NORWALK, Conn.--(BUSINESS WIRE)--Premia Spine, a medical technology company aiming to change the way debilitating chronic leg and back pain is treated, today announced a growing foundation of clinical and economic evidence supporting its TOPS facet arthroplasty system. 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.
Dr. Jared Ament, a neurosurgeon at the Sierra Neuroscience Institute, Los Angeles, will present healthcare economic data on TOPS at the Spine Summit, San Diego, during the Minimally Invasive/Motion Preservation Abstract Session on July 29 at 4:05 pm. In the session, he will share with attendees a cost-effectiveness and economic analysis of the TOPS™ System versus transforaminal lumbar interbody fusion (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 clinical trial.
The data from the study was analyzed by Neuronomics, an independent professional corporation focusing on healthcare economic analyses. Its findings demonstrate that TOPS provides both a health system and societal benefit versus fusion. 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 extrapolated past two years. TOPS is even more highly cost-effective from the societal perspective at one year and dominant at two years.
“TOPS represents an entirely new treatment paradigm for lumbar spinal stenosis and spondylolisthesis that has not only shown the potential for great clinical benefit but also improved healthcare economics,” said Dr. Ament. “The device is well-poised to fit as an alternative to lumbar fusion to improve clinical outcomes, reduce cost and advance population health.”
The health economic findings come on the heels of a TOPS System five-year UK outcomes study conducted at the University of Southampton by Drs. Haleem, McGillion, and Fowler, the results of which were published this week in the peer-reviewed journal World Neurosurgery. Visual Analog Scale (VAS) leg and back pain fell from 73 and 71 at baseline to 3 and 16 at five years, respectively. Oswestry Disability Index (ODI) improved from 51 to 8.
Promising outcomes with TOPS have also been the subject of recent podium presentations at the International Society for the Advancement of Spine Surgery (ISASS), Mazama Spine, Lumbar Spine Research Society, and the Korean Spine Society Meetings. Additional clinical outcomes will be featured at upcoming presentations at the Texas Association of Neurological Surgeons and the Florida Neurosurgical Society meetings.
“The growing body of evidence supporting TOPS for the treatment of lumbar spinal stenosis and spondylolisthesis should give hope to physicians and patients that a return to a full quality of life is achievable with a motion-preserving alternative to fusion,” said Premia Spine CEO Ron Sacher. “We continue to demonstrate a clear clinical, healthcare system and societal cost advantage for the TOPS facet replacement in the treatment of spondylolisthesis and spinal stenosis.”
TOPS recently won Breakthrough Device Designation from the US Food and Drug Administration (FDA) and is currently the subject of a pivotal clinical trial under an investigational device exemption from the FDA.
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, a medical technology company, aims to improve 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.