April 11, 2017 – Zyga Technology, Inc., a medical device company focused on the design, development and commercialization of minimally invasive devices to treat underserved conditions of the lumbar spine, today announced that it will release the 24-month results from its study, Evaluation of Fusion after Minimally Invasive Sacroiliac Joint Fusion Surgery with Decortication, on Wednesday evening at the 2017 Annual Meeting of the International Society for Minimally Invasive Spine Surgery (ISASS) in Boca Raton, Fla. This prospective, multi-site study evaluated long-term fusion and pain reduction in patients receiving SImmetry® Sacroiliac Joint Fusion.
The study evaluated 18 patients for radiographic evidence of fusion at 12 and 24 months following SI joint fusion with decortication and bone grafting. A systematic Computed Tomography (CT) review was predefined and performed by independent radiologists blinded to each other’s assessments. Previously-reported results demonstrated a 72 percent reduction in average pain and evidence of bridging bone in 79 percent of patients at 12 months. The evidence will be presented by Dr. William W. Cross III, an orthopedic surgeon at Mayo Clinic in Rochester, Minn.
The Company will also release results of another study: Biomechanical Evaluation of Trans-ilium Sacroiliac Joint Decortication and Fixation with Threaded Implants. This study analyzed the contribution of threaded implants to stability of the SI joint following SI joint fixation and quantified resulting rigidity in the presence of joint decortication. The study was led by Dr. Jonathan Sembrano, an orthopedic surgeon at the University of Minnesota Fairview in Minneapolis, Minn.
“Clinical evidence is the bedrock of market development for innovative surgical technology,” stated Jim Bullock, president and CEO of Zyga Technology. “While studies have shown that fixation of the SI joint can provide relief for SI joint disorders, there is little data today showing the ability of many SI joint fusion technologies to achieve long-term, solid bony fusion across the joint. Zyga is committed to building the evidence needed to expand access for patients to a minimally invasive procedure built on proven orthopedic principles of fusion. Our 250 patient, prospective, multi-center EVoluSIon study will build on the findings in this study to demonstrate the benefit of a true fusion for long-term relief for patients.”
The Centers for Disease Control and Prevention lists back problems as the second most common cause of disability in U.S. adults. It has been reported that approximately 20 percent of all chronic low back pain derives from the sacroiliac joint.