Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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"...
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT007263

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel