On-X® Life Technologies, Inc. announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market the 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. These associated aortic root diseases coexist in as many as 10 percent of all aortic valve replacements.
The On-X valve, which is presently being studied to determine if certain patients may be maintained without the use of warfarin (PROACT Trial), has received wide acceptance worldwide as well as in the United States. 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. With the new AAP product, the graft is pre-attached, thereby relieving surgeons of this task.
In a statement concerning the FDA approval, Clyde Baker, president and CEO of On-X Life Technologies, Inc. noted, "The development of and 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 sinus of Valsalva graft from Vascutek simplifies the reattachment of coronary arteries while the generous cuff of the On-X valve helps surgeons with fixation of the valve to aortic annulus."
"Prior to this approval, in order to offer patients with aortic root disease the advantages of the On-X valve, surgeons had to attach the conduit at the operating table by sewing the Vascutek graft to the On-X valve," said Marc W. Gerdisch, M.D., director of Cardiothoracic Surgery at St. Francis Heart Center of Indianapolis. "Now, when patients with aortic root disease ask for the On-X valve, we can offer it without the explanation of the extra measures that were previously required. The On-X valve conduit will clearly enhance the implantation of this technology to patients with disease involving the aortic valve and the adjacent aorta."
The On-X valve is the result of a breakthrough in medical grade carbon technology—On-X® pure pyrolytic carbon. In addition to providing a more thromboresistant surface, the comparatively high strength of pure On-X Carbon® enabled On-X LTI to make significant valve design changes that resulted in a prosthesis that acts more like a natural valve in its treatment of blood. It is well documented that the On-X valve does not produce the turbulence and blood damage commonly produced by other mechanical heart valve prostheses and, therefore, significantly reduces the potential for life-threatening blood clots.
The On-X valve is presently the subject of the ground-breaking PROACT study in the United States. The purpose of the PROACT trial is 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. The study is U.S. FDA IDE approved and is being conducted in 40 centers in the U.S.
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