Abiomed May Not Meet Enrollment Timeline in Mechanical Heart Trial

Abiomed Inc. said on Wednesday that it is slowing patient enrollment in a clinical trial of its AbioCor implantable self-contained mechanical heart while it reviews the implantations already conducted in the trial.

However, the company said that a filing for US approval for limited indications is still expected before the end of 2003.

“Previously, we had announced that all 15 clinical trial patients and implants would be complete by June 30,” a company spokeswoman told Reuters Health. She said the company now believes that goal might not be met “because we really are taking time to reflect on the previous six implants to ensure the clinical success of the remaining nine.”

The clinical study is designed to evaluate whether the AbioCor can double the survival time of irreversible biventricular heart failure patients who have a life expectancy of less than 30 days and no other clinical alternative.

To date, six patients have been enrolled in the trial. Five have actually received the AbioCor device, of whom three have died, the spokeswoman said. The sixth patient died during surgery before implantation.

The spokeswoman said Abiomed believes that one of the deaths resulted from a stroke that may have been caused by a cage — essentially two semicircular struts — that surrounded the original AbioCor device.

She said a thrombus may have developed on the struts, dislodged, and contributed to the stroke. A total of three AbioCor patients have experienced stroke.

The company, the spokeswoman said, has already addressed this issue by removing the cage from the AbioCor.

Despite the deaths, the spokeswoman said that the AbioCor has been extremely successful, with four of five patients supported by the device meeting the trial’s primary endpoint. “One patient missed it by about four days,” she said.