Archive for Wednesday, September 6, 2006

FDA approves sale of artificial heart devices

September 6, 2006


— A Massachusetts company received federal approval Tuesday to sell the world's first fully implantable artificial heart.

The 2-pound mechanical hearts would be used only in patients who are close to death and have no other treatment options.

The Food and Drug Administration granted Abiomed Inc. a humanitarian exemption allowing it to sell the AbioCor artificial hearts, agency spokeswoman Susan Bro said.

So far, the artificial heart has been tested in only 14 men. Two died from the operation, and another never regained consciousness. The rest survived only an average of five months, though notably one patient lived 10 months following surgery, and another 17 months.

Abiomed is targeting men - but not precluding women - with heart failure who are too sick for a heart transplant, have exhausted other options and are likely to die within a month. The current device is too large for about 90 percent of U.S. women and many men.

The mechanical pump is expected to cost about $250,000. It is unclear whether insurance would cover it.

The devices themselves now last about 18 months, or longer than most patients receiving them can be expected to live.


Use the comment form below to begin a discussion about this content.

Commenting has been disabled for this item.