LivaNova Concludes PRELUDE Study for Transcatheter Mitral Valve Replacement System
Company now focused on INTERLUDE CE Mark trial, building upon positive patient outcomes
“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.
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.1,2
“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
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 relentless commitment to improve the lives
of patients around the world. LivaNova’s advanced technologies and
breakthrough treatments provide meaningful 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 (
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1. Lloyd-Jones D, Adams RJ, Brown TM, et al; American Heart
Association Statistics Committee and Stroke Statistics Subcommittee.
Heart disease and stroke statistics—2010 update: a report from the
2. Mirabel M, Iung B, Baron G, et al. What are the
characteristics of patients with severe, symptomatic, mitral
regurgitation who are denied surgery?
Deanna Wilke, +1 281-727-2764
Director, Corporate Communications