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Zyga completes trial enrollment for chronic facetogenic pain treatment
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Zyga Technology Inc., announced that is has completed enrollment in the GLISSADE Trial to study the Glyder Facet Resurfacing System for treatment of chronic facetogenic pain.
The results of this prospective, 40-patient trial will serve as the foundation for future investigation, including the DUET Clinical Trial in Europe and the UK, and mid-2013 submission for an Investigational Device Exemption Study to the FDA, according to a press release. Zyga anticipates CE Marking approval in late 2013.
“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,” Jim Bullock, president and chief executive office of Zyga Technology, stated. “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.”