San Carlos, Calif. (April 27, 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 submitted Premarket Approval (PMA) Module II in the US Food & Drug Administration (FDA) approval process for its LimiFlex™ Dynamic Sagittal Tether™ (DST).
LimiFlex is an investigational device targeting grade 1 lumbar degenerative spondylolisthesis patients with spinal stenosis. It is designed to restore natural segmental motion and stability after lumbar decompression by augmenting the posterior tension band. This creates elastic resistance to flexion and maintains lordosis, giving patients the stabilization their spines need while preserving normal motion. The Dynamic Sagittal Tether is intended to be an alternative to spinal…