FDA granted Premarket Approval (PMA) to Empirical Spine’s LimiFlex Dynamic Sagittal Tether, a motion-preserving system for the treatment of lumbar spinal stenosis associated with Grade I degenerative spondylolisthesis following decompression.
Initial U.S. limited launch will begin shortly at select medical centers that participated in the company’s IDE trial, with a broader launch to establish additional centers of excellence later this year.
The device stabilizes the spine following decompression without rigid fixation. By providing dynamic restraint to pathologic motion while preserving controlled movement, the procedure offers an alternative surgical strategy. Motion-preserving stabilization for these patients creates a new treatment category positioned between decompression alone and fusion. The device stabilizes pathologic motion while preserving native anatomy, maintaining a surgical magnitude similar to decompression rather than reconstruction.
In the FDA pivotal trial, LimiFlex demonstrated non-inferior 2-year clinical outcomes compared with instrumented fusion. Procedures were substantially shorter than fusion surgery and supported outpatient treatment in appropriately selected patients.
FDA granted Premarket Approval (PMA) to Empirical Spine's LimiFlex Dynamic Sagittal Tether, a motion-preserving system for the treatment of lumbar spinal stenosis associated with Grade I degenerative spondylolisthesis following decompression.
Initial U.S. limited launch will begin shortly at select medical centers that participated in the...
FDA granted Premarket Approval (PMA) to Empirical Spine’s LimiFlex Dynamic Sagittal Tether, a motion-preserving system for the treatment of lumbar spinal stenosis associated with Grade I degenerative spondylolisthesis following decompression.
Initial U.S. limited launch will begin shortly at select medical centers that participated in the company’s IDE trial, with a broader launch to establish additional centers of excellence later this year.
The device stabilizes the spine following decompression without rigid fixation. By providing dynamic restraint to pathologic motion while preserving controlled movement, the procedure offers an alternative surgical strategy. Motion-preserving stabilization for these patients creates a new treatment category positioned between decompression alone and fusion. The device stabilizes pathologic motion while preserving native anatomy, maintaining a surgical magnitude similar to decompression rather than reconstruction.
In the FDA pivotal trial, LimiFlex demonstrated non-inferior 2-year clinical outcomes compared with instrumented fusion. Procedures were substantially shorter than fusion surgery and supported outpatient treatment in appropriately selected patients.
Copy to clipboard 
