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: Relay® Thoracic Stent-Graft with Plus Delivery System
Manufacturer: Bolton Medical
Address: 799 International Parkway, Sunrise, Florida 33325
Approval Date: September 21, 2012
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf11/p110038a.pdf
What is it? The Relay® Thoracic Stent-Graft with Plus Delivery System is an endovascular stent graft and is used to repair fusiform aneurysms or saccular aneurysms/penetrating ulcers of the aorta in the chest. The Relay® Thoracic Stent-Graft is made of a fabric tube supported by a metal framework. Each endovascular stent-graft is compressed into the end of a long, thin, tube-like device called a delivery catheter.
An aneurysm is a diseased, weakened, and bulging section of an artery wall. A fusiform aneurysm is a type of thoracic aortic aneurysm that has a varying diameter and length and typically involves all sides of the diseased vessel. A saccular aneurysm is a type of aneurysm that is circular in shape and typically involves only one side of the diseased vessel. Saccular aneurysms are often associated with penetrating ulcers. A penetrating ulcer is a weak area of the aorta that causes one side of the diseased vessel to bulge or expand. Unlike a saccular aneurysm, a penetrating ulcer does not go completely through the first layer of the aorta.
How does it work? The delivery catheter containing the endovascular stent-graft is inserted into an artery in the groin through a small incision in the skin. It is carefully guided within the artery into the chest to bridge the site of the aneurysm or penetrating ulcer in the aorta. The endovascular stent-graft is then released (deployed) in the aorta where it self-expands to the diameter of the aorta to seal off the aneurysm or penetrating ulcer and relines the artery wall.
When is it used? The Relay® Thoracic Stent-Graft with Plus Delivery System is used instead of an open (more invasive) surgery in patients who have a fusiform aneurysm or saccular aneurysm/penetrating ulcer of the aorta in the chest or instead of another manufacturer’s endovascular stent-graft.
What will it accomplish? The Relay® Thoracic Stent-Graft with Plus Delivery System should benefit patients with a fusiform aneurysm or saccular aneurysm/penetrating ulcer of the aorta in the chest by preventing further growth and rupture of the aneurysm or penetrating ulcer.
When should it not be used? The Relay® Thoracic Stent-Graft with Plus Delivery System should NOT be used in patients who have a condition that threatens to infect the graft or in patients with known sensitivities or allergies to the device materials.
Additional Information: The Summary of Safety and Effectiveness Data and labeling are available online.