Adiana Post-Approval Clinical Study (APACS) (APACS)

Inclusion Criteria:

• Subjects who are seeking permanent sterilization
• Women 18-45 years old
• Subjects who are at risk of becoming pregnant
• Subjects willing to use alternative contraception for at least three (3) months following device placement and bilateral tubal occlusion is confirmed by HSG
• Subjects who are able to provide informed consent

Exclusion Criteria:

• Subjects who are uncertain about their desire to end fertility
• Clinical evidence of an active pelvic infection or history of a recent pelvic infection
• Has intra-uterine pathology which would prevent access to either tubal ostium or the intramural portion of either fallopian tube (i.e., large submucous fibroids, uterine adhesions, apparent uni or bilateral proximal tubal occlusion, suspected unicornuate uterus, etc.)
• Is pregnant (as evidenced by pregnancy test result) or suspects pregnancy
• Is currently less than three (3) months since her last pregnancy
• Has previously undergone a tubal ligation
• Is currently taking immunosuppressive medication (e.g., steroids)
• Has a known allergy to contrast media
• Has external pacemaker or internal cardioverter defibrillator
• Subject is unable to follow the protocol and return for follow up visits
• In the opinion of the investigator, the subject has a medical condition that precludes safe participation in the study