OrbusNeich Medical and P&F Products and Features received the CE mark for their TricValve transcatheter bicaval valves system.

The device is now cleared for treating caval reflux in cases of severe tricuspid regurgitation without removal of the defective tricuspid valve.

The European clearance offers a treatment option for patients who cannot undergo surgery or who have a dilated aortic annulus, a large coaptation gap or a pacemaker, the companies said.