coflex® Interlaminar Stabilization®
Is the coflex® device the right choice for me?
For decades, LSS patients’ surgical options were limited to either decompression or decompression with spinal fusion. In 2012, the FDA approved the coflex® spinal implant, which is a small, U-shaped titanium device that provides spinal stability without the mobility loss associated with spinal fusion.
To be a candidate for treatment for decompression with the coflex® device, you must be skeletally mature and must have moderate-to-severe spinal stenosis in your lower back. Symptoms of LSS include difficulty walking a long way, such as half a mile, and having pain in your lower back while standing that subsides when you bend forward.
How is the coflex® device implanted?
After the surgical decompression, which removes pressure on the impinged nerves, your surgeon will insert the coflex® implant through the same incision. The implant is then positioned onto the laminar bone, which is the strongest bone in the back of your spine. The unique design of the coflex® implant maintains stability in the spine while preserving more natural movement at the affected area.
How do patients with coflex® compare to patients with spinal fusion?
A 2013 published study comparing the coflex® device with spinal fusion found that the coflex® device had advantages in perioperative outcomes and that equivalent or superior 2-year clinical outcomes were seen with coflex®. The article concluded that coflex® is a safe, efficacious, and viable alternative to spinal fusion in the treatment of spinal stenosis with low back pain.
What are the benefits of coflex® vs. decompression with pedicle screws?
In comparative research vs. spinal fusion, the data demonstrates that coflex® patients do better, faster.1 Patients receiving the coflex® implant experienced faster relief of their symptoms, reported higher satisfaction rates with their outcomes, and required less post-operation pain medication than spinal fusion patients.2 Decompression with the coflex® device is faster than decompression with pedicle screws, causes less blood loss and requires a shorter hospital stay.
FDA Tested and Approved
The coflex® procedure was studied and compared to pedicle screw fusion surgery after decompression in a FDA clinical trial. The coflex® patients outperformed fusion patients in all clinical measurements!
- coflex® patients were more satisfied with their outcome
94% of coflex® patients were satisfied with their outcome, compared to 87% of fusion patients at two years
- coflex® patients had faster relief of their symptoms
90% of coflex® patients had early relief of their spinal stenosis symptoms, compared to 77% of fusion patients at six weeks
- coflex® patients had lasting relief of their symptoms
88% of coflex® patients had lasting relief of their spinal stenosis symptoms, compared to 78% of fusion patients at two years
- coflex® surgeries were 36% faster compared to fusion surgeries
(98 minutes vs. 153 minutes)
- coflex® patients stayed one less day in the hospital compared to fusion patients
(1.9 days vs. 3.2 days)
- coflex® patients had less blood loss during surgery compared to fusion patients
(110cc vs. 349cc)