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NovaSure™ Impedance Controlled Endometrial Ablation System - P010013

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product name: NovaSure™ Impedance Controlled Endometrial Ablation System P010013
Manufacturer and Address: Novacept, Inc., 1047 Elwell Court, Palo Alto, California 94303
Approval Date: September 28, 2001
Approval Letter: http://www.fda.gov/cdrh/pdf/P010013a.pdf

What is it? The NovaSure™ Impedance Controlled Endometrial Ablation System is a surgical device that uses radio frequency energy to treat excessive menstrual bleeding by destroying certain tissue in the uterus (womb). The system consists of a controller, a disposable device, connecting cord, desiccant, foot switch and power cord. The disposable device is single-patient use, with a conformable, bipolar electrode array.

How does it work? After the patient has received appropriate anesthesia, the disposable device is introduced through the vagina into the uterus, and an electrode array is deployed in the uterus. The controller provides energy to the electrode array to vaporize and/or coagulate the endometrium, which is the innermost layer of tissue of the uterus. This is the layer of fluffy tissue that is eliminated with the blood when women menstruate. A vacuum pump maintains good contact between the tissue and the electrode array and removes steam, moisture, and other gases during treatment. The treatment stops when the tissue’s electrical impedance reaches a certain level or after 2 minutes.

When is it used? The device is intended for pre-menopausal women whose child-bearing is completed and who have a condition called menorrhagia, in which there is excessive uterine bleeding. The device is only used in women whose menorrhagia is due to benign or non-cancerous causes.

What will it accomplish? The device was shown to reduce menstrual bleeding to normal or below normal levels one year after treatment in approximately 78% of the women in a randomized clinical study. In approximately 36% of women in the study, menstrual bleeding was totally eliminated. Side effects of treatment include uterine cramping, abdominal pain, nausea, and vomiting.

When should it not be used? This device should not be used in a patient who: is pregnant or who desires to become pregnant in the future; has a known or suspected endometrial carcinoma (uterine cancer); has an active genital or urinary tract infection at the time of the procedure; has an intrauterine device (IUD) currently in place; or has had a classical cesarean section. This procedure is not a sterilization procedure.

Additional information

Summary of Safety and Effectiveness and labeling will be available at: http://www.fda.gov/cdrh/pdf/p010013.html

Other: FDA's Office of Women's Health web site : http://www.fda.gov/womens/default.htm

The Consumer Staff in FDA’s Center for Devices and Radiological Health, Division of Small Manufacturers, International and Consumer Assistance provides information to consumers regarding medical devices and radiation-emitting products to enhance their ability to avoid risk, achieve maximum benefit, and make informed decisions about the use of such products.

Website: http://www.fda.gov/cdrh/consumer/index.html
E-Mail: dsmica@cdrh.fda.gov
Phone: Toll Free 1-888-463-6332 or
301-827-3990 directly between the hours of 8:00a.m. - 4:30p.m. EST

Updated August 30, 2004

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Center for Devices and Radiological Health / CDRH