NORWALK, Conn., Sept. 13, 2024 /PRNewswire-PRWeb/ — Premia Spine, a leader in motion-preserving spinal technologies, is proud to announce that its study, titled “Lumbar Facet Arthroplasty: An Analysis Comparing Two-Year Outcomes from a Prospective Randomized Clinical Trial Among Patients with Unstable vs. Stable Spondylolisthesis,” has been awarded the Best Paper Award at the Society for Minimally Invasive Spine Surgery (SMISS) Annual Forum, held from September 5-7, 2024.
The award-winning study was part of a multi-year, multi-center prospective randomized clinical trial, a key factor that led to the FDA approval of Premia Spine’s TOPS™ System. This system is a breakthrough in spinal care, designed to prevent spinal translation while preserving natural motion by addressing both rotational and flexion-extension movements.
“We are thrilled that our study has been recognized by SMISS. This recognition underscores our commitment to advancing spinal health by developing innovative, motion-preserving technologies that improve patient outcomes and quality of life.”Post this
Key findings from the study include:
- Study Focus: The trial targeted single-level pathology between L1 to L5 (excluding L5-S1) in patients aged 35-80 with moderate to severe spinal stenosis and degenerative spondylolisthesis, particularly those with predominant leg symptoms.
- Comparison: The study compared patient outcomes in those with stable vs. unstable spondylolisthesis, and demonstrated that the TOPS™ System performed effectively in both groups, showing superior results compared to traditional spinal fusion.
- Outcome Measures: Success was measured using a composite score that factored in improvements in the Oswestry Disability Index (ODI), Visual Analog Scale (VAS) pain scores, absence of device failure, and avoidance of re-operations or injections.
- Significant Findings: The study showed statistically significant improvements in patient outcomes, with higher composite success rates for the TOPS™ System when compared to spinal fusion procedures.
Ron Sacher, Premia Spine CEO expressed the company’s excitement in receiving this prestigious award: “We are thrilled that our study has been recognized by SMISS. This recognition underscores our commitment to advancing spinal health by developing innovative, motion-preserving technologies that improve patient outcomes and quality of life.”
This award-winning study involved 37 centers across the United States, making it one of the most extensive clinical trials for the TOPS™ System and a critical element in its successful FDA approval.
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. The TOPS System, Premia Spine’s flagship product, has received the CE mark and has now obtained approval for distribution within the United States. For more information about the TOPS™ System and Premia Spine’s groundbreaking work, visit www.premiaspine.com.
Media Contact
Peter Wehrly, Premia Spine, 1 (303) 324-4983, peterw@premiaspine.com, https://premiaspine.us
SOURCE Premia Spine