In Brief: FemRx
This article was originally published in The Gray Sheet
Executive Summary
FemRx: Initiates multi-center, prospective clinical study evaluating its OPERA (Out-Patient Endometrial Resection/Ablation) procedure for treating abnormal uterine bleeding (AUB). Entitled UPROAR (Uterine Preservation: Resection and Ablation to Optimize Amenorrhea Rates), the study will enroll about 500 patients and will aim to show that OPERA cost-effectively eliminates menstrual bleeding and is associated with "significantly faster" recovery times and lower complication rates than hysterectomy, the firm says. FemRx' OPERA system received 510(k) clearance in March based on acute data from a 63-patient trial. The system's cost-effectiveness and long-term benefit are supported by retrospective studies in peer review literature, FemRx says, but UPROAR "fills a void in the literature by prospectively studying the OPERA procedure on a multi-center basis using a clearly defined methodology"...