Zyga Reports First Implantation of its Glyder Facet Restoration Device

Officials from Minnetonka, Minn.-based Zyga Technology Inc. report the first implantation of the company’s Glyder Facet Restoration Device.

The operation took place in Cyprus.

The device was implanted to address new-onset facet joint pain in a patient with a previous total disc replacement (TDR).

“The ability to preserve motion in patients who have benefited from a disc prosthesis, or total disc replacement, but suffer from facetogenic pain, is very exciting,” said Antoine Tohmeh, M.D., who performed the surgery at the Cyprus-based American Institute of Minimally Invasive Spine Surgery. “Following a TDR, a significant number of patients may experience facet joint degeneration. The Glyder device enables me to provide long-term relief of facet pain without the need for fusion.”

The origin of chronic low-back pain can be traced to the facet joints in approximately 31 percent of cases, according to data cited by the company. Each year, a growing number of TDR procedures is performed, with approximately 20 percent of patients developing facet joint degeneration. For many patients, steroid injections or denervation provide facet pain relief; but when these treatments fail to provide relief, the only option is fusion.

“The Glyder device was designed to provide motion-preserving pain relief,” said Jim Bullock, president and CEO of Zyga Technology. “Its ability to address the specific pain generator, without sacrificing surrounding anatomy or previous therapeutic successes, holds great potential for physicians and patients dealing with lumbar pain.”

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 solution is designed to allow device implantation without sacrificing future treatment options—a new step in the care continuum for chronic lumbar facet pain.

The company currently is sponsoring a 20-patient, five-site feasibility study of the Glyder technology in the United States.

Zyga markets its SImmetry sacroiliac joint fusion system, a minimally invasive procedure intended for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, and recently received CE mark for the Glyder system.

In January, the company enrolled the first patient in the EVoluSIon study, a multi-center, single-arm trial designed to evaluate fusion and pain reduction with the use of its SImmetry system. The EVoluSlon study will be performed at 10 U.S. sites and will include up to 50 patients.