Essure hysteroscopic sterilization: results based on utilizing a new coil catheter delivery system.

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.