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BOSTON–(HSMN NewsFeed)–Orthofix International N.V. (NASDAQ: OFIX ) announced today that Kevin L. Unger has been appointed as President of the Company’s spinal implants division. Mr. Unger will report directly to Brad Mason, who was previously named Group President of North America and has been serving as the President of Orthofix Spinal Implants since September of last year.

Mr. Unger joins Orthofix after more than 14 years with Stryker Corporation, where he served the last five years as a Vice President and General Manager in the MedSurg Division. While with Stryker Mr. Unger held roles with increasing responsibility in marketing and sales, during which he built sales organizations, was head of a global marketing department and led business development initiatives. He helped create a MedSurg business which grew from $30 million dollars to $200 million dollars under his leadership.

source:HSMN News feed

BOSTON–(HSMN NewsFeed)–Orthofix International N.V. (NASDAQ: OFIX ) (the Company) announced today that the Company has received CE Marking for its Advent(TM) 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.