Empirical Spine’s Motion-Preserving Spinal Fusion Alternative Debuts in U.S.

Empirical Spine has introduced to the U.S. market its LimiFlex Dynamic Sagittal Tether, an outpatient, motion-preserving alternative to spinal fusion after decompression. Empirical Spine Co-Founder Todd Alamin, M.D., successfully performed the first two commercial LimiFlex implants at Stanford Medicine on April 30.

“Being in the OR for the first commercial LimiFlex cases was a defining moment after more than two decades of development,” Dr. Alamin said after completing the procedures. “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.”

Empirical Spine received U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) for LimiFlex on Feb. 12. The Class III dynamic stabilization device is designed to treat Grade I lumbar degenerative spondylolisthesis with stenosis.¹

In an FDA pivotal trial, LimiFlex demonstrated non-inferior two-year clinical outcomes compared with 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.

“This marks an important milestone for patients with lumbar degenerative spondylolisthesis who have failed conservative treatment,” Empirical Spine Co-Founder/President Louie Fielding stated. “LimiFlex offers a motion-preserving, outpatient option that allows us to treat many of these patients without defaulting to fusion.”

The company has initiated a limited U.S. market release, beginning with centers that participated in the LimiFlex IDE trial, with broader commercial expansion planned throughout 2026.

Empirical Spine Inc. is a medical technology company developing surgical solutions that align the magnitude of treatment and magnitude of disease. The company’s solutions aim to address structural spine conditions using motion-preserving approaches intended to reduce the physiologic burden of traditional surgical constructs.

Reference
¹ The LimiFlex Dynamic Sagittal Tether is a motion-preserving spinal implant that is intended to provide dynamic flexion-restricting stabilization of the spine following a lumbar decompression. The LimiFlex Dynamic Sagittal Tether is indicated for use at one level from L3-L5, in skeletally mature patients following surgical decompression for treatment of lumbar degenerative spondylolisthesis (Grade I per Meyerding classification in a lateral radiograph) with spinal stenosis. Patients consist of those with neurogenic claudication or radiculopathic symptoms, including leg pain, muscle weakness, and/or sensation abnormality, with or without back pain, who have been unresponsive for a minimum of three months of non-operative treatment and have a confirmed diagnosis through patient history and diagnostic studies using X-ray, MRI and/or CT.