FDA clears aortic prosthetic valve graft

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The FDA has granted market clearance approval to On-X Life Technologies for its On-X Ascending Aortic Prosthesis (AAP) with the Vascutek Gelweave Valsalva graft.

The combination product is indicated for the replacement of a diseased, damaged or malfunctioning native or prosthetic heart valve in the aortic position in cases that involve an ascending aortic aneurysm, according to the Austin, Texas-based company. These associated aortic root diseases co-exist in as many as 10 percent of all aortic valve replacements.

The On-X valve is presently being studied to determine if certain patients may be maintained without the use of warfarin in the PROACT trial. 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 attach the graft to the valve, On-X Life said. With the new AAP product, the graft is pre-attached.