†The objective performance criterion (OPC) is 66% based on the lower bound of the 95% confidence interval (LB 95% Cl) of the average success rate of the five previously approved global endometrial ablation (GEA) devices measured by PBLAC method. Success in the Minerva RCT was achieved when bleeding was reduced to AH Value of ≤80ml at 12 months after the endometrial ablation procedure. Amenorrhea was defined as a score of 0.1 Secondary study endpoints included the amenorrhea rate, length of procedure (hand piece insertion to removal), and responses from a patient satisfaction questionnaire.1 MEA and ThermaChoice were included in the OPC but are no longer for sale in the United States.
- Minerva Endometrial Ablation System [Operator’s Manual]. Redwood City, CA: Minerva Surgical, Inc; 2017.
- NovaSure Impedance Controlled Endometrial Ablation System [Instructions For Use and Controller Operator’s Manual]. Marlborough, MA: Hologic, Inc; 2014.
- Her Option Office Cryoblation Therapy [package insert]. Minnetonka, MN: American Medical Systems, Inc; 2007.
- Genysys HTA ProCerva Procedure Set [instructions for use]. Marlborough, MA: Boston Scientific Corporation; 2014.