A FDA advisory panel has recommended the agency approve VertiFlex Inc.’s Superion interspinous spacer system for the treatment of spinal stenosis.
According to VertiFlex, the panel based their vote largely on results from the company's 470-patient clinical trial.
"I am grateful for our dedicated team of researchers whose diligence and belief in minimally invasive surgery allowed us to collect such a strong body of evidence. Superion demonstrated clinical success of greater than 80% in all components of the composite primary endpoint. We will continue to work closely with the FDA to complete their review of our Pre-Market Approval while we finalize plans for commercialization in the U.S.," said VertiFlex CEO Earl Fender, in a statement.
Spinal stenosis is a narrowing of the spine, which can put pressure on spinal nerves. The condition, which is often associated with aging, can cause pain, numbness and loss of certain motor function.
The Superion Interspinous Spacer System consists of small devices that are implanted in the spine to relieve pressure. The devices are inserted through a minimally invasive procedure that is generally conducted under local anesthesia.
Superion received CE market clearance in 2007. Approximately 2,000 patients worldwide have been implanted with the devices.
"The Superion interspinous spacer fits uniquely within the treatment continuum for patients who suffer from moderate lumbar spinal stenosis," said Dr. Pierce Nunley, a study investigator who appeared before the FDA panel. "Patients who have failed conservative care will have the option to receive a truly minimally invasive indirect decompression with Superion. This allows patients the potential to avoid traditional open spine surgery. Importantly, this can be performed without restricting options for future care."
In January 2013, VertiFlex secured coverage from the Centers for Medicare and Medicaid Services for its Totalis direct-decompression system for spinal stenosis.