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Man Who Got ‘Illegal’ Heart Near Death

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From Reuters

A 32-year-old man lay close to death today with his third heart implant in three days--one of them an unauthorized mechanical heart that had kept him alive for 11 hours between human heart implants.

“His chances of recovery are guarded,” a hospital spokesman said of the unidentified patient, a Tucson man who is the divorced father of two. “He is, at present, close to death.”

The artificial heart, slightly bigger than a man’s fist and known as the Phoenix Heart, was implanted after the man’s first human donor heart failed Tuesday morning.

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The mechanical heart, previously tested only on calves, had not been authorized by the Food and Drug Administration as required by U.S. law.

Three Hearts

But it kept the Tucson man alive until the surgical team at the University of Arizona Medical Center implanted a second human heart early today--the patient’s third heart in three days.

“A mechanical heart was the patient’s only choice at the time,” the chief surgeon of the operating team, Dr. Jack Copeland, said. “We were faced with a patient who had no alternative other than death.”

The patient, whose identity is being kept secret by the hospital, was reported by a spokesman today to be in critical but stable condition with significant complications caused partly by fluid in the lungs.

In Washington, the FDA, which oversees the approval of new drugs and medical devices, said it wants more information before passing judgment on the doctors’ decision to implant the unapproved artificial heart.

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