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: Thoraflex Hybrid
PMA Applicant: Terumo Aortic (Vascutek Limited)
Address: Newmains Avenue, Inchinnan, Renfrewshire, PA4 9RR, Scotland, UK
Approval Date: April 19, 2022
Approval Letter: Approval order
What is it?
The Thoraflex Hybrid is a device system designed to repair a weakened and bulging section (aneurysm) and/or a tear in the lining (dissection) of the aorta behind the heart (aortic arch). The system includes a polyester graft section that reinforces a weakened section of the blood vessel, a connected stented section (nitinol wire frame on polyester graft material) that holds the artery open, and a delivery catheter that is used to place the device. The polyester graft and stented sections are coated with a protein substance taken from animal body parts (gelatin) to seal the implant and prevent blood from leaking out.
How does it work?
When the Thoraflex Hybrid is implanted within the aorta, it creates a channel for the blood to bypass the damaged or diseased part of the vessel and keep flowing. The graft and stented sections of the implant replace the parts of the aorta that are not working properly.
When is it used?
Thoraflex Hybrid is used during open-heart surgery to repair or replace damaged or diseased sections of the aortic arch and the part of the aorta that flows to the heart (ascending aorta) and lower part of the body (the descending aorta).
What will it accomplish?
In a clinical study of 65 patients, 76.9% (50 patients) did not experience major adverse events such as death, stroke causing permanent disabilities, permanent paralysis of the lower body or limbs or unanticipated procedures through 1 year of receiving the Thoraflex Hybrid.
When should it not be used?
The Thoraflex Hybrid device should not be used in patients who have:
- Known allergy or intolerance to device materials (polyester, nitinol, tantalum or materials of bovine origin).
- Conditions that could cause a graft infection.
Additional information (including warnings, precautions, and adverse events)