LivaNova Builds Strategic Base And Commercial Case To Silence Skeptics
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.
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LivaNova's RECOVER trial will randomize about 1,000 patients with treatment-resistant depression to either LivaNova’s vagus nerve stimulation therapy or a sham therapy and follow them for at least a year.
LivaNova is counting on CMS paying more than lip service to the value-based agenda as it assesses coverage decisions for Vagus Nerve Stimulation (VNS) for the treatment of resistant depression over the coming months. In many ways it is a test for both parties.
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.