Empresas y finanzas
Orthofix Announces First Surgical Procedure Using Advent(TM) Cervical Disc
Orthofix International N.V. (NASDAQ: OFIX) announced today the
completion of the first surgical procedure to implant the Advent(TM)
Cervical Disc, which is the first motion preservation device developed
by Orthofix's spine implant subsidiary, Blackstone Medical. The
successful procedure was performed at the prestigious Sao Paulo
University Medical Center in Sao Paulo, Brazil by Dr. Tarcisio Eloy de
Barros Filho and Dr. Alexandre Fogaca. The Vice-Dean of the Sao Paulo
University Medical School and Titular Professor of the Orthopaedic
Department, Dr. Barros is also the president-elect of the Brazilian
Orthopaedic and Traumatology Society.
"The procedure involving the implantation of an artificial
vertebral disc in a 51-year old female patient went very well," said
Dr. Barros. "I found the simplicity of the surgical technique used to
implant the device and the well-designed, intuitive instrumentation to
be important advantages of the Advent disc."
Dr. Scott Blumenthal of the Texas Back Institute in Dallas, Texas,
a member of Blackstone's medical advisory board who also attended the
surgery and provided additional training, stated that, "as one of the
first artificial cervical discs to incorporate a flexible elastomer
core, the Advent disc has advanced biomechanical properties designed
to provide patients with a natural range of motion post-surgically.
Additionally, the pre-assembled design reduces the need for complex
instrumentation and simplifies the surgical technique."
"This is truly a breakthrough product for the company, as it
represents our entrance into the important motion preservation segment
of the spine industry which is estimated to grow to several billion
dollars worldwide over the next few years", said Alan Milinazzo,
Orthofix's CEO. "Though motion preservation is a surgical trend that
is in its infancy, we believe it will become an accepted standard of
care for many patients."
Matthew Lyons, the President of Blackstone Medical, added that,
"our design team received important advice and feedback from key
surgeons that facilitated the development of the compliant core and
the simplified surgical technique used to implant the Advent disc.
And, our engineers and medical advisory board will continue to work on
the development of innovative products to expand our portfolio of
motion preservation devices."
Orthofix indicated that it hopes to obtain a CE mark for the
Advent Cervical Disc by the fourth quarter of this year, representing
approval for commercial use throughout the European Union. The company
also has plans to begin clinical trials in the U.S. by early next
year, and anticipates obtaining FDA approval by the end of 2011.
About Orthofix International, N.V.
Orthofix International N.V., a global diversified orthopedic
products company, offers a broad line of minimally invasive surgical,
as well as non-surgical, products for the spine, orthopedic, and
sports medicine market sectors that address the lifelong
bone-and-joint health needs of patients of all ages, helping them
achieve a more active and mobile lifestyle. Orthofix's products are
widely distributed around the world to orthopedic surgeons, hospitals
and patients via Orthofix's sales representatives and its
subsidiaries, including Breg, Inc. and Blackstone Medical, Inc., and
via partnerships with other leading orthopedic product companies
including Kendall Healthcare. In addition, Orthofix is collaborating
in R&D partnerships with leading medical institutions such as the
Orthopedic Research and Education Foundation, the Cleveland Clinic
Foundation, and the National Osteoporosis Institute. For more
information about Orthofix, please visit www.orthofix.com.
Forward-Looking Statements
This news release contains certain forward-looking statements
under the Private Securities Litigation Reform Act of 1995. These
forward-looking statements include, but are not limited to, statements
concerning expectations related to new products at Orthofix and its
subsidiaries, and 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. Factors that could cause or contribute
to such differences may include, but are not limited to, unanticipated
expenditures, changing relationships with customers, suppliers and
strategic partners, risks relating to the protection of intellectual
property, changes to the reimbursement policies of third parties,
changes to governmental regulation of medical devices, the impact of
competitive products, changes to the competitive environment, the
acceptance of new products in the market, conditions of the orthopedic
industry and the economy and other factors described in the most
recent report on Form 10-K and other periodic reports filed by
Orthofix with the Securities and Exchange Commission.