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.
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.
