A Multicenter, Objective Performance Criteria–Controlled Study for U.S. Food and Drug Administration Approval of the Minerva Endometrial Ablation System [142

Abstract

INTRODUCTION: The primary objectives were to assess the safety and efficacy of the Minerva procedure compared with an objective performance criteria. Secondary objectives included amenorrhea rate, procedure time, anesthesia type, patient satisfaction, quality of life, and other. METHODS: This study, performed at seven centers in Canada, Hungary, and Mexico, was conducted for U.S. Food and Drug Administration (FDA) approval. A total of 105 premenopausal patients with menorrhagia (Pictorial Blood Loss Assessment Chart score of 150 or higher) underwent the Minerva endometrial ablation procedure. The primary effectiveness endpoint was bleeding at 12 months posttreatment with success defined as a Pictorial Blood Loss Assessment Chart score of less than 75 per cycle. Objective Performance Criteria was assigned by the FDA and composed of the success rates from the FDA clinical studies for the five FDA-approved endometrial ablation systems. RESULTS: At 12 months follow-up, data were available for all patients. Success rate (Pictorial Blood Loss Assessment Chart score less than 75) of the Minerva procedure was 97%, which is statistically significantly superior to the objective performance criteria success rate of 83%. Seventy percent of patients reported amenorrhea (Pictorial Blood Loss Assessment Chart score 0). The safety profile of the device or procedure was unremarkable. At 12 months of follow-up, 97.6% of patients were satisfied and 98.8% would recommend the procedure. Procedure time (device insertion to removal) was 3.8 minutes. Local±intravenous sedation was used in 83% of patients. No patients underwent hysterectomy or any other additional medical or surgical intervention for menorrhagia. CONCLUSION: Results of this multicenter, objective performance criteria–controlled FDA study indicate that Minerva endometrial ablation produces high rates of amenorrhea, success, and patient satisfaction. At 12 months of follow-up, the success rate of the Minerva procedure was statistically significantly superior to the objective performance criteria with avoidance of reintervention being 100%.