VertiFlex® Inc. a leading innovator of advanced minimally invasive interventions for spinal stenosis announced today that the U.S. Food and Drug Administration (FDA) has issued a PMA Approval Order for the company’s Superion® Interspinous Spacer System clearing the way for commercialization in the United States. The Approval Order follows a February FDA Advisory Panel vote 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.
Superion® is indicated for moderate lumbar spinal stenosis and is the least invasive motion preserving device in the category of interspinous spacers.
- Largest most robust IDE device trial for moderate lumbar spinal stenosis
- Superion® demonstrated clinical success of >80% in all major components of the composite primary endpoint at 24 months maintaining durability of effect through 36 months
- Superion® patients exhibited similar leg pain improvement as measured by VAS compared to published literature on open surgical decompression
- Healthcare economic data was captured demonstrating Superion’s cost-effective equivalency to open surgical decompression
- Superion® has been successfully implanted in over 2000 patients around the world and will soon be available in the United States
“We are delighted with this PMA approval based on compelling level one evidence developed in the Superion® IDE Trial” said Earl R. Fender President and Chief Executive Officer of VertiFlex. “Superion® has proven to be a safe effective and least invasive solution for the treatment of spinal stenosis in a mostly Medicare-aged population. Countless numbers of patients in the United States will now benefit from this important technological advancement.”
Nick Shamie MD Professor & Chief UCLA Orthopaedic Spine Surgery and co-Medical Director for VertiFlex commented: “As an early adopter of interspinous spacers they have provided tremendous improvement for my patients suffering from lumbar stenosis. As a next-generation technology Superion® offers the potential for even greater clinical benefit with the least invasive indirect decompression possible and the ability for patients to avoid traditional open spine surgery.”