Zyga Technology Announces First Commercial Implantation and Publication of 12-month Clinical Study Data for Glyder Facet Restoration Device
GLISSADE study provides evidence demonstrating lasting relief of facetogenic low back pain
MINNETONKA, Minn., Nov. 19, 2014 /PRNewswire/ -- Zyga Technology, Inc., a medical device company focused on the design, development and commercialization of minimally invasive products to treat underserved conditions of the lumbar spine, today announced completion of the first Glyder Facet Restoration Device commercial surgery. The Company also announced the publication of 12-month primary outcome data from the GLISSADE study: a prospective, 40-patient trial that studied the Glyder® Facet Restoration System in the treatment of chronic facetogenic pain. The data were published online in Annals of Surgical Innovation and Research.
The Glyder Facet Restoration Device is a minimally invasive solution intended to restore facet joint function in patients with chronic lumbar facetogenic pain. The surgery was performed by Prof. Dr. Hans-Joerg Meisel, Director of Neurosurgery at Berufsgenossenschaftliche Clinic Bergmannstrost in Halle, Germany.
"Through the GLISSADE clinical study we have seen the potential of Glyder Facet Restoration, and understand the considerations for proper patient selection and use," stated Prof. Dr. Meisel, who was also lead author of the GLISSADE publication. "The positive clinical outcomes of the study have given us confidence to offer this unique treatment to patients suffering from facet joint-mediated low back pain."
The purpose of the GLISSADE study was to evaluate safety and effectiveness of the Glyder Facet Restoration Device. The 12-month results of the study demonstrated that patients with symptomatic facet joint degeneration who received the Glyder Device experienced a 41 percent reduction in low back pain severity and a 34 percent improvement in back function compared to pre-treatment levels. Early benefits were seen 6-weeks post-op and continued through 12-month follow-up.
"As physicians, we continually search for therapies that provide patients a meaningful benefit that outweighs potential risk," commented Prof. Dr. Luiz Pimenta, of the Instituto de Patologia de Coluna in Sao Paulo, Brazil, the first surgeon to implant the Glyder device within the study. "The Glyder device fills a significant unmet clinical need; it can provide long-term relief of facet-mediated pain for patients who don't respond to conservative pain management, but have not degenerated enough to receive fusion. There is great value in this new treatment, and I look forward to continued study and use of the technology."
"As the sponsor of this study, we are gratified to see a significant clinical improvement in the patients' condition once implanted with the Glyder device," said Jim Bullock, president and CEO of Zyga Technology. "The GLISSADE study provides critical data to physicians and payers that will support providing patient access to this exciting new device."
About the Glyder Facet Restoration Device
The Glyder® Facet Restoration Device is intended to provide relief from lumbar facet pain, restoring facet joint function while preserving native anatomy. The non-fusion, minimally invasive device is designed to allow implantation without sacrificing future treatment options—a new step in the care continuum for chronic lumbar facet pain. The company is currently sponsoring a 20-patient, five-site feasibility study of the Glyder technology in the U.S. and recently received CE Mark on the device.
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 underserved 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. Earlier this month, Zyga announced the first enrollment in a U.S. multicenter study of the Glyder Device. For more information, visit zyga.com.
CONTACT:
Paul Hess
Tel 952 698 9955
[email protected]
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SOURCE Zyga Technology, Inc.
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