VertiFlex’s Superion Interspinous Spacer Gains PMA Approval
VertiFlex’s Superion interspinous spacer system for moderate lumbar spinal stenosis has won FDA premarket approval, the San Clemente, Calif., devicemaker announced Tuesday.
The approval comes on the heels of a February FDA Advisory Panel endorsement which says Superion showed safety and efficacy in a 470-patient, multicenter investigational device clinical trial.
The system demonstrated greater than 80 percent clinical success in all major primary endpoint components at 24 months, the company says, adding that the device sustained durability of effect through 36 months.
The device is the least invasive interspinous spacer for preserving motion, allowing patients to avoid open spine surgery, the standard of care, the company says.
Superion has been implanted in more than 2,000 patients worldwide. An U.S. launch is planned in the near future.
VertiFlex was founded in 2005 to provide treatments for lumbar spinal stenosis. The disease is the leading cause of age-related spinal procedures. — Jason Scott