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.
Table of Contents
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
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
GLOBAL VASCULAR CLOSURE DEVICE MARKETS: U.S., EUROPE, REST OF WORLD published by Life Science Intelligence, Inc. in July 31, 2008. This report consists of 185 Pages / 85 Exhibits and the price starts from US $ 5995.
