San Clemente-based VertiFlex, the privately held medical device company, has provided the first Interspinous Spacer for use in an investigative device trial.
Superion, a spacing device for lumbar spinal stenosis (LSS), a common and debilating problem for adults over age 50, has been inserted into a patient in a Louisiana hospital this week, marking the first time a device of its kind has been implanted in a patient in the U.S.
The Superion device is intended to correct LSS by opening the space in the spinal column that has gradually narrowed over time; resulting in pain and numbness from pressure on the spinal cord and nerve roots. The Superion device is implanted through a minimal incision that does not require general anesthesia. The out-patient procedure can be completed in as short as 20 minutes.
Compared with traditional fusion procedures, in which patients typically undergo hours of surgery, with extended hospital stays and lengthy rehabilitations, this device hopes to offer patients a much less invasive option, briefer hospital stay and a rapid recovery time. The Superion Interspinous Spacer is a titanium metal implant.
“Superion is available only through this clinical trial at selected sites in the U.S., including the Spine Institute of Louisiana,” says Medical Research Director Ajay Jawahar, M.D. He adds, “This implant procedure may be a solution for elderly patients who are suffering with LSS, and have been reluctant to have surgery to correct it.”
Superion has already had considerable success in Europe. To date hundreds of Superion devices have been implanted in eight countries by over 30 surgeons.