ISASS issues guidance on decompression with interlaminar stabilization
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The International Society for the Advancement of Spine Surgery recently released its recommendations and coverage criteria for decompression with interlaminar stabilization and noted the treatment is an option for carefully selected patients with lumbar spinal stenosis that lacks gross instability and for patients in which the procedure would not result in iatrogenic instability.
According to the guidance, decompression with interlaminar stabilization should only be performed by surgeons who are qualified and well-trained in the procedure. The statement also highlights documents required for patients to undergo the procedure. These documents include a complete history and physical that show clinical and radiological evidence of spinal stenosis with progressive clinical symptoms, MRI and CT evidence of the moderate to severe spinal stenosis that spans “one or two contiguous levels up to grade 1 spondylolisthesis,” a list of conservative treatment options, and symptomology with more than 12 weeks of documented nonoperative care and symptom progression.
“In select patients within the [lumbar spinal stenosis] LSS continuum, decompression with interlaminar stabilization has proven to provide equivalent outcomes with a reduced cost compared to decompression plus fusion,” the authors of the guidance wrote. “Additionally, for patients with significant back pain and associated advanced degenerative segmental disease, decompression with interlaminar stabilization provides benefits beyond decompression alone and may extend the durability of the decompression procedure.”
Marc Viscogliosi, chairman and chief executive officer of Paradigm Spine LLC, which provides the coflex interlaminar stabilization non-fusion device — reportedly the only spine product to gain FDA premarket approval for patients with up to grade 1 spondylolisthesis with a concomitant decompression — said in a press release, “We are excited to have the recognition and support of [International Society for the Advancement of Spine Surgery] ISASS in this publication. The policy statement supports our goals of improving patient access, building awareness among physicians, payers and policy makers, making coflex a compelling covered treatment option for patients with stenosis.”
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Disclosures: Guyer reports he is a 1-day faculty trainer for Paradigm Spine. Please see the full article for a list of all other authors’ relevant financial disclosures.