AbioCor Gets FDA Approval

If a person suffers a severe heart attack and getting a heart transplant is not possible, the heart may still continue to beat, thanks to AbioCor.

The Food and Drug Administration (FDA) of U.S. on Tuesday gave green signal to the first totally implantable artificial heart, the AbioCor. The device can be used for patients ailing with severe congestive heart failure and who are believed to be in the fag end of their life and thus not eligible for a normal heart transplant.

Targeting on a petite patient base, Abiomed Inc. expects to sell about 50 devices a year, although the FDA has given the approval of as many as 4,000 units.

The AbioCor, a grapefruit-sized device weighing about two-pounds is implanted in the patient’s chest, thereby replacing the original heart. This mechanical heart is powered by an internal battery which is recharged through external power pack and transmits current through the skin.

The device also features a controller that is implanted in the patient's abdomen which controls the ‘robo heart’ along with its pumping rate. The batteries provide a backup time of up to an hour, i.e. the charged internal battery allows the patient to move about freely without external connections for up to an hour. The system also includes two external batteries that allow the patient to freely move around for up to two hours.

A limiting factor to the use of this device is that it can only be implanted in people who are at least 6 feet tall and weigh at least 170 pounds. Thus it won't be available to most women. The implant costs a whopping $250,000 thus making it beyond the reach of the common man.

Empirically, out the 14 original recipients off AbioCor, two died on the operating table. The rest survived for an average of 5.2 months, with the longest living 17 months. The time gained by the patient may have been small but it indeed was very precious. As Bram D. Zuckerman, director of the FDA's office of cardiovascular devices puts it, “Just being able to ambulate, to clearly communicate with loved ones, and to celebrate family events is in the view of many patients and family members a significant improvement in quality of life."