Minerva Pivotal Study to Evaluate Safety and Efficacy of the Aurora Endometrial Ablation System Compared to Hysteroscopic Rollerball Ablation

Inclusion Criteria

• Refractory menorrhagia with no definable organic cause
• Female subject from (and including) age 25 to 50 years
• Uterine sound measurement of no greater than10.0cm (external os to internal fundus) and a minimum uterine cavity length of 4.0cm
• A minimum menstrual blood loss of ≥ 160 ml for two baseline cycles within three months prior to treatment as measured by alkaline hematin extraction; OR,
• A minimum menstrual blood loss of ≥ 160 ml for one baseline cycle for women who either
• had at least 3 prior months documented failed medical therapy; or
• had a contraindication to medical therapy
• Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/L
• Not pregnant and no desire to conceive at any time
• Subject agrees to use a reliable form of contraception up to the 12-month follow-up visit. If a hormonal birth control method is used for contraception, the subject must have been on said method for ≥ 3 months prior to enrollment and agrees to remain on the same hormonal regimen through the initial 12-month follow-up
• Able to provide written informed consent using a form that has been approved by the reviewing IRB/EC
• Subject agrees to follow-up exams and data collection requirements
• Subject who is literate or demonstrates an understanding on how to collect menstrual blood loss products for the alkaline hematin method of analysis

Exclusion Criteria

• Pregnancy or subject with a desire to conceive
• Endometrial hyperplasia as confirmed by histology
• Presence of active endometritis
• Active pelvic inflammatory disease
• Active sexually transmitted disease (STD)
• Presence of bacteremia, sepsis, or other active systemic infection
• Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of the procedure
• Known/suspected abdominal pelvic or gynecological malignancy within the past 5 years
• Known clotting defects or bleeding disorders
• Untreated/unevaluated cervical dysplasia, except CIN I
• Prior uterine surgery (except low segment cesarean section) that interrupts the integrity of the uterine wall (e.g., transmural myomectomy or classical cesarean section)
• Previous endometrial ablation procedure
• Presence of an implantable (intrauterine) contraceptive device (e.g. Essure™ or Adiana™)
• Currently on medications that could thin the myometrial muscle, such as long-term steroid use (except inhaler or nasal therapy for asthma)
• Currently on anticoagulants
• Abnormal or obstructed cavity as confirmed by hysteroscopy, SIS or vaginal ultrasound
• Presence of an intrauterine device (IUD) which the Subject is unwilling to have removed at the time of the operative visit
• Subject currently on hormonal birth control therapy (including the Mirena device) for <3 months prior to enrollment
• Subject who is unwilling to use birth control post-ablation whether non-hormonal birth control or the same hormonal birth control therapy as before the procedure
• Subject who is within 6-weeks post partum
• Any subject who is currently participating or considers future participation in a research study of an investigational drug or device during the course of this investigational study
• Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject