Empirical Spine Receives Breakthrough Device Designation for LimiFlex

By Julie A. Vetalice

Empirical Spine Receives Breakthrough Device Designation for LimiFlex

Empirical Spine was granted FDA Breakthrough Device Designation for its LimiFlex™ Paraspinous Tension Band.

Key potential benefits cited in the application include less invasive and shorter surgery, improved intra- and post-operative outcomes, reduction or elimination of hospitalization length of stay, and improved patient quality of life.

LimiFlex is an investigational device designed as an alternative to spinal fusion for patients receiving surgical decompression for lumbar degenerative spondylolisthesis with spinal stenosis. LimiFlex does not involve any screws or bone grafts, and is designed to stabilize the spine without fusing it.

The LimiFlex device is placed following a standard decompression, typically in less than 20 minutes. The less invasive nature of the procedure also offers promise as an outpatient or ambulatory surgery.

Empirical Spine initiated the premarket approval process earlier this year after fully enrolling a pivotal Investigational Device Exemption trial in 2020 comparing LimiFlex to transforaminal lumbar interbody fusion following decompression. LimiFlex received approval under the CE Mark in 2009 and has been implanted in over 2,000 European patients.

Product Labels: Lumbar Spine

Tags: 510(k) Clearance, Regulatory