|
|
Article: Heart implant device is approved by the FDA
- Article from:
- Daily Breeze
- Article date:
- September 6, 2006
- Author:
CopyrightCopyright 2006 Daily Breeze. Provided by ProQuest LLC. (Hide copyright information)
|
WASHINGTON -- The Food and Drug Administration gave limited
approval on Tuesday to a Massachusetts company to sell the first
fully implantable artificial heart, a device that can let patients
move about freely for up to two hours at a time.
The approval was given even though the grapefruit-size device was
implanted in just 14 patients at four hospitals from 2001 to 2004.
All the patients, who agreed to receive the heart as an
experimental device, were men, and all have died.
Nevertheless, the agency gave the company, Abiomed Inc. of
Danvers, Mass., a humanitarian exemption allowing it to sell up to
4,000 ...