April 2 (Reuters) - Abbott Laboratories ( ABT ) said on
Tuesday the U.S. FDA has approved its heart valve repair device
designed for patients at risk of complications or death during
open-heart surgeries.
The device, TriClip, already approved in over 50 countries,
aims to treat tricuspid regurgitation (TR), a potentially fatal
condition where the valve separating the right lower chamber of
the heart from the right upper does not close properly.
The condition typically impacts older individuals with
multiple co-morbid conditions such as irregular heartbeat and
high blood pressure in the lungs or heart.
The Abbott device can offer patients an option "without
subjecting them to high-risk open-heart surgery that may not be
feasible for individuals with TR who are generally older and
sicker," said Paul Sorajja, co-principal investigator of the
device's late-stage trial.
The device is inserted through the femoral vein in the leg
and is then guided and clipped onto the tricuspid valve.
In February, Edwards Lifesciences ( EW ) rival device for the
condition was approved by the U.S. Food and Drug Administration,
around the same time when advisers to the health regulator
backed Abbott's device.
Abbott counts TriClip in its group of so-called "Fab 5"
devices, which are expected to drive sales growth in the coming
years.