WASHINGTON: The U.S. Food and Drug Administration gave limited approval to an artificial heart developed and tested on patients by a Massachusetts company, Abiomed Inc. The device is the first fully implantable artificial heart, which can sustain patients, even in moving conditions, for up to two hours at a time.
The approval for the grapefruit-sized device came even as all the 14 patients on whom it was implanted and tested between 2001 and 2004 had died and all of them were men. While two died immediately after the implant operations, a third person did not regain consciousness after the surgery. The rest survived for an average period of five months. The longest period of survival was 512 days.
FDA said it is giving approval under its Humanitarian Use Device provisions. The Danvers, Massachusetts-based Abiomed is allowed to sell up to 4,000 devices a year. The use will be limited to people with severe heart failure, who are not eligible for a heart transplant and are unlikely to live for more than a month.
The device, the AbioCor Implantable Replacement Heart, costs around $250,000 and it is not clear whether it is covered under the health insurance.
The limited approval is the first after decades of research, funded largely by the National Heart, Lung and Blood Institute, to develop a fully implantable artificial heart. Devices designed and developed earlier had been bulky and were intended for use before a patient receives a heart transplant.
The device, made of titanium and plastic, can be ideally used in patients who are near death from the failure of the natural heart's pumping chambers. It can be implanted only in people 18 years and above and who are ineligible for a transplant and whose life expectancy would be a month without it. The diseased heart will have to be removed to make room for the two-pound implant. A coil transfers power across the skin and recharges the device from the outside. An internal battery and a mechanism to monitor and control the heart rate are implanted in the abdomen. The battery will allow the patient to be mobile for up to one hour. However, the present size limits the device's use by men and women with large chest cavities.
Earlier, a panel of heart experts appointed to advise the FDA on the device had voted, 7 to 6, against approving it, mostly on concern that the risks from complications like bleeding, strokes and infection outweighed the benefits. The approval follows a review of the panel's concerns and discussions with Abiomed. FDA has stipulated that Abiomed will carry out another study of patients who receive the device and subsequently modify it on the basis of the findings.
Abiomed intends to deliver the device to five medical centers initially and to spend the next six months retraining the specialists who had been involved in its trials.
The company's chairman and chief executive Michael Minogue said the company was working on a next generation artificial heart that it hopes to make it available by 2008. This device will be 30 per cent smaller than the current device and it is hoped to extend the life of patients by five years.
