SAN CLEMENTE, Calif.--(BUSINESS WIRE)--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® 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.”
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 2,000 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.”
About VertiFlex, Inc.
VertiFlex is a privately held medical device company dedicated to the advancement of minimally invasive solutions for the treatment of lumbar spinal stenosis, which is the leading cause of spinal surgery in the elderly. Founded in 2005 and headquartered in San Clemente, CA, VertiFlex has developed proprietary, minimally invasive technologies for performing both indirect and direct decompressions of the lumbar spine. These procedures fill the gap in the stenosis treatment continuum between conservative care and traditional spine surgery, providing new options for interventional spine physicians and less invasive options for traditional spine surgeons. To date, VertiFlex has compiled the largest, most rigorous body of device clinical evidence related to lumbar spinal stenosis.