VertiFlex Inc. won a date with an FDA advisory panel to review the data behind its Superion interspinous spacer ahead of its bid for pre-market approval from the watchdog agency.
VertiFlex is seeking the FDA’s permission to market the Superion in the U.S. under an indication for treating patients with lumbar spinal stenosis, according to a press release.
The FDA’s Orthopaedic & Rehabilitation Devices panel is slated to meet Dec. 12 to evaluate the safety and efficacy data on the Superion, according to the release.
"The Superion ISS is indicated for those patients with impaired physical function who experience relief in flexion from symptoms of leg/buttock/groin pain, numbness, and/or cramping, with or without back pain. The Superion ISS may be implanted at 1 or 2 adjacent lumbar (L) levels in patients in whom treatment is indicated at no more than 2 levels, from L1 to L5," according to the release.
VertiFlex, which sold off some of its non-core assets to Stryker (NYSE:SYK) for an undisclosed amount in March 2013, won FDA clearance for its Totalis direct compression system and UniVise spinous process fixation device in January 2013. A year later the company scored coverage from the Centers for Medicare & Medicaid Services for the Totalis device.