The Secure-C device is designed to mimic the normal motion of the spine in order to alleviate pain and restore function as an alternative to fusion in the treatment of symptomatic cervical disc disease. A total of 380 patients have been enrolled in the trial.
Kelly Baker, director of clinical affair and regulatory of Globus Medical, said: “Completion of enrollment in our first IDE is further validation of our unique product development and regulatory process and will set the stage for our extensive efforts in motion preservation. We look forward to continued patient follow-up, and PMA submission for ultimate market entry within the next two years.”