An FDA nod for Hologic (NSDQ:HOLX) will redound to the benefit of rival Conceptus (NSDQ:CPTS), making its Essure female sterilization device legally compatible with endometrial ablations systems made by Hologic, Johnson & Johnson (NYSE:JNJ) and Boston Scientific (NYSE:BSX)
The federal watchdog agency approved labeling changes for Hologic’s NovaSure endometrial ablation system, which uses bipolar radio frequency to treat menorrhagia, or excessive menstrual bleeding.
Conceptus and Hologic are waging a bitter legal war over the Essure and Hologic’s competing Adiana system, with Conceptus looking to reinforce its $19 million win with a permanent injunction to keep Hologic’s Adiana device off the U.S. market.
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The FDA’s NovaSure decision means the Conceptus Essure procedure “is now approved to be safe and compatible with all the major global endometrial ablation technology options that treat menorrhagia,” according to a press release.
“Our competitive advantage and leadership in the permanent birth control market has been significantly strengthened by this upgraded label,” Conceptus CEO Keith Grossman said in prepared remarks. “We will be communicating the change to the OB/GYN community, and especially to those physicians who have used the competitor’s hysteroscopic sterilization product with NovaSure.”
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