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news.Ortoviva, a developer of surgical instruments, has received the CE approval for its distractor system, which improves and simplifies the insertion of disc prostheses in the spinal column.
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From a functional perspective, the instruments in the Ortoviva distractor solution hold and separate the two vertebrae adjacent to a damaged disc. This ability to mechanically control position and orientation enormously simplifies disc insertion, the company said.
Stan Mikulowski. CEO of Ortoviva, said: “CE certification ensures that Ortoviva and the distractor solution meet the most rigorous EU requirements. We’re already seeing growing interest from clinical specialists as well as disc-implant manufacturers to start using the solution in this rapidly growing market.
“Before the end of the year we will begin live patient clinical trial programs and we plan to submit an application for the FDA approval in the US early in 2009.”