LEWISVILLE, Texas--(BUSINESS WIRE)--
Orthofix International N.V. (NASDAQ:OFIX), a diversified, global medical
device company, today announced the 510(k) clearance and U.S. limited
market launch of the FORZA® PTC™ (Peek Titanium
Composite) Spacer System. Designed and manufactured using a proprietary
method, FORZA PTC spacers combine PEEK and 3D printed titanium end
plates into a single porous interbody solution for lumbar spine fusion
procedures. FORZA PTC interbody spacers are designed to restore normal
disc height in patients suffering from degenerative disc disease.
"The Forza PTC Spacing Systems offer a unique porous technology that
allows patient bone ingrowth into the surface of the implant as well as
bone growth through the center of the device," said Dr. Scott Stanley,
an orthopedic surgeon and co-developer of the device. "Additionally, the
PEEK core allows for clear imaging so physicians can assess the
patient's fusion maturation post-operatively to determine if enough
healing has occurred for return to regular activities."
The FORZA PTC Spacer System represents the continuation of innovative
PEEK Titanium Composite (PTC) interbody spacer products that began with
the successful launch of CONSTRUX® Mini PTC™ into
the anterior cervical interbody spacer market in 2013.
"We are excited to offer our surgeon customers this PEEK and titanium
composite lumbar interbody technology," said Ray Fujikawa, President of
Orthofix Spine Fixation. "The addition of the FORZA PTC Spacing System
to our Lumbar Spine Fixation portfolio demonstrates our commitment to
innovation in the spine market and to delivering solutions that help
improve patients' lives."
The FORZA PTC interbody spacing device is designed to provide both the
imaging benefits of PEEK and the bone ingrowth results of a porous
The titanium endplates of FORZA PTC are manufactured using advanced 3D
printing technology to specific pore size, interconnectivity and
porosity requirements. Literature
has shown that interconnected pores greater than 300 microns in diameter
are ideal for bone growth through porous biomaterials. The FORZA PTC
interbody is designed with interconnected 400 micron diameter pores for
potential bone ingrowth. This may compare favorably to the bone ongrowth
potential of traditional plasma titanium coated interbodies with less
than 100 micron pore diameter.
The FORZA PTC 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 (L2-S1). The Forza PTC
Spacer System is intended for use with autograft and/or allograft
comprised of cancellous and/or corticocancellous bone graft and
supplemental fixation, e.g. Firebird Spinal System. Patients must have
undergone a regimen of at least six months of non-operative treatment
prior to being treated with Forza PTC Spacer System.
Orthofix International N.V. is a diversified, global medical device
company focused on improving patients' lives by providing superior
reconstructive and regenerative orthopedic and spine solutions to
physicians worldwide. Headquartered in Lewisville, Texas, the Company
has four strategic business units that include BioStim, Biologics,
Extremity Fixation and Spine Fixation. Orthofix products are widely
distributed via the Company's sales representatives, distributors and
its subsidiaries. In addition, Orthofix is collaborating on research and
development activities with leading clinical organizations such as the
Musculoskeletal Transplant Foundation and the Texas Scottish Rite
Hospital for Children. 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
the risks described in the "Risk Factors" section of our 2015 Annual
Report on Form 10-K, 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/20160516005418/en/
Orthofix International N.V.
Denise Landry, 214-937-2529
Source: Orthofix International N.V.
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