SAN CARLOS, CA / May 19, 2026 / Empirical Spine announces the U.S. market introduction of the LimiFlex Dynamic Sagittal Tether™, an outpatient, motion-preserving alternative to spinal fusion following decompression. Todd Alamin, MD, Empirical Spine Co-founder, successfully performed the first two commercial implantations of the Class III dynamic stabilization device designed to treat Grade I lumbar degenerative spondylolisthesis with stenosis, at Stanford Medicine on April 30, 2026.
After the cases, Dr. Alamin shared, “Being in the OR for the first commercial LimiFlex cases was a defining moment after more than two decades of development. We are one step closer to bringing this technology to surgeons and patients across the U.S. who have been waiting for a motion-preserving alternative to fusion.”
The company received U.S. Food & Drug Administration (FDA) Premarket Approval (PMA) for LimiFlex on February 12, 2026. In the FDA pivotal trial, LimiFlex demonstrated non-inferior 2-year clinical outcomes compared to instrumented spinal fusion. Procedures were substantially shorter than fusion surgery and supported outpatient treatment in indicated patients. LimiFlex patients also demonstrated faster return to work and activities of daily living, improved disability scores (Oswestry Disability Index, ODI), and durable improvements in leg and back pain along with a numerically lower but statistically similar reoperation rate.