LivaNova PLC Announces Approval of Perceval
(Thomson Reuters ONE) -
LONDON, Jan. 11, 2016 (GLOBE NEWSWIRE) -- LivaNova PLC (NASDAQ:LIVN) (LSE:LIVN)
(the "Company") announced that, on January 8, 2016, the Company received
approval from the United States Food and Drug Administration ("FDA") for the
Perceval Sutureless Heart Valve ("Perceval"). The approval is effective
immediately, and the Company will begin commercial distribution of the device in
the U.S. over the coming quarter.
Perceval is a surgical aortic valve with a unique self-anchoring frame that
enables the surgeon to replace the diseased valve without suturing it into
place. The valve's functional component is made of bovine pericardium and is
mounted on a super-elastic alloy frame. Clinical results in patients implanted
with Perceval have shown a significant reduction in surgical procedural time for
both isolated and complex aortic valve replacement with aortic cross-clamp times
typically reduced by at least 50%.
"We are excited to bring this important product to the U.S. market, which will
provide real value to patients and physicians," said André-Michel Ballester,
Chief Executive Officer. "The rapid acceptance of Perceval in Europe, an
increasing number of positive publications on the product, and the solid
preparation of our U.S. sales team, all provide a strong base for the
achievement of our short and long term plans," concluded Mr. Ballester.
Perceval is indicated for the replacement of diseased, damaged, or
malfunctioning native or prosthetic aortic valves. The sale and distribution of
the Perceval heart valve is limited to prescription use by specially-trained
practitioners, and the Company has developed a nationwide training and
proctoring program to help ensure the safety and effectiveness of the device.
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".
For more information, please visit www.livanova.com, or contact:
Investor Relations: Investor Relations and Media:
Vivid Sehgal Greg Browne
Chief Financial Officer Senior Vice President, Finance
e- Phone: +1 (281) 228-7262
mail: investor.relations(at)livanova.com 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
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