EDAP TMS S.A. Completes Follow-Up Phase and Data Collection for FDA ENLIGHT Trial
Published: Aug 17, 2012
LYON, France, Aug. 17, 2012 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today provided an update regarding its Ablatherm-HIFU (High Intensity Focused Ultrasound) ENLIGHT U.S. clinical trial for the indication of low risk, localized prostate cancer. The trial is a multi-center U.S. Phase II/III clinical trial conducted under an Investigational Device Exemption (IDE) granted by the FDA. As previously announced, the last Ablatherm-HIFU patient was treated in June 2010. The two year anniversary of the last patient treated occurred on June 30, 2012, which marked the conclusion of the two year follow-up phase, and the Company confirms the completion of all two year follow-up visits.