LEWISVILLE, Texas--(BUSINESS WIRE)--
Orthofix International N.V., (NASDAQ: OFIX), a global medical device
company focused on musculoskeletal healing products, today announced the
510(k) clearance and U.S. limited market launch of the FORZA® XP
Expandable Spacer System.
This press release features multimedia. View the full release here:
http://www.businesswire.com/news/home/20180206005329/en/
FORZA® XP Expandable Spacer System by Orthofix (Photo: Business Wire)
Designed to restore normal disc height in patients suffering from
degenerative disc disease, the FORZA XP Expandable Spacer System can be
expanded after insertion into the disc space in order to fit the
patient's anatomy. Made primarily of titanium alloy, these expandable
interbodies are used for PLIF (Posterior Lumbar Interbody Fusion) and
TLIF (Transforaminal Lumbar Interbody Fusion) procedures. Unlike the
incremental expansion offered by some expandable interbody devices, the
Orthofix System allows for a continuous controlled expansion and a
custom fit to the disc space. Once the desired expansion is achieved the
device features automatic locking which further adds to its ease of use.
"The FORZA XP Expandable Spacer System is a strong addition to our
robust portfolio and makes Orthofix competitive in one of the fastest
growing segments in spine," said Ray Fujikawa, President of Orthofix
Spine Fixation. "This new system offers an industry-leading 6.5mm
starting height and also enables surgeons to place bone graft material
inside the device after implantation. The ability to pack our new
expandable device with bone graft post expansion is extremely important
to ensure proper contact of the material with the vertebral endplates."
The FORZA XP Expandable Spacer System is indicated for spinal fusion
procedures in skeletally mature patients with degenerative disc disease
(DDD) at one or two contiguous levels in the lumbar spine. The FORZA XP
Expandable Spacer System is intended for use with autograft and/or
allograft comprised of cancellous and/or corticocancellous bone graft
and supplemental fixation such as the Orthofix Trinity ELITE® allograft
tissue and the Firebird® Spinal Fixation System.
About Orthofix
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 orthopedic and spine 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.
Forward Looking Statements
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, 2016, 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20180206005329/en/
Orthofix, International N.V.
Investor Relations:
Mark Quick,
214-937-2924
markquick@orthofix.com
or
Media
Relations:
Denise Landry, 214-937-2529
deniselandry@orthofix.com
Source: Orthofix, International N.V.
News Provided by Acquire Media