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February 5, 2013
16:25 EDTCPTSConceptus enrolls first patient in European clinical trial for next-gen Essure
Conceptus announced that it has initiated enrollment in its European clinical study designed to support the company's CE Mark application for its next generation Essure device. The European clinical trial will enroll up to 60 patients in multiple sites in Europe, and will assess effectiveness for pregnancy prevention at both the 3-months and 1-year endpoints. Dr. Sebastiaan Veersema, the trial's principal investigator, at St. Antonius Hospital in Nieuwegein, Netherlands, performed the first procedure in the clinical study on January 31. The key benefit of the next generation Essure design is immediate, permanent contraception without a three-month waiting period or 90-day confirmation test. To achieve immediate contraception, a proprietary hydrogel component is incorporated into the distal end of what is otherwise very similar to the current Essure insert, and which is intended to immediately occlude the fallopian tube once the device is placed.
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