LivaNova Finishes Feasibility Trial Of Transcatheter Mitral Valve, Anticipates 2020 CE Mark
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.
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Patients with severe secondary mitral regurgitation treated with MitraClip and medical therapy have the same rate of death or unplanned hospitalization for heart failure at one year as patients treated with medical therapy alone, results of MITRA-FR show. Abbott, as well as other companies developing transcatheter mitral-repair technology, will now look to the COAPT trial to establish MitraClip's benefits on clinical outcomes.
Medical innovator LivaNova has a new stated focus: it won’t go outside the head and the heart when it comes to potential M&A and technology development projects. It has set out short- and longer-term solutions to boost sales and/or profitability in its neuromodulation and cardio franchises. What is certain is that eight months into his tenure as CEO, Damien McDonald is stamping his imprint all over LivaNova.
Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial announcements, initiations, completions, and suspensions each month. This month's edition, covering the period between mid-July and mid-August, includes trials from the biggest medtech players, some start-ups, and companies of every size in between.