U.S. Overview

Degenerative Spondylolisthesis and the LimiFlex Spinal Stabilization System

Lumbar spinal stenosis is a common condition characterized by a narrowing of the space around the spinal cord in the lower back. The narrowing can put pressure on nerves and cause pain, numbness, and weakness in the buttocks and legs and, in some cases, back pain. Some patients who have lumbar spinal stenosis also have degenerative spondylolisthesis, a slippage of one vertebrae relative to another. The slippage causes compression of the spinal canal and associated symptoms. In addition, the affected spinal segment(s) in patients with degenerative spondylolisthesis often show excessive motion, or instability, when patients bend forward and flex their lumbar spines.

In most cases, patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis are initially prescribed several months of non-operative treatment, often including physical therapy and medications. When such non-operative treatment fails to adequately address patients’ symptoms, surgery is considered.

Surgery for patients with degenerative spondylolisthesis with lumbar spinal stenosis in the United States typically combines a surgical decompression, in which the surgeon removes the tissues that are pinching the nerves, with an instrumented spinal fusion, in which the surgeon implants materials such as screws, rods, and bone graft to permanently immobilize the treated segment.

The LimiFlex Spinal Stabilization System

The LimiFlex Spinal Stabilization System is a new stabilization option for patients being treated with surgical decompression for degenerative spondylolisthesis. The LimiFlex does not require pedicle screws to anchor to the spine; instead, two dynamic rods are attached by screws to pedicle-sparing straps which encircle adjacent spinous processes.

In the U.S., the FDA has granted Simpirica Spine approval to conduct a clinical study in patients suffering from lumbar degenerative spondylolisthesis with spinal stenosis. The objective of Simpirica Spine’s randomized controlled trial (RCT) is to demonstrate the safety and effectiveness of spinal stabilization with the LimiFlex™ Spinal Stabilization System compared to spinal fusion following surgical decompression for treatment of lumbar degenerative spondylolisthesis with spinal stenosis. Simpirica expects to start this U.S. study in the second half of 2012. For more information on the LimiFlex Spinal Stabilization System and how it will be used in the U.S. IDE study, please click here.

If you are a patient interested in learning more, please contact Simpirica Spine at clinical@simpirica.com.

United States: CAUTION - Investigational device. Limited by United States law to investigational use.