CLINICAL TESTING

Conceptus has conducted research and clinical testing of its micro-insert technology since 1997 in several separate clinical trials. These trials were conducted under strict guidelines in the United States, Europe, Australia, and Mexico:

  • Phase 1A - placement of micro-inserts
  • Phase 1B - placement and comfort of micro-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 35 minutes without incisions or general anesthesia Provides for a rapid recovery and return to all things important to women Has a high patient satisfaction rating

    Phase 1A - Placement feasibility of micro-inserts

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

    Phase 1B - Placement feasibility and comfort of micro-inserts

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

    Phase II Study - Preliminary safety and effectiveness

    The Phase 1A and 1B clinical trials, discussed above, provided evidence that micro-inserts could be safely placed into fallopian tubes and were well tolerated by women. The Phase II Study was conducted to obtain evidence about the effectiveness and long-term use of the Essure system. The study involved about 200 women seeking permanent birth control from the United States, Europe, and Australia. From this study we obtained evidence that the Essure procedure was effective and well tolerated by women. This data supported testing in a larger group of women. Follow-up of all Phase II patients is continuing.

    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. Follow-up of all Pivotal Trial patients is continuing.

    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 day of 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