The Premia Spine TOPS system for lumbar facet joint replacement earned FDA premarket approval, the devicemaker said June 20.
Approval hinged on rigorous testing, including an investigational device exemption study confirming its safety and efficacy, according to a news release. Research has found TOPS was superior over transforaminal lumbar interbody fusion when addressing degenerative spondylolisthesis with stenosis.
"With FDA approval now secured, our priority shifts to ensuring access to the TOPS System for the countless individuals living with spinal stenosis and spondylolisthesis," CEO Ron Sacher said in the release.