Superion Interspinous Spacer

Interspinous Spacer Clinical Trial
An Investigational Device Designed To Treat Moderate Lumbar Spinal Stenosis

You May Be A Candidate

If you experience pain in your legs, buttock or groin when you stand or walk, you may suffer from a condition called lumbar spinal stenosis.

Lumbar (lower back) spinal stenosis can seriously affect your ability to enjoy the activities of everyday living. Many patients find relief with nonsurgical treatment options. However, if these treatments are not successful, your doctor may recommend surgery.

The Superion™ Interspinous Spacer (ISS) is a potential alternative to traditional spinal surgery designed to relieve chronic pain caused by moderate lumbar spinal stenosis. The Superion™ ISS has been implanted in more than 800 patients worldwide.

A clinical study is now underway to evaluate the safety and effectiveness of the Superion™ ISS for the treatment of moderate lumbar spinal stenosis. The FDA will evaluate data collected from this study to determine whether this device should be made commercially available in the U.S.

You or someone you know may be eligible to participate in this study.

The Superion™ Clinical Study

In order to gain approval by the FDA for commercial use in the United States, a clinical study is now underway to determine the safety and effectiveness of Superion™ ISS in treating moderate lumbar spinal stenosis.

The Superion™ device will be compared to the X-STOP® IPD® device, which is commercially available in the United States. Patients who meet the study criteria and agree to participate in the study are randomly chosen to receive either the X-STOP® IPD® or the Superion™ ISS and will be evaluated at specific follow-up visits for 24 months after their surgery.

To see if you may qualify for participation in this clinical study, please take this short survey.

Caution: Investigational device. Limited by Federal (or United States) law to investigational use.