Empirical Spine completed the final step in the FDA submission process for LimiFlex DST. Its Premarket Approval submission included Module III data and analysis of two-year results from a pivotal IDE trial comparing LimiFlex DST stabilization with fusion surgery for degenerative spondylolisthesis.
The FDA accepted and closed Module II of Empirical Spine’s Premarket Approval submission for LimiFlex DST, a milestone in the product’s commercial approval process.
The U.S. Food and Drug Administration (FDA) has granted Premarket Approval (PMA) to the LimiFlex Dynamic Sagittal Tether , a motion-preserving system for the treatment of lumbar spinal stenosis associated with Grade I degenerative spondylolisthesis following decompression.
A paper compared decompression with LimiFlex DST stabilization and transforaminal lumbar interbody fusion for degenerative spondylolisthesis. Interim results showed improved pain and function with both; the DST group had shorter stays and earlier return to work.
Louie Fielding is an original inventor of the LimiFlex Dynamic Sagittal Tether, which was conceived in the Biodesign program at Stanford University while Louie pursued a master’s degree in mechanical engineering.
