TUESDAY, Sept. 5, 2006 (HealthDay News) -- The U.S. Food and Drug Administration on Tuesday approved the first totally implantable artificial heart, for patients with advanced heart disease too ill for a heart transplant.
The device, the AbioCor Implantable Replacement Heart, was approved under the FDA's Humanitarian Use Device provisions, which limits the use of any device to 4,000 units per year.
The use of this new heart will be limited to people with severe heart failure who aren't eligible for a heart transplant and are unlikely to live more than a month.
"This is an important step in this type of technology," said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health. "We hope this approval will encourage the continued refinement and improvement of this technology."
The clinical trial that led to approval of the device included 14 men, all of whom eventually died.
"The device extended survival for an average of 4.5 months, allowing the patients to spend valuable time with family and friends," said Dr. Bram Zuckerman, director of the FDA's Division of Cardiovascular Devices. "In two cases, lives were extended by 10 and 17 months, respectively. One patient was discharged from the hospital."
The device is a two-pound mechanical heart that replaces the patient's own heart, which is removed. In addition, there's a power transfer coil that powers the system across the skin and recharges the internal battery. There's also a controller and an internal battery, which are implanted in the patient's abdomen.
The controller monitors and controls the heart device, including its pumping rate. The internal battery allows the patient to be free from all external connections for up to one hour. The system also includes two external batteries that allow the patient to freely move around for up to two hours. While the batteries are being recharged, the system can be plugged into an electrical outlet.
Due to the size of the device, it can only be implanted in people who are at least 6 feet tall and weigh at least 170 pounds, Zuckerman said. That means it won't be available to most women, he noted.
People who get the device will act as test subjects with the ultimate goal of producing an artificial heart that can be used instead of a heart transplant.
"Those individuals [who get this device] are really pioneers in trying to develop this technology," Zuckerman said. "Hopefully, down the road it will be a better technology and more affordable. Without those people who volunteer to participate in this program, the development of this kind of technology for all of us wouldn't be possible."
The device is expected to cost about $250,000, Schultz said. It is not clear whether insurance will cover the costs.
As part of the FDA approval, there will be a post-market review of the device conducted by the manufacturer at 10 sites in the United States. The study will evaluate the use and safety of the device and lead the way for future improvements. This replacement heart is made by Abiomed Inc. of Danvers, Mass.
One expert thinks this is a breakthrough in technology, but it won't replace heart transplants.
"This will not supplant heart transplantation from human donors, which has many advantages over the artificial heart," said Dr. Byron K. Lee, an assistant professor of cardiology at the University of California, San Francisco. "Nevertheless, this will give those patients who do not qualify for traditional heart transplants an opportunity for improved quality of life."
The American Heart Association can tell you more about heart failure.