NICE Guidance Supported by Literature Review of More than 200 Peer-Reviewed Articles Primarily Reflecting Experience with NuVasive’s Industry-Leading XLIF Procedure
SAN DIEGO – March 20, 2017 – 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.
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.
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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