SAN
DIEGO, March 20, 2023 /PRNewswire/ -- NuVasive,
Inc. (NASDAQ: NUVA), the leader in spine technology innovation,
focused on transforming spine surgery with minimally disruptive,
procedurally integrated solutions, today announced that it received
510(k) clearance from the U.S. Food and Drug Administration (FDA)
for the use of its Precice all-internal limb lengthening solution
to include pediatric patients*. The expanded clearance extends the
clinical benefits of Precice to a wider range of patients.
"Everyone faced with limb length discrepancy (LLD), especially
pediatric patients, should have access to a non-invasive limb
lengthening solution," said Pete
Ligotti, leader of NuVasive Specialized Orthopedics (NSO).
"Backed by more than 100 peer-reviewed studies, the difference with
Precice is that it accommodates the changing clinical needs of
patients as they heal, grow, and age, reducing the need for further
surgeries1 throughout treatment."
Precice is a magnetically adjustable technology that utilizes an
external remote to non-invasively lengthen implants. The Precice
nail has been implanted more than 15,000 times, by more than 2,000
surgeons, and in nearly 50 countries. As a division of NuVasive,
NSO is focused on the design and innovation of disruptive
orthopedic solutions for complex orthopedic reconstruction and limb
lengthening.
"Precice has over a decade's worth of clinical data and has
truly changed the standard of care for my patients," said Dr.
John Herzenberg, director of
pediatric orthopedics at Sinai Hospital. "This new indication is
significant for my practice as the majority of my patients are
under the age of 18, and it provides me with the assurance I need
to offer Precice as a pediatric LLD solution."
Furthering the Company's ability to treat the full continuum of
care, the next phase of NSO's orthopedic innovation is intelligent
surgery. The Company's asset acquisition efforts in December 2022 position NSO as an early player in
next-generation motorized technology for dynamic orthopedic
implants.
*The Precice IMLL
System is indicated for limb lengthening of the femur and tibia in
pediatric patients (greater than 12 years old).
|
1. Richardson, S,
Schairer W, Fragomen A, et al. Cost Comparison of Femoral
Distraction Osteogenesis With External Lengthening Over a Nail
Versus Internal Magnetic Lengthening Nail. J Am Acad Orthop
Surg 2019 May 1;27(9):e430-36.
|
About NuVasive
NuVasive,
Inc. (NASDAQ: NUVA) is the leader in
spine technology innovation, with a mission to transform surgery,
advance care, and change lives. The Company's less-invasive,
procedurally integrated surgical solutions are designed to deliver
reproducible and clinically proven outcomes. The Company's
comprehensive procedural portfolio includes surgical access
instruments, spinal implants, fixation systems, biologics, software
for surgical planning, navigation and imaging solutions,
magnetically adjustable implant systems for spine and orthopedics,
and intraoperative neuromonitoring technology and
service offerings. With more than $1 billion in net
sales, NuVasive operates in
more than 50 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 and
hospitals, development and acceptance of new products or product
enhancements, clinical and statistical verification of the benefits
achieved via the use of NuVasive's products, the
Company's ability to adequately 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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/nuvasive-specialized-orthopedics-expands-indications-of-precice-limb-lengthening-system-to-treat-pediatric-patients-301775389.html
SOURCE NuVasive, Inc.