A Two-Phase Clinical Study of the Minerva AURORA Ablation System

Inclusion criteria

• Refractory menorrhagia with no definable organic cause (abnormal uterine bleeding)
• Female subject from age 35 to 50 years
• Uterine sound measurement of 6.0cm to 10.0cm (external os to internal fundus)
• A minimum PBLAC score of >150 for 3 months prior to study enrollment; OR, A minimum PBLAC score >150 for one month for women who either

• had at least 3 prior months documented failed medical therapy; or
• had a contraindication to medical therapy; or
• refused medical therapy
• Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/ml
• Not pregnant and no desire to conceive at any time
• Patient agrees not to use hormonal contraception or any other medical intervention for bleeding during the study
• 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, including ability to accurately use menstrual diaries
• Subject who is literate or demonstrates an understanding on how to use menstrual diaries

Exclusion criteria

• Pregnancy or subject with a desire to conceive
• Complex 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 gynecological malignancy within the past 5 years
• Known clotting defects or bleeding disorders
• Untreated/unevaluated cervical dysplasia
• Known/suspected abdominal/pelvic cancer
• 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
• Currently on medications that could thin the myometrial muscle, such as long-term steroid use
• Currently on anticoagulants
• Abnormal or obstructed cavity as confirmed by hysteroscopy or SIS, specifically:

• Septate or bicornuate uterus or other congenital malformation of the uterine cavity
• Pedunculated or submucosal myomas distorting the uterine cavity
• Polyps likely to be the cause of the subject's menorrhagia
• Intramural or subserosal myomas that distort the uterine cavity
• Presence of an intrauterine device (IUD)
• Subject currently on hormonal birth control therapy or unwilling to use a non-hormonal birth control post-ablation.
• Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject
• Any subject who is participating in any other research of an investigational drug or device that has not yet completed the primary endpoint evaluation.