San Carlos, Calif. (December 19, 2022) – Empirical Spine, Inc., a medical device company creating a new class of spinal implant, recently completed the final step in the U.S. Food & Drug Administration (FDA) submission process for the LimiFlex™ Dynamic Sagittal Tether™ (DST). The Premarket Approval (PMA) submission included Module III, with data and analysis of the two-year results from the pivotal Investigational Device Exemption (IDE) clinical trial comparing LimiFlex DST stabilization versus fusion surgery for degenerative spondylolisthesis (degen spondy) patients with spinal stenosis.
The LimiFlex DST is the first-of-its-kind minimally invasive, outpatient surgical option for this specific patient population. The device previously received the FDA’s Breakthrough Designation for its potential to provide significant advantages over currently approved spinal stabilization…