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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