BOSTON -- The maker of the first self-contained replacement heart is seeking approval to begin marketing the product for use on thousands of heart disease patients who are at a high risk of death.
If approved, Abiomed Inc.'s application to the U.S. Food and Drug Administration would usher in the first commercial use of the device, which has been under development for 22 years, Michael Minogue, the company's chief executive and president, said Wednesday.
The softball-sized, implantable pump is powered by batteries and has no wires or tubes sticking through the skin, unlike earlier mechanical hearts that were attached to machinery outside the body.
The AbioCor has been limited in human use to an ongoing, nearly completed clinical trial begun more than three years ago. Fourteen patients have been enrolled so far, with expectations that a 15th and final candidate will be identified soon. The 13th and 14th patients were implanted with the devices in May at Jewish Hospital in Louisville, Ky., and are continuing to recover. Some patients have died during surgery or shortly after.
Abiomed said it was not required to enroll the final patient or complete the trial before submitting for approval under the FDA's so-called "humanitarian device" exemption covering novel treatments. If such an exemption is granted, the AbioCor could be used in as many as 4,000 U.S. patients each year who are too sick for human heart transplants or any other treatments because of congestive heart failure.
Products approved under the exemption do not have to meet the same effectiveness requirements that other products must demonstrate for broader marketing approval.
The application was filed with the FDA on Wednesday. The company hopes to win approval by next March.
Abiomed plans to begin offering training to about 20 medical centers nationwide on how to implant and use the device. The plastic-and-titanium AbioCor will likely be priced between $200,000 and $250,000, Minogue said.
Positive results during the clinical trial and lab tests of the device's ability to keep the heart beating for two years or more without wearing down gave the company confidence to file Wednesday's application.
The company makes other products to aid recovery in patients with hearts at risk of failing, but it has staked much of its future on the Abiocor.
Shares of Abiomed rose 11 cents to close at $9.91 Wednesday on the Nasdaq Stock Market.
A second-generation version of the AbioCor is expected to begin undergoing tests in animals in the next few months, with a human trial afterward, Minogue said. That device is designed to continue operating for five years or longer, and will be 35 percent smaller than the first-generation device, which is too large to fit many patients.
The first AbioCor recipient underwent the surgery in July 2001 and lived 151 days before suffering a fatal stroke.
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Abiomed Inc.: http://www.abiomed.com
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