MEA and ThermaChoice are no longer commercially available in the United States
Not Based on a Head-to-Head Study. Data from “Intent-to-Treat” populations at 1 year follow-up from Clinical Trials results in the Instructions for Use for Minerva®, Her Option®, HTA® System, Thermachoice® III, NovaSure®, and MEA®.
- The Minerva 12-month follow-up Success Rate was demonstrated to be Statistically Significantly Greater than the OPC (Objective Performance Criteria) of 66% (p-value <0.0001).
- The OPC is 66% based on the lower bound of the 95% confidence interval (LB 95% CI) of the average success rate of the five previously approved global endometrial ablation (GEA) devices.
- Patient success was defined as a reduction in PBLAC menstrual diary score from ≥150 pre-treatment to ≤ 75 at 12 months post-procedure. Amenorrhea was defined as a score of 0.
- Secondary study endpoints included the amenorrhea rate, length of procedure (Handpiece insertion to removal), and responses from a patient satisfaction questionnaire.