The U.S. FDA’s Orthopedic and Rehabilitation Devices Advisory Panel has voted strongly in support of the PreMarket Approval application for the VertiFlex® 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 trial.
CE marked since 2007 and implanted in over 2000 patients worldwide, 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.
“We are pleased with 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 Chief Executive Officer of VertiFlex, Inc. “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 >80% 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 US.”
Scott L. Blumenthal, MD, spine surgeon at Texas Back Institute, and co-Medical Director for VertiFlex, also presented to the Advisory Panel. Dr. 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.”
Pierce D. Nunley, MD, a study investigator from the Spine Institute of Louisiana, and Panel presenter commented: “The Superion Interspinous Spacer fits uniquely within the treatment continuum for patients who suffer from moderate lumbar spinal stenosis. 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.”
Source: Business Wire