The first completely implantable artificial heart was approved by the U.S. Food and Drug Administration (FDA) on Tuesday. The artificial heart has been approved for patients with severe heart problem, who are too ill for a heart transplant.
Under the FDA's Humanitarian Use Device provisions, the device, the AbioCor Implantable Replacement Heart, was approved. However, it restricts the use of more than 4,000 units of any device per year. The usage of this artificial heart is restricted to people with acute heart failure who cannot accept a heart transplant and are not likely to live for more than a month.
"We're talking about a small group of end-stage patients, whose choice is between immediate death or new, innovative technology," said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health.
Abiomed Inc. of Danvers, Mass. produced this replacement heart.
"This is an important step in this type of technology. We hope this approval will encourage the continued refinement and improvement of this technology," he said.
The clinical trial was conducted on 14 men who finally 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 patient's own heart is replaced by this device, which is a 2-pound mechanical heart. A power transfer coil charges the system across the skin and recharges the internal battery. A controller and an internal battery are implanted in the patient's abdomen.
The functions of the controller are to monitor and control the device and also its pumping rate. The patient can be free from external connections for up to an hour because of the internal battery. There are 2 external batteries also in this system that permit the patient to freely move for about 2 hours. Plugging into an electrical outlet while the batteries are being recharged can charge the system.
The size of the device permits it to be implanted only in people who are at least 6 feet tall and weigh at least 170 pounds, Zuckerman said. Hence, it may not be of use to most women.
Patients, who get the device implanted in them, will be under scrutiny with the ultimate aim of artificial heart devlopment that can replace heart transplant in all cases.
"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."
Around $250,000 will be the cost of the device and whether insurance will cover the costs is not clear, Shultz said.
A post-market review of the device will be carried out by the manufacturer at 10 places in the U.S. as a part of the FDA approval. The use and safety of the device will be assessed by the study and this will pave way for further improvements.
Though it is a revolution in technology it won't replace heart transplants, says an expert.
"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."