PRELUDE feasibility study of Caisson Transcatheter Mitral Valve Replacement (TMVR) system concludes positively.- LivaNova PLC.
LivaNova PLC announced the conclusion of the PRELUDE feasibility study for its Caisson Transcatheter Mitral Valve Replacement (TMVR) system. The PRELUDE first-in-human study evaluated the Company�s TMVR system to treat moderate to severe mitral regurgitation (MR) using a transseptal approach. This is a less invasive approach using a tube (catheter) through an incision in the groin, instead of an opening in the chest, to replace a patient�s mitral valve.
Following the positive patient outcomes from the PRELUDE study, the Company will now focus on enrolling patients in the INTERLUDE CE Mark trial and finalizing the protocol for the U.S. pivotal trial, ENSEMBLE, 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,� said Principal Investigator Dr. Mathew Williams, Chief of Adult Cardiac Surgery and Director of the Heart Valve Program at NYU Langone Health. Williams, who has performed the most LivaNova TMVR implants to date, added, �We are pleased to continue our TMVR research with the INTERLUDE trial.�
MR is a condition in which a patient�s mitral valve does not close tightly, allowing blood to flow backward into the heart. As a result, blood cannot move through the heart or to the rest of the body as efficiently, causing fatigue and shortness of breath. Only a small percentage of the millions of people with moderate to severe MR are treated because of prohibiting factors that can include advanced age, impaired heart function and multiple comorbidities.
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