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LivaNova Finishes Feasibility Trial Of Transcatheter Mitral Valve, Anticipates 2020 CE Mark

 
• By Reed Miller

PRELUDE feasibility study of LivaNova's Caisson transseptal transcatheter mitral valve replacement (TMVR) system is complete and the company the INTERLUDE CE Mark trial has begun, the company announced. The company is now working with the US FDA to finalize the protocol for the ENSEMBLE US pivotal trial.

Liva Nova TMVR System
LivaNova Caisson Transcatheter Mitral Valve Replacement (TMVR) system • Source: LivaNova PLC

LivaNova PLC expects its Caisson transcatheter mitral valve replacement (TMVR) system to earn a CE mark in 2020, based on results of the INTERLUDE registry.

Enrollment in INTERLUDE, a single-arm study planned for 75 patients, has begun in Canada and will enroll patients in Europe and North America, Paul Buckman, LivaNova's General Manager for TMVR,...

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