Abbott Laboratories 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 is approved in more than 50 countries, including Canada and nations in Europe, for treating tricuspid regurgitation (TR), which typically impacts older individuals with multiple co-morbidities, making open-heart surgeries a high-risk procedure.

The condition that can potentially cause heart failure is estimated to affect about 1.6 million Americans, according to government data.

In TR, the valve separating the right lower chamber of the heart from the right upper does not close properly.

Abbott CEO Robert Ford had earlier included TriClip in his "Fab 5" devices, which are expected to see high sales growth in the coming years.