Premia Spine said that its TOPS System for lumbar spinal stenosis and degenerative spondylolisthesis showed potential to relieve back pain and maintain mobility without adjacent level degeneration as per the results of a single-centre study.
The results of the study, which involved 17 patients, were published in the Operative Neurosurgery journal.
The study concluded that the TOPS facet replacement is capable to relieve leg and back pain, while maintaining close-to-normal range-of-motion (ROM) over four years without causing adjacent segment disease (ASD).
Premia Spine secured FDA Breakthrough Device Designation for the spinal joint replacement system in 2021. TOPS is presently the subject of a pivotal clinical trial carried out under an investigational device exemption from the regulator.
The single-centre study also concluded that the TOPS System is the first to let patients in settling into their own natural sagittal balance. This offers new opportunities for the non-fusion treatment of degenerative spondylolisthesis as well as spinal stenosis with mobility-maintaining dorsal instrumentation.
Premia Spine CEO Ron Sacher said: “We are encouraged by these long-term results, which support other studies that demonstrate the potential of the TOPS System as a viable alternative to fusion for the treatment of spinal stenosis and degenerative spondylolisthesis.
“Our goal remains to deliver an implant that allows patients to retain the natural motion of their spine with less pain.
“These data bolster our case for TOPS as a new treatment paradigm for patients suffering from these diseases.”
Patients who took part in the study received Premia Spine’s facet replacement implant after a laminotomy. They were assessed over an average of 51 months in terms of ROM and visual analogue scale improvements.
TOPS delivered an average improvement of 81% with the average decline in VAS scores being 7.5 at 3 months, 6.8 at 12 months, and 6.7 at the longest follow-up.
The average ROMs at the index level was found to be 8.2 degrees at the pre-operative stage and 7.4 degrees at the post-operative stage, respectively.
According to Premia Spine, TOPS is designed to give lumbar spinal stenosis and degenerative spondylolisthesis patients mobility, stability, and durability following decompression.
