FDA inspections part of approval process for TOPS facet joint replacement system for lumbar arthroplasty
NORWALK, Conn.–(BUSINESS WIRE)–Premia Spine, a medical technology company changing the way debilitating chronic leg and back pain is treated, today announced the U.S. Food and Drug Administration (FDA) has completed four Bioresearch Monitoring (BIMO) inspections as part of the PMA approval process for the TOPS facet joint replacement system. The inspections at two company facilities and two clinical trial sites in the U.S. resulted in no FDA Form 483s for objectionable observations.
“While a completely clean site inspection is what everyone strives for, it is a major accomplishment to receive no 483s across four separate sites,” said Ron Sacher, CEO, Premia Spine. “The successful outcomes and completion of the site visits move us one step closer to approval of the TOPS facet joint replacement system, and our goal of providing a viable alternative to fusion for those suffering from painful and debilitating lumbar spinal stenosis and degenerative spondylolisthesis.”
The inspections took place at Premia’s U.S. headquarters in Norwalk, Conn., the company’s production facility in Netanya, Israel, and at two clinical sites—Carolina Neurosurgery & Spine Associates and the Cleveland Clinic’s Neurological Institute Center for Spine Health.
“We are grateful to Drs. Coric, Steinmetz, their staff, and the other 35 clinical sites who diligently performed the IDE study to the highest standards,” responded Jeff Withrow, vice president, Clinical and Reimbursement, Premia Spine.
Premia Spine recently completed a prospective, randomized, multi-center FDA investigational device exemption (IDE) clinical trial comparing 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). Initial findings from that study “Prospective, Randomized and Controlled Multicenter Study of Posterior Lumbar Facet Arthroplasty for the Treatment of Spondylolisthesis,” were published in the Journal of Neurosurgery Spine, and concluded that lumbar facet arthroplasty with the TOPS device demonstrates a statistically significant improvement versus lumbar fusion in patient-reported outcome measures, a low surgical complication rate, and the ability to maintain motion at the index level while limiting sagittal translation.
The first and only facet joint replacement system for the lumbar spine, TOPS was developed to maintain motion 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 FDA in 2021.
About Premia Spine
Premia Spine, a medical technology company, aims to improve the lives of chronic leg and back pain patients. Premia Spine products are designed to provide mobility, stability and durability to patients with lumbar spinal stenosis, degenerative spondylolisthesis and related spinal conditions. The TOPS™ System is CE marked but is not yet approved for sale in the United States.
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.
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Pazanga Health Communications
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