Premia Spine's study on the TOPS™
System, which highlights its effectiveness in treating
spondylolisthesis and preserving spinal motion, has been awarded
the prestigious Best Paper Award at the 2024 SMISS Annual
Forum.
NORWALK,
Conn., Sept. 13, 2024 /PRNewswire-PRWeb/ --
Premia Spine, a leader in
motion-preserving spinal technologies, is proud to announce that
its study, titled "Lumbar Facet Arthroplasty: An Analysis Comparing
Two-Year Outcomes from a Prospective Randomized Clinical Trial
Among Patients with Unstable vs. Stable Spondylolisthesis," has
been awarded the Best Paper Award at the Society for Minimally
Invasive Spine Surgery (SMISS) Annual Forum, held from September 5-7, 2024.
"We are thrilled that our study has been
recognized by SMISS. This recognition underscores our commitment to
advancing spinal health by developing innovative, motion-preserving
technologies that improve patient outcomes and quality of
life."
The award-winning study was part of a multi-year, multi-center
prospective randomized clinical trial, a key factor that led to the
FDA approval of Premia Spine's TOPS™
System. This system is a breakthrough in spinal care, designed to
prevent spinal translation while preserving natural motion by
addressing both rotational and flexion-extension movements.
Key findings from the study include:
- Study Focus: The trial targeted single-level pathology between
L1 to L5 (excluding L5-S1) in patients aged 35-80 with moderate to
severe spinal stenosis and degenerative spondylolisthesis,
particularly those with predominant leg symptoms.
- Comparison: The study compared patient outcomes in those with
stable vs. unstable spondylolisthesis, and demonstrated that the
TOPS™ System performed effectively in both groups, showing superior
results compared to traditional spinal fusion.
- Outcome Measures: Success was measured using a composite score
that factored in improvements in the Oswestry Disability Index
(ODI), Visual Analog Scale (VAS) pain scores, absence of device
failure, and avoidance of re-operations or injections.
- Significant Findings: The study showed statistically
significant improvements in patient outcomes, with higher composite
success rates for the TOPS™ System when compared to spinal fusion
procedures.
Ron Sacher, Premia Spine CEO
expressed the company's excitement in receiving this prestigious
award: "We are thrilled that our study has been recognized by
SMISS. This recognition underscores our commitment to advancing
spinal health by developing innovative, motion-preserving
technologies that improve patient outcomes and quality of
life."
This award-winning study involved 37 centers across the United States, making it one of the most
extensive clinical trials for the TOPS™ System and a critical
element in its successful FDA approval.
About Premia Spine
Premia Spine, a medical
technology company, is committed to enhancing the quality of life
for patients suffering from chronic leg and back pain. Its products
are specifically designed to offer durability, stability, and
increased mobility to those struggling with lumbar spinal stenosis,
degenerative spondylolisthesis, and related spinal conditions. The
TOPS System, Premia Spine's flagship
product, has received the CE mark and has now obtained approval for
distribution within the United
States. For more information about the TOPS™ System and
Premia Spine's groundbreaking work,
visit www.premiaspine.com.
Media Contact
Peter Wehrly, Premia Spine, 1 (303) 324-4983,
peterw@premiaspine.com, https://premiaspine.us
View original content to download
multimedia:https://www.prweb.com/releases/premia-spine-wins-best-paper-award-at-smiss-2024-for-study-on-lumbar-facet-arthroplasty-and-the-tops-system-302247988.html
SOURCE Premia Spine