NORWALK, Conn.--(BUSINESS WIRE)--Premia Spine, a medical technology company changing the way debilitating chronic leg and back pain is treated, today announced the publication of clinical data demonstrating that its TOPS System provides significant health system and societal benefit versus transforaminal lumbar interbody fusion (TLIF). The first and only facet joint replacement system for the lumbar spine, TOPS was developed to provide lasting mobility, stability and durability after decompression for patients with lumbar spinal stenosis and degenerative spondylolisthesis.
Published 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,” the study explored the cost-effectiveness and economic analysis of the TOPS System versus TLIF for patients suffering from spondylolisthesis and spinal stenosis. Patients were randomly assigned to either TOPS or TLIF surgery as part of a prospective, multi-center U.S. Food and Drug Administration (FDA) clinical trial.
The data from the 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 Dr. Jared Ament, 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.”
TOPS has been given Breakthrough Device Designation from the FDA and is currently the subject of a pivotal clinical trial under an investigational device exemption from the FDA.
“We developed TOPS to address a significant unmet need in the treatment of spinal stenosis and spondylolisthesis, and this study data demonstrate that TOPS not only provides clinical benefit to patients but also cuts sizeable treatment costs to hospital providers and payers,” said Premia Spine CEO Ron Sacher. “TOPS is well poised to be a win-win for patients, surgeons, facilities, and payers.”
About Spinal Stenosis and Degenerative Spondylolisthesis
Spinal stenosis and degenerative spondylolisthesis are painful, debilitating and highly prevalent conditions impacting over 100 million people globally1. An estimated 350,000 people undergo lumbar spinal fusion each year for these conditions2, representing a $2 billion annual addressable global market.
About Premia Spine
Premia Spine is a medical technology company improving the lives of chronic leg and back pain patients with its TOPS™ System. TOPS is designed to provide lasting mobility, stability and durability to patients with lumbar spinal stenosis, degenerative spondylolisthesis and related spinal conditions. For more information, visit premiaspine.com.
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.