Zyga Technology, Inc., has been issued two U.S. patents related to the design of the company’s proprietary SImmetry Decorticator and for a method for revision of a failed SI joint fusion surgery.
Zyga Technologies Granted Two Patents
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On September 22, 2015, the company announced that U.S. patent number 9, 113, 919 for the design of the SImmetry surgical instrument “enables surgeons to prepare the sacroiliac (SI) joint for fusion by creating bleeding bone and space for autologous bone graft. This is accomplished through a minimally invasive, lateral approach that avoids disruption of supporting ligaments around the SI joint.”
Patent number 9, 101, 371 describes the method for revision for the failed SI joint fusion surgery.
Jim Bullock, president and CEO of Zyga, said, “When added to four patents issued earlier this year, they bring our total number of patents to 11 and demonstrate Zyga’s leadership in innovation for minimally-invasive spine surgery.”
The SImmetry Sacroiliac Joint Fusion System is a minimally invasive procedure intended for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The company is conducting a U.S. multicenter clinical study of the Glyder Facet Restoration Device, a non-fusion, minimally invasive technology intended to provide relief from lumbar facet pain.
David Greenwald, M.D. of the Flagler Brain and Spine Institute in St. Augustine, Florida, said the SImmetry technique allows him adapt the surgery to a patient’s individual anatomy and condition.
The company said revisions for a previously failed SI joint fusion was “rare, ” but it was important to ensure that patients who do not initially achieve satisfactory results have options for future treatment. The company said that it’s been reported that approximately 20% of all chronic low back pain comes from the sacroiliac joint.
The FDA granted 510(k) clearance for the SImmetry system using either a two-incision or a single incision technique in August. In January 2015, Centers for Medicare and Medicaid Services (CMS) assigned a Category 1 CPT code to minimally invasive SI joint fusion.
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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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