GLOBAL VASCULAR CLOSURE DEVICE MARKETS

185 Pages | 85 Exhibits | 2008 Analysis | Forecasts Through 2013

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.

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


COMPANIES COVERED:

  1. Abbott Spine
  2. Advanced Prosthetic Technologies
  3. Aesculap
  4. Amedica
  5. Anulex Technologies
  6. Abbott Laboratories and Abbott Vascular
  7. AccessClosure
  8. Boston Scientific
  9. Cardiva Medical
  10. CloSys
  11. Datascope
  12. Marine Polymer Technologies
  13. Medafor
  14. Medtronic
  15. Morris Innovative Research
  16. Possis Medical
  17. Radi Medical Systems
  18. Scion Cardio-Vascular
  19. St. Jude Medical
  20. Sutura
  21. Therus
  22. TZ Medical
  23. Vascular Solutions
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