Clinical Testing

• Phase 1A - placement of inserts

• Phase 1B - placement and comfort of inserts

• Phase II Study - preliminary safety and effectiveness

• Pivotal Trial - safety and effectiveness

Clinical testing has shown that the Essure procedure:

• Is 99.80% effective in preventing pregnancy based on four years of follow-up
• Can be performed in about 10 minutes without incisions or general anaesthesia
• Provides for a rapid recovery
• Has a high patient satisfaction rating

Phase 1A - Placement feasibility of inserts

In this early clinical trial, inserts were placed in patients immediately before a planned hysterectomy, which was previously planned for medical purposes. These patients never relied on the inserts for contraception, but evidence was obtained that inserts could be safely placed in the fallopian tubes.

Phase 1B - Placement feasibility and comfort of inserts

In this second clinical trial, patients had inserts placed up to 30 weeks before planned hysterectomies, so they never relied on the inserts for contraception. After the hysterectomy, the tubes containing inserts were examined under a microscope by an independent specialist. The specialist found that the tissue response to the inserts caused the tubes to be blocked, preventing sperm from reaching the egg. Additionally, this clinical trial provided evidence that inserts could be safely placed in patients who were awake, and women were comfortable with inserts in their fallopian tubes.

Phase II Study - Preliminary safety and effectiveness

The Phase 1A and 1B clinical trials, discussed above, showed that inserts could be safely placed into fallopian tubes and were well tolerated by women. The Phase II Study was conducted to learn about the effectiveness and long-term use of the Essure system. The study involved about 200 women seeking permanent contraception from the United States, Europe, and Australia. This study provided evidence that the Essure procedure was effective and well tolerated by women. This data supported testing in a larger group of women.

Pivotal Trial - Safety and effectiveness

Based on the positive results obtained from earlier clinical trials, a Pivotal Trial of the Essure procedure was conducted in about 450 women from the United States, Europe, and Australia.

Results from the Phase II and the Pivotal trials showed:

• Essure is 99.80% effective based on four years of follow-up
• Almost all women employed outside the home returned to work 24 hours or less after the procedure
• Almost all women rated their comfort as “good” to “excellent” within one week of the procedure
• Almost all women rated their satisfaction with the Essure procedure as “somewhat satisfied” to “very satisfied” after the one-week visit
• Essure received its CE mark in 2001.  It remains the only permanent contraceptive method with zero pregnancies in clinical trials.