Summary: Empirical Spine has developed the LimiFlex Paraspinous Tension Band, a dynamic stabilization system to support the spine in flexion, offering a minimally invasive alternative to lumbar spinal fusion for degenerative spondylolisthesis. Flexion is the most important motion of the lumbar spine and is the type of motion most exercised during activities of daily living. The technology has been specifically designed to preserve motion. LimiFlex is designed to provide stabilization without the need for pedicle screws or more invasive fusion devices. LimiFlex addresses a large and underserved need for patients who could benefit from spinal stabilization but do not otherwise require fusion. LimiFlex consists of two dynamic titanium rods with attached Ultra-high Molecular Weight Polyethylene straps that wrap around adjacent spinous processes. The attachment mechanisms for the straps are integrated into the rods and allow for simple intraoperative re-adjustment of the device. With recent US Investigational Device Exemption pivotal study approval, Empirical Spine is currently enrolling patients into its IDE clinical program. The study is a non-randomized, concurrently controlled, propensity score-matched study in patients suffering from lumbar degenerative spondylolisthesis with spinal stenosis.
Need: Allowing the spine surgeon to perform a full decompression on appropriate patients without subjecting them to spinal fusion. Instead of having to choose between a substandard decompression versus the invasiveness and complications of fusion, the surgeon can implant LimiFlex.
Value: Available surgical options for degenerative spinal disorders are highly invasive and can lead to a cascade of back problems; surgeons and patients are often torn between more conservative treatments and highly invasive surgery. This compromise creates a major unmet need for a treatment option which offers the potential benefits of the surgery while minimizing risk, invasiveness, and recovery time. LimiFlex meets this need by allowing the surgeon to perform a full decompression on appropriate patients without subjecting them to spinal fusion.