- With approval for sale in Europe, Company expects limited release
in select international markets in Q409
Orthofix International N.V. (NASDAQ: OFIX) (the Company) announced today
that the Company has received CE Marking for its Advent™
Cervical Disc, allowing it to begin selling the new device in Europe.
“Receiving our CE Marking for Advent is an important step in our plans
for the global commercialization of our first artificial cervical disc,”
said Alan Milinazzo, President and CEO of Orthofix International. “A key
element of our plans for the continued expansion of our spinal implant
portfolio is the addition of motion preservation devices that are
designed to help spine patients maintain some degree of natural motion
post surgically.”
Orthofix expects to begin a limited market release of Advent in Europe
during the fourth quarter of this year. The Company also has a U.S.
Advent study underway as part of the process for obtaining FDA approval
for the device. With approximately 100 patients already enrolled at 15
centers, Orthofix plans to add 10 additional sites during the fourth
quarter this year and the first quarter next year, and expects to enroll
a total of 450 patients in the study from all of these sites. Upon
completion of this study, Orthofix anticipates submitting the results to
the FDA seeking its approval for the Company to begin marketing the
device in the U.S.
Constructed with Titanium endplates and a flexible elastomer core,
Advent is designed to be implanted in the cervical spine using a
surgical procedure that is very similar to a standard anterior cervical
discectomy and fusion (ACDF) procedure, which is the current standard of
care for the treatment of many degenerative or traumatic disc conditions.
The European market for artificial cervical discs was estimated to be
approximately €37.5 million in 2008, and is expected to increase at a
compound annual growth rate of 14% over the next several years.
About Orthofix
Orthofix International, N.V., a global medical device company, offers a
broad line of minimally invasive surgical, and 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
and patients via Orthofix’s sales representatives and its subsidiaries,
including BREG, Inc.
