Dr. Lee’s procedure is part of a clinical trial to evaluate the safety and effectiveness of the Superion ISS in the treatment of leg pain caused by moderate lumbar spinal stenosis, which is the degenerative narrowing of the spaces in the spine that can lead to spinal cord and/or nerve root compression.
The trial is investigating use of the Superion ISS compared to the X-STOP Interspinous Process Distraction, an FDA-approved interspinous spacer that is implanted in a slightly different manner than Superion ISS. Study participants must be over 45 years old and have been diagnosed with lumbar spinal stenosis and have been undergoing non-operative treatment of unrelieved symptoms for at least six months, according to the release. Participants must also have leg, buttock or groin pain that is relieved by sitting or bending forward, and participants cannot have a history of prior surgery of the lumbar spine.
The results of the study will determine if the Superion ISS should be made commercially available in the United States, according to the release. The device is made of titanium and is designed to relieve leg, buttock and groin pain resulting from pressure that can be placed on the spinal nerve roots from walking or standing for long periods.
More information about the clinical trial is available in the news release.
Read the release about the Superion ISS clinical trial.
