The "humanitarian" approval is not full approval. It applies only to what Bram Zuckerman, MD, director of the FDA's heart device division, calls "the sickest of the sick."
Patients who have only a month to live, suffer from failure of both chambers of the lower heart, and aren't eligible for a heart transplant can now receive the AbioCor.
In clinical trials, the device extended patients' lives by only four and a half months, on average. One patient survived 17 months, another 10 months. Only one patient was able to go home.
Yet the announcement represents a major milestone on the road to a fully functional artificial heart, says Daniel Schultz, MD, director of the FDA's Center for Devices and Radiological Health.
"The reason this is such an exciting day is we are talking about an innovative device that will save lives," Schultz said in a news conference. "This approval, under the humanitarian-use program, is part of our way to ensure this technology will become available to patients for whom waiting for full approval is not a possibility."
So far, there's only one size AbioCor heart -- large. Patients to date have been 6-feet-tall men weighing more than 170 pounds. A large chest is needed to accommodate the current version of the device.
The Artificial Heart
The AbioCor system consists of:
- A 2-pound mechanical heart implanted in the chest. The patient's diseased heart is removed during implantation.
- A power transfer coil across the skin that powers the system and recharges the internal battery from the outside.
- A controller and battery implanted in the belly. The controller adjusts the artificial heart's pumping rate. The internal battery allows the patient to be free from all external connections for up to 1 hour.
- Two external batteries that allow free movement for up to 2 hours.
- During sleep and while batteries are being recharged, the system can be plugged into a normal electrical outlet.
Abiomed, the manufacturer of the device, says five to 10 medical centers will be trained to implant the AbioCor devices.
This humanitarian approval is intended for treatment of conditions that affect fewer than 4,000 patients a year in the U.S., according to an FDA news release. As the short survival times suggest, the device remains experimental.
"It is important to recognize that right now the device is a niche device targeted to an extremely sick heart failureheart failure population," Zuckerman says.
"The vast majority of these patients are bed bound, extremely short of breath, and hooked up to multiple intravenous medications.
"For many of these patients in the clinical trial, just the ability to ambulate, to clearly communicate with loved ones, to take excursions out of the hospital, and to celebrate important family events, were -- in the eyes of the patients and family members -- seen to be an improvement," Zuckerman says.
People who receive the device will be enrolled in a post-approval study. The results of this study will be used to develop the next generation of artificial hearts.