The Associated Press
A surgeon who implanted an artificial heart in an unsuccessful attempt to save a California man under emergency permission from the government says he hopes regulators are beginning to accept the device.
Dr. Jack Copeland of the University of Arizona has successfully used the artificial heart three times in the last year to keep patients alive while they wait for suitable human donor hearts.
But the operations are allowed by the U.S. Food and Drug Administration only under strict rules governing a limited study of the device, called the Cardiowest heart.
The operation at Sharp Memorial Hospital in San Diego on Wednesday was allowed under an emergency "compassionate-use" waiver from the FDA on grounds the heart was the patient's only chance.
"We did it with the blessing and even at the suggestion of the FDA, which recognized that the Cardiowest was his best chance, so we're working as a team, Copeland said.
The patient, Don L. La Pierra, 60, of Temecula, Calif. died Wednesday evening, presumably from blood clots in his lungs, a spokeswoman at Sharp said. Before the artificial heart was implanted, he was being kept alive on a heart-lung machine after a heart transplant was rejected.
The operation was approved Tuesday by Dr. Wolf Sapirstein, chief of medical affairs for the FDA in Bethesda, Md. He said it was the first time the agency has issued a compassionate-use waiver for such a device.
Sapirstein declined comment on whether issuing the waiver meant the agency is convinced the Cardiowest heart works.
He said FDA officials felt obligated to a patient considered a suitable transplant candidate and who was at risk of death without it. Read Next Article