Company is advancing clinical research with three aortic valve studies
LONDON--(BUSINESS WIRE)--Jan. 11, 2018--
LivaNova PLC (NASDAQ:LIVN) (“LivaNova” or the “Company”), a
market-leading medical technology company, today announced that the
first patient has been enrolled in the Behavior of Valve Leaflets
and the Incidence of Reduced Mobility Post-Surgical Aortic
Valve Implant Study (“BELIEVE”). This study is a post-market,
prospective, interventional, multi-center trial designed to report the
overall incidence of reduced leaflet motion identified by CT imaging in
patients receiving a commercially approved LivaNova bioprosthetic aortic
heart valve.
“Thrombus formation on valve leaflets has been shown to occur in some
patients receiving prosthetic tissue valve replacement via transcatheter
or open surgical procedures and may lead to leaflet thickening and
immobility,” said Dr. Brian Duncan, LivaNova’s Vice President of Medical
Affairs in Cardiac Surgery. “BELIEVE is the first trial to examine this
process with advanced imaging and a standardized approach to
anticoagulation in patients undergoing implantation of LivaNova
bioprosthetic aortic valves.”
The BELIEVE study is expected to enroll approximately 230 patients at 15
sites from the U.S. and Canada to ascertain whether valve leaflets are
fully operational following surgery. Four-dimensional, volume-rendered
CT scans will be obtained from patients at a minimum of 30 days after
they discontinue anticoagulation or dual antiplatelet therapy. There
will be one year of follow-up for all patients.
“The BELIEVE study is designed to enhance the understanding of reduced
leaflet motion phenomenon, while providing important information to
clinicians and patients to ensure the best possible outcomes after
surgical aortic valve replacement,” said Dr. Basel Ramlawi, who enrolled
the first patient in BELIEVE and is the attending cardiothoracic surgeon
and chairman of The Heart & Vascular Center at Valley Health System in
Winchester, Va., in the U.S.
In addition to BELIEVE, LivaNova is sponsoring two global studies to
advance clinical evidence for aortic valve replacement. The Sorin Universal
Registry on Aortic Valve Replacement
(“SURE-AVR”) is a post-market, international, prospective, multi-center
observational registry collecting clinical outcomes data from up to
5,000 patients implanted with LivaNova aortic devices (bioprosthetic or
mechanical). Currently, more than 1,400 patients have been enrolled in
the registry from 35 active sites in 13 countries. U.S. sites are
currently being activated within this registry, which will follow all
patients through five years of follow-up.
The Perceval® Sutureless Implant vs. Standard
Aortic Valve Replacement (“PERSIST-AVR”) Study is a
global, randomized controlled trial in the surgical treatment of aortic
valve replacement. More than 1,200 patients will be randomized to
receive either a LivaNova sutureless valve, Perceval, or a standard,
sutured, stented bioprosthetic valve on market (LivaNova or other).
Currently, more than 570 patients have been enrolled in the study from
43 active sites in multiple countries. U.S. sites are currently being
activated within this study, which will follow all patients through five
years of follow-up. The primary endpoint of the study is one year
freedom from major adverse cardiovascular and cerebral events (composite
endpoint of all cause deaths, myocardial infarction, stroke and
valve-related re-intervention).
About LivaNova
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 and with a presence in more than 100 countries worldwide, the
company employs more than 4,500 employees. LivaNova operates as three
business franchises: Cardiac Surgery, Neuromodulation and Cardiac Rhythm
Management, with operating headquarters in Mirandola (Italy),
Houston (U.S.A.) and Clamart (France), respectively.
For more information, please visit www.livanova.com.
Safe Harbor Statement
This news release may include certain statements concerning expectations
for the future that are forward-looking statements as defined by U.S.
federal law. Such forward-looking statements are subject to a variety of
known and unknown risks, uncertainties and other factors that are
difficult to predict and many of which are beyond management's control.
An extensive list of factors that can affect future results are
discussed in LivaNova's Annual Report on Form 10-K and other documents
filed from time to time with the Securities and Exchange Commission.
LivaNova undertakes no obligation to update or revise any
forward-looking statement to reflect new information or events. Actual
results may differ materially from anticipated results.
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Source: LivaNova PLC
LivaNova PLC Investor Relations and Media
Karen King, +1
(281) 228-7262
Vice President, Investor Relations & Corporate
Communications
or
Deanna Wilke, +1 (281) 727-2764
Corporate
External Communications Manager
corporate.communications@livanova.com