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 Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: GORE® Carotid Stent
PMA Applicant: W. L. Gore & Associates, Inc.
Address: 4150 W. Kiltie Lane
Flagstaff, AZ 86005
Approval Date: November 1, 2018
Approval Letter: Approval Order
What is it?
The GORE® Carotid Stent is used to re-open narrowed regions of the carotid arteries in the neck which supply blood to the brain. The implant consists of a self-expanding stent mounted on a delivery catheter system. The stent is made of a nickel-titanium alloy (nitinol) tubing, laser-cut into a mesh shape, with an expanded polytetrafluoroethylene (ePTFE) lattice attached to its outer surface. The delivery catheter is a long, thin, tube-like device used to deliver the stent into the artery.
The GORE® Carotid Stent is used with a protection device (GORE® Embolic Filter) that filters blood flow at the treatment site to capture and remove particles that may come loose during the procedure.
How does it work?
The GORE® Embolic Filter is placed with a tube in the leg and advanced up to the blood vessel in the neck where there is blockage. The GORE® Embolic Filter 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 GORE® Embolic Filter is in place, the doctor inserts the GORE® Carotid Stent delivery catheter into the leg and moves the stent to the blocked area in the neck. The GORE® Carotid Stent is then released from the catheter and opens automatically over the blockage. The stent delivery catheter and the GORE® Embolic Filter are both removed. The stent remains permanently implanted in the neck artery and acts as a support for the newly opened section of the blood vessel.
When is it used?
The GORE® Carotid Stent is intended to be used with the GORE® Embolic Filter in patients who:
- have a high likelihood of complications due to other medical problems or body abnormalities if they had the surgical alternative (called carotid endarterectomy).
- have had a recent stroke and have at least a moderate (greater or equal to 50%) blockage in the blood vessels of the neck, or
- have not had a recent stroke but have a very large (greater or equal to 80%) blockage in the vessels of the neck.
What will it accomplish?
The stent opens blockages in the blood vessel in order to prevent future strokes. In a clinical study, the stent was implanted successfully in 265 out of 265 patients in the United States, with six (6) patients suffering a stroke.
When should it not be used?
The GORE® Carotid Stent should not be used in patients who:
- are allergic to heparin.
- cannot take blood thinners or who have bleeding disorders.
- are allergic to nitinol.
- have blockages at the beginning of the neck artery.
- have problems preventing the GORE® Embolic Filter from being placed properly.
- have problems preventing the GORE® Carotid Stent catheter from getting to the blockage.
Additional information (including warnings, precautions, and adverse events):