MINNETONKA, Minn. – April 18, 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 enrollment of its 100th patient in the EVoluSIon (EVSI) Clinical Study. This prospective, 40-site, 250-patient trial will evaluate long-term fusion and pain reduction in patients receiving SImmetry® Sacroiliac Joint Fusion.
“There is clear evidence demonstrating the value of minimally Invasive SI joint fixation for appropriately selected patients,” said Antoine G. Tohmeh M.D., the orthopedic surgeon who performed the procedure at Deaconess Hospital in Spokane, Wash. “But spine surgeons know that any metal implant will weaken over time. To ensure that a patient’s clinical benefit lasts, a true fusion, including decortication, bone grafting and fixation, is critical. Studies such as EVoluSIon are important to demonstrate that efficacy.”
Last week the Company released results of a 19-patient, prospective, multi-center study of Minimally Invasive Sacroiliac Joint Fusion Surgery with Decortication. At 24 months post-op, 94 percent of patients had evidence of bridging bone across the SI joint, with 83 percent categorized as solid fusion. Of patients with solid fusion, 88 percent of the joints were fused within the area of decortication, demonstrating the importance of this step in achieving fusion. In addition to fusion, the study demonstrated a 73 percent reduction in average pain. The EVSI study is designed to build on the findings of this study.
The Centers for Disease Control and Prevention lists back problems as the second most common cause of disability in U.S. adults[i]. It has been reported that approximately 20 percent of all chronic low back pain derives from the sacroiliac joint[ii].
About Zyga Technology, Inc.
In addition to marketing the SImmetry System, Zyga Technology is conducting a U.S. multicenter clinical study of the Glyder Facet Restoration Device, an investigational, non-fusion, minimally invasive technology intended to provide relief from lumbar facet pain.
[i] Centers for Disease Control and Prevention. Prevalence of disabilities and associated health conditions among adults—United States, 1999. JAMA. 2001; 285(12):1571-1572.
[ii] Cohen SP et al. Sacroiliac Joint Pain: A Comprehensive Review of Epidemiology, Diagnosis and Treatment. Expert Rev Neurother. 2013; 13(1):99-116