This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: StarClose™ Vascular Closure System
PMA Applicant: Abbott Vascular Devices
Address: 400 Saginaw Drive, Redwood City, California 94063
Approval Date: December 21, 2005
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf5/p050007a.pdf
What is it? The StarClose™ Vascular Closure System (VCS) is used to close a puncture site in the femoral artery and stop bleeding following a 5 or 6 French diagnostic cardiac catheterization procedure. After a cardiac catheterization procedure it is necessary to stop the bleeding in a blood vessel in the leg (the femoral artery). The StarClose™ VCS uses a nitinol clip to stop bleeding by closing the hole in the artery.
How does it work? During a cardiac catheterization procedure:
- A needle is used to make a small tunnel through the skin and tissue and into the femoral artery.
- A thin, flexible, hollow tube (catheter) is threaded through the blood vessel until it reaches the heart.
- The catheter is used to carry specialized tools and medicines for the diagnosis and treatment of heart disease.
- The catheter is removed and the StarClose™ VCS is used to clip the hole in the femoral artery closed.
When is it used? The StarClose™ VCS is used following a 5 or 6 French diagnostic cardiac catheterization procedure. For an illustrated explanation of cardiac catheterization, use the following link: http://www.nlm.nih.gov/medlineplus/ency/imagepages/1080.htm
What will it accomplish? The StarClose™ VCS uses a nitinol clip to seal the puncture site in the femoral artery. Without this or a similar device, manual compression is applied to the puncture site to stop the bleeding. The StarClose™ VCS allows patients to get out of bed and walk sooner than is possible with standard compression methods.
Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p050007