San Carlos, Calif. (July 12, 2022) – Empirical Spine, Inc., a medical device company creating a new class of spinal implant that works in parallel with the natural structures of the spine to restore functionality and optimize quality of life, recently had its Premarket Approval (PMA) Module II accepted and closed by the US Food & Drug Administration (FDA), an important milestone in the commercial approval process for its LimiFlex™ Dynamic Sagittal Tether™ (DST).
The LimiFlex DST is the first-of-its-kind surgical option for grade 1 degenerative spondylolisthesis (degen spondy) patients with spinal stenosis. Recognized with FDA’s Breakthrough Device Designation, LimiFlex has the potential to offer grade 1 degen spondy patients a better solution compared to current options such as fusion.
“We believe LimiFlex is an exciting advancement in stabilization surgery that uses a…