|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 (
Safe Harbor Statement
This news release contains forward-looking statements within the meaning
of Section 27A of the United States Securities Act of 1933, as amended,
and Section 21E of the United States Securities Exchange Act of 1934, as
amended. Forward-looking statements are not historical facts but are
based on certain assumptions of management and describe LivaNova’s
future plans, strategies and expectations. Forward-looking statements
can generally be identified by the use of forward-looking terminology,
including, but not limited to, "may," “could,” “seek,” “guidance,”
“predict,” “potential,” “likely,” "believe," "will," "expect,"
"anticipate," "estimate," "plan," "intend," "forecast," or variations of
these terms and similar expressions, or the negative of these terms or
similar expressions. Forward-looking statements contained in this news
release are based on information presently available to
All information in this news release is as of the date of its release.
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?