September 25, 2006
"AbioCor is the first fully implantable device for patients who aren't eligible for transplants."
Federal regulators on Tuesday approved the first fully implantable artificial heart for use by dying heart failure patients who are not eligible for a transplant.
The device, called AbioCor, was tested in 14 male patients. The 12 who survived the surgery lived an average of five months after receiving the mechanical heart.
The Food and Drug Administration said it approved the artificial heart for humanitarian use — a designation that meant the device was not tested in large clinical trials but might benefit 4,000 or fewer people a year.
The company that manufactures the device, Abiomed Inc. of Danvers, Mass., said up to 10 hospitals would begin offering the device within the next six to eight months.
For the full story, please go to: