Maquet Cardiovascular has received FDA 510(k) clearance, as well as European CE mark approval, to market its Cardioroot aortic graft, a one-piece design, aortic root graft.
The Wayne, N.J.-based company said its Cardioroot will be used by vascular and cardiovascular surgeons to surgically repair or replace diseased and damaged aortas. It is expected to be commercially available in the EU within the next 60 days.
The graft design of mimics the anatomy of the patient's aortic root, including the natural sinuses of valsalva, which supply blood to the heart's own arteries. Cardioroot's shape allows sewing of valve remnants or a prosthetic valve within the tube, Maquet said.
Cardioroot is now commercially available in the U.S., according to the company, and is expected to be commercially available in the EU within the next 60 days.