LivaNova touts completion of 1st-in-man transseptal Caisson TMVR feasibility study

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 an...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves LivaNova Source Type: news