FDA Tested and Approved: 5 Year Study Results

Evaluation of Decompression and Interlaminar Stabilization Compared with Decompression and Fusion for the Treatment of LSS
Musacchio M, Lauryssen C, Davis R, Bae H, Peloza J, Guyer R, Zigler J, Ohnmeiss D, Leary S
International Journal of Spine Surgery. January 2016.

The objective of the clinical study was to see if the coflex® device was safe and if it would work in patients who had moderate to severe spinal stenosis in their lower back. Patients from the study had leg/buttocks/groin pain, with or without back pain. Each of the patients tried at least 6 months of non-surgical treatment options for their pain before joining in the coflex® study. The study consisted of 322 patients total. 215 of those patients had coflex® implanted, and 107 patients had a posterolateral fusion surgery. 

For more information related to FDA’s approval to market the coflex® device, visit the Food and Drug Administration’s website.

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. This content is for educational purposes only and does not replace having a conversation with your doctor.
 
*This data is based on validated clinical measurements from a randomized FDA clinical study comparing the coflex® Interlaminar Technology to pedicle screw fusion surgery for moderate to severe spinal stenosis. Every patient is different; therefore, results may vary. All data is on file at Paradigm Spine, LLC.