Following an FDA supplemental approval, a new disposable spinal instrument kit will be available to outpatient and ambulatory surgery centers. The approval marks the first time the agency has signed off on such a kit for a class III spinal device, according to New York-based Paradigm Spine LLC. The kit will complement Paradigm Spine's Coflex interlaminar stabilization product, which is indicated for use in one or two level lumbar stenosis in skeletally mature patients. These patients have at least moderate impairment in function and have undergone six months or more of nonoperative treatment. Read More
