SAN DIEGO, Oct. 16, 2017 /PRNewswire/ -- NuVasive, Inc.
(NASDAQ: NUVA), a leading medical device company focused on
transforming spine surgery with minimally disruptive,
procedurally-integrated solutions, today announced an expanded U.S.
Food and Drug Administration (FDA) 510(k) clearance of the
Company's TLX interbody system, used in the leading spinal fusion
surgery. New clearance introduces an expandable 20 degree cage and
broader indications for use, including use with allogeneic bone
graft and use in additional levels of the spine.
The TLX interbody system is a market-leading solution that is
inserted through a conventional transforaminal lumbar interbody
fusion (TLIF) approach. NuVasive developed a minimally invasive
approach for the TLIF procedure, the MAS® TLIF or Maximum Access
Surgery (MAS) TLIF. Designed to be used with a minimally invasive
spine surgery approach, TLX implants can be placed seamlessly into
the disc space due to their low profile, bulleted design. A
proprietary inserter allows the surgeon to insert, expand and
rapidly post pack the implant through the same instrument,
optimizing surgical efficiency. The TLX interbody system provides
restoration of sagittal alignment with customizable degrees of
lordosis and was designed to induce lordosis in an anatomical
fashion, unique to what is currently on the market.
Prior to the expanded 510(k) clearance, TLX interbodies were
available in 15 degree lordotic options and were only indicated for
use with allograft. The recent clearance includes a 20 degree
expandable interbody, and additional indications for use with
allogeneic bone graft comprised of cancellous and/or
corticocancellous bone graft to facilitate fusion. The new
indications also include use in the thoracic spine and at the
thoracolumbar junction for treatment of disc degeneration disease
or degenerative spondylolisthesis at one or two adjacent levels.
Use of the TLX interbody system as an adjunct to fusion in patients
diagnosed with multilevel degenerative scoliosis was also cleared.
The TLX system's size offerings provide multiple options for
varying patient size and anatomic considerations.
"With the additional clearance for our latest TLX system, we now
provide the leading tools for TLIF procedures with our MAS TLIF
solution, validating our commitment to improving spine solutions,"
said Matt Link, executive vice
president of strategy, technology and corporate development of
NuVasive. "This clearance highlights our persistant investment in
transforming spine outcomes by developing spine's leading
procedures, materials, expandables, systems and services."
The TLX interbody system, coupled with the Company's Integrated
Global Alignment® (iGA) suite of software that allows surgeons to
calculate, correct and confirm a patient's pathology, has the
ability to improve TLIF procedures overall. The software can
calculate alignment parameters with the preoperative planning tools
NuvaLine® and NuvaMap® and can intraoperatively correct using
real-time intraoperative assessment with NuvaMap O.R. software.
Surgeons can then confirm the restoration and preservation of
global sagittal alignment postoperatively.
"The procedurally-integrated TLIF platform from NuVasive has
allowed me to become much more efficient in my TLIF procedures,"
said William Hunter, MD,
neurosurgeon at The Spine Clinic at Neuroscience and Spine Center
of the Carolinas. "The platform also allows me to confirm
restoration of my patients' lordosis intra-operatively using
NuvaMap O.R. These tools have made my procedures more predictable,
providing optimal treatment for my patients."
NuVasive will showcase its market-leading,
procedurally-integrated technologies, including the new TLX
interbody system in NuVasive Booth #713 at the North American Spine
Society Annual Meeting held October 25-28,
2017 in Orlando, Fla.
About NuVasive
NuVasive,
Inc. (NASDAQ: NUVA) is transforming spine surgery and beyond with
minimally invasive, procedurally-integrated solutions designed to
deliver reproducible and clinically-proven surgical outcomes. The
Company's portfolio includes access instruments, implantable
hardware, biologics, software systems for surgical planning,
navigation and imaging solutions, magnetically adjustable implant
systems for spine and orthopedics, and intraoperative monitoring
service offerings. With $962 million
in revenues (2016), NuVasive has an approximate 2,300 person
workforce in more than 40 countries serving surgeons, hospitals and
patients. 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.
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SOURCE NuVasive, Inc.