Orthofix International N.V. announced 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.