The first patient is enrolled in Zyga Technology, Inc.’s facet DUET clinical study.
Zyga’s Facet Restoration Study Has First Patient
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The company announced on November 11, 2014 that Reginald Davis, M.D. FACS, Chief of Neurosurgery at Greater Baltimore Medical Center, performed the first surgery in the study, a multi-site, single-arm study of the Zyga Glyder facet restoration device in subjects with lumbar facet pain syndrome. The study will be performed at five sites and will include up to 20 patients.
Non-Fusion Procedure
Davis said the 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.”
The company says that 30% of all chronic low back pain derives from the facet joint.
The device consists of two small polymer discs that cover the articulating surfaces of the facet joint.
CE Mark and Financing
Jim Bullock, president and CEO of Zyga, said, “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.” The company announced receiving CE Mark on the device on October 27, 2014.
In the CE Mark announcement, Professor Dr. Hans-Joerg Meisel, Director of Neurosurgery at Berufsgenossenschaftliche Clinic Bergmannstrost in Halle, Germany, said his results in the Glyder clinical study demonstrated the potential long-term benefits of the new technology. “Now we can provide a minimally invasive solution that relieves pain without the need for lumbar fusion.”
The company completed a $10 million round of financing in September. According to the company, the money will be used to prepare for the implementation of a Category 1 CPT code for SI joint fusion in procedures in January 2015 and support three clinical studies including VSI (EVoluSIon Study using the Zyga SImmetry Sacroiliac Joint Fusion System), a U.S. multicenter single-arm study; SAIF (SAcro Iliac Fusion Study), a single-center single-arm study; and the DUET study.
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Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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