Indications:

The NovaSure System is intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.

Contraindications:

NovaSure Endometrial Ablation is contraindicated for use in patients who:

• Are pregnant or want to become pregnant in the future; pregnancies following ablation can be dangerous for both mother and fetus.
• Have known or suspected endometrial carcinoma (uterine cancer) or pre-malignant conditions of the endometrium, such as unresolved hyperplasia.
• Have any anatomic condition (e.g. history of previous classical cesarean section or transmural myomectomy) or pathologic condition (e.g., long term medical therapy) that could lead to weakening of the myometrium.
• Have active genital or urinary tract infections at the time of the procedure (e.g., cervicitis, vaginitis, endometritis, salpingitis, or cystitis).
• Have an intrauterine device (IUD) in place.
• Have a uterine cavity length less than 4 cm and width less than 2.5 cm. (The minimum length of the electrode array is 4 cm; treatment of a shorter uterine cavity will result in thermal injury to the endocervical canal).
• Have active pelvic inflammatory disease.
• A patient with a uterine cavity width less that 2.5 cm, as determined by the Width Dial of the Disposable Device following Device deployment.