US-based medical device company Zyga Technology has enrolled the first patient in EVoluSIon Study, a multicenter single-arm trial designed to evaluate fusion and pain reduction following use of the Zyga SImmetry Sacroiliac Joint Fusion System.
According to the company, the trial will include around 50 patients, and will be carried out at ten sites.
The SImmetry Sacroiliac has been developed for conditions, including sacroiliac joint disruptions and degenerative sacroiliitis.
Zyga Technology president and CEO Jim Bullock said: ""The SImmetry system offers a unique surgical solution for patients suffering from sacroiliac joint dysfunction.
"The EVoluSIon Study, along with our SAIF (Sacroiliac Joint Fusion System) Study and additional ongoing clinical research, will be critical to demonstrate clinical value and assist with proper utilization of this new surgical option."
The American Medical Association (AMA) CPT Panel provided a category I CPT code for minimally invasive Sacroiliac Joint Fusion, which offers validation that current clinical data support efficacy of the procedure and improve patient access to the surgery.
The company also has CE mark approval for Glyder Facet Restoration Device, an invasive technology intended to provide relief from lumbar facet pain.