Facet Replacement Fda Study Garners Best Paper Award At Lumbar Spine Research Society Meeting

Premia Spine's study on the TOPS® System, showcasing its advantages over traditional lumbar fusion, received the Best Paper award at the LSRS 2024 Annual Meeting. This recognition underscores the system's ability to improve patient outcomes and quality of life by allowing natural spinal motion.

NORWALK, Conn., May 2, 2024 /PRNewswire-PRWeb/ --Premia Spine, a leader in innovative spinal treatment solutions, today announced that the pioneering study titled "Lumbar Facet Arthroplasty for Degenerative Spondylolisthesis with Stenosis: Interim Analysis of Three-Year Outcomes from a Prospective Randomized Clinical Trial" has been awarded the prestigious Best Paper at the Lumbar Spine Research Society (LSRS) 2024 Annual Meeting. The award-winning study, reported by Zachariah Pinter, MD, showcased the significant advantages of facet replacement over traditional lumbar fusion.

The research involved 300 patients who were prospectively randomized across thirty-seven centers to receive either the Total Posterior Spine (TOPS) facet joint replacement system or a TLIF lumbar fusion. Patients' outcomes were meticulously analyzed, revealing that 77% of TOPS patients experienced a statistically significant better outcome compared to just 24% in the fusion cohort in the FDA study. Excellent TOPS® System outcomes continued out to three years.

Peter Wehrly, President of Premia Spine, stated, "We are thrilled with the recognition from LSRS, which reflects our commitment to advancing spinal health. The TOPS System is designed to offer patients a life free from the limitations of spinal fusion, enabling them to enjoy a quality of life they thought was lost."

The LSRS, known for its dedication to the unbiased and transparent discussion of lumbar spine research, highlighted the significance of this study in contributing to the evolving landscape of spinal treatment options.

Ron Sacher, CEO of Premia Spine, commented, "Receiving this award is a testament to our rigorous scientific approach and innovation. The TOPS System not only improves clinical outcomes but also enhances patients' overall functionality and lifestyle."

The TOPS System is revolutionizing the treatment of conditions such as spinal stenosis and spondylolisthesis by allowing natural spinal motion, thereby protecting adjacent levels and maintaining patient mobility. Patients suffering from lower back and leg pain now have a viable alternative to fusion surgeries. The TOPS Posterior Arthroplasty System is particularly effective in treating debilitating symptoms such as back pain, sciatica, numbness, and tingling sensations associated with walking. The TOPS System has received the CE mark and has now obtained FDA approval with a "superiority to fusion" label. The device is in full distribution within the United States.

About Premia Spine

Premia Spine, a medical technology company, is committed to enhancing the quality of life for patients suffering from chronic leg and back pain. Its products are specifically designed to offer durability, stability, and increased mobility to those struggling with lumbar spinal stenosis, degenerative spondylolisthesis, and related spinal conditions. Visit https://premiaspine.us/ to learn more.

Media Contact

Peter Wehrly, Premia Spine, 1 (303) 324-4983, [email protected], https://premiaspine.us

SOURCE Premia Spine