Hologic's Adiana Permanent Birth Control Device Takes On Conceptus' Essure
This article was originally published in The Pink Sheet Daily
Adiana uses a polymer matrix insert to block the fallopian tubes instead of a metal coil, offering a benefit over Essure, which carries a perforation risk on implantation, Hologic exec says.
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In a lawsuit filed in Northern California federal court, the maker of the Essure non-incisional permanent birth control device alleges Hologic's Adiana permanent contraception system violates several patents held by Conceptus. The firm is seeking an injunction prohibiting Hologic from selling Adiana in the U.S., Conceptus says May 22. Adiana was deemed "approvable" by FDA in March, pending inspection of Hologic's Costa Rican facility. An FDA advisory panel voted to recommend approval of the product in late 2007 (1"The Gray Sheet" Dec. 17, 2007, p. 3). In 2002, Essure became the first permanent birth control device approved by FDA as an alternative to tubal ligation
Hologic's Adiana permanent female birth control system should be approved by FDA, contingent upon a postmarket study comparing the device with an alternative method of permanent female birth control, the agency's Obstetrics and Gynecology Devices Panel recommended Dec. 13
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