LEWISVILLE, Texas--(BUSINESS WIRE)--
Orthofix International N.V. (NASDAQ: OFIX), a diversified, global
medical device company, today announced the print publication of a
12-month study of patients that have undergone single-level anterior
cervical discectomy and fusion (ACDF) with Trinity
Evolution® in combination with a PEEK interbody spacer
and supplemental anterior fixation. Published in the European
Spine Journal, the data demonstrates the effectiveness of the
bone graft with patient fusion rates of 78.6 percent at 6 months and
93.5 percent at 12 months. Seventy-five percent of the study
participants were current or former smokers, diabetic, overweight, obese
or extremely obese and considered to be at high risk for bone growth
"To alleviate pain and neurological deficits resulting from nerve
compression caused by degenerative disc disease, the most common
recourse is surgical decompression through an anterior approach followed
by the insertion of a structural interbody spacer filled with bone graft
material," said Dr. Timothy A. Peppers, at Scripps Hospital and a
co-author of the journal article. "This study demonstrated the
effectiveness of Trinity Evolution in achieving a solid fusion when used
in this manner, indicating that it is a viable option for patients
needing anterior cervical discectomy and fusion."
This prospective, multi-center, clinical study was designed to evaluate
the effectiveness of Trinity Evolution, a viable cellular bone allograft
in patients undergoing a single level fusion at the vertebral locations
between C3/C4 and C6/C7. Trinity Evolution was placed within and around
each Orthofix PEEK interbody spacer to promote bone growth.
"We are committed to investing in meaningful clinical research to aid
physicians in their treatment decisions," said Orthofix Chief Scientific
Officer James Ryaby, Ph.D. "These results are important as they further
substantiate that Trinity Evolution is effective even in challenging
patient populations who might not respond well to traditional allograft
and autograft materials."
The primary endpoint was radiographic fusion status based on independent
review of CT scans and radiographic review of angular motion. The
criteria for fusion was the presence of bridging bone across the
adjacent endplates as seen on thin cut CT scans in addition to angular
motion from flexion/extension X-rays.
In addition, secondary endpoints were measured including function as
assessed by the Neck Disability Index and neck and arm pain as assessed
by individual Visual Analog Scales (VAS). Neck function and neck/arm
pain were found to significantly improve at both 6 and 12 months. There
were no serious adverse events attributable to Trinity Evolution as
determined by an independent consultant.
Processed by the Musculoskeletal
Transplant Foundation (MTF), a nonprofit organization dedicated to
providing quality tissue, Trinity Evolution is a cryopreserved allograft
that consists of cancellous bone with viable cells retained within that
matrix and a demineralized cortical bone component. It possesses all
three of the key properties for successful bone grafting, which makes it
an ideal autograft substitute.
"MTF is committed to research to ensure innovative clinical options
exist for all patients," said Bruce Stroever, President and Chief
Executive Officer of MTF. "We are pleased these results support the use
of a high quality MTF allograft like Trinity Evolution to augment the
Trinity Evolution is the predecessor of Trinity
ELITE®, a moldable bone graft material that enables
physicians to easily control the placement of tissue during procedures.
To date there have been more than 150,000 procedures using Trinity
Evolution and Trinity ELITE.
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.
The Musculoskeletal Transplant Foundation, a non-profit organization
based in Edison, NJ, is a national consortium comprised of leading organ
procurement organizations, tissue recovery organizations and academic
medical institutions. Since its inception in 1987, MTF has received
tissue from more than 100,000 donors and distributed more than six
million grafts for transplantation. For more information, visit www.mtf.org
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/20160727005339/en/
Orthofix International N.V.
Denise Landry, 214-937-2529
Source: Orthofix International N.V.
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