The coflex® Interlaminar Stabilization® device is the only lumbar spinal device with Level 1 evidence in two separate clinical studies. The coflex device has been implanted in more than 175,000 patients in over 60 countries. Many patients experience relief of their leg and back pain, return to their physical function, and were satisfied with their overall results. The following is a list of peer-reviewed studies and articles demonstrating the efficacy of the coflex device.

U.S. FDA Trial Overview

The objective of this study was to test the safety of the coflex® Interlaminar Stabilization® device in patients with moderate to severe spinal stenosis.

The Study

  • 322 patients (215 coflex, 107 fusion)

  • 21 investigational locations

  • Follow up visits at 3, 12, 24, 26, 48, and 60 months

Conclusion

The coflex device proved to be an effective alternative when compared to pedicle screw fusion after 5 years. Results demonstrated that patients with the coflex device performed just as well or better in all measurements.

ESCADA Trial Overview

The coflex treatment was compared to decompression in the ESCADA trial to see if it would be an improved method for patients with moderate to severe spinal stenosis.

The Study

  • 230 patients (115 coflex, 115 decompression alone)

  • 7 investigational locations

  • Follow up visits at 3, 12, and 24 months

Conclusion

The coflex device statistically outperformed decompression alone for Composite Clinical Success*. The results were tangible:

  • Increase in walking distance

  • Decrease in pain management

  • Maintained foraminal height

  • Extended the lifetime of the decompression procedure to 2 years

*CCS: Criteria where overall trial success was based on a composite endpoint; a combined outcome measure in which all four components must be met: 1) disability score improvement of at least 15 points; 2) no reoperations or subsequent lumbar injections; 3) neurological maintenance or improvement without worsening; and 4) no device- or procedure-related severe adverse events.

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