VertiFlex earned FDA PMA Approval Order for the Superion Interspinous Spacer System.
Here are five things to know:
1. Earlier this year, the FDA Advisory Panel voted that Superion demonstrated safety and effectiveness and a favorable risk-benefit profile based on the results of a multi-center, prospective and randomized controlled IDE trial.
2. The device is indicated for moderate lumbar spinal stenosis and is the least invasive motion preserving device among interspinous spacers.
3. Superion demonstrated clinical success more than 80 percent in all major components of the composite primary endpoint at 24 months after surgery and maintained that effect through 36 months after surgery.
4. Patients reported similar leg pain improvement from the VAS score as compared to published literature on open surgical decompression.
5. Additional healthcare economic data shows Superion is cost-effective in equivalency to open surgical decompression.
6. The system has been implanted in more than 2,000 patients around the world.
7. The company plans to make it available in the United States soon.
"As an early adopter of interspinous spacers they have provided tremendous improvement for my patients suffering from lumbar stenosis," said Nick Shamie, MD, professor and chief at UCLA Orthopaedic Spine Surgery and co-medical director for VertiFlex. "As a next-generation technology Superion offers the potential for even greater clinical benefit with the least invasive indirect decompression possible and the ability for patients to avoid traditional open surgery."