FDA approves temporary artificial heart

An FDA advisory committee in March recommended that the agency approve the device with caution, since complex surgery to install it raises the potential for such complications as infection, bleeding, and stroke. Despite those risks, the panel found the device to have benefits for a small number of patients with no other choice.

The FDA approved the device for patients awaiting heart transplants who don't respond to other treatment and who are likely to die within 30 days due to nonreversible, biventricular failure. In such cases, patients typically are short of breath, even while resting, because their hearts cannot efficiently pump blood.

Donna-Bea Tillman, director of the FDA's Office of Device Evaluation, said the artificial heart is to be an option for a very small group of patients, perhaps 100 a year in the United States.

Of the 2,200 patients who get heart transplants each year, roughly 500 need some temporary assistance to ensure they're still alive when the donor heart arrives. Within the group of 4,000 waiting for heart transplants, 100 have nonreversible failure affecting both sides of their heart.

SynCardia's clinical trials looked at using the artificial heart in 81 patients eligible for transplants at five medical centers. All the patients had severe biventricular heart failure.

After receiving the artificial heart, 79 percent of patients lived long enough to receive a donor heart. The average patient lived 79 days, and the longest lived for 400 days before heart transplantation, the company said.

The most common adverse events were infection, affecting 72 percent of patients, and bleeding, suffered by 42 percent of patients.