Vertiflex – Superion Interspinous Spacer Implants
Background – Lumbar Spinal Stenosis occurs when the spinal canal narrows with age. The spinal canal can narrow from disc degeneration, ligamentum flavum hypertrophy, or facet hypertrophy. The resulting narrowing leads to burning and cramping in the legs with walking which improves with flexion or bending forward. Patients often exhibit the “shopping cart sign” in that they lean forward while walking to relieve symptoms.
Interspinous Spacer (ISS) – The Vertiflex Interspinous Spacer is a minimally invasive, outpatient procedure. The interspinous space is implanted between the spinous processes through a cannula. The procedure is performed under fluoroscopic (XR) guidance. The cannula is smaller than the diameter of a dime so only a small incision is needed to implant the device. The ISS works to limit extension and maintain the diameter of the spinal canal and neuroforamen. The device is implanted dorsal to the lamina. There are no plates or screws to hold the device in place, so mobility and the underlying anatomy are preserved. A randomized and controlled FDA trial demonstrates statistically significant improvement in leg pain, improvement in back pain, improvement in back-pain disability, and substantial patient satisfaction. The initial FDA approval trial has been continued for five years with evidence of treatment durability and sustained back pain relief, sustained leg pain relief, and sustained functional improvement. This same trial demonstrated an 85% decrease in the proportion of subjects using opioids during the trial period.