LivaNova Concludes PRELUDE Study for Transcatheter Mitral Valve Replacement System

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 U.S. Food and Drug Administration (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.
 
“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,” said Paul Buckman, LivaNova general manager of TMVR.
 
The INTERLUDE trial will be conducted in North American and European centers with enrollment completion expected by 2020.
 
LivaNova PLC is a global medical technology company built on nearly five decades of experience and a commitment to improve the lives of patients around the world. LivaNova’s technologies and  treatments provide solutions for the benefit of patients, healthcare professionals and healthcare systems. Headquartered in London, LivaNova has a presence in more than 100 countries worldwide. The company currently employs approximately 4,000 employees. LivaNova operates as two businesses: Cardiac Surgery and Neuromodulation, with operating headquarters in Mirandola (Italy) and Houston, Texas, respectively.