Studies indicate that Tenon Medical's Catamaran™ Sacroiliac Joint Fixation System (CAT SIJ) demonstrated an over 85% reduction in SIJ pain at six weeks, and radiographic evidence of the presence of solid continuous bridging bone across the treated joint at six months.
This completes the first phase of post-approval clinical study for Catamaran, which is specifically indicated for conditions including sacroiliac joint disruptions and degenerative sacroilitis. The company received FDA 510(k) clearance for the device in 2018. CAT SIJ is reportedly the first patented single implant SIJ fusion system to employ a posterior approach for minimal tissue disruption.
CAT SIJ allows for direct visualization of the joint, supporting a significant increase in reimbursement. It can be used with either a navigated procedure or fluoroscopic imaging, providing flexibility in access and visibility. CAT SIJ is designed to breach the joint and allow for bone graft materials to be loaded and delivered before and after implant placement to promote fusion. The unique trajectory eliminates the risk of sacral nerve root injury encountered with other fusion techniques, and reduces the risk of entry into the retroperitoneal space.