Applied Spine Technologies Receives Permission From FDA To Commence Pivotal Clinical Trial Of Its Flagship Product, Stabilimax NZ(TM) Dynamic Spine Stabilization System

NEW HAVEN, Conn.--(BUSINESS WIRE)--Applied Spine Technologies (AST) Inc. (www.appliedspine.com) announced today that it has received permission under an Investigational Device Exemption (IDE) from the FDA to commence a multi-center, randomized, controlled clinical trial comparing posterior dynamic stabilization using the Stabilimax NZ Dynamic Spine Stabilization System to patients receiving traditional fusion stabilization to treat degenerative lumbar spinal stenosis. A total of 266 Stabilimax NZ patients and 133 control patients will be enrolled in the trial, which is expected to start next month at 20 sites across the U.S.
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