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news.Impliant has received the FDA approval to restart patient enrollment in a pivotal IDE trial of its Tops system, a total posterior arthroplasty device to treat spinal stenosis with or without facet arthrosis and spondylolisthesis.
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Impliant voluntarily suspended enrollment in the study in September 2007 following one device-related failure. After an extensive investigation conducted by a third-party expert in medical device retrievals and the Impliant R&D team, it was determined that device misalignment coupled with excessive shear loading caused the failure. As a result, Impliant has made a few minor design and manufacturing changes to the internal components of the Tops device that allow it to better withstand high shear loads and misalignment while not affecting its range of motion.
Impliant has enrolled 74 patients to date in its prospective, randomized IDE study comparing the Tops system to a traditional posterior fusion. The company also currently has 75 Tops patients enrolled under single and multi-level protocols in Brazil, Belgium, Turkey, and Israel.