FDA approves limited use of artificial heart

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The Food and Drug Administration (FDA) in the United States has given approval for limited use of an artificial heart.

Only those patients who are seriously ill with heart failure and ineligible for a transplant will be able to have an implant of a permanent artificial heart.

According to the American Heart Association’s 2006 Statistics, each year 57,000 patients in the United States die from chronic heart failure.

Around 2,200 donor hearts are transplanted into patients suffering from heart failure, but there are many more patients awaiting a second chance at life, for whom a heart transplant is not an option.

The artificial heart called AbioCor produced by Abiomed Inc, is made of titanium and plastic, is the size of a grapefruit and weighs two pounds.

The device promises patients only a few extra months and costs in the region of $250,000.

The device potentially offers an improved quality of life and is the only artificial heart without wires piercing through the skin, which reduces the chance of infection.

It simulates the rhythm of a heartbeat and is able to pump blood through the body and has the potential to allow patients to return home and resume normal activities including bathing.

The system consists internally of a thoracic unit, a rechargeable battery, a miniaturized electronics package, a power receiver coil, and externally, a power transmitter coil, power and battery pack, handheld alarm monitor and sophisticated computer console.

In a study to test the artificial heart the 14 male recipients lived on average less than five months after the surgery and only one was discharged from a hospital to live at home.

The longest survivor lived 17 months and another 10 months.

Dr. Daniel Schultz, director of the FDA’s Center for Device Evaluation and Research says the step is an important milestone towards better and more affordable technology.

Schultz says the FDA decided that for a small group of dying patients the option to try the artificial heart and decide for themselves, was worth the risks and the cost involved.

An advisory panel in 2005 urged the FDA to reject approval, even for patients with only weeks to live as they were not sure patients would live long enough with a good quality of life to justify the risk of complications.

It is thought that only 25 to 50 heart failure patients each year will meet the AbioCor eligibility requirements.

They must be ineligible for a heart transplant, expected to live less than one month and have no other options available.

It is thought many women will not qualify because a patient must have a relatively large chest cavity; the men in the study had an average height of 6 feet and a weight of 170 to 180 pounds.

FDA officials approved the device implants under “humanitarian” exemptions that allow a product to be used when it is safe and has a “probable” benefit for a condition affecting fewer than 4,000 patients per year.

Such approvals do not require the full-scale safety and effectiveness testing of a standard device approval.

In order to ensure the highest standards of patient care, Abiomed intends to make the AbioCor available through a controlled roll-out at approximately five to ten heart hospitals in the United States, including qualified clinical trial sites and additional qualified centers once they have completed a comprehensive and rigorous training program which may take six to eight months.

Abiomed is currently working on the next artificial heart that it hopes to have ready by 2008.

The newer device is 30 percent smaller than the current AbioCor and officials hope it will extend the life of patients by 5 years.

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