HighLife wins CE mark for TMVR system

HighLife announced today that it received CE mark approval for its transcatheter mitral valve replacement (TMVR) system.

The company received European approval for its valve system to treat adult patients with symptomatic moderate-severe-or severe mitral valve regurgitation (MR) deemed unsuitable for surgical repair/replacement and transcatheter edge-to-edge repair (TEER) by a multi-disciplinary heart team.

Paris-based HighLife says commercial availability for the system offers access to a transfemoral mitral valve replacement option. It features a dual-component, valve-in-ring design for treating native mitral annulus sizes between 30 mm and 53 mm. The company says this represents the broadest range of native mitral annulus sizes for any CE mark-approved TMVR system.

Sign up for Blog Updates