SAN DIEGO, June 20, 2018 /PRNewswire/ -- NuVasive, Inc.
(NASDAQ: NUVA), the leader in spine technology innovation, focused
on transforming spine surgery with minimally disruptive,
procedurally-integrated solutions, today announced the results of
the study "Early Outcomes of Anterior Cervical Discectomy and
Fusion Using Porous PEEK™ Interbody Fusion Device," published
online in the Journal of Spine &
Neurosurgery, which concludes that NuVasive patented
porous polyetheretherketone (PEEK) technology is a clinically
viable alternative for improving osseointegration and fusion rates
of interbody implants to treat degenerative cervical disc
disease.1
In the study, 50 patients (31 women and 19 men) with an average
age of 60 with degenerative cervical disc disease underwent
anterior cervical discectomy and fusion using a Cohere® cervical
interbody fusion device from NuVasive—with 100 percent of
participants experiencing positive results.
Cohere provides a unique three-dimensional Porous PEEK
architecture to help elicit and encourage bone ingrowth without
compromising implant strength. NuVasive incorporated the
technology, which had been validated with 10 years of scientific
research, into its portfolio with its acquisition of Vertera Spine
in September 2017.
"This interbody fusion device with Porous PEEK surface
technology provided improved osseointegration and supported spinal
fusion in single level and multi-level cervical fusions," said Dr.
J. Kenneth Burkus of the Hughston
Clinic in Columbus, Ga.
"Twelve-month clinical outcomes have demonstrated the efficacy and
stability of the Cohere Porous PEEK interbody device and shown that
it is a clinically viable implant alternative for achieving
successful clinical and radiological outcomes in cervical spine
fusion surgery, particularly in multi-level or revision surgeries
where fusion rates are lower."
During the course of the clinical study, there were 11 1-level,
23 2-level and 16 3-level fusions between C3 and C7. Patients came
from all walks of life and with various comorbidities. Thirteen of
them had previously had an unsuccessful anterior cervical fusion
procedure. It is notable that all patients who had revision surgery
with Cohere achieved fusion six months after the surgery.
At 12 months post-operative ACDF surgery, all 50 patients
demonstrated improved motion, decreased neck pain and average disc
height increased by more than 4 mm. In addition, each of them
showed radiographic fusion.
"NuVasive is the only company in the industry able to offer
Porous PEEK technology so that surgeons can deliver life-changing
clinical outcomes," said Matt Link,
executive vice president, strategy, technology and corporate
development for NuVasive. "The fact that all 50 patients in the
clinical study experienced fusion is a testament to the enhanced
osseointegration as well as biomechanical and imaging properties of
Cohere and Porous PEEK technology, the entire NuVasive Advanced
Materials Science™ portfolio, which also includes
Modulus® titanium interbody implants, represents the
future of porous implant technologies."
About NuVasive
NuVasive, Inc. (NASDAQ:
NUVA) is the leader in spine technology innovation, focused on
transforming spine surgery and beyond with minimally disruptive,
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
over $1 billion in revenues, NuVasive
has an approximate 2,400 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.
1 Burkus, J. (2018). Early outcomes of anterior
cervical discectomy and fusion using porous PEEK interbody fusion
device. Journal of Spine & Neurosurgery. Doi:
10.4172/2325-9701.1000295
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SOURCE NuVasive, Inc.