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Premia Spine announced results of a single-center study evaluating its TOPS™ System for lumbar spinal stenosis and degenerative spondylolisthesis. Study authors concluded that TOPS facet replacement has the potential to relieve leg and back pain and maintain close-to-normal range-of-motion (ROM) over four years without inducing adjacent segment disease (ASD).
The authors also conclude that the TOPS System is the first to allow patients to settle into their own natural sagittal balance, thus presenting new possibilities for non-fusion treatment of degenerative spondylolisthesis and spinal stenosis with mobility-maintaining dorsal instrumentation.
This study presents a single-center experience with a facet replacement implant designed to stabilize the spine and prevent further degeneration, while maintaining a normal ROM. Seventeen patients who received the implant following a laminotomy were evaluated for long-term improvements in visual analog scale and ROM over an average of 51 months.
“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,” said Ron Sacher, CEO, Premia Spine. “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.”
TOPS won Breakthrough Device Designation from FDA in 2021 and is currently the subject of a pivotal clinical trial under an investigational device exemption from FDA.
Source: Premia Spine
Premia Spine announced results of a single-center study evaluating its TOPS™ System for lumbar spinal stenosis and degenerative spondylolisthesis. Study authors concluded that TOPS facet replacement has the potential to relieve leg and back pain and maintain close-to-normal range-of-motion (ROM) over four years without inducing adjacent segment...
Premia Spine announced results of a single-center study evaluating its TOPS™ System for lumbar spinal stenosis and degenerative spondylolisthesis. Study authors concluded that TOPS facet replacement has the potential to relieve leg and back pain and maintain close-to-normal range-of-motion (ROM) over four years without inducing adjacent segment disease (ASD).
The authors also conclude that the TOPS System is the first to allow patients to settle into their own natural sagittal balance, thus presenting new possibilities for non-fusion treatment of degenerative spondylolisthesis and spinal stenosis with mobility-maintaining dorsal instrumentation.
This study presents a single-center experience with a facet replacement implant designed to stabilize the spine and prevent further degeneration, while maintaining a normal ROM. Seventeen patients who received the implant following a laminotomy were evaluated for long-term improvements in visual analog scale and ROM over an average of 51 months.
“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,” said Ron Sacher, CEO, Premia Spine. “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.”
TOPS won Breakthrough Device Designation from FDA in 2021 and is currently the subject of a pivotal clinical trial under an investigational device exemption from FDA.
Source: Premia Spine
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
