On-X Life Technologies has received FDA approval for its On-X Ascending Aortic Prosthesis (AAP) with the Vascutek Gelweave Valsalva Graft. It combines a prosthetic valve and a prosthetic ascending aortic prosthesis for patients with aortic root diseases. Previously the two separate devices would have to be connected together by means of the operating surgeon sewing them together before implantation.
The On-X valve uses On-X pure pyrolytic carbon, a proprietary carbon technology that promises a more thromboresistant surface and high strength. This allows for valve design changes that resulted in a prosthesis that acts more like a natural valve in its treatment of blood, producing less turbulence and blood damage than other mechanical heart valve prostheses.
A trial called PROACT is currently underway in the United States to determine if patients implanted with the On-X valve can be safely maintained with reduced levels of warfarin anticoagulation or eliminate the use of warfarin altogether.