By: Mark Speegle
(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
The press release also notes that Superion has already been successfully implanted in more than 2,000 patients internationally. VertiFlex was founded in 2005 and is based in San Clemente, CA.