LivaNova has announced plans to end the Caisson Transcatheter Mitral Valve Replacement (TMVR) programme and restructure its heart valve business for improved profitability and business continuity.

According to LivaNova, its heart valve business line, which generated approximately $130m in revenue in 2018, has seen a decline in revenue over the past five years across both biological and mechanical valves.

Market conditions, increased portfolio maintenance costs and higher regulatory requirements are cited by the company as causes for the decline in revenue.

LivaNova chief executive officer Damien McDonald said: “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.”

LivaNova’s restructuring decision follows a comprehensive analysis

Under the restructuring plan, the company intends to dedicate its Saluggia facility in Italy for R&D and production of mechanical heart valves, rings, accessories, and Nitinol stents, while its Vancouver plant will be used for the production of tissue heart valves.

LivaNova said the restructuring plan is expected to impact approximately 150 employees across sites at Saluggia, Vancouver and Minneapolis.

As part of the restructuring plan, the closure of Caisson TMVR operations in Minneapolis, Minnesota, will be effective at the end of 2019.

Patients who participated in clinical trials related to the TMVR would continue to be followed within the parameters of the trial, said the company.

Employing nearly 4,000 employees, LivaNova has a presence in more than 100 countries. It operates as two businesses, Cardiovascular and Neuromodulation, with headquarters in Mirandola, Italy, and Houston in the US, respectively.