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Abiomed receives FDA approval for replacement heart

Medical device firm Abiomed has received FDA humanitarian device exemption supplement approval on system upgrades for its AbioCor implantable replacement heart.

The AbioCor implantable replacement heart is intended to replace the severely damaged native heart for patients who are not eligible for a transplant and have no other treatment alternative. The company said that its implantable replacement heart sustains the body’s circulation and is designed to extend the lives of patients who would otherwise die of heart failure, while also offering a probable benefit for a satisfactory quality of life.

Michael Minogue, chairman, CEO and president of Abiomed, said: “This is a momentous day for Abiomed and advanced heart failure patients who cannot recover their natural heart or receive a transplant. We have selected leading US hospitals committed to the AbioCor program and expect patient implants with AbioCor to commence in early 2008.”