Prostatron receives panel go-ahead
This article was originally published in Clinica
EDAP International's Prostatron was unanimously recommended for approval for the treatment of benign prostatic hypertrophy by an FDA panel on October 2Oth. The gastroenterology and urology devices advisory committee indicated that post-marketing follow-up should be performed on 100 patients for five years after surgery to ensure that no chronic complications develop. EDAP has the option of performing the extended follow-up on patients who were part of the clinical trials or on new patients.