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’s (FDA) Orthopedic and Rehabilitation Devices Advisory Panel has voted strongly in support of the PreMarket Approval application for the company’s Superion® Interspinous Spacer System. The Panel voted 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.
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