LivaNova has announced the conclusion of the PRELUDE feasibility study for its Caisson transcatheter mitral valve implantation (TMVI) system. The PRELUDE first-in-human study evaluated the company’s TMVI system to treat moderate to severe mitral regurgitation using a transseptal approach. Following the positive patient outcomes from the PRELUDE study, a press release reports, the company will now focus on enrolling patients in the INTERLUDE CE mark trial and finalising the protocol for the US pivotal trial, ENSEMBLE, with the US FDA.
Principal investigator of the PRECLUDE study, Mathew Williams (NYU Langone Health, New York, USA), says: “Patients with moderate to severe mitral regurgitation are often too sick for traditional open-heart surgery. We saw encouraging outcomes in patients within the PRELUDE trial. Follow-up results showed positive acute valve performance, which was maintained over time, along with improved quality of life.” He adds: “We are pleased to continue our TMVI research with the INTERLUDE trial.”
Paul Buckman, LivaNova general manager of TMVI, says: “At LivaNova, we believe our transseptal approach for TMVI 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 TMVI system is durable over time, while demonstrating its fully repositionable and retrievable capabilities.”
The INTERLUDE trial will be conducted in North American and European centres with enrolment completion expected by 2020.