U.S. FDA Trial Overview

In the U.S. FDA clinical trial, the objective of this study was to see if the coflex device was safe and effective in patients with moderate to severe spinal stenosis and no instability (≤ Grade 1 spondylolisthesis).

Study Design:

  • 322 patients studied (215 coflex, 107 fusion)
  • 21 investigational locations
  • Follow up visits at 3, 12, 24, 36, 48 and 60 months

Sample Text

Conclusion:

The coflex device proved to be a viable alternative treatment option compared to pedicle screw fusion out to 5 years, and results showed that coflex patients performed as good as, if not better, in all clinical measurements.

  • Insert all bullets used on the media kit “clinical summary” page for the FDA study.
  • On Basecamp: file “KEY STUDY RESULTS” is an image and needs to be converted to text bullets.
  • Only take the RIGHT SIDE bullets for FDA Study.

Patient Labeling can be found here.

Click on each graph to enlarge

VAS Back Pain
VAS Back Pain
VAS Leg Pain
VAS Leg Pain
Range of Motion – Operative Level and Level Above
Range of Motion – Operative Level and Level Above
Foraminal Height
Foraminal Height
Operative Time
Operative Time

Next: ESCADA Trial Overview