Patients at high risk for ACDF surgery failure saw a significant
increase in bone fusion when treated with pulsed electromagnetic field
LEWISVILLE, Texas--(BUSINESS WIRE)--
Orthofix International N.V., (NASDAQ:OFIX), a global medical device
company focused on musculoskeletal healing products and value-added
services, today announced the publication of new data in Bone
& Joint Research from a study evaluating the effect
of pulsed electromagnetic field (PEMF) treatment for patients who have
an increased risk for pseudoarthrosis (failure for the vertebrae to
fuse) after anterior cervical discectomy and fusion (ACDF) procedures.
Study findings showed that after ACDF surgery, use of PEMF stimulation
significantly increased the fusion rate relative to the control group at
six and 12 months for participants who were at risk for pseudoarthrosis.1
Participants included patients who had a risk factor that could impair
their cervical spine fusion success; or they had a risk factor and
received at least a two- or three-level arthrodesis.
"Anterior cervical discectomy and fusion procedures are common spinal
operations in the U.S. However, successful spine fusion can be impaired
in some patients, leaving them at risk for pseudoarthrosis which
ultimately impacts their long-term recovery," said Dr. Richard D. Guyer,
orthopedic spine surgeon and Chairman of the Texas Back Institute
Research Foundation in Dallas and senior author of the paper. "This is
the first published report to show that PEMF treatment significantly
increased fusion rates at both six and 12 months in high-risk patients
who underwent ACDF surgery."
The evaluations were conducted with historical data from Orthofix's
prospective, randomized, multicenter U.S. Food and Drug Administration
(FDA) investigational device exemption PMA study of 323 patients
conducted in 2014 and a new multicenter, retrospective cohort study
consisting of 274 patients enrolled at three institutions. In the new
study, participants were required to have one or more risk factors for
pseudoarthrosis. All patients were treated with PEMF following ACDF
surgery. The primary endpoint was fusion at six and 12 months as
determined by the presence of continuous bridging bone on plain films as
assessed by the treating surgeon.
"This data is important as it builds on the findings of the original
Orthofix PMA study that proved the safety and effectiveness of PEMF
stimulation with the Cervical-Stim device," said James Ryaby, Ph.D.,
Chief Scientific Officer for Orthofix. "The results published in Bone
& Joint Research support the use of PEMF treatment for high-risk
ACDF patients and should help surgeons feel confident when prescribing
The Orthofix Cervical-Stim device is currently approved by the FDA as an
adjunct to cervical spinal fusions. The device is the only bone growth
therapy device approved by the FDA as a noninvasive, adjunctive
treatment option for cervical fusion in high risk patients. To learn
more, please visit bonegrowththerapy.com.
Orthofix International N.V. is a global medical device company focused
on musculoskeletal healing products and value-added services. The
Company's mission is to improve patients' lives by providing superior
reconstruction and regenerative musculoskeletal solutions to physicians
worldwide. Headquartered in Lewisville, Texas, the Company has four
strategic business units: BioStim, Extremity Fixation, Spine Fixation,
and Biologics. Orthofix products are widely distributed via the
Company's sales representatives and distributors. For more information,
please visit www.orthofix.com.
This communication contains certain forward-looking statements under the
Private Securities Litigation Reform Act of 1995. These forward-looking
statements, which may include, but are not limited to, statements
concerning the projections, financial condition, results of operations
and businesses of Orthofix and its subsidiaries, are based on
management's current expectations and estimates and involve risks and
uncertainties that could cause actual results or outcomes to differ
materially from those contemplated by the forward-looking statements.
The forward-looking statements in this release do not constitute
guarantees or promises of future performance. Factors that could cause
or contribute to such differences may include, but are not limited to
risks described in the "Risk Factors" section of our Annual Report on
Form 10-K for the fiscal year ended December 31, 2017, as well as in
other reports that we file in the future. Existing and prospective
investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof. The
Company undertakes no obligation to update or revise the information
contained in this press release.
1.Coric D, Bullard DE, Patel VV, et al. Pulsed
electromagnetic field stimulation may improve fusion rates in cervical
arthrodesis in high-risk populations. Bone Joint Res 2018;7:124-130.
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Orthofix International N.V.
Denise Landry, 214-937-2529
Source: Orthofix International N.V.
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