MINNETONKA, Minn., Jan. 2, 2018 /PRNewswire/ — 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 publication of clinical outcomes for the first 50 patients 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.
At 6 months, mean low back pain as measured on a 100-point Visual Analog Scale (VAS) demonstrated a significant reduction from 76.2 pre-operatively to 35.1 (54% reduction, p<0.0001), with 72% of patients attaining the minimal clinically important difference (MCID, ≥20 point improvement). While pain and disability improvement is comparable to similar studies, the reduction in opioid use (55%) was much greater than previously reported in other studies. Additional follow-up will be performed at 12- and 24-months to assess the presence of bony fusion across the joint via CT imaging as well as ongoing pain reduction.
“It is very exciting to see prospective, multi-center clinical data reaffirm the positive feedback I’ve received from my patients over the past few years,” said Ali Araghi, D.O., an orthopedic surgeon at Core Institute in Phoenix, Ariz. and lead author of the publication. “As a physician working with patients who are in significant pain, it is also incredibly meaningful to know I have a surgical option that can reduce the need for opioid medications. Longer-term follow-up and CT imaging will be important to demonstrate the longevity of these results, but this is very encouraging for our first look at the data.”
Earlier this year, 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.
The company is marketing the SImmetry® Sacroiliac Joint Fusion System, a minimally invasive procedure intended for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The SImmetry System is known for its ability to create a true SI joint arthrodesis, including decortication, bone grafting and fixation with a threaded implant. 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
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SOURCE Zyga Technology, Inc.