(May 26, 2015) VertiFlex, Inc.announced that it has been granted pre-market approval by the FDA for its minimally invasive treatment of lumbar spinal stenosis, the Superion Interspinous Spacer System.  This approval comes after a successful 470 patient IDE study of the Superion system.  VertiFlex’s press release highlighted the following results from the IDE study:

  • 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