Paradigm Spine Highlights AANS/CNS Joint Sections Statement Supporting NASS Coverage Policy Recommendation For coflex®

Published: May 09, 2018

NEW YORK, May 9, 2018 /PRNewswire/ -- Paradigm Spine, LLC, a leader in providing motion preservation solutions for the treatment of lumbar spinal stenosis, today announced that the American Association of Neurological Surgeons (AANS) and Congress of Neurological Surgeons (CNS) Joint Section on Disorders of the Spine and Peripheral Nerves (DSPN) published a statement supporting the North American Spine Society (NASS) coverage policy recommendation for coflex® Interlaminar Stabilization®.

The NASS coverage policy recommendation covers interspinous devices without fusion in conjunction with a direct decompression, for which coflex is the only technology specifically approved. coflex offers a motion preservation solution that is applied post-decompression to stabilize the spine and prevent future re-stenosis. The recent publication of data from the 2-year ESCADA (European Study of coflex And Decompression Alone) trial demonstrated that patients with decompression alone are almost twice as likely to require subsequent intervention (reoperation or epidural steroid injection) compared to coflex patients, effectively proving that the pain relief provided by a decompression procedure is more sustainable with the addition of coflex.

"It is extremely important to see additional professional societies' support of the guidance from NASS, as it also provides additional validation of our coflex technology, which has treated more than 150,000 patients worldwide for their stenosis-related back-pain," said Marc Viscogliosi, Chairman and CEO of Paradigm Spine. "We thank AANS and CNS for their support, as these recommendations further demonstrate to physicians, patients and payors the safety and effectiveness of coflex and provide the opportunity to open further market access to successfully treat additional patients."

About Lumbar Spinal Stenosis (LSS)
Lumbar spinal stenosis (LSS), affecting 1.6 million patients annually in the United States, is a debilitating and degenerative disease often associated with significant leg and back pain, leg numbness and weakness, and significant reduction in an active lifestyle. Historically, the two traditional surgical treatment options for LSS included decompression alone or decompression with lumbar fusion. Decompression alone has proven effective at relieving pain symptoms caused by lumbar spinal stenosis, however, patients may not experience long term symptomatic relief, 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.

About Paradigm Spine, LLC:
Paradigm Spine, LLC, founded in 2004, is a privately held company and remains focused on the design and development of solutions for the disease management of spinal stenosis. The Company's signature product is the coflex® Interlaminar Stabilization® device, which is currently used in over 60 countries worldwide. coflex is the only lumbar spinal device that has produced Level I evidence in two separate prospective, randomized, controlled studies against two different control groups, changing the standard of care for lumbar spinal stenosis treatment. For additional information visit www.paradigmspine.com or www.coflexsolution.com.

 

 

CONTACT: The Ruth Group: Kirsten Thomas, Tel: (508) 280-6592, Email: kthomas@theruthgroup.com

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SOURCE Paradigm Spine, LLC

     

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