Paradigm Spine LLC announced the FDA granted pre-market approval for the coflex interlaminar stabilization disposable instrument kit for the treatment of lumbar spinal stenosis.
According to a company press release, this is the first disposable spinal instrument kit for a class III spinal device to receive supplemental pre-market approval (PMA). The coflex is a posterior lumbar motion-preservation solution for patents with moderate to severe spinal stenosis. The kit will include injection-molded instruments in a pre-sterilized peel pack.
“We are thrilled to have the first PMA-approved disposable instrument kit for a class III spinal device and be able to offer this resource to our surgeon customers, further improving their experience with coflex,” Marc Viscogliosi, chairman and CEO of Paradigm Spine, said in the release. “These kits are ideal for outpatient and ambulatory surgery centers because they are simple, disposable, sterile, and will reduce both financial and operational burdens on facilities. In addition, through a more streamlined manufacturing process, the kits are created to have a low carbon footprint, so they benefit physicians without causing excessive harm to the environment.”