FDA APPROVES EARLY END TO STUDY OF ESSURE BIRTH CONTROL PROCEDURE

The FDA recently approved early termination of a postapproval study of Conceptus' Essure birth control procedure because of the positive data obtained so far. The purpose of the study was to determine the success rate in placing the device. The Essure procedure deploys a soft micro-insert into the fallopian tube through the cervix using a minimally invasive transcervical tubal access catheter. Once in place, the device is designed to block the fallopian tube.

Although the treatment of the number of patients usually required by the FDA has not been completed, the positive results thus far convinced the agency to end the study. The FDA's decision moves the agency one step closer to approving a supplemental label for bilateral placement rates.