NovaSure Endometrial Ablation System Indications and Contraindications
NovaSure System Indications:
The NovaSure system is intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (heavy bleeding) due to benign causes for whom childbearing is complete.
NovaSure System Contraindications:
The NovaSure impedance controlled endometrial ablation system is contraindicated for use in:
A patient who is pregnant or who wants to become pregnant in the future. Pregnancies following ablation can be dangerous for both mother and fetus.
A patient with known or suspected endometrial carcinoma (uterine cancer) or pre-malignant conditions of the endometrium, such as unresolved adenomatous hyperplasia.
A patient with 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.
A patient with active genital or urinary tract infection at the time of the procedure (e.g., cervicitis, vaginitis, endometritis, salpingitis, or cystitis).
A patient with a intrauterine device (IUD) currently in place.
A patient with a uterine cavity length less than 4 cm. The minimum length of the electrode array is 4 cm. Treatment of a uterine cavity with a length less than 4 cm will result in thermal injury to the endocervical canal.
A patient with a uterine cavity width less than 2.5 cm, as determined by the WIDTH dial of the disposable device following device deployment.
A patient with active pelvic inflammatory disease.