Edwards acquires FDA clearance for first transcatheter tricuspid valve replacement treatment.

Edwards Lifesciences has gained FDA approval for its Evoque tricuspid valve replacement system, marking a significant advancement as the first transcatheter treatment for tricuspid regurgitation in the US.

Tricuspid regurgitation occurs when the valve between the two right heart chambers fails to close properly, resulting in blood leakage backward. Edwards' Evoque device is inserted through minimally invasive surgery, designed specifically for tricuspid valve replacement.

Competitor Abbott has submitted its TriClip device for FDA approval, aimed at clipping together tricuspid valve leaflets to prevent blood leakage. An FDA advisory panel is scheduled for February 13th to review the TriClip.

Edwards' FDA approval came earlier than expected, based on favorable outcomes in its Triscend II pivotal trial. 98.8% of patients achieved moderate or lower tricuspid regurgitation after six months, with a 27.4% adverse event rate after 30 days.

Edwards also secured a CE Mark for the Evoque device in October. It's indicated for patients with severe symptomatic tricuspid regurgitation despite medication treatment.