Artificial Heart Gets Limited FDA Approval
Wednesday, September 6, 2006
The Food and Drug Administration yesterday approved for use the first totally implantable artificial heart under a program that will make the complicated, $250,000 device available for as many as 4,000 people.
The decision reverses an FDA advisory panel's recommendation last year that the device was not yet ready for widespread use after many of its first 14 test patients suffered strokes. No engineering changes have been made in the heart since then, but FDA officials believe that physicians will now be able to better manage the complications that often follow its use.
The approval is the latest chapter in a half-century quest to make a mechanical replacement for the human body's most essential and hardest-working organ. It also raises anew questions about how much money should be spent briefly extending the lives of critically ill patients and how to judge the cost-benefit balance of devices that are far from perfect but better than nothing.
Whether insurance companies and the federal government's Medicare program will pay for the AbioCor (and its $100,000 implantation cost) is unknown. Medicare regulations specifically list artificial hearts as uncovered devices.
The president of Abiomed Inc., which makes the AbioCor, said yesterday that the company will seek to have that policy reversed, arguing that the device is the only alternative for many patients and that the expense compares favorably to some drug therapies for rare diseases.
The device would be limited to people with severe congestive heart failure who are estimated to have about a month to live and do not qualify for heart transplants. Those patients must also be able to take anticoagulant drugs.
Because of its size -- about two pounds -- only large women would be able to accommodate it. All the original recipients were men.
While the AbioCor's target population is relatively small, the number of Americans with less severe congestive heart failure is huge -- about 5 million. Some qualify for heart transplants but die before they can get one. Both are potential future markets for the artificial heart.
"We see this as an important milestone. It is not the beginning, and it is certainly not the end of the journey," said Daniel G. Schultz, director of the FDA's Center for Devices and Radiological Health.
The device was approved under a "humanitarian device exemption" that effectively lowers the bar for FDA approval. Normally, devices must demonstrate "safety and effectiveness," but under the exemption they need only to show "safety and probable benefit." The latter can include largely subjective measurements, such as improvement in quality of life. No more than 4,000 of the artificial hearts can be implanted under the exemption.
Unlike previous artificial hearts, the AbioCor runs with no wires or tubes piercing the skin. It is powered by a battery that is recharged with an induction coil placed against the skin. The patient can be away from an external power source for about an hour.
Of the 14 original recipients, two died on the operating table. The rest survived for an average of 5.2 months, with the longest living 17 months. Ten left the hospital only with occasional day passes. One moved to a nearby hotel, and another went home.