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.

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.

It was a robust month for medtech M&A deal making with 17 deals in May, making it the busiest month of the year to date. The total number of acquisitions beat the number recorded in May last year and picked up slightly from the 14 deals inked in the previous month.