TOPS is developed as a new treatment option for patients suffering from spinal stenosis or spondylolisthesis
Premia Spine has secured FDA breakthrough device designation for TOPS facet arthroplasty system. (Credit: Premia Spine)
Medical technology company Premia Spine has secured breakthrough device designation from the US Food & Drug Administration (FDA) for its TOPS facet arthroplasty system.
TOPS is claimed to be the first and only facet joint replacement system for the lumbar spine.
Premia Spine has developed the TOPS system to serve as a new treatment option for patients suffering from spinal stenosis or spondylolisthesis.
The TOPS facet arthroplasty system has the potential to deliver mobility, stability, and durability after decompression.
According to the company, the system has been shown in early clinical studies to offer immediate and sustained pain relief and improvement in patient quality of life.
Premia Spine CEO Ron Sacher said: “The TOPS System is designed to relieve debilitating lower back and leg pain while enabling long-term mobility, stability, and durability for patients.
“We are gratified that the FDA recognizes TOPS’s potential to advance the standard of care for patients with spinal stenosis and spondylolisthesis.”
The company has designed the TOPS system to deliver mobility, stability and durability to patients with lumbar spinal stenosis, degenerative spondylolisthesis and related spinal conditions.
At present, the system is the subject of a pivotal clinical trial under an investigational device exemption from the FDA.
The US pivotal trial lead investigator Dr Dom Coric said: “TOPS has the potential to fill a void in our treatment armamentarium for spinal stenosis and spondylolisthesis. If the results of the pivotal study mirror those found in early clinical trials, TOPS could be a game changer for surgeons and their patients.
“There’s no other posterior arthroplasty device for the lumbar spine. Like most surgeons, I welcome the opportunity to advance spinal therapy with pioneering solutions like TOPS.”