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Under certain conditions, the FDA requires human clinical trials to evaluate the safety and efficacy of new products before they can be marketed. Globus is currently conducting the FDA-approved clinical trials noted below. Patients who are interested in participating in Globus’ clinical trials should contact their physician. Physicians who are interested in participating in Globus’ clinical trials should contact the Company.
This is a clinical study to compare the safety and effectiveness of SECURE®-C Cervical Artificial Disc for the treatment of symptomatic cervical disc disease (SCDD) at one cervical level between C3 and C7 as compared to cervical fusion. Enrollment in this trial has been completed. The FLEXUS Interspinous Spacer is a unitary device that fits between adjacent spinous processes in the lumbar spine to treat lumbar spinal stenosis. This unique unitary design allows for a unilateral approach and a minimal incision. FLEXUS is made of PEEK radiolucent polymer with tantalum makers for radiographic visualization. It is available in various heights, widths, and profiles to accomodate any patient anatomy. |
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