LivaNova (NSDQ:LIVN) said today it concluded the Prelude first-in-human feasibility study exploring the transseptal use of its Caisson transcatheter mitral valve replacement system designed to treat mitral valve regurgitation.
In the study, investigators explored the use of the Caisson TMVR system through a transseptal approach, which the London-based company claims is a less-invasive approach which uses a catheter inserted through an incision in the groin instead of an opening in the chest.
LivaNova touted “positive patient outcomes” from the study, but has not released data from it. The company said that with the conclusion of the Prelude trial, it is now focusing on enrolling patients in its Interlude trial, which will support CE Mark approval in the European Union, and finalizing protocols for a US pivotal trial with the FDA.
“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. We are pleased to continue our TMVR research with the Interlude trial,” principal trial investigator Dr. Mathew Williams of NYU Langone Health, who has performed the most TMVR procedures with the company’s system, said in a prepared statement.
“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,” LivaNova TMVR GM Paul Buckman said in a press release.
The company said its Interlude trial is slated to be conducted at North American and European centers, and that it expects to complete enrollment by 2020.
Earlier this month, LivaNova handily topped the consensus forecast for its second-quarter results despite a huge bottom-line slide.