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Ortho Panel Green Lights VertiFlex’s Superion Spine Spacer

A majority of FDA advisors say the device intended to treat lumbar spinal stenosis has a positive risk-benefit profile but should require an extended postmarket trial to evaluate its safety and efficacy over a longer time period.

FDA’s Orthopaedic and Rehabilitation Devices Panel voted 4-2 with two abstentions that VertiFlex Inc.’s Superion interspinous spacer’s benefits outweigh its potential risks to treat lumbar spinal stenosis. If approved by the agency, it would be the second such interspinous device to reach the U.S. market following Medtronic PLC’s X-Stop spacer, which was approved by FDA in 2005 over the orthopedic panel’s objections. (See Also see "St. Francis’ X-Stop Gets FDA Green Light To Treat Lumbar Spinal Stenosis" - Medtech Insight, 28 November, 2005.).

Agency reviewers acknowledged that Superion proved to be non-inferior to X-Stop in clinical trial data provided by the company, but expressed concern with the higher rate of spinous process fractures...

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