LONDON--(BUSINESS WIRE)--May 30, 2018--
LivaNova PLC (NASDAQ:LIVN) (“LivaNova” or the “Company”), a
market-leading medical technology company, today issued a statement in
regard to the U.S. Centers for Medicare & Medicaid Services’ (“CMS”)
publication of a tracking sheet to reconsider its National Coverage
Determination (“NCD”) for the Company’s Vagus Nerve Stimulation Therapy®
(“VNS Therapy”) System for Treatment-Resistant Depression (“TRD”):
LivaNova has been engaged with CMS on this important issue and submitted
a letter to CMS requesting a formal reconsideration of the NCD for VNS
Therapy for patients with TRD. The Company is encouraged that CMS has
taken this initial step, which may provide access to this important
therapy for TRD that has been a Medicare non-covered indication for more
than a decade. A change in the Medicare coverage status of VNS Therapy
for TRD that ensures adequate patient access to this important therapy
would be a positive outcome for patients and physicians. The posting of
the National
Coverage Analysis (“NCA”) tracking sheet has opened the 30-day
public comment period. Interested parties may comment on the NCA
tracking sheet until June 29 as CMS brings greater attention to this
important public health issue. Over the last decade, a significant body
of new evidence has emerged showing that the addition of VNS Therapy is
effective in reducing symptoms in patients with TRD. We look forward to
working with CMS as they consider a change in Medicare coverage.
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, LivaNova has a presence in more than 100 countries worldwide.
The Company currently employs more than 3,500 employees.
LivaNova operates as two business franchises: Cardiac Surgery and
Neuromodulation, with operating headquarters in Mirandola (Italy)
and Houston (U.S.A.), respectively.
For more information, please visit www.livanova.com.
Safe Harbor Statement
This news release contains forward-looking statements within the meaning
of Section 27A of the United States Securities Act of 1933, as amended,
and Section 21E of the United States Securities Exchange Act of 1934, as
amended. Forward-looking statements are not historical facts but are
based on certain assumptions of management and describe LivaNova’s
future plans, strategies and expectations. Forward-looking statements
can generally be identified by the use of forward-looking terminology,
including, but not limited to, "may," “could,” “seek,” “guidance,”
“predict,” “potential,” “likely,” "believe," "will," "expect,"
"anticipate," "estimate," "plan," "intend," "forecast," or variations of
these terms and similar expressions, or the negative of these terms or
similar expressions. Forward-looking statements contained in this news
release are based on information presently available to LivaNova and
assumptions that LivaNova believes to be reasonable, but are inherently
uncertain. As a result, LivaNova’s actual results, performance or
achievements may differ materially from those expressed or implied by
these forward-looking statements, which are not guarantees of future
performance or actions that may be taken by LivaNova and involve known
and unknown risks, uncertainties and other factors that are, in some
cases, beyond LivaNova’s control. You should carefully consider the
risks and uncertainties that affect LivaNova, including those described
in the “Risk Factors” section of LivaNova’s Annual Reports on Form 10-K,
Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other
documents filed from time to time with the United States Securities and
Exchange Commission.
All information in this news release is as of the date of its release.
LivaNova does not undertake or assume any obligation to update publicly
any of the forward-looking statements in this news release to reflect
actual results, new information or future events, changes in assumptions
or changes in other factors affecting forward-looking statements, except
to the extent required by applicable law. If we update one or more
forward-looking statements, no inference should be drawn that we will
make additional updates with respect to those or other forward-looking
statements. We caution you not to place undue reliance on any
forward-looking statements, which are made only as of the date of this
news release.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180530006514/en/
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
Director,
Corporate Communications – Products & Therapies
corporate.communications@livanova.com