LivaNova PLC Announces the First Patient Enrolled in the PERSIST-AVR Trial
(Thomson Reuters ONE) -
New International Study Evaluates Perceval, the First Truly Biological
Sutureless Valve, for Patients Requiring Aortic Valve Replacement Surgery
LONDON, April 04, 2016 (GLOBE NEWSWIRE) -- LivaNova, PLC
(NASDAQ:LIVN) (LSE:LIVN) (the "Company"), a global medical technology company,
announced today the first implant of the Perceval sutureless valve in
the PERSIST-AVR (Perceval Sutureless Implant
Vs Standard Aortic Valve Replacement) trial at CHU Brabois, University of
Lorraine, Nancy, France. Engineered to restore the natural valve performance,
Perceval is a sutureless heart valve for patients who require replacement of
their aortic valve.
PERSIST-AVR is the first worldwide, prospective, randomized, multi-center trial,
comparing Perceval sutureless aortic valve with standard sutured bioprostheses
in patients with aortic valve disease. The study will enroll over 1,200 patients
with severe symptomatic aortic stenosis or steno-insufficiency in patients who
are candidates for surgical replacement of their native aortic valve. The
primary endpoint of the trial is non-inferiority of Major Adverse Cardiac
Cerebrovascular Events (MACCE) at one year according to VARC-2 criteria.(1)
"The clinical experience with the Perceval valve has been positive on multiple
fronts as measured by reduced cross-clamp time, great hemodynamic performance,
low structural valve deterioration and freedom from reoperation up to five-year
follow-up.(2) PERSIST-AVR is designed to confirm these results compared to
standard sutured stented valves. Moreover, the trial will demonstrate how the
use of Perceval in aortic valve surgery is linked with significant cost savings,
driven primarily by reduced procedural costs and reduced hospital stay," said
Professor Thierry Folliguet, M.D., Ph.D., who enrolled the first patient in
PERSIST-AVR. Prof. Folliguet is part of the Steering Committee of the study and
one of the early implanters of Perceval.
Conducted worldwide, the study is planned to have a two-year enrollment period
and a yearly follow-up for a five-year period. The primary endpoint is expected
to be available in 2019.
"We know that PERSIST-AVR is a landmark clinical trial, being the first
randomized study in 30 years in the field of valvular surgery. Its initiation is
a great endeavor in the cardiac surgery communities. More than 60 centers around
the world will be recruited pointing out the strong interest generated by
Perceval. We look forward to obtaining promising data for the use of Perceval in
the daily aortic valve replacement setting," said Professor Theodor Fischlein,
M.D., Ph.D., Paracelsus Medical University Cardiovascular Center, Nuremberg,
Germany, and Dr. Roberto Lorusso, M.D., Ph.D., Cardio-Thoracic Surgery
Department, Maastricht University Medical Centre (MUMC+), Maastricht, The
Netherlands, both principal investigators of the study.
"As the first trial of its kind, the PERSIST-AVR study is a significant
milestone for LivaNova, the healthcare community and patients worldwide," said
Michel Darnaud, President, Cardiac Surgery B.U., LivaNova, PLC. "We are proud to
support this important trial. We anticipate its results could significantly
impact daily practice and establish the Perceval sutureless valve as the
prosthesis of choice for future heart valve surgeries."
To date, the Perceval sutureless valve has been implanted in more than 15,000
patients in over 310 hospitals worldwide. More than 115 publications testify the
good clinical results obtained with the device. The Perceval valve is approved
for use in Europe, US and other international markets including Canada and
Australia.
References
(1 )Kappetein, A. P., Head S. J., Genereux P., et al. "Updated Standardized
Endpoint Definitions for Transcatheter Aortic Valve Implantation: The Valve
Academic Research Consortium-2 Consensus Document." J Thorac Cardiovasc
Surg 145, no. 1 (2013): 6-23.
(2) Shrestha M. , Fischlein T., Meuris B. et al. "European multicentre
experience with the sutureless Perceval valve: clinical and haemodynamic
outcomes up to 5 years in over 700 patients" Eur J Cardiothorac Surg. 2016
Jan;49(1):234-41
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 and Media
Karen King
Vice President, Investor Relations & Corporate Communications
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#2000252]
Datum: 04.04.2016 - 15:00 Uhr
Sprache: Deutsch
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