EDAP TMS SA announced the submission of its Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration (FDA) on Jan. 31, 2013 for the Company's Ablatherm-HIFU (high intensity focused ultrasound) for treatment of low risk, localized prostate cancer. EDAP's PMA submission includes data from the ENLIGHT study, a multi-center U.S. Phase II/III clinical trial that completed the two year follow-up needed to evaluate its primary endpoint in August 2012, as well as data from the company's extensive worldwide database of treatment information and follow-up data from patients who have undergone HIFU therapy for prostate cancer.
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