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USA approval for Abbott's heart valve repair device

Abbott Laboratories (ABT.N), opens a new tab said on Tuesday the U.S.A. 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 Life-sciences rival device for the condition was approved to open a new tab 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.