Empirical Spine Submits PMA for Outpatient Spine Stabilization Device

Empirical Spine has submitted a premarket approval (PMA) application to the FDA for its LimiFlex Dynamic Sagittal Tether, a minimally-invasive outpatient alternative to spinal fusion which stabilizes the spine and enables natural motion.

The LimiFlex device is implanted after laminectomy, a surgical procedure that removes the roof of the spinal canal. The device is implanted through the laminectomy incision to restore stability and preserve balanced mobility of the spine. The implant does not need screws, rods or bone grafts.

The PMA submission includes data from an Investigational Device Exemption study comparing the device to fusion surgery for degenerative spondylolisthesis patients with spinal stenosis.

The LimiFlex tether previously received Breakthrough Device status from the FDA.