Have you recently had 5 or 6 French gauge diagnostic cardiac catheterization procedures, but are plagued by those pesky puncture site femoral artery leaks? Well have no fear, the StarClose ™ Vascular Closure System (VCS) from Abbot Vascular Devices has been approved to market by the FDA. Those of you familiar with the process will recognize the standard FDA language:
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.
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.