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: Cordis PRECISE™ OTW Nitinol Stent System
PMA Applicant: Cordis Corporation
Address: 7 Powder Horn Drive , Warren, NJ 07059
Approval Date: September 22, 2006
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf3/p030047a.pdf
What is it? The device consists of a stent and delivery catheter system (PRECISE™ OTW Nitinol Stent System) and is used in conjunction with an embolic protection system (ANGIOGUARD™). 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? First, the ANGIOGUARD™ wire is inserted into the vessel in the groin and moved up to the blood vessel in the neck a little past the blockage. The end of the ANGIOGUARD™ opens like an umbrella. It has small holes to allow blood to flow through, but small enough to catch any pieces of debris that may break off from the blockage. After the ANGIOGUARD is opened, the physician uses the same wire to move the PRECISE stent to the blocked area. The PRECISE stent 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 ANGIOGUARD and remove it, along with any pieces of debris that were trapped.
When is it used? The PRECISE OTW Nitinol Stent System is put into patients who have had a stroke, or who have a very tight (≥80%) blockage in the vessels of the neck. Patients should also 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 stent is supposed to open blockages in the blood vessel in order to prevent future strokes. When this stent was compared to surgery, the risk of combined complications of death, stroke and heart attack were similar. When only stroke on the side where the stent was put in were considered, there was no difference between surgery and getting a stent one year after the operation.
When should it not be used? Stents should not be used in patients who cannot take blood thinners or who have bleeding disorders, who are allergic to nitinol, who have blockages at the beginning of the neck artery, or who have problems preventing the catheter from getting to the blockage.
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=p030047