Texas-based On-X Life Technologies (Nasdaq:LIFE) announced Friday that it has recieved approval from the US FDA to market its On-X aortic valve replacement product.
The On-X Ascending Aortic Prosthesis (AAP), with the Vascutek Gelweave Valsalva(TM) Graft , is a combination product indicated for the replacement of a diseased, damaged or malfunctioning heart valve in cases that involve an ascending aortic aneurysm, which can cause heart failure or shortness of breath.
Before today, surgeons treating patients with a need for a prosthetic valve manually attached the graft to the valve. With the new AAP product, the graft is pre-attached, the company said.
It has also been proven in studies that the On-X valve, made of pyrolytic carbon, does not cause blood damage commonly caused by other such products, therefore significantly reducing the potential for life-threatening blood clots.
Currently, the product is undergoing an FDA-approved study across 40 centres in the US, which will determine if patients implanted with the On-X valve can be safely maintained with reduced or zero levels of warfarin, which stops blood from clotting.
The company already has EU and Japanese approval for the sale of the heart valve replacement product.