To help ensure you have all the information you need to make an educated decision, here is a listing of educational resources, press releases, and articles about the coflex® Interlaminar Stabilization® device.
The North American Spine Society (NASS) has issued a coverage policy recommendation for Lumbar Interlaminar Device without Fusion and with Decompression. Health insurance companies look to NASS for guidance when determining appropriate coverage decisions for state-of-the-art technologies. This is significant for Surglign’s coflex device which is the only FDA approved device in this product class.
Two prospective, randomized, multi-centered, controlled, Level 1 clinical studies were conducted in order to better understand the sustainability of decompression with Interlaminar Stabilization. Spine surgeon expertise and proper patient selection were critical to determining the correct surgical solution. Lumbar decompression combined with Interlaminar Stabilization is recommended especially if decompression alone may create iatrogenic instability.
It is key that while discussing surgery options with a doctor to understand all of the options available. Each operation has benefits and downsides, so it is extremely important to understand all of these before a final decision is made.
Two-year results from a European study of the coflex device compared to decompression alone were published in the Journal of Neurosurgery Spine. Patients in the decompression group had 2.2 times more subsequent epidural steroid injections than the coflex device group. The coflex device patients reported 2.4 times more improvement in walking distance measurements. Also, at the two-year follow up, the decompression alone group was 1.4 times more likely to be using opioids. The study was done in seven sites across Europe with a total of 225 patients.
Two focal clinical research articles addressed both the costs and morbidity associated with fusion procedures performed in the treatment of spinal stenosis. They compared the effectiveness relative to the company’s coflex device and procedure. The coflex device and procedure were better for the treatment of lumbar spinal stenosis, when compared to instrumented spinal fusion.
Demonstration of the coflex device insertion using the Inserter and Mallet.
The coflex Device Single Level Flexion
Demonstration of the flexion that can be expected from the inserted device.
Surgalign Holdings, Inc. Announces the Publication of Clinical Research Demonstrating the Effectiveness of Decompression and Interlaminar Stabilization® using the colfex device in the Medicare Population