SAN DIEGO, Oct. 12, 2017 /PRNewswire/ -- NuVasive, Inc.
(NASDAQ: NUVA), a leading medical device company focused on
transforming spine surgery with minimally disruptive,
procedurally-integrated solutions, today announced that it has
received expanded 510(k) clearance from the U.S. Food and Drug
Administration (FDA) for the Company's PRECICE® system from
NuVasive Specialized Orthopedics™ (NSO) with expanded indications
that now include open and closed fracture fixation,
pseudoarthrosis, malunions, nonunions, and bone transport.
The PRECICE system is an innovative, market-leading solution to
treat patients with limb length discrepancy, limb deformities and
chronic nonunions. The platform consists of an intramedullary
device that once implanted utilizes an external remote controller
to non-invasively compress and distract long bones. The key to the
PRECICE platform is the magnetic interaction between the PRECICE
intramedullary nail and external remote control. The proprietary
technology includes a complex internal gear system remotely
activated and controlled by permanent magnets. This advancement in
limb reconstruction allows for a precision controlled distraction
phase with the ability to non-invasively customize treatment.
Prior to the expanded FDA clearance, the PRECICE system was
indicated for limb lengthening of the femur and tibia. The system
is now indicated for bone transport of long bones in addition to
limb lengthening. Bone transport is a technique that allows for
regeneration of bony tissue and is typically used to fill segmental
bone loss due to trauma or infection, i.e. infected nonunions,
segmental defect, and chronic bone infections. The expanded
indications for use allows the Company to continue to build a
platform for further growth in the limb reconstruction and trauma
markets.
"This FDA 510(k) clearance of PRECICE for expanded indications,
including bone transport, demonstrates the evolving innovative
capabilities of our technology to transform and expand the limb
reconstruction and trauma markets," said Massimo Calafiore, president of NSO. "NSO
remains committed to providing trauma surgeons with proper
solutions to treat unmet clinical needs and challenging fractures.
This allows us to treat more patients suffering from debilitating
segmental bone defects through the use of PRECICE in bone transport
procedures."
The Company has also created a patient and family online
resource dedicated to providing information on limb length
discrepancy with Reach Your Height. The digital resource center
provides education on treatment options and shares patient success
stories. To learn more, visit reachyourheight.com.
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.