In the first procedure of its kind in the United States, a valve from a cow's neck has been transplanted into the heart of a 13-month-old boy.
Ryan Doty, who was reportedly born with one heart valve instead of two, underwent the operation on May 4 at Riley Hospital for Children. When Ryan was four months old, he received a new heart valve that was transplanted from another infant, but the valve leaked.
Although the procedure is not approved for general use, the Food and Drug Administration reportedly OK'd the operation on a compassionate use basis because Ryan otherwise would have died. According to the Associated Press, 13 patients have undergone such operations in Switzerland and Italy since the procedure was approved in Europe a year ago. In the United States, FDA approval is expected sometime this year.
Although valves from pigs are often implanted into the hearts of adults, they are too large for use in infants.
In related news, CryoLife, Inc., of Atlanta announced progress in its efforts to develop a new biologic human heart valve. The company said it has transplanted an unfixed pig's heart valve into a sheep without the valves calcifying or being rejected. This early finding "bodes very well for future trials," CryoLife consultant Dr. Mark O'Brien reported recently at the Stentless Bioprostheses Third International Symposium in the Cayman Islands. The company plans to file an investigational device exemption with the FDA later this year to begin testing its heart valve technology in humans.
For Your Information:
CryoLife press release
www.cryolife.com/corporat/cryopress.html
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