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Market Research Report
2008 GLOBAL VASCULAR CLOSURE DEVICE MARKETS: U.S., EUROPE, REST OF WORLD
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Table of Contents
1. EXECUTIVE SUMMARY
- 1.1 Methodology
- 1.1.1 Supporting Research
- 1.2 Percutaneous Procedure Forecasts
- 1.3 External Compression Products
- 1.4 Implantable Vascular Closure Devices
- 1.5 The Global Market for Vascular Closure
- Exhibit 1-1: Global Catheterizations Requiring Vascular Closure, 2006-2013
- Exhibit 1-2: Selected Vascular Closure Products and Companies, 2008
- Exhibit 1-3: Global Vascular Closure Procedures by Type, 2006-2013
- Exhibit 1-4: Global Vascular Closure Procedures by Type in 2007 & 2013
- Exhibit 1-5: External Compression Products, U.S. Supplier Shares, 2007
- Exhibit 1-6: Implantable Closure Devices, Global Supplier Shares, 2007
- Exhibit 1-7: Vascular Closure Devices, Global Market Forecast, 2006-2013
2. OVERVIEW - OPPORTUNITIES IN VASCULAR CLOSURE
- 2.1 Overview of Global Regions
- 2.1.1 North America
- 2.1.1.1 The United States
- 2.1.1.1.1 The U.S. Healthcare System
- 2.1.1.2 Canada
- 2.1.2 Europe
- 2.1.2.1 Healthcare Systems in Europe
- 2.1.2.1.1 Western Europe
- 2.1.2.1.2 Eastern Europe
- 2.1.2.2 Cardiovascular Disease in Europe
- 2.1.3 The Rest of the World
- 2.1.3.1 Relevant Factors in ROW Markets
- Exhibit 2-1: Trends in Global Populations by Region, 2006-2013
- Exhibit 2-2: Prevalence of Cardiovascular Disease in the U.S., 2006-2013
- Exhibit 2-3: Prevalence of Peripheral Vascular Disease in the U.S., 2006-2013
- Exhibit 2-4: Prevalence of Cardiovascular Disease in Europe, 2006-2013
- Exhibit 2-5: Prevalence of Peripheral Vascular Disease in Europe, 2006-2013
- Exhibit 2-6: Prevalence of Cardiovascular Disease in the Rest of the World, 2006-2013
- Exhibit 2-7: Prevalence of Peripheral Vascular Disease in the Rest of the World, 2006-2013
3. VASCULAR ANATOMY, PHYSIOLOGY, AND DISEASE STATES
- 3.1 The Circulatory System
- 3.2 Vascular Anatomy and Physiology
- 3.2.1 Peripheral Arteries
- 3.2.2 Coronary Arteries
- 3.2.3 Arteries of the Head and Neck
- 3.3 Vessel Tissue Structures
- 3.4 The Wound Healing Process
- 3.4.1 Inflammatory Phase
- 3.4.2 Proliferative Phase
- 3.4.3 Remodeling Phase
- 3.5 Other Factors Influencing Vascular Closure
- 3.6 Arterial Access
- 3.7 Vascular Disease States
- 3.7.1 Arterial Stenosis and Arteriosclerosis
- 3.7.2 Coronary Stenosis
- 3.7.3 Peripheral Vascular Disease
- 3.7.3.1 Carotid Artery Stenosis
- 3.7.3.2 Subclavian Artery Stenosis
- 3.7.3.3 Renal Artery Stenosis
- 3.7.3.4 Iliac Artery Stenosis
- 3.7.4 Aneurysms
- 3.7.4.1 Abdominal Aortic Aneurysms
- 3.7.4.2 Cerebral Aneurysms
- 3.7.5 Patent Foramen Ovale
- 3.7.6 Thrombi and Emboli
- 3.7.7 Venous Thromboembolism
- 3.7.8 Phlebitis
- Exhibit 3-1: Overview of the Circulatory System
- Exhibit 3-2: Major Vessels of the Cardiovascular System
- Exhibit 3-3: Anatomy and Function of the Blood Vessels
- Exhibit 3-4: Peripheral Arteries and Arteries of the Lower Extremity
- Exhibit 3-5: Coronary Arteries
- Exhibit 3-6: Arteries of the Head and Neck
- Exhibit 3-7: Anatomy of the Arteries and Veins
- Exhibit 3-8: The Wound Healing Process
4. DIAGNOSTIC AND INTERVENTIONAL VASCULAR PROCEDURES
- 4.1 Diagnostic Angiography
- 4.1.1 Cardiac Angiography
- 4.1.1.1 Diagnostic Cardiac Catheterizations in the U.S.
- 4.1.1.2 Diagnostic Cardiac Catheterizations in Europe
- 4.1.1.3 Diagnostic Cardiac Catheterizations in the Rest of the World
- 4.1.2 Peripheral Angiography
- 4.1.2.1 Peripheral Vascular Diagnoses and Therapies in the U.S.
- 4.1.2.2 Peripheral Vascular Procedures in Europe
- 4.1.2.3 Peripheral Vascular Procedures in the Rest of the World
- 4.1.3 Cerebral Angiography
- 4.1.3.1 Cerebral Angiography Procedures
- 4.2 Interventional Procedures
- 4.2.1 Percutaneous Interventions
- 4.2.1.1 PTCA and Stenting
- 4.2.1.1.1 Percutaneous Coronary Interventions in the U.S.
- 4.2.1.1.2 Percutaneous Coronary Interventions in Europe
- 4.2.1.1.3 Percutaneous Coronary Interventions in the Rest of the
World
- 4.2.1.2 Coronary Atherectomy
- 4.2.1.3 Percutaneous Electrophysiologic Ablation
- 4.2.1.4 Percutaneous Valve Repair
- 4.2.1.5 Percutaneous Repair of Patent Foramen Ovale
- 4.2.1.6 Percutaneous Procedures in the Peripheral Arteries
- 4.2.1.7 Carotid Angioplasty and Stenting
- 4.2.1.8 Cerebral Angioplasty and Stenting
- 4.2.1.9 Peripheral Atherectomy
- 4.2.1.10 Renal Artery Angioplasty
- 4.2.1.11 Iliac Artery Angioplasty
- Exhibit 4-1: Diagnostic Cardiac Catheterizations in the U.S., 1996-2013
- Exhibit 4-2: Diagnostic Cardiac Catheterizations in Europe, 1996-2013
- Exhibit 4-3: Diagnostic Cardiac Catheterizations in the Rest of the World, 1996-2013
- Exhibit 4-4: Peripheral Vascular Procedures in the U.S., 1996-2013
- Exhibit 4-5: Peripheral Vascular Procedures in Europe, 1996-2013
- Exhibit 4-6: Peripheral Vascular Procedures in the Rest of the World, 1996-2013
- Exhibit 4-7: Percutaneous Coronary Interventions in the U.S., 1996-2013
- Exhibit 4-8: Percutaneous Coronary Interventions in Europe, 1996-2013
- Exhibit 4-9: Percutaneous Coronary Interventions in Rest of the World, 1996-2013
5. FACTORS DRIVING THE PERFORMANCE OF VASCULAR CLOSURES
- 5.1 Clinical Settings and Needs
- 5.1.1 Inpatient versus Outpatient Settings
- 5.2 Stages of the Vascular Procedure
- 5.2.1 Patient Preparation
- 5.2.2 The Catheterization Procedure
- 5.2.3 Clean-Up
- 5.2.4 Vascular Closure
- 5.2.5 Turnaround
- 5.3 Procedural Economics
- 5.3.1 Costs
- 5.3.2 Reimbursement
- 5.3.2.1 Revenue Codes
- 5.3.2.2 DRG Codes
- 5.3.2.3 Reimbursement for Diagnostic Procedures
- 5.3.3 Economic Justification for Vascular Closure Technologies
- Exhibit 5-1: Global Catheterizations Requiring Arterial Closure, 1996-2013
- Exhibit 5-2: Results of the CLIP Study - Diagnostic Patients
- Exhibit 5-3: Results of the CLIP Study - Interventional Patients
- Exhibit 5-4: Results of Cardiva Medical' s Boomerang Device for Vascular Closure
- Exhibit 5-5: Direct Facility Costs for Diagnostic and Interventional Procedures
- Exhibit 5-6: Average Medicare Reimbursements for Common Catheterization Procedures in 2008
6. VASCULAR CLOSURE DEVICES
- 6.1 Manual Compression
- 6.2 Vascular Closure Devices
- 6.2.1 Implantable Vascular Closure Devices
- 6.2.1.1 Implantable Devices and Companies
- 6.2.1.1.1 Angio-Seal VIP
- 6.2.1.1.1.1 St. Jude Medical
- 6.2.1.1.2 Perclose
- 6.2.1.1.3 StarClose
- 6.2.1.1.3.1 Abbott Laboratories and Abbott Vascular
- 6.2.1.1.4 EVS (Expanding Vascular Stapling) Vascular Closure System
- 6.2.1.1.5 Femoral Introducer Sheath and Hemostasis (FISH) Device
- 6.2.1.1.5.1 Morris Innovative Research
- 6.2.1.1.6 SuperStitch
- 6.2.1.1.7 Boomerang
- 6.2.1.1.7.1 Cardiva Medical
- 6.2.1.1.8 Mynx Vascular Closure System (VCS)
- 6.2.1.1.8.1 AccessClosure
- 6.2.2 External Compression Products
- 6.2.2.1 External Compression Products & Suppliers
- 6.2.2.1.1 SyvekPatch
- 6.2.2.1.1.1 Marine Polymer Technologies
- 6.2.2.1.2 Chito-Seal
- 6.2.2.1.3 Clo-Sur P.A.D.
- 6.2.2.1.3.1 Scion Cardio-Vascular
- 6.2.2.1.4 D-Stat Dry
- 6.2.2.1.4.1 Vascular Solutions
- 6.2.2.1.5 Neptune Pad
- 6.2.2.1.6 Safeguard
- 6.2.2.1.7 SafeSeal Patch
- 6.2.2.1.7.1 Possis Medical
- 6.2.2.1.7.2 Medafor
- 6.2.2.1.8 FemoStop
- 6.2.2.1.8.1 Radi Medical Systems
- 6.2.2.1.9 CloSys Hemostatic Device
- 6.2.2.1.10 Therus Acoustic Hemostasis System
- 6.2.2.1.10.1 Therus
- 6.2.2.1.10.2 Boston Scientific
- 6.3 Effectiveness and Complication Rates Associated with Closure Devices
- 6.4 Global Vascular Closure Market Analysis
- 6.4.1 Implantable Devices - Supplier Analysis
- 6.4.2 External Compression Products - Market Analysis
- Exhibit 6-1: Selected Vascular Closure Devices in 2008
- Exhibit 6-2: Time to Hemostasis for Angio-Seal VIP
- Exhibit 6-3: Time to Recovery for Angio-Seal VIP
- Exhibit 6-4: Complication Rates for Angio-Seal VIP
- Exhibit 6-5: The Angio-Seal VIP Procedure
- Exhibit 6-6: The Perclose Procedure
- Exhibit 6-7: Selected Outcomes of Perclose Procedures
- Exhibit 6-8: Complication Rates for Perclose
- Exhibit 6-9: The StarClose Procedure
- Exhibit 6-10: Complication Rates for StarClose
- Exhibit 6-11: Clinical Performance Data for StarClose
- Exhibit 6-12: The EVS Vascular Closure System
- Exhibit 6-13: The EVS Procedure
- Exhibit 6-14: Clinical Results for the EVS System
- Exhibit 6-15: The FISH Procedure
- Exhibit 6-16: Clinical Results of the FISH Device
- Exhibit 6-17: The SuperStitch Procedure
- Exhibit 6-18: The Boomerang Procedure
- Exhibit 6-19: The Mynx Procedure
- Exhibit 6-20: Clinical Results for the Mynx Vascular Closure System
- Exhibit 6-21: Clo-Sur P.A.D., Method of Operation
- Exhibit 6-22: Clinical Results of D-Stat Dry in Diagnostic Procedures
- Exhibit 6-23: Safeguard Pressure Assisted Device
- Exhibit 6-24: CloSys Hemostatic Device
- Exhibit 6-25: Costs of Vascular Complications at Brigham and Women' s Hospital
- Exhibit 6-26: Selected Studies of Major Closure Complications from Diagnostic Catheterization
- Exhibit 6-27: Selected Studies of Minor Closure Complications from Diagnostic Catheterization
- Exhibit 6-28: Selected Studies of Major Closure Complications from Interventional Catheterization
- Exhibit 6-29: Selected Studies of Minor Closure Complications from Interventional Catheterization
- Exhibit 6-30: Complications and Associated Costs of Vascular Closure Procedures
- Exhibit 6-31: Global Catheterizations Requiring Arterial Closure, 1996-2013
- Exhibit 6-32: Global Vascular Closure Procedures by Type in 2007 & 2013
- Exhibit 6-33: U.S. Vascular Closure Procedure Forecast, 2006-2013
- Exhibit 6-34: U.S. Vascular Closure Device Procedures by Type in 2007
- Exhibit 6-35: U.S. Vascular Closure Device Market Forecast, 2006-2013
- Exhibit 6-36: Vascular Closure Procedure Forecast for Europe, 2006-2013
- Exhibit 6-37: Vascular Closure Procedures in Europe by Type in 2007
- Exhibit 6-38: Vascular Closure Device Market Forecast for Europe, 2006-2013
- Exhibit 6-39: Vascular Closure Procedure Forecast for the Rest of the World, 2006-2013
- Exhibit 6-40: Rest of the World Vascular Closure Procedures by Type in 2007
- Exhibit 6-41: Rest of the World Vascular Closure Market Forecast by Type, 2006-2013
- Exhibit 6-42: Global Vascular Closure Procedures by Type, 2006-2013
- Exhibit 6-43: Vascular Closure Devices, Global Market Forecast, 2006-2013
- Exhibit 6-44: U.S. Implantable Closure Devices, Sales by Supplier, 2006-2013
- Exhibit 6-45: U.S. Implantable Closure Devices, Units by Supplier, 2006-2013
- Exhibit 6-46: U.S. Implantable and Semi-Implantable Closure Device Market, Unit Shares by Supplier, 2008
- Exhibit 6-47: Global Implantable and Semi-Implantable Closure Device Market Forecast, Unit Shares by Supplier, 2006-2013
- Exhibit 6-48: U.S. External Compression Products, Supplier Unit Shares, 2007
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