FDA advisers debating fate of artificial heart

Thursday, June 23rd 2005, 11:06 am

By: News On 6

WASHINGTON (AP) _ The first fully implantable artificial heart provided priceless extra days, families of two recipients told the government Thursday as its maker sought special permission to sell the AbioCor to heart-failure patients near death.

Just how much good the device does is the question: All 14 patients given it so far have died, some immediately and most within a few months. Just one was able to move back home, and only a few even ventured out of the hospital.

But its maker called the AbioCor a big step in the 40-year quest to develop a true artificial heart, and pointed to the one long-term survivor _ who lasted more than a year _ as the goal.

``We have the capability, we think, of returning dying patients to some level of normal living,'' Robert Kung, chief scientific officer at Abiomed Inc., told advisers to the Food and Drug Administration Thursday.

Abiomed is seeking special permission to sell the artificial heart, despite such little testing, through a ``humanitarian device exemption.'' It's designed for devices that might help fewer than 4,000 people a year who have no other options, and requires far less proof of how well a device works.

Under this program, the mechanical heart must promise ``probable benefit'' without too much risk for patients who have run out of other treatments for their heart failure, are too sick for a heart transplant, and are likely to die within a month.

FDA gave the AbioCor a tepid review, calling it difficult to assess quality of life.

The agency turned to its scientific advisers Thursday because ``this one, I think, is a real dilemma,'' said FDA's Dr. Julie Swain, a cardiovascular surgeon.

She asked if, for some patients, the AbioCor was really ``prolonging life, not prolonging death,'' and said it was important to publicly debate that question to avoid unrealistic patient expectations.

The AbioCor is a softball-sized implant that, powered by batteries, takes over the pumping action of patients' flabby, diseased hearts. Unlike earlier mechanical hearts, the AbioCor has no wires or tubes sticking through the skin.

Instead, an external battery powers the device by passing electricity across the skin. A rechargeable internal battery can last about an hour, allowing the patient time to do such things as take a shower.

Abiomed has implanted them in 14 patients, two of whom didn't survive the operation. Another died when the device stopped working; Abiomed says it fixed that problem. Half had strokes.

But the second recipient, Tom Christerson, 71, lived for 17 months before the device wore out. It was long enough to meet his first great-grandchild, move back to his Central City, Ky., home and spend another Thanksgiving with his family.

``Frankly, coming from this daddy's girl, each and every moment was priceless,'' said his daughter, Patti Pryor.

``I wanted to tell you how important it was for him to have that implant,'' added the wife of the first recipient, Robert Tools, 59, who lived five months. He got to go fishing a last time, Carol Tools recalled.