Picking up a loose end from last week’s North American Spine Society (NASS) meeting, device company Zyga Technology, Inc., announced the first patient enrollment in DUET (A Multi-Site Study of the Zyga GlyDer Facet Restoration Device in Subjects with LUmbar FacET Pain Syndrome), a U.S. multicenter single-arm study.
The Centers for Disease Control and Prevention lists low back pain (LBP) as the second most common cause of disability in U.S. adults . It has been reported that over 30 percent of all chronic low back pain derives from the facet joint, with an estimated 3.2 million facet joint interventions performed annually.
A new visitor to our pages, Zyga Technology busies itself designing, developing and commercializing minimally invasive products to treat what it calls underserved conditions of the lumbar spine, one such being treatment of the facet joint. The Glyder® Facet Restoration Device comprises two small polymer discs that cover the articulating surfaces of the facet joint. It is intended to provide relief from lumbar facet pain, restoring facet joint function while preserving native anatomy.
The DUET study will be performed at five sites and will include up to 20 patients.
The Glyder system was recently CE marked.
“The Glyder device fills a significant gap in the care continuum for facet joint pain,” stated Reginald J. Davis, MD, FACS, Chief of Neurosurgery at Greater Baltimore Medical Center, who performed the first surgery. “When conservative treatments such as facet injection or rhizotomy fail to provide relief for these patients, our only recourse has been to perform a fusion, a procedure that eliminates motion and permanently alters the natural movement of the spine. The Glyder Device is designed to provide longterm relief of facet joint pain through a non-fusion procedure that preserves surrounding anatomy and future treatment options.”
“It is rare and exciting to develop a truly novel technology that fills such a clear unmet clinical need,” said Jim Bullock, president and chief executive officer of Zyga. “With the DUET clinical study, as well as a 150-patient Post Market Registry in the E.U. to be launched later this year, we continue to build the clinical evidence needed to support market adoption of the Glyder Facet Restoration Device.”
Source: Zyga Technology, Inc.