MINNEAPOLIS, Jan. 31, 2013 /PRNewswire/ -- Zyga Technology, Inc., a medical device company, today announced that it has completed enrollment in the GLISSADE Trial, a prospective, 40-patient trial that studied the GLYDER® Facet Resurfacing System in the treatment of chronic facetogenic pain. Preliminary data analyses from this five-site trial indicate a significant reduction in pain and improvement in function as measured by Visual Analogue Pain Scale (VAS) and Oswestry Disability Index (ODI). The results of this trial will serve as the foundation for future investigation including the DUET Clinical Trial in Europe and the U.K., and mid-2013 submission for an Investigational Device Exemption (IDE) Study to the U.S. Food and Drug Administration (FDA). The company anticipates CE Marking approval in late 2013.
The Centers for Disease Control and Prevention lists low back pain (LBP) as the second most common cause of disability in US adults[i]. Ten percent of the U.S. population, over 31 million people, suffer from chronic low back pain[ii]. Approximately 31% of chronic low back pain is attributed to the facet joints[iii], small stabilizing joints located between and behind adjacent vertebrae.
"For patients suffering from chronic facet pain, there has never been a viable procedure providing long term relief," said Prof. Dr. Hans Jorg Meisel, Director of the Center of Neurosciences of the BG-Clinic Bergmannstrost Halle, Germany. "Their options were to receive injections several times each year or to undergo a more aggressive, permanent spine fusion procedure. The GLYDER System offers simple, minimally invasive implantation of a device designed to preserve the patient's anatomy and to provide long-term pain relief. Our initial patients are now reaching two years post-surgery, and we are very encouraged to see that they are experiencing sustainable pain relief."
"We are very encouraged by the preliminary results in the GLISSADE Trial, and the available data suggest the GLYDER System's clinical and economic value," said Jim Bullock, president and chief executive officer of Zyga Technology. "Facet joint injections have risen steadily over the past decade. This study has indicated how GLYDER Facet Resurfacing provides a safe, appropriate, clinically effective treatment for facetogenic pain and will pave the way for a successful IDE submission later in the second quarter of this year."
About Zyga Technology
Zyga Technology is dedicated to the research, development and commercialization of solutions that provide empirical clinical and economic value in the treatment of under-served conditions of the spine. The company is currently marketing the SImmetry® Sacroiliac Joint Fusion System, a minimally invasive procedure intended for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. Zyga Technology is headquartered in Minneapolis, Minn. For more information, please visit www.zygatech.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] Freuberger, JK et al. The Rising Prevalence of Low Back Pain. Arch Intern Med 2009; 169(3): 251 - 258.
[iii] DePalma M et al. What is the source of chronic low back pain and does age play a role? Pain Med 2011; 12:224 – 233.
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SOURCE Zyga Technology, Inc.