LivaNova PLC Announces FDA Approval of Stented Heart Valve CROWN PRT(TM) for Aortic Valve Disease
(Thomson Reuters ONE) -
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 tissue(1) 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 replacements."
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: www.livanova.com.
References: (1 )Based on 60-day animal model. Data on file.
About LivaNova
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".
Safe harbor statement
This press release contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended and Section 21E of the
Securities Exchange Act of 1934, as amended. These statements can be identified
by the use of forward-looking terminology, including "may," "believe," "will,"
"expect," "anticipate," "estimate," "plan," "intend," "forecast," or other
similar words. Statements contained in this press release are based on
information presently available to LivaNova and assumptions that the parties
believe to be reasonable. LivaNova is not assuming any duty to update this
information if those facts change or if the assumptions are no longer believed
to be reasonable. Investors are cautioned that all such statements involve
risks and uncertainties, including without limitation, statements concerning
developing novel opportunities in heart failure, sleep apnea and percutaneous
mitral valve, creating new innovative solutions that benefit patients,
healthcare professionals, and healthcare systems, and building significant
shareholder value. Important factors that may cause actual results to differ
include, but are not limited to: risks that the new businesses will not be
integrated successfully or that the combined companies will not realize
estimated cost savings, value of certain tax assets, synergies and growth, or
that such benefits may take longer to realize than expected; the inability of
LivaNova to meet expectations regarding the timing, completion and accounting
and tax treatments; risks relating to unanticipated costs of integration,
including operating costs, customer loss or business disruption being greater
than expected; reductions in customer spending, a slowdown in customer payments
and changes in customer demand for products and services; unanticipated changes
relating to competitive factors in the industries in which the company operates;
the ability to hire and retain key personnel; the ability to attract new
customers and retain existing customers in the manner anticipated; reliance on
and integration of information technology systems; changes in legislation or
governmental regulations affecting the company; international, national or local
economic, social or political conditions that could adversely affect the company
or its customers; conditions in the credit markets; risks to the industries in
which LivaNova operates that are described in the "Risk Factors" section of the
Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents
filed from time to time with the SEC by Cyberonics, Inc. and LivaNova and the
analogous section in annual reports and other documents filed from time to time
by Sorin S.p.A. with the Italian financial market regulator (CONSOB); risks
associated with assumptions made in connection with critical accounting
estimates and legal proceedings; LivaNova's' international operations, which are
subject to the risks of currency fluctuations and foreign exchange controls; and
the potential of international unrest, economic downturn or effects of
currencies, tax assessments, tax adjustments, anticipated tax rates, raw
material costs or availability, benefit or retirement plan costs, or other
regulatory compliance costs. The foregoing list of factors is not exhaustive.
You should carefully consider the foregoing factors and the other risks and
uncertainties that affect the parties' businesses, including those described in
Cyberonics' Annual Report on Form 10-K, as amended from time to time, Quarterly
Reports on Form 10-Q, Current Reports on Form 8-K and other documents filed from
time to time with the SEC by Cyberonics and LivaNova and those described in
Sorin's annual reports, registration documents and other documents filed from
time to time with CONSOB by Sorin. LivaNova does not give any assurance (1) that
LivaNova will achieve its expectations, or (2) concerning any result or the
timing thereof, in each case, with respect to any regulatory action,
administrative proceedings, government investigations, litigation, warning
letters, consent decree, cost reductions, business strategies, earnings or
revenue trends or future financial results.
For more information, please visit www.livanova.com, or contact:
Investor Relations:
Vivid Sehgal
Chief Financial Officer
e-mail: investor.relations(at)livanova.com
Investor Relations and Media:
Greg Browne
Senior Vice President, Finance
Phone: +1 (281) 228-7262
Fax: +1 (281) 218-9332
e-mail: corporate.communications(at)livanova.com
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: LivaNova plc via GlobeNewswire
[HUG#1982392]
Datum: 01.02.2016 - 14:00 Uhr
Sprache: Deutsch
News-ID 447742
Anzahl Zeichen: 10095
contact information:
Town:
London
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 239 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"LivaNova PLC Announces FDA Approval of Stented Heart Valve CROWN PRT(TM) for Aortic Valve Disease"
steht unter der journalistisch-redaktionellen Verantwortung von
LivaNova plc (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
