9.3 SpeediBag Compact 166
9.9.4 SpeediCath Complete 166
9.9.5 SpeediCath Compact Male 167
9.9.6 Conveen Optima 167
9.9.7 Conveen Optima and Conveen Active 167
9.10 Cook Medical, Inc. 168
9.10.1 Anesthetic Injection Catheter 168
9.10.2 Angled Tip Ureteral Catheter 168
9.10.3 Bush DL™ Ureteral Illuminating Catheter Set 168
9.10.4 Bush SL™ Ureteral Illuminating Catheter Set 169
9.10.5 Cohen Deflecting Wire Guide Catheter 169
9.10.6 Cone Tip Ureteral Catheter 169
9.10.7 Echotip® Open-End Ureteral Catheter 169
9.10.8 Flexi-Tip® Ureteral Catheter 169
9.10.9 Kumpe Access Catheter 170
9.10.10 Laser Ureteral Catheter 170
9.10.11 Madduri Ureteral Stone Pushing Catheter 170
9.10.12 Malleable Tip Open-End Ureteral Catheter 170
9.10.13 Open-End Flexi-Tip® Ureteral Catheter 171
9.10.14 Open-End Tapered Tip Ureteral Catheter 171
9.10.15 Open-End Ureteral Catheter Sof-flex® 171
9.10.16 Pediatric Ureteral catheter 171
9.10.17 Pigtail Ureteral Catheter Sof-Flex® AQ® 171
9.10.18 Pigtail Ureteral Catheter Set 172
9.10.19 Renal Access Cobra Catheter 172
9.10.20 Round Tip Ureteral Catheter 172
9.10.21 Rutner Universal Wedge Catheter 172
9.10.22 Schoborg Angled Tip Laser Catheter 173
9.10.23 Spiral Tip Ureteral Access Catheter 173
9.11 Edwards Lifesciences Corporation 173
9.11.1 Edward’s Central Venous Catheters 174
9.11.1.1 Vantex Antimicrobial Central Venous Catheters 174
9.11.1.2 IntroFlex Introducers 174
9.11.1.3 Multimed Catheters 174
9.11.1.4 AVA 3Xi Device 175
9.11.1.5 AVA High-Flow Device 175
9.11.1.6 PreSep Central Venous Oximetry Catheter (ScvO2) 175
9.11.1.7 PediaSat Oximetry Catheter (ScvO2) 176
9.11.2 Balloon Atrioseptostomy Catheters 176
9.12 Hollister, Inc. 177
9.12.1 Hollister’s Continence Care Products 177
9.12.1.2 Apogee Intermittent Catheters 177
9.12.1.3 Apogee Closed System 177
9.12.1.4 Advance Plus Touch Free Intermittent Catheter 177
9.12.1.5 InView Male External Catheters 178
9.12.1.6 Extended Wear Male External Catheter 178
9.12.1.7 Everyday Male External Catheter 178
9.13 Medcomp 179
9.13.1 Long Term Hemodialysis Catheters 179
9.13.1.1 Split Cath 179
9.13.1.2 Split Stream 179
9.13.1.3 Eschelon 180
9.13.1.4 Bio-Flex Tesio Cath 180
9.13.1.5 Titan HD 180
9.13.1.6 Hemo Flow 180
9.13.1.7 Hemo-Cath LT 181
9.14 Prolinx GmbH 181
9.14.1 ProCath® Silicone-Elastomer Coated Foley Catheters 181
9.14.2 ProCath® Silicone Foley Catheter 182
9.14.3 ProCath® Solo Intermittent Catheter 182
9.14.4 ProCath® Plus Intermittent Catheter 183
9.14.5 ProCath® Kit Plus Intermittent Catheter 183
9.14.6 ProCath® Closed Urine Drainage Systems PL 2000 184
9.14.7 ProCath® Bed Drainage Bag PL 2000E 184
9.14.8 ProCath® Leg bag PL 500 184
9.14.9 ProCath® Closed Urine Drainage Systems PL 1000 185
9.14.10 Catheterization Kit 185
9.15 Rochester Medical Corporation 186
9.15.1 Male External Catheters 186
9.15.2 Intermittent Catheters 186
9.15.3 Silicone Foley Catheters 186
9.15.4 Anti-Infection Foley Catheters 187
9.15.5 Urethral Inserts 187

APPENDIX

Appendix 1: Guidelines for Indwelling Catheterization in Adults 188
Appendix 1.1: Transurethral or Suprapubic Catheterisation 188
Appendix 1.2: Short-Term and Long-Term Catheterization 188
Appendix 1.3: Closed Drainage System 188
Appendix 1.4: Alternatives to Placing an Indwelling Catheter 189
Appendix 1.5: Indications for Urethral Catheterization 189
Appendix 1.6: Contraindications for Urethral Catheterization 189
Appendix 1.7: Short-Term vs. Long-Term Catheterization 189
Appendix 1.8: Indications for Suprapubic Catheterization 190
Appendix 1.9: Contraindications for Suprapubic Catheterization 190
Appendix 1.10: Advantages of Suprapubic Catheterization 190
Appendix 1.11: Limitations of Suprapubic Catheters 190
Appendix 1.12: Equipment and Products for Catheterization 191
Appendix 1.12.1: Types of Catheters 191
Appendix 1.12.2: Catheter Material 193
Appendix 1.12.3: Catheter Diameter 194
Appendix 1.12.4: Catheter Length 194
Appendix 1.12.5: Catheter Tip Dewsign 194
Appendix 1.12.6: Drainage Bags 196
Appendix 2: Minimally Invasive Medical Technologies 200
Appendix 2.1: Market Share for Minimally-Invasive Medical Technologies 200
Appendix 2.2: Market Size and Growth 201
Appendix 2.3: Patient Demand for Minimally-Invasive Procedures 205
Appendix 2.4: Advances in Electrosurgical Tools 206
Appendix 2.5: Advances in Robotics 207
Appendix 2.6: Clinical Opportunities for Minimally-Invasive Medical Technologies 207
Appendix 3: High-Impact Emerging Medical Technologies 209
Appendix 3.1: Emerging Cardiology/Vascular Market 209
Appendix 3.1.1: Diagnostic Technologies 210
Appendix 3.1.1.1: Implantable Cardiac Pressure Monitors 210
Appendix 3.1.1.2: Ultra-Wideband Radar 211
Appendix 3.1.1.3: Bioimpedance Plethsmograph 212
Appendix 3.1.2: Therapeutic Technologies 214
Appendix 3.1.2.3: MRI-Compatible Pacemakers 216
Appendix 3.1.2.4: Ultrasound-Enhanced Thrombolytics 217
Appendix 3.1.2.5: Image-Guided Intracardiac Surgery (IGIS) 218
Appendix 3.1.2.6: Autologous Cell Therapy 219
Appendix 3.1.2.7: External Cardiac Basal Annuloplasty 220
Appendix 3.1.2.8: Symplicity Catheter/Therapeutic Renal Denervation Procedure 221
Appendix 3.1.2.9: Laser Circumferential Pulmonary Vein Ablation/Atrial Fibrillation Therapy 222
Appendix 3.1.2.10: Non-Invasive Cardiac Radiosurgery/CyberHeart 224
Appendix 3.2: Oncology Market 225
Appendix 3.2.1: Diagnostic Technologies 225
Appendix 3.2.1.1: Radioactive Trace Biomarker/FLT 225
Appendix 3.2.1.2: Vivo Confocal Microscopy / Skin Cancer Diagnosis 227
Appendix 3.2.1.3: Lung Cancer/Breath Test 228
Appendix 3.2.1.4: Magnetically-Charged Cancer Biomarker/MagArray Technology 229
Appendix 3.2.1.5: NIR Tissue Analyzer/Optical Tissue Analyzer 230
Appendix 3.2.2: Therapeutic Technologies 231
Appendix 3.2.2.1: Acoustic-Enhanced Chemotherapy 231
Appendix 3.2.2.2: Electrochemotherapy/Novo – TTF device 232
Appendix 3.2.2.3: MRI-Guided Laser Coagulation Therapy (LITT)/AutoLITT 233
Appendix 3.2.2.4: MRI-Guided Robotic Radiotherapy/Renaissance System 234
Appendix 3.2.2.5: PDT for Solid Tumors/Light Infusion Therapy 236
Appendix 3.2.2.6: Prostate Cooling Catheter/UroCool 237
Appendix 3.3: Gastrointestinal Market 238
Appendix 3.3.1: Diagnostic Technologies 238
Appendix 3.3.1.1: Urea Breath Test/Breath ID 238
Appendix 3.3.1.2: Robotic GI Capsule 239
Appendix 3.3.1.3: Minimally Invasive GERD Procedure/EndoFlip 240
Appendix 3.3.2: Therapeutic Technologies 242
Appendix 3.3.2.1: Non-Invasive Obesity Treatment/LINX Reflux Management 242
Appendix 3.4: Pulmonology Market 243
Appendix 3.4.1: Diagnostic Technologies 243
Appendix 3.4.1.1: Electrical Impedance Tomography/EIT Lung Function 243
Appendix 3.4.2: Therapeutic Technologies 244
Appendix 3.4.2.1: Artificial Lung/Hemolung 244
Appendix 3.4.2.2: Endobronchial Valves/Spiration’s® IBV 245
Appendix 3.5: Nursing 247
Appendix 3.5.1: Diagnostic Technologies 247
Appendix 3.5.1.1: Real-Time Blood Test Glucose, Electrolytes, Amino Acids/MicroEye 247
Appendix 3.5.1.2: Drug Metabolism/Breath-Based P450 248
Appendix 3.5.2: Therapeutic Technologies 250
Appendix 3.5.2.1: Contrast-Induced Nephropathy/RenalGuard Therapy 250
Appendix 3.5.2.2: Antimicrobial Coating on Catheters/CeraShield 251
Appendix 3.5.2.3: Sepsis Microfilter 252
Appendix 3.6: Neurology 253
Appendix 3.6.1: Diagnostic Technologies 254
Appendix 3.6.1.1: Electric Impedance Myography 254
Appendix 3.6.1.2: Brain Injury Blood Test/S100B Biomarker 255
Appendix 3.6.1.3: Alzheimer’s Blood Test/NuroPro, LymPro Test 256
Appendix 3.6.1.4: Navigated Brain Stimulation Mapping/eXimia NBS System 257
Appendix 3.6.2: Therapeutic Technologies 259
Appendix 3.6.2.1: Deep Brain Stimulation/Stroke Therapy 259
Appendix 3.6.2.2: Hypoglossal Nerve Stimulation/Sleep Apnea 260
Appendix 3.6.2.3: Alzheimer's Therapeutic Drug/PBT2 261
Appendix 3.6.2.4: Spinal Cord Nerve Regeneration/Andara™ OFS 262
Appendix 3.7: Women’s Health 263
Appendix 3.7.1: Non-Invasive Fetal EKG 264
Appendix 3.7.2: Cervical Spectroscopy/Optical Cervical Cancer Detection 265
Appendix 3.7.3: Laser Opto-Acoustic Imaging/Mammography 266
Appendix 3.8: Surgical 267
Appendix 3.8.1: Intraoperative Near-Infrared Guidance Technology 268
Appendix 3.8.2: Acoustic Hemostasis 269
Appendix 3.8.3: Photochemical Bonding 270
Appendix 3.9: Imaging 272
Appendix 3.9.1: Elastography/Advanced Ultrasound 272
Appendix 3.9.2: Computer-Assisted Tortuosity/Tumor Blood Vessel Analysis 273
Appendix 3.9.3: Dynamic Light Scattering/Early Cataract Detection 274
Appendix 4: A Guide for U.S. Exporters of Healthcare Technologies 276
Appendix 4.1: Opportunities in the E.U. 276
Appendix 4.2: U.S. Opportunities in Austria 282
Appendix 4.3: Opportunities in Belgium 283
Appendix 4.4: Opportunities in Bulgaria 284
Appendix 4.5: Opportunities in Czech Republic 286
Appendix 4.6: Opportunities in Denmark 287
Appendix 4.7: Opportunities in Finland 288
Appendix 4.8: Opportunities in France 289
Appendix 4.9: Opportunities in Germany 291
Appendix 4.10: Opportunities in Greece 295
Appendix 4.11: Opportunities in Hungary 298
Appendix 4.12: Opportunities in Ireland 300
Appendix 4.13: Opportunities in Italy 302
Appendix 4.14: Opportunities in Netherlands 304
Appendix 4.15: Opportunities in Norway 305
Appendix 4.16: Opportunities in Poland 306
Appendix 4.17: Opportunities in Romania 308
Appendix 4.18: Opportunities in Slovak Republic 309
Appendix 4.19: Opportunities in Spain 311
Appendix 4.20: Opportunities in Sweden 312
Appendix 4.21: Opportunities in Switzerland 314
Appendix 4.22: Opportunities in Ukraine 315
Appendix 4.23: Opportunities in U.K. 316
Appendix 4.24: Opportunities in Argentina 318
Appendix 4.25: Opportunities in Brazil 319
Appendix 4.26: Opportunities in Dominican Republic 320
Appendix 4.27: Opportunities in Equador 322
Appendix 4.28: Opportunities in El Salvador 323
Appendix 4.29: Opportunities in Mexico 324
Appendix 4.30: Opportunities in Panama 325
Appendix 4.31: Opportunities in Israel 326
Appendix 4.32: Opportunities in Saudi Arabia 328
Appendix 4.33: Opportunities in Turkey 331
Appendix 4.35: Opportunities in China 333
Appendix 4.36: Opportunities in India 335
Appendix 4.37: Opportunities in Indonesia 337
Appendix 4.38: Opportunities in Japan 338
Appendix 4.39: Opportunities in Philippines 340
Appendix 4.40: Opportunities in Republic of Korea 341
Appendix 4.41: Opportunities in Singapore 343
Appendix 4.42: Opportunities in Taiwan 344
Appendix 5: A Snapshot of Medical Device Industry, Based on a Survey by Professionals 346
Appendix 5.1: Change in Domestic Sales in 2011 346
Appendix 5.2: Companies Seeking Outside Opportunities for Medical Devices 346
Appendix 5.3: Continued International Expansion of Medical Device Firms in 2011 347
Appendix 5.4: Emerging Markets Targeted by Medical Device Firms in 2012 348
Appendix 5.5: Markets Offering the Best Growth Potential for the Next Five Years 348
Appendix 5.6: The Biggest Challenges in Running a Medical Device Business 349
Appendix 5.7: Prospects for Existing Medical Device Firms in 2012 350
Appendix 5.8: Medical Device Firm’s Outlook on Overall Business Environment in 2012 351
Appendix 6: Medtech Mergers and Acquisitions, 2011 352
Appendix 6.1: J & J’s Acquisition of Synthes 352
Appendix 6.2: Stryker’s Strike 352
Appendix 6.3: The Battle Won by Danaher 353
Appendix 6.4: Major Acquisition for Private Equity Firm 353
Appendix 6.5: Thermo Fisher’s Hook on Diagnostics Companies 353
Appendix 6.6: Other Diagnostics Transactions 353
Appendix 6.7: Pelvic Health Transactions 354
Appendix 6.8: Diversification Move by Dentsply 354
Appendix 6.9: Gentinge’s Foray into Cardiovascular Sector 355
Appendix 6.10: Medtronic’s Hyperactive Year 355
Appendix 6.11: Acquisition of U.S. Companies by Japanese 355
Appendix 6.12: Boston Scientific’s Acquisition Trail 356
Appendix 6.13: Future Outlook 356
Appendix 7: Hospital Acquired Infections in Europe 358
Appendix 7.1: Urinary Tract Infections 358
Appendix 7.2: Respiratory Infections 359
Appendix 7.3: Blood Stream Infections 359
Appendix 7.4: Surgical Site Infections 360
Appendix 7.5: Other Infections 360
Appendix 7.6: An Overview of Hospital-Acquired Infections (HAI) 361
Appendix 7.7: Prevalence of HAI in Europe 361
Appendix 7.8: Microorganisms Isolated from HAIs 362
Appendix 7.9: Hospitals and Infections 362
Appendix 7.9.1: HAIs Based on Wards 363
Appendix 7.9.2: HAIs from Intensive Care Units 363
Appendix 7.10: An Overview of Urinary Tract Infections 363
Appendix 7.10.1: Catheter Associated Urinary Tract Infections (CAUTI) 365
Appendix 7.10.2: HAIs UTI Population in Europe 365
Appendix 7.11: Hospital-Acquired Pneumonia Infections 366
Appendix 7.11.1: Hospital-Acquired Pneumonia Infection in ICUs 367
Appendix 7.12: Surgical Site Infections 368
Appendix 7.12.1: SSI in Orthopedic Surgery 368
Appendix 7.13: Bloodstream Infections 369
Appendix 7.13.1: Catheter-Related Bloodstream Infections 369
Appendix 7.14: Antimicrobial Resistence 370
Appendix 7.15: HAIs in France 372
Appendix 7.16: HAIs in Germany 373
Appendix 7.17: HAIs in Italy 374
Appendix 7.18: HAIs in Spain 374
Appendix 7.19: HAIs in U.K. 375
Appendix 8: IV Catheter Needlestick Prevention in Europe 377
Appendix 8.1: Occurrence of Needlestick Injuries 378
Appendix 8.2: Transmissable Diseases 378
Appendix 8.2.1: Hepatitis B Virus (HBV) Infection 379
Appendix 8.2.2: Hepatitis C Virus Infection (HCV) 380
Appendix 8.2.3: HIV/AIDS 381
Appendix 8.3: Safety Devices in Catheters 382


INDEX OF FIGURES

Figure 2.1: Insertion of Foley Catheters into Male and Female Urinary Tracts 39
Figure 3.1: Projection for All Cardiovascular Disease Prevalence (%) in the U.S., 2010-2030 41
Figure 3.2: Projected Direct Medical Cost of All Cardiovascular Diseases in the U.S., 2010-2030 41
Figure 3.3: Projections for the Prevalence of Hypertension in the U.S., 2010-2030 42
Figure 3.4: Projected Direct Medical Cost of Hypertension in the U.S., 2010-2030 42
Figure 3.5: Projections for the Prevalence of Coronary Heart Disease in the U.S., 2010-2030 43
Figure 3.6: Projected Direct Medical Cost of Coronary Heart Disease in the U.S., 2010-2030 43
Figure 3.7: Projections for the Prevalence of Heart Failure in the U.S., 2010-2030 44
Figure 3.8: Projected Direct Medical Cost of Heart Failure in the U.S., 2010-2030 44
Figure 3.9: Projections for the Prevalence of Stroke in the U.S., 2010-2030 45
Figure 3.10: Projected Direct Medical Cost of Stroke in the U.S., 2010-2030 45
Figure 3.11: Ischemic Heart Disease, Mortality Rates in Selected OECD Countries, 2009 46
Figure 3.12: Stroke Mortality Rates in Selected OECD Countries, 2009 47
Figure 3.13: Total Worldwide Cardiovascular Devices Market, 2011-2018 48
Figure 3.14: Leaders in Cardiovascular Devices Market 49
Figure 3.15: Estimated New Cancer Cases in the U.S. for Select Sites, 2011 50
Figure 3.16: All Cancers Mortality Rates in Selected OECD Countries, 2009 53
Figure 3.17: Lung Cancer Mortality Rates in Selected OECD Countries, 2009 54
Figure 3.18: Breast Cancer Mortality Rates in Selected OECD Countries, 2009 55
Figure 3.19: Prostate Cancer Mortality in Males in Selected OECD Countries, 2009 56
Figure 3.20: Global Oncology Market, 2011-2018 57
Figure 3.21: Prevalence of Patients Undergoing Dialysis in OECD Countries, 1990 and 2009 58
Figure 3.22: Prevalence of Patients Living with a Functioning Kidney Transplant, 1990 and 2009 59
Figure 3.23: Worldwide Dialysis Market, 2011-2018 60
Figure 3.24: Global Number of Dialysis Patients, 2011 61
Figure 3.25: Number of U.S. Dialysis Patients, 2011-2018 61
Figure 3.26: U.S. Dialysis Market, 2011-2018 62
Figure 3.27: U.S. Dialysis Procedures by Segment, 2011 63
Figure 4.1: Worldwide market for Medical Devices, 2011-2018 64
Figure 4.2: Medical Device Market in Americas, 2011-2018 65
Figure 4.3: Medical Device Market in Western Europe, 2011-2018 66
Figure 4.4: Medical Device Market in Central and Eastern Europe, 2011-2018 66
Figure 4.5: Medical Device Market in Asia/Pacific, 2011-2012 67
Figure 4.6: Medical Device Market in Middle East/Africa, 2011-2018 68
Figure 4.7: Combined Chinese and Indian Market for Medical Devices, 2011-2018 68
Figure 5.1: Global Catheter Market Sales Segmentation 70
Figure 5.2: Global Catheter Market, 2011-2018 71
Figure 5.3: Market for Catheters in Americas, 2011-2018 71
Figure 5.4: Catheter Market in Europe, Middle East, Russia and Africa, 2011-2018 72
Figure 5.5: Catheter Market in Asia/Pacific, 2011-2018 73
Figure 5.6: Catheter Market in Japan, 2011-2018 73
Figure 5.7: Global Catheter Market by Region, 2011 74
Figure 5.8: Global Catheter Market by Segmentation in 2014 75
Figure 5.9: Global Market for Cardiovascular Catheters, 2011-2018 76
Figure 5.10: Global Diagnostic Cardiac Catheter Market by Type, 2011 77
Figure 5.11: Global Market for Balloon Catheters, 2011-2018 77
Figure 5.12: Estimated Addressable U.S. Market for Drug-Coated Balloon Catheters 78
Figure 5.13: U.S. Market for Drug Coated Balloon Catheters in Peripheral Applications 79
Figure 5.14: Global Market for Electrophysiology Ablation Catheters, 2011-2018 79
Figure 5.15: North American Market for Electrophysiology Ablation Catheters, 2011-2018 80
Figure 5.16: European Market for Electrophysiology Ablation Catheters, 2011-2018 81
Figure 5.17: Asia/Pacific Market for Electrophysiology Ablation Catheters, 2011-2018 81
Figure 5.18: Global Single Use Device (SUD) Cardiac Catheter Market, 2011-2018 82
Figure 5.19: Global Market for SUD Cardiac Catheters Used in Conventional Diagnostics, 2011-2018 83
Figure 5.20: Global Market for SUD Cardiac Catheters Used in Standard Ablation, 2011-2018 83
Figure 5.21: Global Market for SUD Cardiac Catheters Used in Advanced Diagnostics, 2011-2018 84
Figure 5.22: Global Market for SUD Cardiac Catheters Used in Irrigated Ablation, 2011-2018 85
Figure 5.23: Global Market for Urological Catheters, 2011-2018 85
Figure 5.24: Manufacturers with Largest Number of FDA-Approved Catheters 86
Figure 5.25: U.S. Urology Device Market by Segment, 2011 87
Figure 5.26: U.S. Intermittent Catheter Market, 2011-2018 88
Figure 5.27: Market Leaders in Intermittent Catheters 88
Figure 5.28: Market Leaders in Foley Catheters 89
Figure 5.29: U.S. Market Share of Urinary Incontinence Products by Type 89
Figure 5.30: U.S. Urinary Incontinence Market by Sub-Segment, 2011 90
Figure 5.31: Market Leaders in Male External Catheters 90
Figure 5.32: Global Market for Central Venous Catheters, 2011-2018 91
Figure 5.53: CVC Global Market by Region/Country 92
Figure 5.54: Leaders in the Global Central Venous Catheter Market 92
Figure 5.55: U.S. Market Leaders in Implantable Catheter Ports, 2010 93
Figure 6.1: Relative Share of Ablation Technologies Market by Clinical Specialty, 2010 95
Figure 6.2: Global Ablation Devices Market by Device Type, 2011 95
Figure 6.3: Global Market for Electrical Ablation Devices, 2011-2018 96
Figure 6.4: Global Market for Radiation Ablation Devices, 2011-2018 97
Figure 6.5: Global Market for Light-Based Ablation Devices, 2011-2018 98
Figure 6.6: Global Market for Radiofrequency Ablation Devices, 2011-2018 99
Figure 6.7: Market Leaders in RF Ablation Devices, 2011 99
Figure 6.8: Global Market for Ultrasound Ablation Devices, 2011-2018 100
Figure 6.9: Global Market for Cryotherapy Ablation Devices, 2011-2018 100
Figure 6.10: Global Market for Thermal Ablation Devices, 2011-2018 101
Figure 6.11: Global Market for Microwave Ablation Devices, 2011-2018 102
Figure 6.12: Global Market for Hydromechanical Ablation Devices, 2011-2018 102
Figure 6.13: U.S. Market for Tissue Ablation Devices, 2011-2018 103
Figure 6.14: U.S. Market for Cryoablation Devices, 2011-2018 104
Figure 6.15: U.S. Market for Hydromechanical Ablation Devices, 2011-2018 104
Figure 6.16: U.S. Market for Ultrasound Ablation Devices, 2011-2018 105
Figure 6.17: U.S. Market for Radiofrequency Ablation Devices, 2011-2018 106
Figure 6.18: Asia/Pacific Market for Ablation Devices, 2011-2018 106
Figure 6.19: Growth in Japanese Market for Ablation Technologies, 2011-2018 107
Figure 6.20: Growth in Chinese Market for Ablation Technologies, 2011-2018 108
Figure 6.21: Growth in Australian Market for Ablation Technologies, 2011-2018 108
Figure 6.22: Growth in Indian Market for Ablation Technologies, 2011-2018 109
Figure 6.23: Relative Share of Ablation Technologies Market by Clinical Specialty, 2010 110
Figure 6.24: Cancer Ablation Market Segmentation, 2011 110
Figure 6.25: Global Ablation Technologies Market by Modality, 2011 111
Table 9.1 IV Catheters from BD 150
Figure A.2.1: Number of Minimally-Invasive Surgeries Worldwide 201
Figure A2.2: Market for Minimally-Invasive Medical Technologies by Region/Country, 2009-2014 202
Figure A2.3: Market Share of Minimally-Invasive Medical Technologies by Device Type 202
Figure A2.4: Profound Medical’s Energy Wand Emitting Ultrasound in Two Different Wavelengths 206
Figure A2.5: Coil RFA Ablation Technology for Treating Solid Tumors 207
Figure A4.1: French Medical Device Market Size, 2009-2011 290
Figure A4.2: German Medical Market, 2009-2011 292
Figure A4.3: Size of Turkey’s Medical Device Market, 2010-2012 332
Figure A4.4: Medical Device Market in Republic of Korea, 2008-2010 341
Figure A5.1: Change in Domestic Sales by Medical Device Companies in 2011 346
Figure A5.2: Change in International Sales of Medical Devices in 2011 347
Figure A5.3: Continued International Expansion of Medical Device Firms in 2011 347
Figure A5.4: Emerging Markets Targeted by Medical Device Firms in 2012 348
Figure A5.5: Markets Offering the Best Growth Potential from 2012-2017 349
Figure A5.6: Biggest Challenges in Running a Medical Device Business 350
Figure A5.7: Prospects for Existing Medical Device Firms in 2012 350
Figure A5.8: Medical Device Firm’s Outlook on Overall Business Environment in 2012 351
Figure A7.1: Hospital-Acquired Infections: Percent Split by Type in Europe 362
Figure A7.2: HAIs of Urinary Tract Infections (UTI) Percent by Type 364
Figure A7.3: HAIs of Urinary Tract Percent Split by Pathogens 364
Figure A7.4: Population of HIS UTI Population in Europe by Country 366
Figure A7.5: Six Most Common Pathogens of Pneumonia Infection in ICUs 367
Figure A7.6: Incidence of SSI by Type of Orthopedic Surgery 368
Figure A7.7: Bloodstream Infections by Site of Origin 369
Figure A7.8: HAIs in France by Type 372
Figure A7.9: HAIs in Germany by Type 373
Figure A7.10: HAIs in Spain by Type of Pathogen 374
Figure A7.11: HAIs in the U.K. by Type 375
Figure A8.1: Frequency of Needlestick Injuries in Europe and the U.S. 377
Figure A8.2: Occurrence of Needlestick Injuries 378
Figure A8.3: The Three Dangerous Infections through Needlestick Injuries 379
Figure A8.4: Percent Population of Chronic HBV Infected People by Region 380
Figure A8.5: The Prevalence Rate of Chronic Hepatitis C Virus in Europe 380
Figure A8.6: The Prevalence Rate of Chronic Hepatitis C Virus in Europe 381
Figure A8.7: People Living with HIV by Region 382

INDEX OF TABLES

Table 7.1: Medicare Fee Schedule for Common Cath Procedure Codes in the State of Washington 112
Table 7.2: Payer Mix for Cath Procedures 113
Table 7.3: Projected Revenue in Free Standing Cath Lab 114
Table 7.4: Suggested Minimal Room Sizes in a Cardiac Cath Suite 115
Table 7.5: Medicare Reimbursement 2009: Hospital O.P Department vs. Free Standing Cath Lab 117
Table 7.6: Revenue Projections Based on 50% Practice 118
Table 8.1: Codes and Payments for Catheter Procedures, 2012 121
Table A4.1: The Top Three Countries in the Export and Import of Medical Devices into China, 2010 334
Table A6.1: Medtech Merger and Acquisition, 2011 357
Table A7.1: Pathogens Causing CAUTI Ranked in Order 365
Table A7.2: Classification of Pathogens Based on the Onset of Pneumonia 367
Table A7.3: MRSA Incidence per 100,000 Patient Days in Europe 370
Table A7.4: List of Antibiotic Resistent Pathogens 370
Table A7.5: Economic Burden of Infections Due to Antibiotic-Resistant Bacteria 371

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