02 Mar Premia Spine’s TOPS™ Facet Joint Replacement Demonstrates Significant Improvement in All Patient-Reported Outcome Measures Versus Fusion in FDA Trial

Interim two-year data from clinical IDE trial published in Journal Neurosurgery Spine; lumbar facet arthroplasty moves closer to proving TOPS System viable alternative to fusion.

NORWALK, Conn.–(BUSINESS WIRE)–Premia Spine, a medical technology company changing the way debilitating chronic leg and back pain is treated, today announced publication of two-year outcomes from the TOPS facet joint replacement system’s clinical trial in the Journal of Neurosurgery Spine. The study, “Prospective, Randomized and Controlled Multicenter Study of Posterior Lumbar Facet Arthroplasty for the Treatment of Spondylolisthesis,” found lumbar facet arthroplasty with the TOPS device demonstrated a statistically significant improvement versus lumbar fusion in all patient-reported outcome measures, a low surgical complication rate, and the ability to maintain motion at the index level while limiting sagittal translation.

The objective of the prospective, randomized, multi-center U.S. Food and Drug Administration (FDA) investigational device exemption (IDE) clinical trial is to compare the two-year clinical and radiographic outcomes and safety profile of patients undergoing either a lumbar TOPS facet arthroplasty or a transforaminal lumbar interbody fusion (TLIF). This publication is the first interim comparative analysis of early clinical outcomes and complications from the TOPS IDE trial. The study will help surgeons more accurately counsel patients on the best treatment for lumbar spinal stenosis and degenerative spondylolisthesis.

“The two-year data from this study indicate the TOPS System compares favorably in all respects to outcomes reported in the FDA trial to a single-level TLIF,” said Dr. Dom Coric, principal investigator in the TOPS IDE study and lead author of the publication. “If at the conclusion of the ongoing clinical trial we see continued favorable outcomes, we will be able to conclude that motion preservation with TOPS facet arthroplasty is a viable alternative to fusion in select patients with spinal stenosis and spondylolisthesis for restoring segmental stability while maintaining motion at the affected segment.”

In the publication, 249 patients were evaluated, with 170 patients in the TOPS investigational arm of the clinical trial and 79 in the TLIF group. TOPS demonstrated a statistically significant advantage over fusion in achieving a meaningful improvement in daily function as measured by ODI (93% versus 81% of patients). The facet replacement group also had a lower reoperation rate than the TLIF group (5.9% versus 8.8%). The TOPS patients maintained complete segmental motion at two years versus their pre-operative measurements.

Lumbar facet arthroplasty with the TOPS device demonstrated a low complication rate, significant improvement in all PROMs, and the ability to maintain motion at the index level while limiting sagittal translation. Additional findings suggest that the TOPS device maintains motion at the index surgical level while preventing further sagittal translation.

“We are encouraged by the data presented in this publication, which show promising results for TOPS when compared to TLIF,” said Ron Sacher, CEO, Premia Spine. “We are demonstrating that the TOPS device dramatically improves patients’ quality of life without sacrificing motion at a previously pathologic intervertebral segment. These data further indicate that we are getting closer to our goal of providing a viable alternative to fusion for those suffering from lumbar spinal stenosis and degenerative spondylolisthesis.”

The first and only facet joint replacement system for the lumbar spine, TOPS was developed to provide mobility, stability and durability after decompression for patients with lumbar 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. TOPS won Breakthrough Device Designation from the US Food and Drug Administration (FDA) in 2021.

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.

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.

Contacts

Joe Duraes
Pazanga Health Communications
jduraes@pazangahealth.com
(917) 687-6419

SOURCE: Business Wire, February 28 2023

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