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Transcend Medical preparing FDA application for CyPass micro-stent
Transcend Medical plans to file a premarket approval application with the FDA later this year for the CyPass micro-stent, the company announced in a press release.The COMPASS trial, a prospective, multicenter, randomized controlled trial including 500 patients with mild to moderate glaucoma undergoing cataract surgery, was completed as required for the PMA, according to the release. In that trial, patients were randomized to receive the micro-stent after cataract surgery or undergo no additional intervention.