Zyga Technology, a medical device company focused on the design, development and commercialization of minimally invasive devices to treat underserved conditions of the lumbar spine, announced enrollment of its first four patients in the expanded 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.
"Minimally Invasive SI joint fusion procedures are rapidly gaining acceptance within the medical community, but it is important that the technology gives patients the best opportunity for long-term relief," said Antoine G. Tohmeh M.D., the orthopedic surgeon who performed the procedures at Deaconess Hospital in Spokane, Wash.
"I believe that a true fusion, including decortication, bone grafting and fixation, is critical to achieving that goal. Studies such as EVoluSIon are important to reinforce our knowledge and the growing base of clinical evidence for SI joint fusion."
The Centers for Disease Control and Prevention lists back problems as the second most common cause of disability in U.S. adultsi. It has been reported that approximately 20 percent of all chronic low back pain derives from the sacroiliac jointii.
The Company will exhibit at the 2016 International Society for the Advancement of Spine Surgery (ISASS) meeting in Las Vegas, Nev., April 6 – 8 and on April 6 will present a workshop entitled: Clinical Data and Experience with an MIS Decortication and Fixation System for Sacroiliac Joint Fusion.
Dr. Richard A. Kube of Prairie Spine in Peoria, Illinois, and Dr. Ali Araghi of CORE Spine in Phoenix, Arizona, will present.
Zyga Technology, Inc. is dedicated to the research, development and commercialization of solutions that provide empirical clinical and economic value in the treatment of underserved conditions of the spine.
In addition to marketing the SImmetry System, the company is conducting a U.S. multicenter clinical study of the Glyder Facet Restoration Device, an investigational, non-fusion