This article was originally published in The Gray Sheet
VertiFlex plans to file a pre-market approval application in 2013 for its Superion interspinous spacer to percutaneously treat spinal stenosis. The firm has enrolled 173 patients to date in a randomized, pivotal non-inferiority trial comparing Superion with St. Francis Medical Technologies' X-Stop. The latter device was the first interspinous spacer, approved by FDA in November 2005 (1"The Gray Sheet" Nov. 23, 2005). VertiFlex says it plans to complete trial enrollment during the first half of 2011 and will follow patients for two years. On Aug. 27, VertiFlex announced the divestiture of its Silverbolt percutaneous pedicle screw system for $3.5 million to Exactech. Silverbolt generates $6 million in sales annually and will complement Exactech's current spine product portfolio. The move will allow VertiFlex to refocus on Superion, which the firm expects to be its future primary revenue driver. While Silverbolt competes with numerous similar products, Superion would be unique as the only percutaneous interspinous spacer on the market following its approval, the firm explains. Superion gained a CE mark in 2007 and is already available overseas. Privately-held VertiFlex, located in San Clemente, Calif., was founded in 2005 and has raised $64 million in capital to date
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