Opportunities in U.S. Peripheral Vascular Stent Markets

Companies Covered

Abbott Laboratories 

Boston Scientific Corporation 

C.R. Bard, Inc. 

Cook Group

Edwards Lifesciences Corporation 

Endologix, Inc

ev3, Inc

Guidant Corporation 

Johnson & Johnson (Cordis)

Medtronic, Inc

Vascular Architects, Inc

W.L. Gore & Associates

Table of Contents

EXECUTIVE SUMMARY 

Overview of Peripheral Vascular Disease 

Role of Peripheral Vascular Stenting

Stent Technology 

Peripheral Vascular Stenting Procedures

Peripheral Vascular Stent Markets

Supplier Shares 

Summary Exhibit 1: Overview of Peripheral Vascular Disease 

Summary Exhibit 2: Overview of Peripheral Stenting Applications 

Summary Exhibit 3: Major Arteries and Veins of the Body

Summary Exhibit 4: Properties of the Ideal Peripheral Vascular Stent 

Summary Exhibit 5: Overview of Developments in Stent Surface Modification

Summary Exhibit 6: U.S. Peripheral Vascular Stenting Procedures by Segment, 2001-2008 

Summary Exhibit 7: U.S. Market for Peripheral Vascular Stents by Segment, 2001-2008 

Summary Exhibit 8: Peripheral Vascular Stents, Supplier Shares, 2002

1.0 STENT TECHNOLOGY 

1.1 Stent Materials 

1.1.1 Metal Stents 

1.1.1.1 Materials 

1.1.1.1.1 Stainless Steel 

1.1.1.1.2 Cobalt Alloys 

1.1.1.1.3 Nitinol 

1.1.1.2 Metal Stents and MRI Imaging

1.1.1.3 Material Developments

1.1.2 Standard Polymers 

1.1.3 Biodegradable Polymers 

1.1.3.1 Materials 

1.1.3.2 Biocompatibility 

1.2 Stent Design

1.2.1 Balloon-Expandable versus Self-Expanding 

1.2.2 Manufacturing Methods

1.2.3 Configurations 

1.3 Surface Modifications

1.3.1 Radiopaque Surface Modifications

1.3.2 Biocompatibility Coatings 

1.3.3 Therapeutic Coatings 

1.3.4 Stent Coverings/Linings 

1.4 Stent Testing 

Exhibit 1-1: Performance Requirements of Biomedical Stent Implants

Exhibit 1-2: Properties of the Ideal Peripheral Vascular Stent 

Exhibit 1-3: Overview of Principal Stent Materials

Exhibit 1-4: Metal Stent Materials

Exhibit 1-5: Selected Polymer Materials Used in Stents 

Exhibit 1-6: Comparison of Two Major Metal Stent Designs 

Exhibit 1-7: Comparison of Stent Designs 

Exhibit 1-8: Overview of Developments in Stent Surface Modification

2.0 PERIPHERAL VASCULAR STENT PRODUCTS AND SUPPLIERS 

2.1 Regulatory Issues 

2.2 Products and Suppliers

2.2.1 Abbott Vascular Devices 

2.2.1.1 Balloon Expandable Stents

2.2.2.2 Self-Expanding Stents

2.2.2 Angiodynamics 

2.2.3 Bard Peripheral Vascular 

2.2.4 Boston Scientific

2.2.4.1 Balloon Expandable Stents 

2.2.4.1.1 NIR

2.2.4.1.2 Express

2.2.4.2 Self-Expanding Stents

2.2.4.2.1 Wallstent 

2.2.4.2.2 Neuroform (Smart Therapeutics)

2.2.4.2.3 NexStent (EndoTex Interventional Systems)

2.2.4.2.4 Symphony (NMT Medical) 

2.2.4.2.5 Sentinol 

2.2.5 Cook

2.2.6 Cordis Endovascular 

2.2.6.1 Balloon Expandable Stents 

2.2.6.2 Self-Expanding Stents

2.2.7 Edwards Lifesciences

2.2.8 ev3 (IntraTherapeutics)

2.2.8.1 Balloon Expandable Stents 

2.2.8.1.1 IntraStent

2.2.8.1.2 IntraStent DoubleStrut 

2.2.8.2 Self-Expanding Stents

2.2.8.2.1 IntraCoil 

2.2.8.2.2 Protégé 

2.2.9 Guidant

2.2.9.1 Balloon Expandable Stents 

2.2.9.2 Self-Expanding Stents

2.2.10 Medinol

2.2.11 Medtronic Vascular

2.2.11.1 Balloon Expandable Stents 

2.2.11.2 Self-Expanding Stents

2.2.12 Vascular Architects

2.3 Emerging Product Trends 

2.3.1 Drug Eluting Stents

2.3.2 Stent-Grafts (Covered Stents) 

2.3.2.1 Abbott Vascular Devices 

2.3.2.2 Boston Scientific

2.3.2.3 CardioVasc

2.3.2.4 Design & Performance

2.3.2.5 Edwards Lifesciences

2.3.2.6 W.L. Gore & Associates 

2.3.3 Bifurcation Stents 

2.4 Competitive Analysis

Exhibit 2-1: Selected Balloon Expandable Peripheral Vascular Stent Products and Suppliers, 2003

Exhibit 2-2: Selected Balloon Expandable Peripheral Vascular Stents, 2003 

Exhibit 2-3: Selected Self-Expanding Peripheral Vascular Stent Products and Suppliers, 2003

Exhibit 2-4: Selected Self-Expanding Peripheral Vascular Stents, 2003 

Exhibit 2-5: Overview of Emerging Trends in Peripheral Vascular Stents 

Exhibit 2-6: Selected Drug Eluting Stent Programs 

Exhibit 2-7: Selected Stent-Graft Products and Suppliers 

Exhibit 2-8: Selected Stent-Grafts

Exhibit 2-9: Selected Bifurcation Stent Programs 

Exhibit 2-10: Peripheral Vascular Stent Product Market, 2001-2008 

Exhibit 2-11: Balloon Expandable versus Self-Expanding Stents, 2002 & 2008

Exhibit 2-12: Peripheral Vascular Stents, Market Shares by Segment, 2002

3.0 STENTING IN THE MANAGEMENT OF STROKE

3.1 Stroke Etiology 

3.2 Types and Causes

3.3 Diagnosis 

3.4 Stroke Intervention 

3.4.1 Carotid Endarterectomy

3.4.1.1 Procedures.

3.4.1.2 Indications and Clinical Outcomes 

3.4.2 Carotid Artery Stenting

3.4.2.1 Procedure 

3.4.2.2 Specialties Performing

3.4.2.3 Indications and Patient Selection 

3.4.2.4 Clinical Studies and Outcomes 

3.4.3 Intracranial Stenting

3.4.3.1 Stenting for Intracranial Atherosclerosis 

3.4.3.2 Intracranial (Cerebral) Aneurysms 

3.5 Products and Suppliers

3.5.1 Carotid Artery Stents 

3.5.2 Embolic Protection Devices

3.5.3 Intracranial Stents 

3.6 Procedure Forecasts 

3.6.1 Carotid Artery Stenting Procedures 

3.6.2 Intracranial Stenting Procedures 

3.7 Market Analysis 

3.7.1 Carotid Artery Stents 

3.7.2 Embolic Protection Devices

3.7.3 Intracranial Stents 

Exhibit 3-1: Overview of Stroke in the U.S.

Exhibit 3-2: Carotid Artery Stenting: Indications and Contraindications

Exhibit 3-3: Overview of Completed Randomized Carotid Stent Clinical Studies, 2003

Exhibit 3-4: Overview of Ongoing Carotid Stent Clinical Trials, 2003 

Exhibit 3-5: Characteristics of Ideal Carotid Artery Stent

Exhibit 3-6: Selected Carotid Artery Stent Products and Suppliers, 2003 

Exhibit 3-7: Selected Carotid Artery Stents, 2003

Exhibit 3-8: Comparison of Embolic Protection Designs

Exhibit 3-9: Selected Embolic Protection Products and Suppliers, 2003 

Exhibit 3-10: Selected Embolic Protection Devices 

Exhibit 3-11: Selected Intracranial Stent Programs, 2003 

Exhibit 3-12: Carotid Artery Stenting, Procedure Forecast, 2001-2008

Exhibit 3-13: Carotid Artery Stent Market, 2001-2008 

4.0 RENAL ARTERY STENTING

4.1 Renal Artery Stenosis 

4.1.1 Diagnosis 

4.1.2 Treatment Options 

4.1.2.1 Surgical Renal Revascularization 

4.1.2.2 Percutaneous Transluminal Renal Angioplasty 

4.1.2.3 Percutaneous Transluminal Stent Placement 

4.1.3 Clinical Outcomes

4.2 Products and Suppliers

4.3 Procedure Forecast

4.4 Market Analysis 

Exhibit 4-1: Current Practice Guidelines for Renal Angiography 

Exhibit 4-2: Current Treatment Options for Renal Artery Stenosis 

Exhibit 4-3: Current Indications for Renal Angioplasty 

Exhibit 4-4: Renal Artery Stenting Indications and Contraindications 

Exhibit 4-5: Selected Renal Artery Stents, 2003 

Exhibit 4-6: Renal Artery Stenting, Procedure Forecast, 2001-2008 

Exhibit 4-7: Renal Artery Stents, Market Forecast, 2001-2008

5.0 STENTING IN PVD OF THE LOWER EXTREMITIES

5.1 Disease Background

5.1.1 Diagnosis 

5.1.2 Treatment 

5.2 Iliac Artery Stenting

5.2.1 TASC Recommendations

5.2.2 Clinical Outcomes

5.2.3 Products and Suppliers

5.2.4 Procedure Forecasts 

5.2.5 Market Analysis 

5.3 Femoropopliteal Stenting

5.3.1 Indications

5.3.2 Clinical Outcomes

5.3.3 Products and Suppliers

5.3.4 Procedure Forecasts 

5.3.5 Market Analysis 

5.4 Infrapopliteal Stenting 

Exhibit 5-1: TASC Morphological Stratification of Iliac Lesions and Treatment Recommendations 

Exhibit 5-2: Selected Iliac Artery Stents, 2003

Exhibit 5-3: Iliac Artery Stenting, Procedure Forecast, 2001-2008

Exhibit 5-4: Iliac Artery Stents, Market Forecast, 2001-2008

Exhibit 5-5: TASC Morphological Stratification of Femoropopliteal Lesions and Treatment Recommendations

Exhibit 5-6: Selected Clinical Studies Comparing Femoropopliteal PTA and Stenting 

Exhibit 5-7: Selected Outcomes of Femoropopliteal Stenting Using Next Generation Technologies 

Exhibit 5-8: Selected Femoropopliteal Stent Products and Suppliers, 2003 

Exhibit 5-9: Femoropopliteal Artery Stenting, Procedure Forecast, 2001-2008 

Exhibit 5-10: Femoropopliteal Stents, Market Forecast, 2001-2008

Exhibit 5-11: Total Market for Lower Extremity Peripheral Vascular Stents, 2001-2008 

6.0 OTHER PERIPHERAL VASCULAR STENTING APPLICATIONS

6.1 Transjugular Intrahepatic Portosystemic Shunts (TIPS)

6.1.1 Variceal Bleeding

6.1.1.1 Treatment Options 

6.1.1.2 Decompression Shunt Procedures

6.1.2 TIPS Technique 

6.1.3 Clinical Results 

6.1.4 TIPS Products 

6.1.5 Procedure Forecasts 

6.1.6 Market Analysis 

6.2 Subclavian Artery Stenting 

6.2.1 Subclavian Stenting Technique

6.2.2 Clinical Experience

6.2.3 Stent Design

6.2.4 Products 

6.3 Other Venous Stenting

6.3.1 Clinical Experience

6.3.2 Products 

6.3.3 Procedures

Exhibit 6-1: Overview of Other Peripheral Vascular Stenting Applications

Exhibit 6-2: Transjugular Intrahepatic Portosystemic Shunts (TIPS), Procedure Forecast, 2001-2008 

Exhibit 6-3: Transjugular Intrahepatic Portosystemic Shunt (TIPS) Stents, Market Forecast, 2001-2008 

Exhibit 6-4: Selected Outcomes of Subclavian Stenting 

Exhibit 6-5: Selected Outcomes of Central Venous Stenting 

7.0 ENDOVASCULAR AORTIC STENT-GRAFTS

7.1 AAA Diagnosis

7.2 AAA Treatments

7.2.1 Watchful Waiting

7.2.2 Open Surgical Repair

7.2.3 Endovascular Stent-Graft Placement 

7.2.3.1 Patient Selection 

7.2.3.2 Stent-Graft Designs

7.2.3.3 Complications 

7.2.3.4 Clinical Experience

7.3 Stent-Grafting of the Thoracic Aorta

7.3.1 Thoracic Artery Aneurysm 

7.3.2 Acute Aortic Dissection

7.3.3 Stent-Graft Design 

7.3.4 Clinical Experience

7.4 Products and Suppliers

7.4.1 Boston Scientific

7.4.2 Cook

7.4.3 Cordis

7.4.3.1 Quantum LP 

7.4.3.2 Fortron 

7.4.4 Edwards Lifesciences

7.4.5 Endologix

7.4.6 Endomed 

7.4.7 Guidant

7.4.8 Implant Sciences/CardioTech International

7.4.9 Lombard Medical

7.4.10 Medtronic Vascular

7.4.10.1 AneuRx 

7.4.10.2 Talent 

7.4.11 TriVascular 

7.4.12 Vascutek (Terumo) 

7.4.13 W.L. Gore & Associates 

7.5 Procedure Forecasts 

7.6 Market Analysis 

Exhibit 7-1: Treatment Options for Abdominal Aortic Aneurysms 

Exhibit 7-2: Risk of AAA Rupture by Aneurysm Size

Exhibit 7-3: Overview of Stent-Graft Design Characteristics 

Exhibit 7-4: Selected Clinical Outcomes of Endovascular AAA Repair

Exhibit 7-5: Selected Clinical Outcomes of Endovascular Thoracic Aortic Repair

Exhibit 7-6: Selected Endovascular Aortic Stent-Graft Products and Suppliers, 2003 

Exhibit 7-7: Selected Endovascular Aortic Stent-Grafts 

Exhibit 7-8: Market Drivers and Limiters of Endovascular Aortic Repair

Exhibit 7-9: Endovascular Aortic Repairs, Procedure Forecast, 2001-2008 

Exhibit 7-10: Endovascular Aortic Stent-Graft Systems, Market Forecast, 2001-2008

Exhibit 7-11: AAA Stent-Graft Systems, Supplier Shares, 2001-2003 

8.0 COMPANY PROFILES

8.1 Abbott Laboratories 

8.2 C.R. Bard, Inc. 

8.3 Boston Scientific Corporation 

8.4 Cook Group

8.5 Edwards Lifesciences Corporation 

8.6 Endologix, Inc

8.7 ev3, Inc

8.8 Guidant Corporation 

8.9 Johnson & Johnson (Cordis)

8.10 Medtronic, Inc

8.11 Vascular Architects, Inc

8.12 W.L. Gore & Associates