FDA Approves Updated Indications for use for the SImmetry™ Sacroiliac Joint Fusion System
MINNEAPOLIS, Aug. 18, 2011 /PRNewswire/ -- Zyga Technology, Inc. announced today that the U.S. Food & Drug Administration (FDA) has approved the company's request to update the indications for use of its SImmetry™ Sacroiliac Joint Fusion System. The updated indications for use states: The SImmetry™ Sacroliliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
"We are very pleased that the FDA approved the updated indications for use for SImmetry. We believe performing a true, intra-articular arthrodesis of the SI joint provides the best pathway to a successful fusion and a successful patient outcome. The updated indications for use reflect the clinical intent of the SImmetry system," said Robert Assell, President and CEO of Zyga Technology, Inc.
Sacroiliac joint dysfunction has been shown to be the source of pain for up to 25% of patients suffering from low back pain. Sacroiliac joint dysfunction can cause SI joint pain and is typically characterized by sacroiliac ligament pain, lower back pain, buttock pain, or pain in one or both legs. Patients who suffer from this condition typically receive SI Joint injections which temporarily address the problem but require long-term repeat treatments. Traditional, open fusion of the SI joint has been performed for decades but is limited in practice due to its complexity, high complication rate and generally poor outcomes.
About Zyga Technology, Inc.
Based in Minneapolis, MN, Zyga Technology, Inc. was founded to develop and market innovative, minimally invasive surgical solutions to treat conditions of the spine. In addition to SImmetry the company is also developing the GLYDER™ Facet Resurfacing System. GLYDER is being developed as a minimally invasive technique for treating patients with facetogenic pain. Zyga has put together a team of engineers, marketing personnel, and management with significant experience developing medical devices for the spine industry.
SOURCE Zyga Technology, Inc.