CLINICAL TRIALS & PUBLICATIONS
SImmetry® SI Joint Fusion Clinical Trials The SImmetry Sacroiliac Joint Fusion System is a minimally invasive surgical (MIS) procedure for patients with sacroiliac (SI) joint dysfunction who have not gained relief from conservative care. The SImmetry System utilizes the proprietary SImmetry DecorticatorTM, allowing surgeons to prepare the articular region of the SI joint and insert bone graft into the joint to help facilitate a true SI joint fusion. The muscles and ligaments surrounding the SI joint are maintained, enabling a more rapid return to regular activities for patients and a greater potential for a successful SI joint fusion. The SImmetry System is cleared by the US Food and Drug Administration (FDA) for commercial distribution. In early 2015, the American Medical Association (AMA) CPT Panel approved a Category I CPT code for Minimally Invasive Sacroiliac Joint Fusion, providing validation that current clinical data support efficacy of the procedure and improving patient access to the surgery. More studies are underway to ensure that access to minimally invasive SI joint fusion continues to improve.
Intended Use The SImmetry System is intended for SI joint fusion for conditions including SI joint disruptions and degenerative sacroiliitis.
EVoluSIon Clinical Study: Zyga is sponsoring a post market clinical study to evaluate long term results in patients implanted with the SImmetry System. The purpose of the study is to evaluate fusion and pain reduction following use of the SImmetry System. This study will be performed at up to 40 sites and will include up to 250 patients. Patients may enroll in the study if they are at least 18 years old and have been diagnosed with SI joint pain.
Rx Only. Caution: Federal law restricts this device to sale by or on the order of a physician. For SImmetry indications, contraindications, warnings and precautions, refer to the product Instructions for Use.