FDA Panel Recommends VertiFlex Superion Interspinous Spacer System for PMA

San Clemente, Calif.-based VertiFlex Inc., which makes minimally invasive interventions for spinal stenosis, has received support from the U.S. Food and Drug Administration’s (FDA) Orthopedic and Rehabilitation Devices Advisory Panel for the premarket approval application (PMA) for the company’s Superion interspinous spacer system. The panel voted that Superion demonstrated safety, effectiveness, and a favorable risk benefit profile based on the results from a 470-patient, multi-center, prospective and randomized controlled IDE (investigational device exemption) trial.

We are pleased with the panel’s support for PMA approval based on their thorough analysis of the level one evidence in our Superion IDE trial,” said Earl R. Fender, president and CEO of VertiFlex. “A study of this magnitude is a monumental effort. 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 more than 80 percent in all components of the composite primary endpoint. We will continue to work closely with the FDA to complete their review of our PMA while we finalize plans for commercialization in the United States.”

“The Superion interspinous spacer fits uniquely within the treatment continuum for patients who suffer from moderate lumbar spinal stenosis,” said Pierce D. Nunley, M.D., a study investigator from the Spine Institute of Louisiana, and panel presenter. “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.”

Scott L. Blumenthal, M.D., spine surgeon at Texas Back Institute, and co-medical director for VertiFlex, also presented to the Advisory Panel. Blumenthal noted that “in the IDE study, Superion demonstrated durability of effect beyond the 24-month primary endpoint, continuing through 36 months, and also performed comparably to what is reported in published literature on traditional decompression surgery. Thus Superion becomes a very viable treatment option for both surgeons and patients.”

The Superion interspinous spacer system is a minimally invasive spinal implant designed to treat moderate lumbar spinal stenosis. Superion is delivered through a cannula about the size of a dime and typically performed under local anesthesia. Once in place, it is intended to reduce pressure on the affected nerves and allow patients to return to a more active lifestyle. Superion has had the CE mark since 2007 and implanted in more than 2000 patients worldwide. Superion is currently an investigational device in the United States.