coflex
®
Interlaminar Stabilization
®
is the the first and only
device indicated for lumbar spinal stenosis that has produced
Level 1 Evidence in two different randomized studies against
two different control groups in two different countries.
The recent ESCADA publication° shows statistical superiority in
Composite Clinical Success
†
for coflex
®
compared to decompression alone. (p=0.017)
Level 1 Evidence is Adding Up.
° European Study of Coflex and Decompression Alone. Prospective, Randomized, Controlled, Multicenter Study With Two-year Follow-up to Compare the Performance of Decompression With and Without Interlaminar Stabilization;
Joerg Franke, MD, PhD, Michael Rauschmann, MD, Dieter Adelt, MD, Sven Schmidt, MD, Matteo Bonsanto, MD, Steffen Sola, MD. Journal of Neurosurgery: Spine. EPub ahead of Print, Jan 26, 2018
†
Composite Clinical Success (CCS).
Overall trial success was based on a composite endpoint; a combined outcome measure in which all four components must be met: 1) ODI success with improvement > 15 points; 2) survivorship with no secondary surgical interventions
or lumbar injections; 3) neurologic maintenance or improvement without worsening; 4) no device-related severe adverse events. coflex
®
and Interlaminar Stabilization
®
are registered trademarks of Paradigm Spine, LLC.
coflex
®
: a proven option for treating lumbar spinal stenosis
that can be used in any setting of care, including your ASC.
Key Findings at 24 Months:
• coflex patients experienced significant improvement in
walking distance from baseline (p<0.001)
• the coflex group demonstrated statistical superiority for
foraminal and posterior disc height maintenance
compared to decompression alone (p<0.001)
• the decompression alone group had a 1.75x higher risk
for secondary intervention compared to the coflex group
(p=0.055)
• the decompression alone group experienced 228% more
lumbar injections than the coflex group (p=0.0065)
Learn more at ParadigmSpine.com or CoflexSolution.com