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® Excluder® Conformable (EXCC) AAA Endoprosthesis
PMA Applicant: W. L. Gore and Associates, Inc.
Address: 32360 N. North Valley Parkway, Phoenix, AZ 85085
Approval Date: 12/22/2020
Approval Letter: Approval Order
What is it?
The Gore® Excluder® Conformable AAA Endoprosthesis is a device used to repair an aneurysm (a weakened and "ballooning" part) of the infrarenal abdominal aorta, the largest artery in the abdomen below the kidneys. The device is a multi-component system that consists of permanent implantable flexible fabric tubes with a metal frame (stent graft) and a long thin tube-like device (delivery catheter) that is used to place the device.
How does it work?
The doctor inserts the delivery catheter into the femoral artery (a blood vessel in the upper leg) through a small cut at the top of each leg. The delivery catheter system is then guided to the site of the aneurysm in the abdominal aorta and placed to provide a new path for blood flow. This lowers the pressure on the weakened section of the aorta and may prevent the aneurysm from growing, bursting (rupture), or causing death.
When is it used?
The Gore® Excluder® Conformable AAA Endoprosthesis is intended to be used to treat patients with an aneurysm of the infrarenal abdominal aorta.
What will it accomplish?
The Gore® Excluder® Conformable AAA Endoprosthesis may prevent the aneurysm from getting bigger, bursting (rupture), or causing death. In a clinical study of 80 patients, 93% of patients were successfully treated with the Gore® Excluder® Conformable AAA Endoprosthesis without complications after one year. FDA recommends yearly, lifelong follow-up for all patients who have had their AAA treated with any endovascular graft system. If the aneurysm continues to grow after treatment with the Excluder, there is a chance more procedures will be needed.
When should it not be used?
The Gore® Excluder® Conformable AAA Endoprosthesis should not be used in patients who:
- have a sensitivity to plastic (ePTFE, FEP), nitinol (nickel-titanium), and gold
- have a whole-body infection and may be at higher risk of getting an infection from the device.