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Tuesday, September 5th 2006

Keepin' Beatin'

The AbioCor artificial heart has been approved by the FDA.

The U.S. Food and Drug Administration on Tuesday approved the sale of the first implantable artificial heart — the AbioCor, pioneered in Louisville.

The decision runs against the advice of an FDA advisory panel last year, which essentially said the risks of the AbioCor heart were greater than the benefits.

Under Tuesday’s ruling, Massachusetts-based Abiomed Inc. can sell up to 4,000 AbioCor hearts a year for patients with no other options —although company officials and doctors expect the number of implants to be much smaller.

The AbioCor, made of titanium and plastic, is about the size of a softball and has no wires sticking out of the skin. It has been tested in 14 men, seven of whom received their hearts at Jewish Hospital in Louisville. The first was Robert Tools of Franklin, Ky., who received his implant in 2001 and lived with it for five months. Christerson’s artificial heart operated the longest.

The AbioCor has faced similiar problems that other artificial hearts (such as the famous Jarvik-7) have. This 2002 article details some of the early bumps faced as the heart was tested.

Over at Medgadget they dismiss some criticisms of the approval (such that the device is a poor use of limited healthcare resouces).

Ah yes, the cost:benefit problem. Seems like the question for biomedical engineers no longer lies with solving an unsolvable medical problem, but with doing so in a cost effective manner.

Pretty Amazing

Despite the equiptment’s problems, and even if we can only extend a life for 6 months or a year, and no matter how “simplistic” the action of the heart, it will always amaze me we can replace someone’s failing heart with a piece of man made equiptment.

Although my thoughts on my future are more wide open with a year plus in medical school, one of the “ah ha!” moments in my decision to become a doctor came when I got to stand at the tableside of some CT surgeries. Heart surgery is an amazing thing, even if some figure cardiothoracic surgery to be a specialty on the rocks.

Get It? On The Rocks