VertiFlex, a developer of minimally invasive and motion-preserving spinal surgery technologies, has concluded patient enrolment in its pivotal IDE clinical trial of the Superion Interspinous Spacer (ISS).
The prospective multicentre controlled Superion IDE clinical trial will evaluate the safety and efficacy of the Superion ISS compared with control arm X-STOP IPD in healthy adults suffering from at least six months of moderate lumbar spinal stenosis who have been unresponsive to conservative care.
The trial is being conducted at 31 leading spinal surgery sites in the US, and the results from the Superion trial will form the basis for a PMA approval application to the US Food and Drug Administration (FDA).
The Superion ISS is performed through a single, half-inch skin incision, and is designed to act as a support column to open the passageways that contain the spinal cord and nerve roots.
The study examines the safety and efficacy of a minimally invasive Interspinous Spacer for relieving lower back and leg pain caused by lumbar spinal stenosis, the condition of degenerative narrowing of the spaces in the spine.
Yale University School of Medicine Department of Orthopedics and Rehabilitation associate professor Peter Whang said the Superion ISS from VertiFlex may provide a less invasive, motion-preserving solution to traditional spinal surgery, and over the next 24 months they will further investigate the data for submission to the FDA.
"Spinal stenosis can have a tremendous impact on a person's mobility and physical activity. While there are treatment options available, many patients want less invasive options for lower back and leg pain relief," Whang said.
VertiFlex president and CEO Earl Fender said the Superion IDE study is the largest ever FDA clinical trial for lumbar spinal stenosis with 470 patients enrolled.
''The study brings us closer to the day when hundreds of thousands of patients suffering from lumbar spinal stenosis will have access to Superion's differentiated, advanced and less invasive technology," Fender added.