Premia Spine today said it received FDA breakthrough device designation for its Tops facet arthroplasty system.
Tops is a facet joint replacement system for the lumbar spine that is a new treatment option for people with spinal stenosis or spondylolisthesis. It is designed to provide mobility, stability and durability after decompression.
“The Tops System is designed to relieve debilitating lower back and leg pain while enabling long-term mobility, stability, and durability for patients,” CEO Ron Sacher said in a news release. “We are gratified that the FDA recognizes TOPS’s potential to advance the standard of care for patients with spinal stenosis and spondylolisthesis.”
In early clinical studies, the system was proven to deliver immediate and sustained pain relief and improvement in patient quality of life, according to Premia Spine. It is currently the subject of a pivotal clinical trial under an investigational device exemption from the FDA.
“Tops has the potential to fill a void in our treatment armamentarium for spinal stenosis and spondylolisthesis. 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,” Dr. Dom Coric, chief of neurosurgery at Carolinas Medical Center in Charlotte and lead investigator on the pivotal trial, said. “There’s no other posterior arthroplasty device for the lumbar spine. Like most surgeons, I welcome the opportunity to advance spinal therapy with pioneering solutions like Tops.”