The FDA has awarded Premia Spine's Tops facet arthroplasty system its breakthrough device designation, which expedites the time taken to reach clinical trials.
Tops is the first facet joint replacement device for the lumbar spine, according to the company.
Designed for patients suffering from spinal stenosis or spondylolisthesis, the product aims to relieve lower back and leg pain and provide long-term mobility and stability after decompression.
Early clinical trials found Tops to be an effective treatment for spinal stenosis and spondylolisthesis, the company said. Tops is currently undergoing a clinical trial under an investigational device exemption from the FDA.
"There's no other posterior arthroplasty device for the lumbar spine," Dom Coric, MD, chief of neurosurgery at Carolinas Medical Center in Charlotte, N.C., said in a March 31 news release. "If the results of the pivotal study mirror those found in early clinical trials, Tops could be a game changer for surgeons and their patients."