VertiFlex announced that the US 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 US.
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 2,000 patients around the world, and will soon be available in the US.
"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."