Paradigm Spine wins coverage for spinal stenosis implant

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Image courtesy of Paradigm Spine

BlueCross BlueShield of South Carolina has extended coverage to Paradigm Spine’s Coflex interlaminar stabilization implant, the company announced today.

Approved by the FDA in 2012, Coflex is a non-fusion, motion-preserving stabilization implant for the treatment of lumbar spinal stenosis (LSS). Used in conjunction with a decompression procedure or in lieu of a spinal fusion, Coflex is a single-piece, U-shaped titanium alloy dynamic stabilization device with pairs of wings that surround the superior and inferior spinous processes. This device was previously called the Interspinous U.

Spinal stenosis is a narrowing of the spaces within the spine, which can put pressure on the nerves that travel through the spine. Lumbar spinal stenosis affects 1.6 million patients annually, is a debilitating and degenerative disease in people over age 50,  often associated with significant leg and back pain, leg numbness and weakness, and causing a significant reduction in an active lifestyle. Traditional surgical treatment options for LSS includes a decompression that removes bone and soft tissue and may also require a fusion to stabilize the spine.

Coflex is indicated for use in 1- or 2-level lumbar stenosis from L1-L5 in skeletally mature patients with at least moderate impairment in function, who experience relief in flexion from their symptoms of leg/buttocks/groin pain, with or without back pain, and who have undergone at least six months of non-operative treatment, according to BlueCross Blue Shield. It is intended to be implanted midline between adjacent lamina of one or two contiguous lumbar motion segments.

“With more than 90 peer-reviewed published articles, including landmark long-term follow-up clinical studies, spine medical society guidelines, and now with additional commercial insurance coverage, it is wonderful to be able to expand patient access to the Coflex technology,” Paradigm Spine chairman and CEO Marc Viscogliosi said in a prepared statement.

The FDA gave premarket approval in May to the Coflex interlaminar stabilization disposable instrument kit, which Pardigm touted as the first FDA PMA-cleared disposable spinal instrument set for a Class III spinal device.

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