First Facet Replacement to Transform Spinal Treatment of Spinal Stenosis and Spondylolisthesis with Superior Alternative to Traditional Fusion Surgery
NORWALK, Conn., Oct. 2, 2023 /PRNewswire-PRWeb/ — Premia Spine, an innovator in spine medical devices, announced the initiation of the Centers for Medicare & Medicaid Services (CMS) New Technology Add-on Payment (NTAP) Program for the TOPS™ System. The payment, of up to an additional $11,375 beyond the standard DRG payment for the procedure, is available to all facilities who provide inpatient care to patients with spinal stenosis and spondylolisthesis. This is only the third time that CMS has granted an incentive payment to facilities for the use of any spinal implant.
The U.S. Food and Drug Administration (FDA) designated the TOPS™ System as a Breakthrough Technology in 2020 and granted PMA approval to the TOPS System in June 2023 with a “superior-to-fusion” claim, underscoring its safety and efficacy. The TOPS System provides patients with spinal stenosis and spondylolisthesis unparalleled advantages over lumbar fusion, including enhanced mobility, decreased post-operative neuro deficit, and more rapid and sustained return to normal activity.
In the TOPS US clinical trial, the mean age of patients was 64 years, thus indicating a sizable addressable market for the NTAP program.
Ron Sacher, CEO of Premia Spine commented, “We are honored by the recognition of CMS. TOPS™ has proven its ability to provide both clinical excellence and healthcare economic advantage to patients, providers, and payers. The NTAP program is an example of forward-thinking policy that aligns incentives so that patients receive the best short-term and long-term care.”
A publication in the Journal of Health Economics and Outcomes Research, “A Prospective Study of Lumbar Facet Arthroscopy in the Treatment of Degenerative Spondylolisthesis and Stenosis: Early Cost-Effective Assessment from the Total Posterior Spine System (TOPS) IDE Study” confirmed the cost-effectiveness and economic benefit of the TOPS System versus TLIF fusion for patients suffering from spondylolisthesis and spinal stenosis.
The data from the prospective randomized study was analyzed by Neuronomics, an independent professional corporation focusing on healthcare economic analyses. Its findings demonstrate that, even at a premium of $4,000 over the cost of a TLIF implant, TOPS™ still achieves cost-effectiveness at a willingness-to-pay threshold of $100,000 within one-year after surgery. Furthermore, TOPS becomes the dominant strategy when data is examined at two years and beyond. From the societal perspective, TOPS is even more highly cost-effective at one year and dominant at two years and beyond.
The paper, led by author Jared Ament, MD, a neurosurgeon at the Neurosurgery & Spine Group, Los Angeles, states, “TOPS™ appears to be a highly cost-effective surgical modality compared with TLIF as a motion-preserving, non-fusion alternative for the treatment of grade 1 spondylolisthesis with lumbar spinal stenosis. Since the TOPS System yields greater QOL [quality of life] at a lower total cost over time, it deserves serious attention.”
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.us to learn more.
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Peter Wehrly
Premia Spine
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PeterW@premiaspine.com, https://premiaspine.us
SOURCE Premia Spine
