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.
Anything that uses nitinol gets extra points around here.
Abbott hasn’t updated their product page to reflect the approval, so they only get a link to their main site…
Link to the FDA approval page…