The US Food and Drug Administration (FDA) has issued a pre-market approval (PMA) order for Vertiflex’s Superion interspinous spacer system, clearing the way for commercialisation in the USA. The order follows a February FDA advisory panel vote that Superion demonstrated safety, effectiveness, and a favourable risk benefit profile based on the results from a 470 patient, multicentre, prospective and randomised controlled investigational device exemption trial.
Superion is indicated for moderate lumbar spinal stenosis, and is the least invasive motion preserving device in the category of interspinous spacers.
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 the visual analogue scale, compared to published literature on open surgical decompression, while healthcare economic data was also recorded, demonstrating Superion’s cost-effective equivalency to open surgical decompression.
Nick Shamie, professor and 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.”