– Attrax Putty is now the first and only ceramic bone graft substitute supported by Level I evidence to demonstrate non-inferior fusion performance compared to autograft(1) –
SAN DIEGO, March 10, 2020 /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 “Efficacy of a Standalone Microporous Ceramic vs. Autograft in Instrumented Posterolateral Spinal Fusion; a Multicenter, Randomized, Intra-patient Controlled, Non-inferiority Trial” published online in Spine. The results of this trial support the use of Attrax® Putty as a standalone bone graft substitute for autograft in instrumented thoracolumbar posterolateral lumbar fusion (PLF). Supported by the results of this study, NuVasive received U.S. Food and Drug Administration (FDA) 510(k) clearance for expanded use of Attrax Putty without autograft.
“A study of this quality immediately differentiates Attrax Putty from
other biologics on the market,” said Matt Link, president of NuVasive. “Attrax
has proven the critical role surface optimization plays in the effectiveness of
bone grafting technology, and underscores the NuVasive approach to developing
innovative solutions which deliver positive clinical outcomes for surgeons and
their patients.”
The trial enrolled 100 patients across four hospital centers where they
underwent an instrumented PLF procedure. Following randomization, Attrax Putty
was applied to one side of the spine and iliac crest autograft and local bone
was applied to the contralateral side, with each patient serving as their own
control. Fusion was assessed by blinded observers at one year with CT scans
showing fusion rates of 55 percent for the Attrax Putty side and 52 percent for
the autograft side, with an overall fusion rate of 71 percent of levels. Attrax
Putty alone successfully demonstrated non-inferior fusion performance compared
to autograft in instrumented PLF.
“With increased focus on value-based medicine, surgeons and hospitals
seek improved evidence when choosing a biologic for spinal fusion,” said
Dr. Tyler Koski, associate professor of neurological surgery and orthopedic
surgery at Northwestern Memorial Hospital in Chicago, IL. “Most data for
bone graft materials is of lower quality and supports their use as bone graft
extenders combined with autograft. The fact that Attrax Putty by itself
demonstrates non-inferiority to autograft, the gold standard for bone grafts,
speaks to the power of its unique surface technology, and with this study, I’m
better informed in my clinical decision-making.”
Attrax Putty is a synthetic, bioactive and osteoconductive bone void filler
for the repair of bone defects. This proprietary, advanced biomaterial features
a surface microarchitecture which provides an instructive environment for bone
formation without added cells or growth factors. The moldable graft material is
resorbed and replaced by bone during the healing process.
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 access, implants and fixation
systems, biologics, software for surgical planning, navigation and imaging
solutions, magnetically adjustable implant systems for spine and orthopedics,
and intraoperative monitoring service offerings. With more than $1 billion in
revenue, NuVasive has approximately 2,800 employees and 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, 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) Based on review of publicly available materials at the time of this
release.
CONTACT: Investor Contact: Suzanne Hatcher, NuVasive, Inc., 858-458-2240, [email protected];
Media Contact: Jessica Tieszen, NuVasive, Inc., 858-736-0364, [email protected]
