The FDA postponed a meeting of 1 of its advisory panels that’s slated to review the pre-market approval application for the Superion spine implant made by VertiFlex.
The FDA’s orthopedic & rehabilitation devices panel was originally scheduled to convene Dec. 12, but the federal watchdog agency yesterday said will delay the hearing until Feb. 20, 2015. No reason was given for the postponement.
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.
"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 FDA. The goal of a Minimally Invasive Spine Surgery is usually to relieve pain caused by nerve root pinching. There are two common causes of lumbar nerve root pressure: from a lumbar herniated disc or lumbar spinal stenosis.
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.
