Innovative Implant Treats Lumbar Spinal Stenosis

The Paradigm Spine (New York, NY, USA) coflex device is a small, U-shaped interlaminar titanium stabilization device indicated for use after a spinal decompression procedure on one or two level contiguous lumbar motion segments (L1-L5) in skeletally mature patients, with at least moderate impairment in function, who experience relief during flexion from leg, buttocks, or/and groin pain (with or without back pain), and who previously underwent at least six months of non-operative treatment. The device is implanted midline between adjacent lamina, and is available in five different anatomical sizes.

During the clinical procedure, the “U” is positioned horizontally, with the apex oriented anteriorly and the two long side arms paralleling the long axis of the spinous processes. The bone-facing surfaces are ridged to provide resistance to migration. Features include a biocompatible and x-ray visible titanium composition; crimped wings for increased primary stability; a center of rotation close to the spinal canal to provide increased rotational stability; stress reduction on facet joints; a large contact area for optimized stress distribution; protection of posterior elements; and maintenance of foraminal height.

“There is now potentially a more effective surgical option between the two typical treatments for lumbar spinal stenosis, and we are proud to lead the way in changing the standard of care for surgeons and their patients with this diagnosis,” said Marc Viscogliosi, chairman and CEO of Paradigm Spine. “Paradigm Spine has worked diligently to build the pieces of the puzzle in establishing coflex as the new standard of care for the treatment of moderate to severe lumbar spinal stenosis.”

Lumbar spinal stenosis is a debilitating and degenerative disease in older patients, often associated with significant leg and back pain, leg numbness, and weakness, which causes a significant reduction activity. Decompression alone is effective at relieving pain symptoms caused by lumbar spinal stenosis, but long term symptomatic relief is elusive, often resulting in subsequent opioid pain control, epidural injections for pain management, or additional surgeries for conversion to a fusion. Decompression with fusion has proven to provide pain relief and stabilize the diseased segment, but may lead to adjacent level disease requiring subsequent surgeries.

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