On-X Life Technologies Inc (On-X LTI) has received the US Food and Drug Administration (FDA) approval to market its aortic valve - On-X Ascending Aortic Prosthesis (AAP), with the Vascutek Gelweave Valsalva Graft.
The combination product is indicated for the replacement of diseased, damaged or malfunctioning native or prosthetic heart valve in the aortic position in cases that involve an ascending aortic aneurysm.
Until the approval of the AAP product, surgeons treating patients with a need for both a prosthetic valve and a prosthetic ascending aortic prosthesis manually attached the graft to the valve.
As the new product features a pre-attached graft, it relieves the surgeons of this task.
On-X Life Technologies president and CEO Clyde Baker said the approval to market the AAP product permits On-X LTI to better serve surgeons who treat patients with combined aortic valve and ascending arch disease.
The study on On-X valve is currently being conducted to determine if patients implanted with the valve can be safely maintained with reduced levels of warfarin anticoagulation or eliminate the use of warfarin altogether.