First Patient Enrolled in Evolusion Clinical Study:
Prospective, Multi-Center Study to Evaluate Outcomes of SImmetry Sacroiliac Joint Fusion System
MINNETONKA, Minn. – January 19, 2015 – Zyga Technology, Inc., a medical device company focused on the design, development and commercialization of minimally invasive products to treat underserved conditions of the lumbar spine, today announced the first patient enrollment in the EVoluSIon Study,(a U.S. multicenter single-arm study designed to evaluate fusion and pain reduction following use of the Zyga SImmetry Sacroiliac Joint Fusion System. The study will be performed at ten sites and will include up to 50 patients.
“The SImmetry technology helps provide an ideal environment for symptom relief to sacroiliac joint fusion patients,” stated Gowriharan “Ty” Thaiyananthan, MD, FAANS, Founder and Head Neurosurgeon at BASIC Spine, who performed the surgery. “It enables me to perform a true fusion, including decortication and bone grafting, through an efficient, minimally invasive approach; the procedure was completed in 30 minutes and the patient went home the next morning.”
The Centers for Disease Control and Prevention lists low back pain (LBP) 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 SImmetry system offers a unique surgical solution for patients suffering from sacroiliac joint dysfunction,” said Jim Bullock, president and chief executive officer of Zyga. “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.”
On January 1, 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.
About Zyga Technology, Inc.
Zyga Technology 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. The company is marketing the SImmetry® Sacroiliac Joint Fusion System, a minimally invasive procedure intended for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, and recently received CE Marking for the Glyder® Facet Restoration Device, a non-fusion, minimally invasive technology intended to provide relief from lumbar facet pain. For more information, visit zyga.com.
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