LivaNova PLC Announces FDA Approval of Stented Heart Valve CROWN PRT™ for Aortic Valve Disease
By GlobeNewswire, February 01, 2016, 08:00:00 AM EDT
LivaNova Demonstrates Commitment to Advancing Cardiac Surgery Through
Broad Portfolio of Aortic Valve Replacement Solutions
LONDON, Feb. 01, 2016 (GLOBE NEWSWIRE) -- LivaNova PLC (NASDAQ:LIVN)
(LSE:LIVN) (the "Company"), a global medical technology company and a
leader in the treatment of cardiovascular diseases, today announced it
has been granted approval from the United States Food and Drug
Administration (FDA) for its innovative stented aortic bioprosthesis
CROWN PRT for the treatment of aortic valve disease. This is the
second valve to be approved in the U.S. this year and is expected to
be launched in the coming months. LivaNova's Perceval valve, the
sutureless biological valve on the market for aortic valve replacement
procedures, was approved on January 8, 2016.
The CROWN PRT is the latest advancement in stented aortic
bioprosthesis technology and features a surgeon-friendly design,
optimizing hemodynamics and the patented Phospholipid Reduction
Treatment (PRT), which was designed to enhance valve durability. As a
high-performing, durable valve, CROWN PRT is an ideal aortic valve
replacement option for older patients.
"CROWN PRT is a modern bioprosthesis enabling a simple, safe, reliable
and reproducible cardiac surgery procedure for patients in need of an
aortic valve replacement," said Prof. Rainald Seitelberger, M.D.,
Salzburg University Clinic in Austria. "Data have shown that
phospholipids play an important role in the calcification process of
bioprosthesis, and LivaNova's CROWN PRT has proven to decrease
phospholipid content in the tissue1 leading to superior valve
longevity. CROWN PRT's durability, along with its ease of use during
procedures and ability to provide excellent hemodynamic performance,
makes it an ideal valve for current and future aortic valve
CROWN PRT enables intuitive intraoperative handling through enhanced
ease of implant with visible markers and improved radiographic
visualization through dedicated X-ray markers. The stented aortic
heart valve replacement is strategically designed to provide
physicians with greater surgical versatility and provides patients a
long-lasting valve replacement.
"LivaNova is excited to launch CROWN PRT with its outstanding
hemodynamic performance and durability, and we look forward to its
adoption in the dynamic and evolving market of cardiac surgery," said
Michel Darnaud, President, LivaNova Cardiac Surgery Business Unit.
"With nearly 50 years of experience in heart valve design and
innovation, LivaNova is proud to be the only cardiac surgery company
offering the most comprehensive spectrum of heart valves available in
the U.S., including sutureless, stented and stentless valves. The
introduction of our state-of-the-art aortic valve technologies, CROWN
PRT and Perceval valve, reflects LivaNova's commitment to providing
cardiac surgery treatments that optimize a surgeon's ability to
deliver the best care possible to their patients."
To learn more about LivaNova and its broad range of cardiac surgery
solutions, including the Perceval and CROWN PRT, please visit:
References: 1 Based on 60-day animal model. Data on file.
LivaNova PLC, headquartered in London, UK, is a global medical
technology company formed by the merger of Sorin S.p.A, a leader in
the treatment of cardiovascular diseases, and Cyberonics Inc., a
medical device company with core expertise in neuromodulation.
LivaNova transforms medical innovation into meaningful solutions for
the benefit of patients, healthcare professionals, and healthcare
systems. The company employs approximately 4,500 employees worldwide.
With a presence in more than 100 countries, LivaNova operates as three
business units: Cardiac Rhythm Management, Cardiac Surgery, and
Neuromodulation, with operating headquarters in Clamart (France),
Mirandola (Italy) and Houston (U.S.A.), respectively.
LivaNova is listed on NASDAQ and listed on the Official List of the
UK's Financial Conduct Authority and traded on London Stock Exchange
(LSE) under the ticker symbol "LIVN".
Erich A. Sandoval, Chief Media Strategist
L A Z A R P A R T N E R S L T D - WEST - Los Angeles