Level 1 Evidence coflex® Provides Significant Improvement and Better Outcomes
Outcome measures of patients with moderate to severe lumbar spinal stenosis who received surgical treatment using the coflex® device demonstrate significant clinical improvement. By adding the coflex® device to your surgical toolbox, you can help more patient's reclaim their lives.
coflex® patient satisfaction*
- 93% of patients were satisfied with their outcome 2 years after surgery coflex® patients had lasting improvement at 2 and 3 years post-op*
coflex® patients had lasting improvement at 2 and 3 years post-op*
- 88% of patients had lasting improvement in pain and function at 2 years after surgery (ODI)
- 90% of patients had lasting improvement in pain and function at 3 years after surgery (ODI)
coflex® patients had clinically significant VAS measurements at 2 years post-op*
- 88% of patients had a clinically signifificant improvement in back pain relief at 2 years (VAS back)
- 83% of patients had a clinically significant improvement in leg pain relief at 2 years (VAS leg)
coflex® patients had early symptom improvement/relief at 6 weeks post-op*
- 90% of patients had early relief of their spinal stenosis symptoms at 6 weeks after surgery (ZCQ)
- 85% of patients had early improvement in pain and function at 6 weeks after surgery (ODI)
- 82% of patients had early successful clinical outcome at 6 weeks after surgery (Composite Clinical Success)
- Fewer patients needed narcotics 6 weeks after surgery, which was sustained through 2 years compared to fusion patients
*This data is based on validated clinical measures 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.
In the brief video below, Dr. Hyun Bae speaks with his patient, Ken Josefsberg 5 years after his surgery with the coflex® device for lumbar spinal stenosis. Ken's comments reflect what is important to patients.
The statements and claims made by surgeon(s) and patient(s) herein are their own voluntary and independent opinions, and do not represent the views of Paradigm Spine. None of the individuals quoted or depicted were compensated in any way for their participation.
Indications for Use
The coflex® Interlaminar Technology is an interlaminar stabilization device indicated for use in one or two level lumbar stenosis from L1-L5 in skeletally mature patients with at least moderate impairment in function, who experience relief in flexion from their symptoms of leg/ buttocks/ groin pain, with or without back pain, and who have undergone at least 6 months of non-operative treatment. The coflex® is intended to be implanted midline between adjacent lamina of 1 or 2 contiguous lumbar motion segments. Interlaminar stabilization is performed after decompression of stenosis at the affected level(s).