As we reported on June 19, an FDA advisory panel was scheduled to hold a hearing yesterday to decide whether a “humanitarian device exemption” should be granted with respect to a fully implantable artificial heart called the AbioCor.

Following that hearing, the panel refused to endorse the application by a slim 7-6-1 vote. Two votes to approve the device failed by one vote as did a vote to reject the device. Since 2000, only 23 such exemptions have been granted.

In limited trial implantations, the device had extended the average life expectancy in fourteen men with severe heart failure from less than 30 days to an average of 5.3 months.

In the AbioCor, Abiomed Inc. of Danvers, Massachusetts, has 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. That 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 AbioCor 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 “humanitarian device exemption” would have allowed the device, which had not yet gone through final large scale trials, to be marketed if it could be used beneficially by 4,000 or fewer people per year.

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 was seen as a permanent replacement for patients with severe heart failure. Temporary use by patients waiting for extended periods of time for heart transplant surgery was also a possibility.

The AbioCor was seen as a device that would prolong a patient’s life for about 20-months. The next generation AbioCor II was anticipated to extend that figure to about five years.

Abiomed saw the device as the only alternative for desperately ill  end-stage heart failure patients for whom heart transplantation is not an option due to a shortage of donor hearts or because of medical conditions which disqualify the recipient.

Although other similar devices are in development, advances have been slow due to technological limitations, adverse blood interactions, and the risk of bleeding, strokes, and blood clotting. AbioCor recipients suffered these side effects as well as two cases where the device itself failed. Mr. Cristerson was one of the volunteers whose AbioCor failed. He declined a second implantation.

According to the Associated Press, in debating the special exemption, the FDA’s chief reviewer (Julie Swain) questioned whether the device was really “prolonging life” as opposed to “prolonging death.” Another panelist (Dr. John C. Somberg), however, saw the device as providing a benefit to “some patients facing near death.

The panel also considered the fact that six of the recipients were never able to leave the hospital and one lived for 53 days without regaining consciousness. In addition, about 75% of the recipients suffered multiple debilitating strokes following implantation surgery.

In the end, the vote was a technical one as to whether the device met the agency’s definition of a humanitarian device, namely, one whose probable benefits outweigh its potential risks. The panel determined it did not meet that threshold. The $250,000 price tag was also a negative factor.     

This was probably because the maker failed to offer enough objective proof of improved quality of life with the device. Although some family members of volunteers told the committee that the device allowed them to spend more quality time with their loved ones, several of the recipients remained debilitated and even noncommunicative after surgery.   

Nonetheless, some panelists supported the application under the theory that, to a terminally ill patient, some hope of survival is better than no hope at all. Thus, even the high risk of stroke and other serious complications was worth the prospect of extending the life of someone with no other chance of survival.

Although the CEO of Abiomed (Dr. Michael Minogue) expressed the company’s disappointment at the vote, he has not given up hope of approval. Abiomed intends to enter discussions with the FDA to see if enough data can be provided to support an application to approve the device.

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