US-based medical device firm Zyga Technology has enrolled the first patient in DUET, a multi-site trial of the Glyder facet restoration device in patients with lumbar facet pain syndrome.
The US multicentre single-arm trial will be conducted at five sites and includes 20 patients.
Zyga is focused on the design, development and commercialisation of minimally invasive products to treat underserved conditions of the lumbar spine.
Greater Baltimore Medical Center Neurosurgery chief Reginald Davis said: "The Glyder device fills a significant gap in the care continuum for facet joint pain.
"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 long-term relief of facet joint pain through a non-fusion procedure that preserves surrounding anatomy and future treatment options."
Low back pain (LBP) is listed as the second most common cause of disability in US adults, by the Centers for Disease Control and Prevention.
According to reports, more than 30% of all chronic low back pain derives from the facet joint, with an estimated 3.2 million facet joint interventions performed annually.
Zyga president Jim Bullock said: "It is rare and exciting to develop a truly novel technology that fills such a clear unmet clinical need.
"With the DUET clinical study, as well as a 150-patient Post Market Registry in the EU to be launched later this year, we continue to build the clinical evidence needed to support market adoption of the Glyder facet restoration device."
Zyga’s Glyder facet restoration device is intended to provide relief from lumbar facet pain, restoring facet joint function, while preserving native anatomy.
It consists of two small polymer discs that cover the articulating surfaces of the facet joint.
