The U.S. Food and Drug Administration (FDA) granted Premia Spine’s TOPS™ Spinal Arthroplasty System Breakthrough Device Designation to treat patients diagnosed with spinal stenosis and spondylolisthesis. The approval marks the first ever joint replacement system for the lumbar spine, designed to provide patients better stability and mobility as well as durability following decompression. Clinical trials have also shown promising results that TOPS provides immediate and lasting pain relief for patients, improving their quality of life. Ron Sacher, Premia Spine CEO, stated, “The TOPS System is designed to relieve debilitating lower back and leg pain while enabling long-term mobility, stability, and durability for patients. We are gratified that the FDA recognizes TOPS’s potential to advance the standard of care for patients with spinal stenosis and spondylolisthesis.”

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