Conceptus (CPTS) Announces FDA Approved 10-Year Commercial Data for Essure Label

Conceptus, Inc. (Nasdaq: CPTS) announced today that the U.S. FDA has approved inclusion of 10 years of data on Essure effectiveness in commercial settings in the Essure procedure U.S. Instructions for Use (IFU) and Patient Information Booklet (PIB). In addition, the FDA has approved inclusion of the full five-year clinical study results and effectiveness rate of 99.83% in the IFU and PIB, which brings to a close the Essure clinical trials that began in 1998. The Essure procedure has maintained its unprecedented record of zero pregnancies among clinical trial subjects over five years.

During the 10-plus years that Essure has been available commercially worldwide, Conceptus has collected records of all reported pregnancies from commercial use of the Essure procedure and their causes. Based on these reports, the Essure procedure's 10-year commercial pregnancy experience tracks closely with its new five-year clinical rate of 99.83%. Pregnancies that occurred in commercial use primarily stemmed from patient non-compliance or misinterpreted confirmation tests.

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