coflex® Study Results
The coflex® implant was compared to pedicle screw spinal fusion surgery in a randomized FDA clinical trial. A brief overview of information related to FDA’s approval to market coflex®, as well as links to the Summary of Safety and Effectiveness Data (SSED) and product labeling can be accessed at the Food and Drug Administration's website. LEARN MORE
The results of the trial are presented below.
A patient was deemed a clinical success if they had clinically significant improvement in pain and function (Oswestry Low Back Pain Disability Index (ODI)); no revisions, reoperations, removals, or major device related complications; and no epidural injections. Successful pain relief was measured by a 15-point improvement in ODI. In the clinical study, patients who received coflex® demonstrated favorable results compared to those patients who had pedicle screw spinal fusion surgery.
Although the coflex® device provides tremendous benefits to many patients, it is not for everyone. If you are a patient, please contact your spine specialist to discuss whether or not you are a candidate for this procedure.
Disclaimer: This content is for educational purposes only and does not replace having a conversation with a doctor.