First-of-a-kind TOPS System designed to supply therapy different for sufferers with spinal stenosis and spondylolisthesis
June 2, 2022
NORWALK, Conn.–(BUSINESS WIRE)–Premia Backbone, a medical expertise firm altering the best way debilitating continual leg and again ache is handled, as we speak introduced the publication of scientific information demonstrating that its TOPS System supplies vital well being system and societal profit versus transforaminal lumbar interbody fusion (TLIF). The primary and solely side joint substitute system for the lumbar backbone, TOPS was developed to supply lasting mobility, stability and sturdiness after decompression for sufferers with lumbar spinal stenosis and degenerative spondylolisthesis.
Printed within the Journal of Health Economics and Outcomes Analysis, “A Potential Research of Lumbar Aspect Arthroscopy within the Therapy of Degenerative Spondylolisthesis and Stenosis: Early Price-Efficient Evaluation from the Whole Posterior Backbone System (TOPS) IDE Research,” the research explored the cost-effectiveness and financial evaluation of the TOPS System versus TLIF for sufferers affected by spondylolisthesis and spinal stenosis. Sufferers have been randomly assigned to both TOPS or TLIF surgical procedure as a part of a potential, multi-center U.S. Food and Drug Administration (FDA) scientific trial.
The info from the research was analyzed by Neuronomics, an unbiased skilled company specializing in healthcare financial analyses. Its findings display that, even at a premium of $4,000 over the price of a TLIF implant, TOPS nonetheless achieves cost-effectiveness at a willingness-to-pay threshold of $100,000 inside one-year after surgical procedure. Moreover, TOPS turns into the dominant technique when information is examined at two years and past. From the societal perspective, TOPS is much more extremely cost-effective at one 12 months and dominant at two years and past.
The paper, led by creator Dr. Jared Ament, a neurosurgeon on the Neurosurgery & Backbone Group, Los Angeles, states, “TOPS seems to be a extremely cost-effective surgical modality in contrast with TLIF as a motion-preserving, non-fusion different for the therapy of grade 1 spondylolisthesis with lumbar spinal stenosis. Because the TOPS System yields higher QOL [quality of life] at a decrease complete value over time, it deserves severe consideration.”
TOPS has been given Breakthrough Gadget Designation from the FDA and is presently the topic of a pivotal scientific trial below an investigational system exemption from the FDA.
“We developed TOPS to handle a big unmet want within the therapy of spinal stenosis and spondylolisthesis, and this research information display that TOPS not solely supplies scientific profit to sufferers but in addition cuts sizeable therapy prices to hospital suppliers and payers,” stated Premia Backbone CEO Ron Sacher. “TOPS is nicely poised to be a win-win for sufferers, surgeons, amenities, and payers.”
About Spinal Stenosis and Degenerative Spondylolisthesis
Spinal stenosis and degenerative spondylolisthesis are painful, debilitating and extremely prevalent circumstances impacting over 100 million folks globally1. An estimated 350,000 folks endure lumbar spinal fusion every year for these circumstances2, representing a $2 billion annual addressable world market.
About Premia Backbone
Premia Backbone is a medical expertise firm bettering the lives of continual leg and again ache sufferers with its TOPS™ System. TOPS is designed to supply lasting mobility, stability and sturdiness to sufferers with lumbar spinal stenosis, degenerative spondylolisthesis and associated spinal circumstances. For extra info, go to premiaspine.com.
1 Ravindra, V. M., et al. Degenerative Lumbar Backbone Illness: Estimating World Incidence and Worldwide Quantity. World Backbone Journal: 2018, Vol 8, Concern 8. https://journals.sagepub.com/doi/full/10.1177/2192568218770769
2 2019 Spinal Surgical procedure Replace. Orthopedic Community Information: Quantity 30, Quantity 4, October 2019.
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