Essure Hysteroscopic Sterilization: Results Based on Utilizing a New Coil Catheter Delivery System

Abstract

Study Objective To assess the safety and placement effectiveness of a new delivery catheter for the Essure micro-insert hysteroscopic sterilization system. Design Prospective, multicenter, single-arm clinical study. (Canadian Task Force classification II-3). Setting Hospital-based clinical research centers. Patients One hundred two women of reproductive age and proven fertility. Intervention A new coil catheter delivery system was used for micro-insert placement. Measurements and Main Results The bilateral placement of micro-inserts using the coil catheter delivery system occurred in 100 women out of 102 attempts (98%). The two women who did not have successful micro-insert placement were subsequently shown to have proximal tubal stenotic disease. Conclusion These findings indicate that the introduction of the coil catheter delivery system for Essure hysteroscopic sterilization improves the micro-insert bilateral placement rate when compared with previous studies. It is hypothesized that the coil catheter has superior navigational properties, particularly within tortuous or narrowed tubal lumens.