Global Vascular Closure Device Markets
Published January 2008 | 185 Pages | 85 Exhibits | Forecasts Through 2013
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Overview
As analyzed in this report by Life Science Intelligence, the global market for vascular closure devices will reach nearly $1 billion by 2013. The market for vascular closure technologies, which includes implantable devices and external compression products,has traditionally been concentrated in the U.S. and Western Europe. These technologies are used to replace or augment manual compression following diagnostic catheterizations. By reducing time to hemostasis and facilitating more rapid recovery, implantable technologies are able to reduce time in the recovery room, which contributes to better patient throughput and higher profits for catheterization labs. External compression products, which include chemically-treated patches, also simplify the process of vascular closure for the clinician and staff.LSI expects that by 2013, implantable devices and external compression products will account for nearly half of all vascular closures in the U.S. while implantable devices will account for 56% of all device-based procedures. In Europe, the use of vascular closure devices in the West has been offset by broad use of manual compression in the East. Driven by favorable demographics and better access to technologies, however, vascular closure devices, especially external compression products, should experience greater adoption.
To date, the high cost of implantable vascular closure devices has limited adoption in other international markets. By 2013, however, growing catheterization volumes, better access to new healthcare technologies, an expanding middle class, and the need to increase patient throughput while meeting the standards of Western healthcare will contribute to greater adoption of these technologies. Although only limited use of implantable devices is expected, external compression products, which are significantly less expensive than implantable devices, will experience broader adoption.
Companies Covered
Abbott SpineAdvanced Prosthetic Technologies
Aesculap
Amedica
Anulex Technologies
Abbott Laboratories and Abbott Vascular
AccessClosure
Boston Scientific
Cardiva Medical
CloSys
Datascope
Marine Polymer Technologies
Medafor
Medtronic
Morris Innovative Research
Possis Medical
Radi Medical Systems
Scion Cardio-Vascular
St. Jude Medical
Sutura
Therus
TZ Medical
Vascular Solutions
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 5.2.4.1 Hemostasis 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 6.2.1.1.4.1 Medtronic 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 6.2.1.1.6.1 Sutura 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 6.2.2.1.5.1 TZ Medical 6.2.2.1.6 Safeguard 6.2.2.1.6.1 Datascope 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 6.2.2.1.9.1 CloSys 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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