Newly FDA-Approved VertiFlex Superion Offers Back Pain Relief

A newly-approved device, the VertiFlex Superion, may offer chronic pain patients relief from common causes of back pain and leg pain. Read on to learn more.

What causes back pain?

The most common source of chronic pain is the lower back, specifically the lumbar spine. Several painful conditions can develop in the lumbar spine, such as arthritic degeneration of the spine joints, degeneration of the intervertebral discs, and herniation of the discs (that is, bulging outward).

Another very common, painful spine condition is spinal stenosis, which refers to the narrowing of spaces in the spinal column through which the spinal cord passes. This can result from various changes to the spine, such as thickening of the bones or ligaments in the spine or misalignment of the vertebrae. As the spinal column narrows, it may put pressure on the spinal cord in certain places. This causes pain and sometimes numbness both in the back and radiating down into the legs. The pain is often increased by certain activities such as standing or walking, and may be relieved by postures such as bending forward or sitting.

What is the VertiFlex Superion?

VertiFlex developed a procedure for treating spinal stenosis pain with an implanted device called the Superion, an “H” shaped spinal spacer. This procedure involves making an incision in the back and inserting a metal tube that passes between the bones of the spine. The VertiFlex Superion spacer is inserted through the tube and locked into place against the spine, holding open the spinal column in the area where stenosis was occurring.

By creating and maintaining space at the right location, the VertiFlex Superion can provide permanent relief from spinal stenosis pain. Compared to traditional surgeries, this procedure is minimally invasive. This means most of the tissues of the back are not damaged or disrupted and patients can be discharged the same day and have a faster recovery.

VertiFlex conducted a large 470 patient randomized trial comparing the Superion to an alternative stenosis procedure. The VertiFlex Superion provided substantial pain relief, which continued through the entire three-year follow-up period. Last year, VertiFlex presented this data to the FDA and received approval for this device. VertiFlex is continuing to collect data on the safety and efficacy of the Superion through a non-randomized (meaning all qualifying patients receive the Superion) registry study.

Innovative Pain Treatment Solutions and Surgery Center is participating in this study, called the PRESS registry. For this study, 100 patients across multiple sites around the U.S. will receive the Superion for spinal stenosis pain.

If you are interested in learning more about this study and whether you might qualify for it, you can discuss this study with your pain management provider.