UK-based medical technology company LivaNova has completed the PRELUDE feasibility study of its transcatheter mitral valve replacement (TMVR) system called Caisson for the treatment of moderate to severe mitral regurgitation (MR).
The system is used via a less invasive transseptal approach, where a tube/catheter is inserted through an incision in the groin, instead of standard open-heart surgery, for replacing a patient’s mitral valve.
Results from the feasibility study are said to indicate an encouraging profile, with positive, sustained acute valve performance and better quality of life.
LivaNova general manager of TMVR Paul Buckman said: “At LivaNova, we believe our transseptal approach for TMVR is an ideal and less invasive treatment option for patients who suffer from mitral regurgitation since they are typically very ill.
“The initial PRELUDE study results have been meaningful and suggest that our TMVR system is durable over time while demonstrating its fully repositionable and retrievable capabilities.”
The PRELUDE study will be followed by the initiation of patient enrolment in the INTERLUDE CE-Mark clinical trial, which will be performed at sites across North American and Europe.
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LivaNova will also work with the US Food and Drug Administration (FDA) to finalise the protocol for a pivotal trial called ENSEMBLE to be conducted in the country.
MR is characterised by the improper closing of the mitral valve, leading to a backward flow of blood into the heart. This affects the efficient flow of blood through the heart and other body parts.
The condition results in fatigue and shortness of breath but only a small proportion of the millions of patients with moderate to severe MR receive treatment due to various factors such as advanced age, impaired heart function and different comorbidities.