This is a brief overview of information related to the FDA’s approval to of the expansion of indications. See the links below to the Summary of Safety and Effectiveness Data and product labeling for more information on this product, its indications for use, and the basis for the FDA’s approval.
Product Name: RelayPro Thoracic Stent-Graft System
PMA Applicant: Bolton Medical, Inc.
Address: 799 International Parkway, Sunrise, FL 33325
Approval Date: March 7, 2023
Approval Letter: Approval Order
What is it?
The RelayPro Thoracic Stent-Graft System is designed to repair damage of the largest artery in the body (aorta) in the area behind the heart (descending thoracic aorta). The system consists of a delivery catheter and tube-shaped implants (stent grafts) made of nitinol, polyester, and platinum-iridium. The system has two types of implants, the proximal bare stent and the non-bare stent (NBS).
How does it work?
A doctor inserts the delivery catheter, carrying the stent graft, into the femoral artery (located in the upper thigh) by making a small cut, or incision, in the patient’s groin. The delivery catheter is carefully guided through the blood vessels to the damaged area behind the heart. Once the stent is positioned, the doctor removes the delivery catheter. The stent expands and stays permanently implanted in the artery. This allows blood to keep flowing past the aorta’s damaged or diseased parts.
When is it used?
Doctors use the RelayPro Thoracic Stent-Graft System for endovascular repair of blood vessel damage, or lesions, of the descending thoracic aorta. This device can repair several types of lesions, including:
- Aneurysm, a diseased, weakened, and bulging section of the aortic wall.
- Transection, a rupture or tear of the aortic wall, typically from blunt force trauma.
- Dissection, when the inside lining of the aorta tears away from the outer wall.
What will it accomplish?
In a clinical study of 50 people treated for dissection, 45 people (89.1%) of people did not experience major adverse events such as death, heart attack, respiratory failure, or lack of blood supply to the gut (ischemia). In a clinical study of 50 people treated for transection, 49 people (98%) did not experience major adverse events such as death, heart attack, respiratory failure, or gut ischemia up to 30 days after the procedure.
When should it not be used?
The RelayPro Thoracic Stent-Graft System should not be used in in patients who have:
- A known allergy or intolerance to device materials such as nitinol (including nickel), polyester, or platinum-iridium
- Conditions that might lead to a graft infection
Additional information (including warnings, precautions, and adverse events):