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: Xact® Carotid Stent System
Applicant: Abbott Vascular Devices
Address: 400 Saginaw Drive, Redwood City, CA 94063
Approval Date: September 6, 2005
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/p040038a.pdf
What is it? This device has two systems: the stent and delivery catheter system (Xact® Carotid Stent System) used with an embolic protection system (Emboshield? Embolic Protection System). The stent is a metal mesh tube on a delivery catheter, and the embolic protection device is a micromesh filter basket on the end of a delivery catheter.
How does it work? The Xact® Carotid Stent System is inserted during angioplasty, a less invasive procedure in which the stent is threaded up to the neck artery (carotid) via a catheter inserted in the groin.
- The Emboshield® Embolic Protection System is inserted into the vessel in the groin and advanced up to the blood vessel in the neck where there is blockage.
- The Emboshield® Filtration Element is opened up like an umbrella. It has small holes to allow blood to flow through, but small enough to catch any particles that may break off from the blockage during the operation.
- After the Emboshield® Filtration Element is deployed, the physician uses the same wire to advance the metal stent to the blocked area.
- The metal (nitinol) stent (Xact® Carotid Stent System) is then allowed to come out of the catheter and opens automatically over the blockage.
- The catheter is removed, and another catheter is put up into the neck vessel to close the Emboshield? Filtration Element and remove it, along with any pieces of debris that were trapped.
When is it used? The Xact® Carotid Stent System is used in patients who:
- have had a stroke
- who have a very tight (80%) blockage in the vessels of the neck
- have either medical problems or body abnormalities that would put them at a high risk if they had the surgical alternative (called carotid endarterectomy).
What will it accomplish? The Xact® Carotid Stent System is supposed to open blockages in the blood vessel in order to prevent future strokes. When compared to complications reported in literature from patients undergoing surgery, the risk of death, stroke and heart attack at 30 days and or any stroke in the area of the blockage at one year were similar. In addition, the study showed that the stent still allowed blood flow to the brain out past one year after the procedure.
When should it not be used? The Xact® Carotid Stent System should not be used in patients who:
- cannot take blood thinners
- have bleeding disorders
- are allergic to nitinol
- have blockages at the beginning of the neck artery
- have problems preventing the catheter from getting to the blockage
Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p040038