08.14.15
Zyga Technology Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the SImmetry System using either a two-incision or a single-incision technique.
“In the operating room, surgeons need as many options as possible to effectively treat each individual,” said David Greenwald, M.D., of the Flagler Brain and Spine Institute in St. Augustine, Fla. “This new SImmetry technique allows me to offer patients a single, one-inch incision and to adapt the surgery to their individual anatomy and condition.”
The Centers for Disease Control and Prevention lists low back pain (LBP) as the second most common cause of disability in U.S. adults. It has been reported that approximately 20 percent of all chronic LBP derives from the sacroiliac joint. In January 2015, the Centers for Medicare and Medicaid Services assigned a Category 1 CPT code to minimally invasive SI joint fusion, improving patient access to the procedure.
The SImmetry Sacroiliac Joint Fusion System was granted 510(k) clearance by the FDA in March 2013.
Zyga Technology designs, develops and commercializes minimally invasive devices to treat underserved lumbar spine conditions. The Minnetonka, Minn.-based company is marketing the SImmetry Sacroiliac Joint Fusion System, a minimally invasive procedure intended for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, and 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.
“In the operating room, surgeons need as many options as possible to effectively treat each individual,” said David Greenwald, M.D., of the Flagler Brain and Spine Institute in St. Augustine, Fla. “This new SImmetry technique allows me to offer patients a single, one-inch incision and to adapt the surgery to their individual anatomy and condition.”
The Centers for Disease Control and Prevention lists low back pain (LBP) as the second most common cause of disability in U.S. adults. It has been reported that approximately 20 percent of all chronic LBP derives from the sacroiliac joint. In January 2015, the Centers for Medicare and Medicaid Services assigned a Category 1 CPT code to minimally invasive SI joint fusion, improving patient access to the procedure.
The SImmetry Sacroiliac Joint Fusion System was granted 510(k) clearance by the FDA in March 2013.
Zyga Technology designs, develops and commercializes minimally invasive devices to treat underserved lumbar spine conditions. The Minnetonka, Minn.-based company is marketing the SImmetry Sacroiliac Joint Fusion System, a minimally invasive procedure intended for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, and 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.