World Cardiovascular Catheters and Systems Market

CARDIOVASCULAR CATHETERS AND SYSTEMS MCP-3206
A GLOBAL STRATEGIC BUSINESS REPORT

CONTENTS

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation & Reporting Level I-2
Quantitative Techniques & Analytics I-3
Product Definitions and Scope of Study I-3
A. Diagnostic Catheters I-4
Angiography Catheters I-4
Electrophysiology (EP) Mapping Catheters I-4
B. Therapeutic Catheters I-4
Rapid -Exchange PTCA Balloon Catheter I-4
Over-The-Wire PTCA Balloon Catheter I-4
Electrophysiology Ablation Catheters I-5
Atherectomy Catheters I-5
Perfusion and Fixed Balloon Catheters I-5
Guide Catheters I-5

II. EXECUTIVE SUMMARY

1. Market Overview II-1
Technological Advancements to Drive Growth II-1
Worldwide Cardiovascular Catheters Market II-1
Market Trends & Issues II-2
Lack of Pharmacological Alternatives Boost Demand for
Cardiovascular Catheters II-2
Energy-Based Solutions Compete with Conventional
Interventional Systems II-2
Repeat Interventional Procedures Affected by the Advent of
Drug-Eluting Stents II-2
RF Catheter Ablation Gains Popularity II-3
Molding Material and Technology II-3
Diagnostic Catheters - Advance from the Workhorse 8 Fr II-3
Smaller the Better II-3
PTCA Catheters - Affected by Direct Stenting II-4
Angioplasty - Under Price Pressure II-4
Restenosis - The Unsolved Problem II-4
New Pharmacological Therapies - Minimizing the Need for
Interventional Procedures? II-4

2. Competitive Scenario II-6
Cardiovascular Catheters - Highly Concentrated Market II-6
Table 1: Leading Players in Global Angioplasty / Angiography
Catheter Market (2004 & 2005E): Percentage Breakdown of Value
Sales for Boston Scientific Johnson & Johnson, Guidant,
Medtronic, and Others (includes corresponding Graph/Chart) II-6

Table 2: Leading Players in Global Guide Catheters Market
(2004 & 2005): Percentage Breakdown of Value Sales for
Johnson & Johnson, Boston Scientific, Guidant, Medtronic and
Others (includes corresponding Graph/Chart) II-7

Table 3: Leading Players in Global Electrophysiology (EP)
Catheter (Mapping and Ablation) Market (2004 & 2005):
Percentage Breakdown of Value Sales for Johnson & Johnson,
St. Jude Medical, Boston Scientific,C.R.Bard and Others
(includes corresponding Graph/Chart) II-7
Balloon Catheters II-8
Table 4: Leading Players in Global Balloon Catheter Market
(2004 & 2005): Percentage Breakdown of Value Sales for Boston
Scientific, Guidant, Medtronic, Johnson & Johnson and Others
(includes corresponding Graph/Chart) II-8

3. Catheterization - The Procedure II-9
Historical Perspective II-9
Cardiac Catheterization: Most Accurate of all Cardiac
Diagnostic Examinations II-9

4. Product Profile II-10
Catheters II-10
Designing of Specialized Catheters II-10
Factors Determining Competitiveness II-10
Preventing Infection II-10
Catheter Related Infections II-10
Flow and Sealing Capability II-10
Safety II-11
System Suitability and Comprehensiveness II-11
Ease of Insertion II-11
Maneuverability II-11
Cardiovascular Catheters - Product Group/Segment Overview II-11
A. Diagnostic Catheters II-12
Angiography Catheters II-12
Electrophysiology (EP) Mapping Catheters II-12
Purpose II-12
Scope of Electrophysiology Studies II-13
Precaution II-13
B. Therapeutic Catheters II-13
Catheters Designed for Therapeutic Procedures II-13
Angioplasty: Where is it Used? II-13
Types of Angioplasty II-13
Percutaneous Transluminal Coronary Angioplasty or PTCA II-14
PTCA Catheters II-14
Types of Balloon Catheters II-14
Rapid -Exchange PTCA Balloon Catheter II-14
Over-The-Wire PTCA Balloon Catheter II-15
Electrophysiology Ablation Catheters II-15
Atherectomy Catheters II-16
Perfusion and Fixed Balloon Catheters II-16
Guide Catheters II-16

5. An Overview of The CVD Market II-17
Heart - Historic Facts and Figures II-17
Table 5: Number of Deaths from Circulatory Disorders
Worldwide by Region (2002) (in �000) (includes Corresponding
Graph/Chart) II-17
Interventional Cardiology II-17
PTCRA - The procedure II-18
Interventional Cardiology Market in the US & Europe - A
Comparison II-18
Radiation Therapy (Brachytherapy) II-19
An Insight into Cardio Vascular Diseases II-19
Coronary Artery Disease (CAD) II-19
Definition II-19
Causes and Symptoms II-19
Major Risk Factors II-20
Non-Controllable Risk Factors II-20
Heredity II-20
Sex II-20
Age II-20
Controllable Risk Factors II-20
Treatment II-20
Angina Pectoris II-21
Arrhythmias II-21
Atrial Fibrillation - A Common Arrhythmia II-21
More in Women II-22
Stroke II-22
Congestive Heart Failure II-22
Key Terms (For Reference) II-22
Angina II-22
Aneurysms II-23
Angiography II-23
Angioplasty II-23
Aortic Valve II-23
Atherosclerosis II-23
Bradycardia II-23
Catheter II-23
Coronary Arteries II-23
Echocardiogram II-23
Electrocardiogram II-23
Electrophysiology (EP) study II-23
Pacemaker II-24
Plaque II-24
HDL Cholesterol II-24
LDL Cholesterol II-24
Stenosis II-24
Stroke II-24
Tachycardia II-24

6. Technological Developments II-25
US-Based Inventors Granted Patent for Perfusion Balloon
Angioplasty Catheter II-25
California Scientists Create Intravascular Balloon Catheters
for Angioplasty Procedures II-25
Minnesota Scientists Develop New Ablation Catheter II-25
American Inventor Devises Drug Delivery Balloon Catheter II-25
US-Based Inventors Create Atherectomy Catheter II-25
US-Based Inventors Develop Atherectomy Device for Treatment of
Occlusions II-26
US-Based Inventor Creates New Ablation Catheter System II-26
Japanese Inventor Creates RF Thermal Balloon Catheter II-26

7. Product Innovations/Intorductions II-27
Stereotaxis Obtains FDA Approval for 8mm Magnetic Ablation
Catheter II-27
ClearStream Gains FDA Approval for PTA Angioplasty Balloon
Catheters II-27
AngioSculpt� Gains Japanese Approval for AngioSculpt� Catheter II-27
Cordis Introduces Fire Star Rx and Dura Star Rx Catheters II-27
Cordis Introduces AVIATOR� Catheter II-28
FlowCardia Introduces CROSSER Catheter Product Line II-28
Medtronic�s Sprinter� Catheter Gains CE Mark Approval II-28
St. Jude Gains CE Mark & FDA Approvals for Therapy� Cool Path�
Catheter II-28
FDA Clears Venture� Catheter Use with Rapid Exchange Delivery
Platform II-29
Eurocor Unveils DIOR Catheter in Germany II-29
FDA Approves InnerChange Micro-Introducer Catheter II-29
Stereotaxis Gains EU Approval Magnetic Irrigated Ablation
Catheter II-29
Atrium Medical Obtains CE Mark for ClearWay� RX Catheter II-29
Lumen Gains FDA Approval for Large Sized Xtract� Catheters II-30
Opto Circuits Achieves CE Mark Approval for its Catheter II-30
FDA Approves Abiomed�s Impella 5.0 Catheter-Based Circulatory
Support Systems II-30
Medical Ventures Gains CE Mark Approval for Metricath Gemini�
Balloon-Catheter II-31
St. Jude Receives Regulatory Approval for its Safire Ablation
& Inquiry Optima Plus Catheters II-31
Boston Scientific Introduces Sterling� Monorail� Balloon
Dilatation Catheter II-31
St. Jude Receives Approval to Market EnSite� System in Japan II-31
Merit Medical�s Impress Diagnostic Catheter Gains CE Mark &
FDA Approvals II-31
Medtronic Gains FDA Approval for Export� XT spiration Catheter II-32
Medtronic Obtains CE Mark Approval to Market Melody� and
Ensemble� System II-32
Boston Scientific Gains FDA Approval for its Rio� Aspiration
Catheter II-32
Possis Introduces AngioJet� Spiroflex�Rheolytic Thrombectomy
Catheter II-32
Boston Scientific Launches Chilli II Cooled Ablation Catheter II-33
Terumo Introduces PTCA Catheter with the Smallest Diameter II-33
Japan Lifeline Introduces OTTIMO ROSSO Balloon atheter for
PTCA Procedures II-33
FDA Clears St. Jude�s Therapy� EP & IBI-1500T6 Cardiac
Ablation Generator Catheters II-33
Terumo Introduces Heartrail II PTCA Guiding Catheter II-33
FDA Grants Approval to Alliance for Reprocessing AcuNav�
Ultrasound Catheter II-34
Cook Introduces New ATB� PTA Dilatation Catheter II-34
St. Jude Unveils New Venture� Wire Control Catheter Across the
United States II-34
Possis Medical Adds Two New Catheters to its AngioJet�
Rheolytic� Thrombectomy Line II-34
Cook Introduces CODA for Endovascular Market II-34
Spectranetics Develops Laser Catheter for Peripheral Vascular
Disease II-35
Medrad Inc Introduces Avanta� Fluid Management Injection
System and Vanguard Dx� Angiographic Catheter II-35
Medtronic Releases Medtronic Attain Select 6238 TEL Guide
Catheter II-35
AngioScore Receives CE Mark Approval for its AngioSculpt
Scoring Balloon Catheter II-35
Spectranetics Introduces New Catheters II-36
Guidant Corporation Unveils VOYAGER� Coronary Dilatation Catheter II-36
Medtronic Introduces Two New Catheters II-36

8. Recent Industry Activity II-37
Micrus Enters into Agreement with Genesis II-37
Teleflex Acquires Arrow International II-37
FoxHollow Merges with ev3 II-37
J&J Bags Marketing Rights for Topspin�s Catheter II-38
Cordis to Market ClearStream Technologies� Catheters II-38
Relisys to Establish Catheter Production Facility in India II-38
Boston Scientific Acquires Guidant II-38
Abbott Acquires Guidant�s Vascular Business II-39
Cordis in Distribution Agreement with Brivant II-39
Cordis Enters into Definitive Agreement to Distribute
ClearStream�s PTCA Balloon Catheter II-39
St. Jude and GE Healthcare Collaborate to Develop Advanced
Technologies for Cardiac Procedures II-40
Bard Acquires Venetec International II-40
Koninklijke Philips Takes Over Witt Biomedical II-40
FoxHollow Enters into Definitive Agreement to Acquire Kerberos II-40
Biosense Recieves Expanded Indication for NAVISTAR�
THERMOCOOL� Catheter for Treatment of Ventricular Tachycardia II-40
Hansen Medical Completes Clinical Trial for Sensei Robotic
Catheter System II-40
Biosense and Siemens Enter into Strategic Alliance Involving
Catheters II-41
Recom Inks MOU with TZ Medical to Develop Cardiac Catheters II-41
Cordis Takes Over LuMend II-41
Hansen Medical Enters into Cross-Licensing Agreement with
Intuitive Surgical II-42
Hansen Medical Acquires Intellectual Assets of endoVia Medical II-42
Micrus Takes Over VascularFX II-42
St. Jude Medical Acquires Endocardial Solutions II-42
St. Jude Medical Acquires Velocimed II-42
FlowCardia Bags European Approval for Crosser Catheter II-43
AVI BioPharma Regains Full Control on Resten-NG Antisense Therapy II-43
Boston Scientific Acquires Precision Vascular Systems II-43
Edwards Lifesciences Acquires PVT II-43
St. Jude Medical Acquires IBI II-43
St. Jude Medical Takes Over Epicor Medical II-44
Merit Medical Systems Inks an Agreement with Novation II-44
Rochester Medical Enters into a Supply Agreement with Hollister II-44
CardioTech International Enters into a Licensing Agreement
with BAS II-44
CryoCor�s Model 1200 Cardiac Catheter Series Receives FDA
Clearance II-44
CryoCath�s Freezor MAX Catheter Device Receives FDA Clearance II-44
LubriLAST�-coated Catheters Receives MOHLW Clearance II-45
Abbott Laboratories Acquires Assets of JOMED II-45
JOMED Sells IVUS and Functional Management Business to Volcano
Therapeutics II-45
Boston Scientific in Alliance with Corautus Genetics II-45
Mogul Obtains FDA Approval for Diagnostic Catheters II-45

9. Focus on Select Global Players II-46
Abbott Laboratories (USA) II-46
Boston Scientific (USA) II-46
C.R. Bard, Inc. (USA) II-47
Cardima, Inc. (USA) II-47
CryoCath Technologies Inc. (Canada) II-47
Edwards Lifesciences Corporation (USA) II-48
EP Medsystems (USA) II-48
Johnson & Johnson (USA) II-48
Cordis Corporation (USA) II-49
Biosense Webster (USA) II-49
Medtronic (USA) II-50
Merit Medical Systems, Inc. (USA) II-50
St. Jude Medical (USA) II-51
Endocardial Solutions, Inc. (USA) II-51
Teleflex Medical (USA) II-52
Terumo Medical Corporation (Japan) II-52

10. Global Market Perspective II-53
Table 6: World Recent Past, Current & Future Analysis for
Cardiovascular Catheters by Geographic Region - USA, Canada,
Japan, Europe, Asia-Pacific (excluding Japan), and Latin
American Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2000 through 2010 (includes
corresponding Graph/Chart) II-53

Table 7: World Long-term Projections for Cardiovascular
Catheters by Geographic Region - USA, Canada, Japan, Europe,
Asia-Pacific (excluding Japan), and Latin American Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2011 through 2015 (includes corresponding
Graph/Chart) II-54

Table 8: World 10-Year Perspective for Cardiovascular
Catheters by Geographic Region - Percentage Breakdown of
Dollar Sales for USA, Canada, Japan, Europe, Asia-Pacific
(excluding Japan), and Latin American Markets for Years 2003,
2008 & 2012 (includes corresponding Graph/Chart) II-55

Table 9: World Recent Past, Current & Future Analysis for
Diagnostic Catheters by Geographic Region - USA, Canada,
Japan, Europe, Asia-Pacific (excluding Japan), and Latin
American Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2000 through 2010
(includescorresponding Graph/Chart) II-56

Table 10: World Long-term Projections for Diagnostic Catheters
by Geographic Region - USA, Canada, Japan, Europe,
Asia-Pacific (excluding Japan), and Latin American Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2011 through 2015 (includes corresponding
Graph/Chart) II-57

Table 11: World Recent Past, Current & Future Analysis for
Diagnostic Catheters by Product Segment - Angiography
Catheters and EP Mapping Catheters Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2000 through 2010 (includes corresponding Graph/Chart) II-58

Table 12: World Long-term Projections for Diagnostic Catheters
by Product Segment - Angiography Catheters & EP Mapping
Catheters Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2011 through 2015 (includes
corresponding Graph/Chart) II-58

Table 13: World 10-Year Perspective for Diagnostic Catheters
by Geographic Region - Percentage Breakdown of Dollar Sales
for USA, Canada, Japan, Europe, Asia-Pacific (excluding
Japan), and Latin American Markets for Years 2003, 2008 & 2012
(includes corresponding Graph/Chart) II-59

Table 14: World 10-Year Perspective for DiagnosticcCatheters
by Product Segment - Percentage Breakdowncof Dollar Sales for
Angiography Catheters and EP Mapping Catheters Markets for
Years 2003, 2008 & 2012 II-59

Table 15: World Recent Past, Current & Future Analysis for
Angiography Catheters by Geographic Region - USA, Canada,
Japan, Europe, Asia-Pacific (excluding Japan), and Latin
American Markets Independently Analyzedcwith Annual Sales
Figures in US$ Million forcYears 2000 through 2010 (includes
corresponding Graph/Chart) II-60

Table 16: World Long-term Projections for Angiography
Catheters by Geographic Region - USA, Canada, Japan, Europe,
Asia-Pacific (excluding Japan), and Latin American Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2011 through 2015 (includes corresponding
Graph/Chart) II-61

Table 17: World 10-Year Perspective for Angiography Catheters
by Geographic Region - Percentage Breakdown of Dollar Sales
for USA, Canada, Japan, Europe,Asia-Pacific (excluding
Japan), and Latin American Markets for Years 2003, 2008 &
2012 (includes corresponding Graph/Chart) II-62

Table 18: World Recent Past, Current & Future Analysis for EP
Mapping Catheters by Geographic Region - USA, Canada, Japan,
Europe, Asia-Pacific (excluding Japan), and Latin American
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2000 through 2010 (includes
corresponding Graph/Chart) II-63

Table 19: World Long-term Projections for EP Mapping Catheters
by Geographic Region - USA, Canada, Japan, Europe,
Asia-Pacific (excluding Japan), and Latin American Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2011 through 2015 (includes corresponding
Graph/Chart) II-64

Table 20: World 10-Year Perspective for EP Mapping Catheters
by Geographic Region - Percentage Breakdown of Dollar Sales
for USA, Canada, Japan, Europe, Asia-Pacific (excluding
Japan), and Latin American Markets for Years 2003, 2008 & 2012
(includes corresponding Graph/Chart) II-65

Table 21: World Recent Past, Current & Future Analysis for
Therapeutic Catheters by Geographic Region - USA, Canada,
Japan, Europe, Asia-Pacific (excluding Japan), and Latin
American Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2000 through 2010 (includes
corresponding Graph/Chart) II-66

Table 22: World Long-term Projections for Therapeutic
Catheters by Geographic Region - USA, Canada, Japan, Europe,
Asia-Pacific (excluding Japan), and Latin American Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2011 through 2015 (includes corresponding
Graph/Chart) II-67

Table 23: World Recent Past, Current & Future Analysis for
Therapeutic Catheters by Product Segment - Rapid-Exchange PTCA
Balloon Catheters, Over-The-Wire PTCA Balloon Catheters, EP
Ablation Catheters, Atherectomy Catheters, Perfusion and Fixed
Balloon, and Guide Catheters Markets Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2000
through 2010 (includes corresponding Graph/Chart) II-68

Table 24: World Long-term Projections for Therapeutic
Catheters by Product Segment - Rapid-Exchange PTCA Balloon
Catheters, Over-The-Wire PTCA Balloon Catheters, EP Ablation
Catheters, Atherectomy Catheters, Perfusion and Fixed Balloon,
and Guide Catheters Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2011 through 2015
(includes corresponding Graph/Chart) II-68

Table 25: World 10-Year Perspective for Therapeutic Catheters
by Geographic Region - Percentage Breakdown of Dollar Sales
for USA, Canada, Japan, Europe, Asia-Pacific (excluding
Japan), and Latin American Markets for Years 2003, 2008 &
2012 (includes corresponding Graph/Chart) II-69

Table 26: World 10-Year Perspective for Therapeutic Catheters
by Product Segment - Percentage Breakdown of Dollar Sales for
Rapid-Exchange PTCA Balloon Catheters, Over-The-Wire PTCA
Balloon Catheters, EP Ablation Catheters, Atherectomy
Catheters, Perfusion and Fixed Balloon, and Guide Catheters
Markets for Years 2003, 2008 & 2012 (includes corresponding
Graph/Chart) II-70

Table 27: World Recent Past, Current & Future Analysis for
Rapid-Exchange PTCA Balloon Catheters by Geographic Region -
USA, Canada, Japan, Europe, Asia-Pacific (excluding Japan),
and Latin American Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2000 through 2010
(includes corresponding Graph/Chart) II-71

Table 28: World Long-term Projections for Rapid-Exchange PTCA
Balloon Catheters by Geographic Region - USA, Canada, Japan,
Europe, Asia-Pacific (excluding Japan), and Latin American
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2011 through 2015 (includes
corresponding Graph/Chart) II-72

Table 29: World 10-Year Perspective for Rapid-Exchange PTCA
Balloon Catheters by Geographic Region - Percentage Breakdown
of Dollar Sales for USA, Canada, Japan, Europe, Asia-Pacific
(excluding Japan), and Latin American Markets for Years 2003,
2008 & 2012 (includes corresponding Graph/Chart) II-73

Table 30: World Recent Past, Current & Future Analysis for
Over-the-Wire PTCA Balloon Catheters by Geographic Region -
USA, Canada, Japan, Europe, Asia-Pacific (excluding Japan),
and Latin American Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2000 through 2010
(includes corresponding Graph/Chart) II-74

Table 31: World Long-term Projections for Over-the-Wire PTCA
Balloon Catheters by Geographic Region - USA, Canada, Japan,
Europe, Asia-Pacific (excluding Japan), and Latin American
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2011 through 2015 (includes
corresponding Graph/Chart) II-75

Table 32: World 10-Year Perspective for Over-the-Wire PTCA
Balloon Catheters by Geographic Region - Percentage Breakdown
of Dollar Sales for USA, Canada, Japan, Europe, Asia-Pacific
(excluding Japan), and Latin American Markets for Years 2003,
2008 & 2012 (includes corresponding Graph/Chart) II-76

Table 33: World Recent Past, Current & Future Analysis for EP
Ablation Catheters by Geographic Region - USA, Canada, Japan,
Europe, Asia-Pacific (excluding Japan), and Latin American
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2000 through 2010 (includes
corresponding Graph/Chart) II-77

Table 34: World Long-term Projections for EP Ablation
Catheters by Geographic Region - USA, Canada, Japan, Europe,
Asia-Pacific (excluding Japan), and Latin American Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2011 through 2015 (includes corresponding
Graph/Chart) II-78

Table 35: World 10-Year Perspective for EP Ablation Catheters
by Geographic Region - Percentage Breakdown of Dollar Sales
for USA, Canada, Japan, Europe, Asia-Pacific (excluding
Japan), and Latin American Markets for Years 2003, 2008 & 2012
(includes corresponding Graph/Chart) II-79

Table 36: World Recent Past, Current & Future Analysis for
Atherectomy Catheters by Geographic Region - USA, Canada,
Japan, Europe, Asia-Pacific (excluding Japan), and Latin
American Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2000 through 2010 (includes
corresponding Graph/Chart) II-80

Table 37: World Long-term Projections for Atherectomy
Catheters by Geographic Region - USA, Canada, Japan, Europe,
Asia-Pacific (excluding Japan), and Latin American Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2011 through 2015 (includes corresponding
Graph/Chart) II-81

Table 38: World 10-Year Perspective for Atherectomy Catheters
by Geographic Region - Percentage Breakdown of Dollar Sales
for USA, Canada, Japan, Europe, Asia-Pacific (excluding
Japan), and Latin American Markets for Years 2003, 2008 & 2012
(includes corresponding Graph/Chart) II-82

Table 39: World Recent Past, Current & Future Analysis for
Perfusion and Fixed Balloon Catheters by Geographic Region -
USA, Canada, Japan, Europe, Asia-Pacific (excluding Japan),
and Latin American Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2000 through 2010
(includes corresponding Graph/Chart) II-83

Table 40: World Long-term Projections for Perfusion and Fixed
Balloon Catheters by Geographic Region - USA, Canada, Japan,
Europe, Asia-Pacific (excluding Japan), and Latin American
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2011 through 2015 (includes
corresponding Graph/Chart) II-84

Table 41: World 10-Year Perspective for Perfusion and Fixed
Balloon Catheters by Geographic Region - Percentage Breakdown
of Dollar Sales for USA, Canada, Japan, Europe, Asia-Pacific
(excluding Japan), and Latin American Markets for Years 2003,
2008 & 2012 (includes corresponding Graph/Chart) II-85

Table 42: World Recent Past, Current & Future Analysis for
Guide Catheters by Geographic Region - USA, Canada, Japan,
Europe, Asia-Pacific (excluding Japan), and Latin American
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2000 through 2010 (includes
corresponding Graph/Chart) II-86

Table 43: World Long-term Projections for Guide Catheters by
Geographic Region - USA, Canada, Japan, Europe, Asia-Pacific
(excluding Japan), and Latin American Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2011 through 2015 (includes corresponding Graph/Chart) II-87

Table 44: World 10-Year Perspective for Guide Catheters by
Geographic Region - Percentage Breakdown of Dollar Sales for
USA, Canada, Japan, Europe, Asia-Pacific (excluding Japan),
and Latin American Markets for Years 2003, 2008 & 2012
(includes corresponding Graph/Chart) II-88

III. MARKET

1. The United States III-1
A.Market Analysis III-1
Current & Future Analysis III-1
Cardiovascular Catheters Market III-1
Competition III-1
Table 45: Leading Players in the US Cardiovascular
Catheters Market (2005): Percentage Breakdown of Value
Sales for Boston Scientific, Cordis (J&J), Guidant
Corporation, Medtronic, and Others (includes corresponding
Graph/Chart) III-2
Arrhythmia Management Products III-3
Cardiovascular Disease in the US - An Insight III-3
Table 46: Prevalence of Cardiovascular Disease in the US:
2004 (Includes Corresponding Graph/Chart) III-4
Market Trends and Issues III-4
Rising Obesity Rates & Numbers Lead to Increased Number of
Interventional Cardiac Procedures III-4
Reimbursements - A Major Issue Affecting Growth in
Cardiovascular Devices Market III-4
Need for Advanced Cardiovascular Devices at Competitive Prices III-4
Inadequate Clinical Evidence Deters Surgeons from Adopting
New Catheters III-5
Increasing Demand for Atherectomy & Thrombectomy Products III-5
Need for Improvement in Hypotube Design III-5
Reimbursement Rates in the US III-5
Table 47: Common Physician Payments for Percutaneous
Coronary Interventions III-5

Table 48: Common Outpatient Ambulatory Procedure
classifications (APCs) for Percutaneous Coronary
Interventions III-6

Table 49: Medicare Physician Professional Payment III-6
Table 50: Payment for Carotid Artery Stenting III-6
Payment for Peripheral Interventions III-6
Table 51: Hospital In-patient Payment III-6
Table 52: Hospital Outpatient - Based on APCClassification III-6
Table 53: Physician Professional Payment - Based on CPT�
Code III-7
Table 54: Peripheral Stent / Shunt Placement, Percutaneous III-7
Table 55: Catheter Placement III-7
Table 56: Diagnostic Angiography, Radiological S&I III-8
Table 57: Procedural Radiological S&I III-8
Product Launches/ Approvals/Patents III-9
Strategic Developments III-16
Key Players III-24
Abbott Laboratories III-24
Boston Scientific Corporation III-24
C.R. Bard, Inc. III-25
Cardima, Inc. III-25
Cardiofocus, Inc. III-26
Edwards Lifesciences Corporation III-26
EP Medsystems III-27
Johnson & Johnson III-27
Cordis Corporation III-27
Biosense Webster III-28
Medtronic, Inc. III-28
Merit Medical Systems, Inc. III-29
Spectranetics Corporation III-29
St. Jude Medical III-29
Endocardial Solutions, Inc. III-30
Teleflex Medical III-30
B.Market Analytics III-32
Table 58: US Recent Past, Current & Future Analysis for
Cardiovascular Catheters by Product Group/Segment -
Diagnostic Catheters (Angiography Catheters and EP Mapping
Catheters) and Therapeutic Catheters (Rapid-Exchange PTCA
Balloon Catheters, Over-The-Wire PTCA Balloon Catheters, EP
Ablation Catheters, Atherectomy Catheters, Perfusion and
Fixed Balloon, and Guide Catheters) Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2000 through 2010 (includes corresponding Graph/Chart) III-32

Table 59: US Long-term Projections for Cardiovascular
Catheters by Product Group/Segment - Diagnostic Catheters
(Angiography Catheters and EP Mapping Catheters) and
Therapeutic Catheters (Rapid-Exchange PTCA Balloon
Catheters, Over-The-Wire PTCA Balloon Catheters, EP Ablation
Catheters, Atherectomy Catheters, Perfusion and Fixed
Balloon, and Guide Catheters) Markets Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2011
through 2015 (includes corresponding Graph/Chart) III-33

Table 60: US 10-Year Perspective for Cardiovascular
Catheters by Product Group/Segment - Percentage Breakdown of
Dollar Sales for Diagnostic Catheters (Angiography Catheters
and EP Mapping Catheters) and Therapeutic Catheters
(Rapid-Exchange PTCA Balloon Catheters, Over-The-Wire PTCA
Balloon Catheters, EP Ablation Catheters, Atherectomy
Catheters, Perfusion and Fixed Balloon, and Guide Catheters)
Markets for Years 2003, 2008 & 2012 (includes corresponding
Graph/Chart) III-34

2. Canada III-35
A.Market Analysis III-35
Current & Future Analysis III-35
Key Player III-35
CryoCath Technologies, Inc. III-35
B.Market Analytics III-36
Table 61: Canadian Recent Past, Current & Future Analysis
for Cardiovascular Catheters by Product Group/Segment -
Diagnostic Catheters (Angiography Catheters and EP Mapping
Catheters) and Therapeutic Catheters (Rapid-Exchange PTCA
Balloon Catheters, Over-The-Wire PTCA Balloon Catheters, EP
Ablation Catheters, Atherectomy Catheters, Perfusion & Fixed
Balloon, and Guide Catheters) Markets Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2000
through 2010 (includes corresponding Graph/Chart) III-36

Table 62: Canadian Long-term Projections for Cardiovascular
Catheters by Product Group/Segment - Diagnostic Catheters
(Angiography Catheters and EP Mapping Catheters) and
Therapeutic Catheters (Rapid-Exchange PTCA Balloon
Catheters, Over-The-Wire PTCA Balloon Catheters, EP Ablation
Catheters, Atherectomy Catheters, Perfusion and Fixed
Balloon,& Guide Catheters) Markets Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2011
through 2015 (includes corresponding Graph/Chart) III-37

Table 63: Canadian 10-Year Perspective for Cardiovascular
Catheters by Product Group/Segment - Percentage Breakdown of
Dollar Sales for Diagnostic Catheters (Angiography Catheters
and EP Mapping Catheters) and Therapeutic Catheters
(Rapid-Exchange PTCA Balloon Catheters, Over-The-Wire PTCA
Balloon Catheters, EP Ablation Catheters, Atherectomy
Catheters, Perfusion and Fixed Balloon, and Guide Catheters)
Markets for Years 2003, 2008 & 2012 (includes corresponding
Graph/Chart) III-38

3. Japan III-39
A.Market Analysis III-39
Current & Future Analysis III-39
PTCA Catheter Market III-39
Product Launches/Developments III-39
Key Players III-41
Japan Lifeline Co., Ltd. III-41
Terumo Medical Corporation III-41
Tokai Medical Products Co., Ltd. III-41
B.Market Analytics III-42
Table 64: Japanese Recent Past, Current & Future Analysis
for Cardiovascular Catheters by Product Group/Segment -
Diagnostic Catheters (Angiography Catheters and EP Mapping
Catheters) and Therapeutic Catheters (Rapid-Exchange PTCA
Balloon Catheters,Over-The-Wire PTCA Balloon Catheters, EP
Ablation Catheters, Atherectomy Catheters, Perfusion and
Fixed Balloon, and Guide Catheters) Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2000 through 2010 (includes corresponding Graph/Chart) III-42

Table 65: Japanese Long-term Projections for Cardiovascular
Catheters by Product Group/Segment - Diagnostic Catheters
(Angiography Catheters and EP Mapping Catheters) and
Therapeutic Catheters (Rapid-Exchange PTCA Balloon
Catheters, Over-The-Wire PTCA Balloon Catheters, EP
Ablation Catheters, Atherectomy Catheters, Perfusion &
Fixed Balloon, and Guide Catheters) Markets Independently
Analyzed with Annual Sales Figures in US$ Million forYears
2011 through 2015 (includes corresponding Graph/Chart) III-43

Table 66: Japanese 10-Year Perspective for Cardiovascular
Catheters by Product Group/Segment - Percentage Breakdown of
Dollar Sales for Diagnostic Catheters (Angiography
Catheters and EP Mapping Catheters) and Therapeutic
Catheters (Rapid-Exchange PTCA Balloon Catheters,
Over-The-Wire PTCA Balloon Catheters, EP Ablation Catheters,
Atherectomy Catheters, Perfusion and Fixed Balloon, and
Guide Catheters) Markets for Years 2003, 2008 & 2012
(includes corresponding Graph/Chart) III-44

4. Europe III-45
A.Market Analysis III-45
Current & Future Analysis III-45
European Union Cardiovascular Diseases Fact Sheet III-45
Angioplasty Products Market III-46
Trends Observed in Various Countries III-46
Product Launches/Developments III-46
Strategic Corporate Developments III-48
B.Market Analytics III-50
Table 67: European Recent Past, Current & Future Analysis
for Cardiovascular Catheters by Geographic Region - France,
Germany, Italy, UK, and Rest of Europe Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2000 through 2010 (includes
corresponding Graph/Chart) III-50

Table 68: European Long-term Projections for Cardiovascular
Catheters by Geographic Region - France, Germany, Italy,
UK, and Rest of Europe Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2011 through
2015 (includes corresponding Graph/Chart) III-50

Table 69: European Recent Past, Current & Future Analysis
for Cardiovascular Catheters by Product Group/Segment -
Diagnostic Catheters (Angiography Catheters and EP Mapping
Catheters) and Therapeutic Catheters (Rapid-Exchange PTCA
Balloon Catheters, Over-The-Wire PTCA Balloon Catheters, EP
Ablation Catheters, Atherectomy Catheters, Perfusion and
Fixed Balloon, and Guide Catheters) Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2000 through 2010 (includes corresponding Graph/Chart) III-51

Table 70: Canadian Long-term Projections for Cardiovascular
Catheters by Product Group/Segment - Diagnostic Catheters
(Angiography Catheters and EP Mapping Catheters) and
Therapeutic Catheters (Rapid-Exchange PTCA Balloon
Catheters, Over-The-Wire PTCA Balloon Catheters, EP Ablation
Catheters, Atherectomy Catheters, Perfusion & Fixed Balloon,
and Guide Catheters) Markets Independently Analyzed with
Annual Sales Figures in US$ Millionfor Years 2011 through
2015 (includescorresponding Graph/Chart) III-52

Table 71: European 10-Year Perspective for Cardiovascular
Catheters by Geographic Region - Percentage Breakdown of
Dollar Sales for France, Germany, Italy, UK, and Rest of
Europe Markets for Years 2003, 2008 and 2012 (includes
corresponding Graph/Chart) III-53

Table 72: European 10-Year Perspective for Cardiovascular
Catheters by Product Group/Segment - Percentage Breakdown of
Dollar Sales for Diagnostic Catheters (Angiography Catheters
and EP Mapping Catheters) and Therapeutic Catheters
(Rapid-Exchange PTCA Balloon Catheters, Over-The-Wire PTCA
Balloon Catheters, EP Ablation Catheters, Atherectomy
Catheters, Perfusion and Fixed Balloon, and Guide Catheters)
Markets for Years 2003, 2008 and 2012 (includes
corresponding Graph/Chart) III-54

4a. France III-55
A.Market Analysis III-55
Current & Future Analysis III-55
EP Catheters Market III-55
B.Market Analytics III-56
Table 73: French Recent Past, Current & Future Analysis for
Cardiovascular Catheters by Product Group/Segment -
Diagnostic Catheters (Angiography Catheters and EP Mapping
Catheters) and Therapeutic Catheters (Rapid-Exchange PTCA
Balloon Catheters, Over-The-Wire PTCA Balloon Catheters, EP
Ablation Catheters, Atherectomy Catheters, Perfusion and
Fixed Balloon, and Guide Catheters) Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2000 through 2010 (includes corresponding Graph/Chart) III-56

Table 74: French Long-term Projections for Cardiovascular
Catheters by Product Group/Segment - Diagnostic Catheters
(Angiography Catheters and EP Mapping Catheters) and
Therapeutic Catheters (Rapid-Exchange PTCA Balloon
Catheters, Over-The-Wire PTCA Balloon Catheters, EP Ablation
Catheters, Atherectomy Catheters, Perfusion and Fixed
Balloon, and Guide Catheters) Markets Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2011
through 2015 (includes corresponding Graph/Chart) III-57

Table 75: French 10-Year Perspective for Cardiovascular
Catheters by Product Group/Segment - Percentage Breakdown of
Dollar Sales for Diagnostic Catheters (Angiography Catheters
and EP Mapping Catheters) and Therapeutic Catheters
(Rapid-Exchange PTCA Balloon Catheters, Over-The-Wire PTCA
Balloon Catheters, EP Ablation Catheters, Atherectomy
Catheters, Perfusion and Fixed Balloon, and Guide Catheters)
Markets for Years 2003, 2008 & 2012 (includes corresponding
Graph/Chart) III-58

4b. Germany III-59
A.Market Analysis III-59
Current & Future Analysis III-59
Electrophysiology Market Overview III-59
Competitive Scenario III-59
B.Market Analytics III-60
Table 76: German Recent Past, Current & Future Analysis for
Cardiovascular Catheters by Product Group/Segment -
Diagnostic Catheters (Angiography Catheters and EP Mapping
Catheters) and Therapeutic Catheters (Rapid-Exchange PTCA
Balloon Catheters, Over-The-Wire PTCA Balloon Catheters, EP
Ablation Catheters, Atherectomy Catheters, Perfusion and
Fixed Balloon, and Guide Catheters) Markets Independently
Analyzed withAnnual Sales Figures in US$ Million for Years
2000 through 2010 (includes corresponding Graph/Chart) III-60

Table 77: German Long-term Projections for Cardiovascular
Catheters by Product Group/Segment - Diagnostic Catheters
(Angiography Catheters and EP Mapping Catheters) and
Therapeutic Catheters (Rapid-Exchange PTCA Balloon
Catheters, Over-The-Wire PTCA Balloon Catheters, EP Ablation
Catheters, Atherectomy Catheters, Perfusion and Fixed
Balloon, and Guide Catheters) Markets Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2011
through 2015 (includes corresponding Graph/Chart) III-61

Table 78: German 10-Year Perspective for Cardiovascular
Catheters by Product Group/Segment - Percentage Breakdown of
Dollar Sales for Diagnostic Catheters (Angiography Catheters
and EP Mapping Catheters) and Therapeutic Catheters
(Rapid-Exchange PTCA Balloon Catheters, Over-The-Wire PTCA
Balloon Catheters, EP Ablation Catheters, Atherectomy
Catheters, Perfusion and Fixed Balloon, and Guide Catheters)
Markets for Years 2003, 2008 & 2012 (includes corresponding
Graph/Chart) III-62

4c. Italy III-63
A.Market Analysis III-63
Current & Future Analysis III-63
Electrophysiology Market Overview III-63
B.Market Analytics III-64
Table 79: Italian Recent Past, Current & Future Analysis for
Cardiovascular Catheters by Product Group/Segment -
Diagnostic Catheters (Angiography Catheters and EP Mapping
Catheters) and Therapeutic Catheters (Rapid-Exchange PTCA
Balloon Catheters, Over-The-Wire PTCA Balloon Catheters, EP
Ablation Catheters, Atherectomy Catheters, Perfusion and
Fixed Balloon, and Guide Catheters) Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2000 through 2010 (includes corresponding Graph/Chart) III-64

Table 80: Italian Long-term Projections for Cardiovascular
Catheters by Product Group/Segment - Diagnostic Catheters
(Angiography Catheters and EP Mapping Catheters) and
Therapeutic Catheters (Rapid-Exchange PTCA Balloon
Catheters, Over-The-Wire PTCA Balloon Catheters, EP Ablation
Catheters, Atherectomy Catheters, Perfusion and Fixed
Balloon, and Guide Catheters) Markets Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2011
through 2015 (includes corresponding Graph/Chart) III-65

Table 81: Italian 10-Year Perspective for Cardiovascular
Catheters by Product Group/Segment - Percentage Breakdown of
Dollar Sales for Diagnostic Catheters (Angiography Catheters
and EP Mapping Catheters) and Therapeutic Catheters
(Rapid-Exchange PTCA Balloon Catheters, Over-The-Wire PTCA
Balloon Catheters, EP Ablation Catheters, Atherectomy
Catheters, Perfusion and Fixed Balloon, and Guide Catheters)
Markets for Years 2003, 2008 & 2012 (includes corresponding
Graph/Chart) III-66

4d. The United Kingdom III-67
A.Market Analysis III-67
Current & Future Analysis III-67
Healthcare Industry III-67
UK Cardiovascular Diseases Fact Sheet III-67
B.Market Analytics III-68
Table 82: UK Recent Past, Current & Future Analysis for
Cardiovascular Catheters by Product Group/Segment -
Diagnostic Catheters (Angiography Catheters and EP Mapping
Catheters) and Therapeutic Catheters (Rapid-Exchange PTCA
Balloon Catheters, Over-The-Wire PTCA Balloon Catheters, EP
Ablation Catheters, Atherectomy Catheters, Perfusion and
Fixed Balloon, and Guide Catheters) Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2000 through 2010 (includes corresponding Graph/Chart) III-68

Table 83: UK Long-term Projections for Cardiovascular
Catheters by Product Group/Segment - Diagnostic Catheters
(Angiography Catheters and EP Mapping Catheters) and
Therapeutic Catheters (Rapid-Exchange PTCA Balloon
Catheters, Over-The-Wire PTCA Balloon Catheters, EP Ablation
Catheters, Atherectomy Catheters, Perfusion and Fixed
Balloon, and Guide Catheters) Markets Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2011
through 2015 (includes corresponding Graph/Chart) III-69

Table 84: UK 10-Year Perspective for Cardiovascular
Catheters by Product Group/Segment - Percentage Breakdown of
Dollar Sales for Diagnostic Catheters (Angiography Catheters
and EP Mapping Catheters) and Therapeutic Catheters
(Rapid-Exchange PTCA Balloon Catheters, Over-The-Wire PTCA
Balloon Catheters, EP Ablation Catheters, Atherectomy
Catheters, Perfusion and Fixed Balloon, and Guide Catheters)
Markets for Years 2003, 2008 & 2012 (includes corresponding
Graph/Chart) III-70

4e. Rest of Europe III-71
A.Market Analysis III-71
Current & Future Analysis III-71
Spain III-71
Electrophysiology Market III-71
Outlook III-71
B.Market Analytics III-72
Table 85: Rest of Europe Recent Past, Current & Future
Analysis for Cardiovascular Catheters by Product Group/
Segment - Diagnostic Catheters (Angiography Catheters and EP
Mapping Catheters) and Therapeutic Catheters
(Rapid-Exchange PTCA Balloon Catheters, Over-The-Wire PTCA
Balloon Catheters, EP Ablation Catheters, Atherectomy
Catheters, Perfusion and Fixed Balloon, and Guide Catheters)
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2000 through 2010 (includes
corresponding Graph/Chart) III-72

Table 86: Rest of Europe Long-term Projections for
Cardiovascular Catheters by Product Group/ Segment -
Diagnostic Catheters (Angiography Catheters and EP Mapping
Catheters) and Therapeutic Catheters (Rapid-Exchange PTCA
Balloon Catheters, Over-The-Wire PTCA Balloon Catheters, EP