FDA OKs Use of Device With Contraceptive

March 01, 2012

(Reuters) Feb 29 - U.S. health regulators approved the use of Hologic Inc's NovaSure device to treat menorrhagia in women using Conceptus Inc's implanted contraceptive Essure, the women's healthcare product developer said.

Essure, a non-surgical insert, is a permanent form of birth control that's placed in the Fallopian tubes.

Physicians can now prescribe Hologic's device to women with Essure.

Hologic's device, NovaSure Impedance Controlled Endometrial Ablation, treats menorrhagia by using radio frequency to destroy certain tissues in the uterus.

The labeling expansion comes after Conceptus reached an agreement with the U.S. Food and Drug and Administration on Essure's post-approval study protocol.

Conceptus is also currently embroiled in a patent infringement case with Hologic over the latter's contraceptive device Adiana.

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