SAN DIEGO, March 29, 2017 /PRNewswire/ -- NuVasive,
Inc. (NASDAQ: NUVA), a leading medical device company focused on
transforming spine surgery with minimally disruptive,
procedurally-integrated solutions, today announced U.S. Food and
Drug Administration (FDA) 510(k) clearance of the CoRoent® Small
Interbody™ System indicated for intervertebral body fusion at
multiple contiguous levels in the cervical spine. This marks the
first U.S. clearance for a cervical cage to be used at up to four
contiguous levels.
Cervical radiculopathy and myelopathy secondary to cervical
degenerative discs are common diagnoses in adult patients and have
been shown to cause significant disability and loss of
productivity.1 As a result of this common condition,
more than 200,000 cervical surgical procedures are performed in the
U.S. per year.2
"This FDA 510(k) clearance is another key milestone for NuVasive
as we continue to deliver new innovation to the spine market. The
ability to treat multi-level cervical disc degeneration in patients
displaying cervical radiculopathy and myelopathy is a meaningful
advancement for spine surgeons," said Jason
Hannon, NuVasive's president and chief operating officer.
"This first and only clearance is an example of NuVasive's
commitment to defining the components necessary to properly address
an unmet clinical need and expand our presence and competitive
positioning in the cervical market."
The NuVasive CoRoent Small Interbody System is an interbody cage
manufactured from PEEK-Optima that provides stabilization of the
spinal motion segment while fusion takes place. A hollow core
allows for packing of autogenous and/or allogeneic bone graft
comprised of cancellous, cortical, and/or corticocancellous bone
graft material to help promote a solid fusion. Rows of teeth
on the surface of each end of the device serve to grip the adjacent
vertebrae to resist migration and expulsion of the device. The
device includes marker pins composed of titanium alloy or
tantalum.
The implants included in the CoRoent Small Interbody System
clearance are CoRoent Small (S), CoRoent Small Lordotic (SL),
CoRoent Small Lordotic Plus (SLP), CoRoent Small Hyperlordotic
(SHL), and CoRoent Small Contoured (SC).
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
$962 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.
1Grasso G: Clinical and radiological features of
hybrid surgery in multilevel cervical degenerative disease. Eur
Spine J 2015;24(Suppl 7):S842-8.
2American Associated of Neurological Surgeons.
Artificial cervical disc surgery. [AANS web site]. May 2016. Available at:
http://www.aans.org/Patient%20Information/Conditions%20and%20Treatments/-Artificial%20Cervical%20Disc.aspx.
Accessed March 27, 2017.
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SOURCE NuVasive, Inc.