Premia Spine TOPS™ System Achieves FDA Premarket Approval with Superiority-to-Fusion Label
NORWALK, Conn. (PRWEB) June 20, 2023 -- Premia Spine, a medical technology company revolutionizing the treatment of chronic leg and back pain, proudly announces the Food and Drug Administration (FDA) approval of its Total Posterior Spine (TOPS) facet joint replacement system. The TOPS System previously earned the FDA’s Breakthrough Designation status and has now successfully completed its Premarket Approval (PMA) application. Premia Spine undertook rigorous testing to receive FDA approval, including an Investigational Device Exemption (IDE) study to confirm the safety and efficacy of the system. The company's pivotal FDA trial demonstrated that, at two years post-operation, the TOPS System outperformed fusion in treating grade 1 degenerative spondylolisthesis with stenosis. This accomplishment marks the TOPS System as the first lumbar spine implant to receive a superiority claim over lumbar fusion.
Until now, lumbar fusion was the accepted gold standard in surgical treatment for grade 1 degenerative spondylolisthesis with stenosis. However, spinal fusions are linked with high reoperation rates, adjacent segment disease, and additional adverse outcomes. To address these concerns, Premia's prospective randomized controlled trial investigated the potential of TOPS facet arthroplasty as an alternative to TLIF fusion for treating this large patient population.
The study's data revealed that the TOPS arthroplasty group significantly surpassed the TLIF fusion group in overall clinical success, with a 77% success rate compared to 24% respectively. While both arthroplasty and fusion methods stabilized the spine segment, the TOPS facet replacement preserved motion at the index level, leading to fewer complications and reoperations. Furthermore, patients who underwent TOPS arthroplasty reported improved outcomes in areas such as daily function and pain levels at all assessed time points. Notably, the gap in these improvements between the two groups expanded over time, becoming more pronounced from six months to 24 months postoperatively.
This landmark study aimed to demonstrate the clinical superiority of the TOPS System by randomizing patients at a 2:1 ratio to undergo either facet arthroplasty or TLIF fusion. The study was carried out across 37 centers, reinforcing its comprehensive and diverse surgeon and patient base. The primary outcome success was evaluated in a total of 168 subjects (115 TOPS arthroplasty and 53 TLIF fusion) at the two-year mark. The data revealed a significant advantage for the TOPS System over fusion in several areas: daily function improvement, with 95% success for TOPS arthroplasty versus 79% for TLIF fusion as per the Oswestry Disability Index; rates of new or worsening neural deficit, with 3% for TOPS arthroplasty versus 12% for TLIF fusion; rates of postoperative injections or surgical interventions, with 11% for TOPS arthroplasty versus 23% for TLIF fusion; and rates of motion or fusion failure, at a significantly lower 1% failure for TOPS arthroplasty versus 44% failure for TLIF fusion.
"The results of this study validate our hypothesis that TOPS lumbar facet arthroplasty yields a higher rate of clinical success and fewer revision procedures compared to fusion," stated Ron Sacher, CEO of Premia Spine. "With FDA approval now secured, our priority shifts to ensuring access to the TOPS System for the countless individuals living with spinal stenosis and spondylolisthesis."
TOPS features two cross bars that affix to pedicle screws and a central motion mechanism, placed after bilateral facetectomies. The TOPS motion device is designed to allow widened decompression of the neural elements, stabilization of the spondylolisthesis, and preservation of motion in all ranges of motion.
The initial results of the prospective, randomized, multi-center FDA trial, titled “Prospective, Randomized and Controlled Multicenter Study of Posterior Lumbar Facet Arthroplasty for the Treatment of Spondylolisthesis" have been published in the Journal of Neurosurgery Spine.
"The data from our two-year analysis confirms our premise - there is indeed a viable alternative to fusion for patients battling the pain and debility of lumbar spinal stenosis and degenerative spondylolisthesis," stated Danny Bejarano, Chairman of Premia Spine. "The TOPS System, has surpassed fusion - the existing gold standard – and can now claim its superiority based on Level I clinical evidence."
TOPS stands as the first and only facet joint replacement system for the lumbar spine, designed to preserve mobility after decompression in patients suffering from lumbar spinal stenosis and degenerative spondylolisthesis. These painful and debilitating conditions affect over 100 million individuals globally1. Every year, an estimated 350,000 people undergo lumbar spinal fusion for these conditions2, corresponding to a potential $2 billion annual market globally.
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. Visit PremiaSpine.com to learn more.
References:
[1] Ravindra, V. M., et al. Degenerative Lumbar Spine Disease: Estimating Global Incidence and Worldwide Volume. Global Spine Journal: 2018, Vol 8, Issue 8. https://journals.sagepub.com/doi/full/10.1177/2192568218770769
[2] 2019 Spinal Surgery Update. Orthopedic Network News: Volume 30, Number 4, October 2019.
Christy Owenby, Premia Spine, https://premiaspine.com, 1 (646) 583-0995, [email protected]
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