Artificial heart's upgrades win FDA approval

The Food and Drug Administration has approved system upgrades for Abiomed Inc.’s AbioCor implantable replacement heart.

The device replaces severely damaged hearts in patients who are not eligible for a transplant or other treatments.

Danvers-based Abiomed announced the approval today.

AbioCor will be made available to a maximum of 4,000 people in the United States each year.

Abiomed has selected four sites so far as AbioCor centers: Johns Hopkins Hospital in Baltimore; Robert Wood Johnson University Hospital in New Brunswick, N.J.; Texas Heart Institute at St. Luke’s Episcopal Hospital in Houston; and St. Vincent’s Hospital in Indianapolis.

The company said it expects to charge $250,000 per AbioCor unit.
(AP)