Minimally Invasive Dynamic Stabilization of Lumbar Facets for Reduction in Low Back Pain

At any given time, one in ten Americans suffer from lower back pain, and it is estimated that approximately 31% of this is attributed to the facet. The facet is a gliding synovial joint that works to limit motion and support the axial loads of the body. Patients typically experience facetmediated lumbar pain secondary to conditions such as age-related degeneration, trauma, or spinal deformities. Pathophysiologic changes accompanying degeneration of the facet joint can include the following: increased loading, wear of the cartilage surface, painful bone-on-bone contact, micromotion and prolonged inflammation.

Patients who exhaust conservative treatment can receive radiofrequency ablation (RFA) of the peripheral nerve to prevent transmission of pain signals. RFA, however, only provides relief for a limited duration and has decreased efficacy in repeat procedures. The only remaining option for patients is spinal fusion, an extremely invasive procedure that limits the normal motion of the body and has poor long-term outcomes. Therefore, patients experiencing facet-mediated pain need a minimally invasive treatment option to fill the therapeutic gap between non-operative treatments and invasive surgical intervention.

While other solutions exist to address this gap in care, all of these options are addressed towards surgeons who have little incentive to use these products over performing spinal fusion because open surgery is still required. Therefore, we have designed our solution to be targeted towards the skillsets of interventionalists. Our goal is to provide patients with longer and greater pain relief than the current standard without the need for invasive surgery.

To this end, our team has developed ZyGuard, a two-part system comprised of a catheter-based delivery system and an injectable implant. The flexible spacer works to prevent the painful bone-on-bone contact while maintaining a healthy range of motion of the facet. The delivery system enables interventionalists to access the degenerated facet, appropriately re-establish the intra-articular space, and deploy the injectable implant. Our team believes that this two-part ZyGuard system will revolutionize treatment of low back pain.