A press release reports that LivaNova is to discontinue its Caisson transcatheter mitral valve replacement programme and will undertake a restructuring of its heart valve business to improve profitability and ensure business continuity. It adds that LivaNova’s heart valve business line represented nearly $130 million in revenue for full-year 2018 and has experienced a revenue decline over the last five years across both biological and mechanical valves.

These declines in revenue, according to the press release, were because of multiple market conditions; also, portfolio maintenance costs increased specifically due to higher regulatory requirements. Therefore, after a comprehensive analysis, the LivaNova determined a restructuring was necessary.

Under the restructuring plan, LivaNova’s Saluggia (Italy) facility will become dedicated to research and develop as well as production of mechanical heart valves, rings, accessories and nitinol stents. LivaNova tissue heart valve production will be concentrated in the company’s Vancouver (Canada) plant. The closure of Caisson TMVR operations in Minneapolis (USA) will be effective at the end of 2019. Patients who participated in clinical trials related to TMVR will continue to be followed within the parameters of the trial.

Under the restructuring plan, which will be implemented subject to any prior information and consultation procedure with social parties according to local legislation, it is expected that approximately 150 employees can be potentially impacted in the three sites of Saluggia, Vancouver and Minneapolis.

Damien McDonald, CEO, of LivaNova, says: “The time has come to address the continued declines we have experienced in our heart valve business. We will restructure and simplify our heart valve manufacturing network, which will eliminate operational overlap between facilities and enable us to address new regulatory requirements. As we evaluated these changes along with those in the structural heart market, we determined it was no longer viable to continue to invest in our TMVR program. As a result, we will close our Caisson TMVR operations.”