[FDA allows post-approval study to be stopped early due to positive placement data]
>>SAN CARLOS, Calif.--(BUSINESS WIRE)--Sept. 23, 2005--Conceptus, Inc. (Nasdaq:CPTS - News), developer of the Essure® non-incisional permanent birth control procedure, today announced U.S. Food and Drug Administration (FDA) approval to terminate the Company's post-approval study with physicians newly trained in performing the Essure procedure due to the positive placement data obtained to date.
The purpose of the post-approval study, required by FDA as a condition of the November 2002 approval of the Essure system, was to determine the rate of successful bilateral placements of the Essure micro-inserts at first attempt with a large number of newly trained physicians who were not part of the previous clinical studies. Although treatment of the total number of patients required by FDA had not been completed, the data obtained to date provided the Company with the ability to request an early termination of the study.
Because of this ruling, the PMA Supplement submitted in March 2005 has been re-classified as a Final Report. This will require the Company to submit a new PMA Supplement for the bilateral placement rate claims for which it is seeking FDA approval in order to update the labeling for the Essure system.
"We are pleased with the FDA action which underscores the ease with which the Essure procedure can be performed," stated Mark Sieczkarek, president and CEO of Conceptus. "We are hopeful that approval of our PMA Supplement will be quick since the data has already been reviewed in the final report of the post-approval study. We remain confident that the updated bilateral placement rate will be at least 92%." <<
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Cheers, Tuck |
