As the first and only facet joint replacement system for the lumbar spine, Premia Spine's TOPS was developed to provide patients with lumbar spinal stenosis and degenerative spondylolisthesis sustained mobility, stability and durability after decompression.  (Photo: Business Wire)

The first of its kind TOPS system designed as a treatment alternative for patients with spinal stenosis and spondylolisthesis

NORWALK, Conn.–(BUSINESS WIRE)–Premia Spine, a medical technology company transforming the way debilitating chronic leg and back pain is treated, today announced the release of clinical data demonstrating that its TOPS System Transforaminal lumbar interbody fusion (TLIF) offers significant benefits to healthcare systems and society. TOPS, the first and only lumbar facet joint replacement system, is designed to provide sustained post-decompression mobility, stability, and durability to patients with lumbar spinal stenosis and degenerative spondylolisthesis.

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As the first and only facet joint replacement system for the lumbar spine, Premia Spine’s TOPS was developed to provide patients with lumbar spinal stenosis and degenerative spondylolisthesis sustained mobility, stability and durability after decompression. (Photo: Business Wire)

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, published in the Journal of Health Economics and Outcomes Research, examined the cost-effectiveness and Economic analysis of the TOPS system compared to TLIF for patients with spondylolisthesis and spinal canal stenosis. Patients were randomized to either TOPS or TLIF surgery as part of a prospective, multi-center US Food and Drug Administration (FDA) clinical study.

The data from the study were analyzed by Neuronomics, an independent specialist company specializing in health economic analyses. The results show that even at a premium of $4,000 over the cost of a TLIF implant within one year post-surgery, TOPS still achieves cost-efficiency at a $100,000 willingness-to-pay threshold. Additionally, TOPS becomes the dominant strategy when examining data at two years and beyond. From a societal perspective, TOPS is even more cost-effective at 1 year and dominant at 2 years and beyond.

In the author Dr. Jared Ament, a neurosurgeon at Neurosurgery & Spine Group, Los Angeles, states: “TOPS appears to be a highly cost-effective surgical modality for the treatment of grade 1 spondylolisthesis with lumbar spinal canal stenosis compared to TLIF as a motion-preserving non-fusion alternative. Since the TOPS system leads to a higher QOL [quality of life] at a lower total cost over time, it deserves serious attention.”

TOPS has received Breakthrough Device Designation from the FDA and is currently the subject of a pivotal clinical study under an FDA Investigative Waiver.

“We developed TOPS to address a significant unmet need in the treatment of spinal canal stenosis and spondylolisthesis, and these study data demonstrate that TOPS not only provides clinical benefits to patients, but also significantly reduces treatment costs for hospital providers and payers,” said Premia Spine CEO Ron Sacher. “TOPS is well positioned to be a win-win for patients, surgeons, facilities and payers.”

On spinal canal stenosis and degenerative spondylolisthesis

Spinal stenosis and degenerative spondylolisthesis are painful, debilitating and widespread conditions affecting over 100 million people worldwide1. An estimated 350,000 people undergo a lumbar spine fusion2 each year for these conditions2, representing a $2 billion annually addressable global market.

About Premia Spine

Premia Spine is a medical technology company that improves the lives of patients with chronic leg and back pain with its TOPS™ system. TOPS is designed to provide lasting mobility, stability, and durability to patients suffering from lumbar spinal stenosis, degenerative spondylolisthesis, and related spinal conditions. Visit premiaspine.com for more information.

1 Ravindra, VM, et al. Degenerative diseases of the lumbar spine: global incidence and volume estimates. Global Spine Journal: 2018 Volume 8 Issue 8. https://journals.sagepub.com/doi/full/10.1177/2192568218770769

2 Spine Surgery Update 2019. Orthopedic Network News: Volume 30, Number 4, October 2019.

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