Essure birth control
This article was originally published in The Gray Sheet
Executive Summary
FDA's Obstetrics and Gynecology Devices Advisory panel will review one-year data on 400 patients treated with Conceptus' non-incisional permanent birth control device at its July 22-23 meeting. Submitted April 19, the Essure PMA was granted expedited review, and the device could be approved and on the market by the end of 2002, Conceptus notes (1"The Gray Sheet" March 25, 2002, p. 21). In clinical trials, the device has shown 100% effectiveness in preventing pregnancy, leading to a projected one-year efficacy rate of 99.8%, the firm reports...
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Conceptus will ask FDA to drop a labeling requirement that a hysterosalpingogram (HSG) be performed three months after Essure placement, in the event that the condition accompanies approval of the non-incisional permanent birth control device
Financings In Brief
Conceptus: Birth control device developer's plans for a secondary offering of 4 mil. shares of common stock are outlined in a recent filing with the Securities and Exchange Commission. The filing precedes a scheduled July 22-23 FDA Obstetrics & Gynecology Devices Panel meeting to review data on 400 patients treated with the Essure non-incisional, permanent birth control system, which has been granted fast-track status (1"The Gray Sheet" May 27, 2002, In Brief). The implant is expected to debut in the U.S. next year as an alternative to surgical tubal ligation and vasectomy, which currently account for about 1 mil. procedures annually. All of the shares will be offered by the company with UBS Warburg acting as the sole book-running manager. CIBC World Markets, Adams Harkness & Hill and SG Cowen are acting as co-managers...
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