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FDA TO CONSIDER “HUMANITARIAN DEVICE EXEMPTION” FOR FIRST COMPLETELY IMPLANTED ARTIFICIAL HEART

Jun 19, 2005 | www.Newsinferno.com

A little known process by which the FDA may issue a “humanitarian device exemption” is scheduled to begin on June 23 when an advisory committee will hear about patients’ experiences with respect to an experimental artificial heart called the AbioCor.

The Wall Street Journal is reporting that this totally implanted device has extended the average life expectancy in fourteen men with severe heart failure from just a few weeks to an average of 5.2 months.

Abiomed Inc. of Danvers, Massachusetts, has apparently succeeded in creating a design that allows this artificial heart to operate without the need for an internal wire to be connected to an external air pumping console. The older technology significantly limited a patient’s activity and posed a risk of infection.

One 70-year-old recipient, Tom Christerson, lived for 17 months after having the new device implanted in September 2001. Although he had been given less than a month to live, he was able to resume and enjoy many normal activities for almost a year and a half.

The special procedure allows a device that has not yet gone through final large scale trials, to receive an exemption if it is shown to be used beneficially by 4,000 or fewer people per year. Since 2000, only 23 such exemptions have been granted.

The AbioCor is a 2-pound titanium and plastic device that is implanted in the space left when most of the patient’s cardiac muscle is surgically removed. It is powered by internal and external batteries.

The main use for the AbioCor will be as a permanent replacement for patients with severe heart failure. The manufacturer, however, does see the possibility of temporary uses by patients who are waiting for extended periods of time for heart transplant surgery.

The AbioCor is looked at as a device that will prolong a patient’s life for about 20-months. The next generation AbioCor II is anticipated to extend that figure to about five years.

There are many patients for whom heart transplantation will never be an option due to a shortage in donor hearts or because of medical condition which disqualify the recipient. Thus, the AbioCor will give desperately ill patients an end-stage heart failure therapy option which never before existed.

Currently, the rather steep $250,000 price tag has raised questions of affordability and inequality of healthcare options. Some see it as just one more step toward unaffordable healthcare for all but the most affluent. Thus, in order to achieve widespread acceptance and use, the device must offer longer survival times, reduced adverse effects, and shorter hospital stays which is an important factor for insurance companies.

Although there are other similar devices in the pipeline, advances have been slow due to technological limitations, adverse blood interactions, and the risk of strokes due to blood clotting. As these problems are solved, progress in this break-through area of heart failure therapy is expected to speed up.


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