VertiFlex announced that the FDA's Orthopedic and Rehabilitation Devices Advisory Panel has voted in support of the premarket approval application for its Superion Interspinous Spacer System.
The panel voted that Superion demonstrated safety and effectiveness, as well as a favorable risk benefit profile based on the results from a 470-patient, multicenter, prospective and randomized controlled investigational device exemption trial.
"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," said Scott L. Blumenthal, MD, spine surgeon at Plano-based Texas Back Institute, and co-medical director for VertiFlex.
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