SAN DIEGO, March 20, 2017 /PRNewswire/ -- NuVasive,
Inc. (NASDAQ: NUVA), a leading medical device company focused on
transforming spine surgery with minimally disruptive,
procedurally-integrated solutions, today announced updated guidance
from the National Industry for Clinical Excellence (NICE) in the
U.K. for lateral interbody fusion in the lumbar spine. NICE stated
the evidence on efficacy for lateral interbody fusion is adequate
in quality and quantity and the procedure may be used provided that
standard arrangements are in place for clinical governance, consent
and audit. The majority of the evidence submitted to and reviewed
by the panel was peer-reviewed journal articles describing the now
14-year experience with and outcomes following the Company's
eXtreme Lateral Interbody Fusion (XLIF®) procedure, the leading
global lateral approach spine surgical technique.
"Our continued investment into clinical research and outcomes
data from our XLIF procedure was supportive in NICE releasing
updated guidance for this innovative surgical approach," said
Jason Hannon, NuVasive's president
and chief operating officer. "Our team has worked diligently with
NICE since 2015 to gather, analyze and review the available
evidence. The updated guidance further supports the clinical
efficacy of XLIF and will help expand the availability of XLIF to
back pain sufferers in the U.K. and around the world."
With more than 150,000 successful surgeries around the world,
XLIF is the leading global lateral approach procedure. First
introduced in the U.S. in 2003, XLIF is a minimally invasive
surgical procedure performed through the side of the body,
utilizing proprietary neuromonitoring and an integrated portfolio
of instruments and specialized implants for treating a range of
spinal pathologies.
Initial NICE guidance for lateral interbody fusion was published
in 2009 with additional special measures that impacted adoption of
the procedure in the UK. In response to a request for input prior
to a planned re-review of NICE guidance, NuVasive submitted a large
body of evidence for the XLIF procedure, including data outlining
safety profile, rate of fusion, and improvements in pain and
disability. The updated guidance was supported by a systematic
literature review of more than 200 previously published studies as
a high-quality summary of the safety and efficacy of the XLIF
procedure1. For more information on the updated NICE
guidance for lateral interbody fusion, visit
https://www.nice.org.uk/guidance/ipg574.
About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is a world leader in minimally
invasive, procedurally-integrated spine solutions. From complex
spinal deformity to degenerative spinal conditions, NuVasive is
transforming spine surgery with innovative technologies designed to
deliver reproducible and clinically proven surgical outcomes.
NuVasive's highly differentiated, procedurally-integrated solutions
include access instruments, implantable hardware and software
systems for surgical planning and reconciliation technology that
centers on achieving the global alignment of the spine. With
$956 million in revenues (2016),
NuVasive has an approximate 2,300 person workforce in more than 40
countries around the world. For more information, please visit
www.nuvasive.com.
Forward-Looking Statements
NuVasive cautions you that statements included in
this news release that are not a description of historical facts
are forward-looking statements that involve risks, uncertainties,
assumptions and other factors which, if they do not materialize or
prove correct, could
cause NuVasive's results to differ
materially from historical results or those expressed or implied by
such forward-looking statements. The potential risks and
uncertainties which contribute to the uncertain nature of these
statements include, among others, risks associated with acceptance
of the Company's surgical products and procedures by spine
surgeons, development and acceptance of new products or product
enhancements, clinical and statistical verification of the benefits
achieved via the use of NuVasive's products (including
the iGA™ platform), the Company's ability to effectually manage
inventory as it continues to release new products, its ability to
recruit and retain management and key personnel, and the other
risks and uncertainties described
in NuVasive's news releases and periodic
filings with the Securities and Exchange
Commission. NuVasive's public filings with
the Securities and Exchange Commission are
available
at www.sec.gov. NuVasive assumes
no obligation to update any forward-looking statement to reflect
events or circumstances arising after the date on which it was
made.
1 Lehmen JA et al. Eur Spine J
2015;24(Suppl 3):S287–S313
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SOURCE NuVasive, Inc.