Clinical Data

The Essure procedure has proceeded through four phases of clinical testing:

1. Phase IA: Peri-Hysterectomy Study
2. Phase IB: Pre-Hysterectomy Study
3. Phase II Study: Preliminary Safety and Effectiveness
4. Pivotal Trial: Safety and Effectiveness

Clinical data has shown that the Essure procedure:

• Is 99.80% effective in preventing pregnancy after four years of follow-up
• Can be performed in about 35 minutes without general anesthesia or incisions
• Allows women to quickly resume regular physical activities
• Has a high patient satisfaction rating

Phase IA: Peri-Hysterectomy Study
Clinical development of the Essure system began with testing in peri-hysterectomy patients. The objective of the peri-hysterectomy study was: to evaluate the feasibility of micro-insert placement; to evaluate placement techniques and delivery systems; and, to assess acute tubal occlusion. This testing was conducted in the U.S., Europe, and Mexico.

The results of the peri-hysterectomy study provided preliminary evidence regarding the safety of the placement procedure, the ability of the device to acutely anchor in the fallopian tube as well as the immediate space filling design of the device to occlude the fallopian tube.

Phase IB: Pre-Hysterectomy Study
After obtaining valuable feedback on device placement, the Essure system was then tested in pre-hysterectomy patients who wore the devices for a range of 1 day to 7 months, with the majority of patients wearing the devices for 10-12 weeks. This study was primarily intended to yield histological data to support the theorized mechanism of action. In addition, these patients provided the first opportunity to obtain feedback on the safety and comfort of the device placement procedure in an awake patient, as well as limited safety and comfort data on wearing the device. This study was conducted in the U.S. and Mexico.

Based on the histological observations from this study, the tissue response to the micro-insert was found to be occlusive in nature and localized to the device. The tissue response to the device is believed to result in both device retention and pregnancy prevention.

Phase II Study
Data from both the peri-hysterectomy testing and the pre-hysterectomy testing was supportive of moving to the next stage of clinical development, and so a Phase II study of women seeking sterilization was conducted in the U.S., Europe, and Australia. The purpose of the Phase II study was to gather safety and effectiveness data for the first time in the intended patient population.

The objectives of this study were to evaluate the:

• effectiveness of the Essure procedure in preventing pregnancy
• safety of the placement procedure
• participant's tolerance of and recovery from the procedure
• long-term safety and stability of the micro-inserts

The following table summarizes the micro-insert placement results of the Phase II Study:

Patients who underwent a placement procedure	227
Bilateral placement rate	86% (1st attempt) 88% (with 2nd attempt)
Average hysteroscopy time	18 minutes
Effectiveness rate after four years of follow-up	99.80%
Patient comfort with wearing micro-insert at subsequent visits up to 4 years of follow-up	>97% “Good” to “Excellent”

Pivotal Trial
Since the preliminary data from the Phase II study were supportive, a Pivotal Trial in women seeking sterilization was begun in the U.S., Australia, and Europe in mid-2000. The primary purpose of the Pivotal Trial was to establish a reasonable assurance of the product's safety and effectiveness for purposes of a PMA filing with the FDA. Enrollment into this study was completed in February 2001.

The primary endpoints of the Pivotal Trial were pregnancy prevention, safety of the placement procedure, and safety of long-term use.

Secondary endpoints included patient satisfaction and bilateral placement rate.

The following table summarizes the results of the Pivotal Trial:

Patients who underwent a placement procedure	518
Bilateral placement rate	86% (1st attempt) 90% (with 2nd attempt)
Average hysteroscopy time	13 minutes
Average procedure time	35 minutes
Patient satisfaction with the Essure procedure at all visits up to 3 years of follow-up	>92% “Somewhat” to “Very Satisfied”

As with all procedures, there are risks associated with the Essure procedure
To view a summary of the key risks and considerations of the Essure procedure, click here. Additionally, please refer to the Patient Information Booklet, which contains a detailed discussion of the risks associated with an Essure procedure.

Download a summary of the Prescribing Information from this web site. Access to and use of the Prescribing Information from this web site is governed by the terms set forth in the "Terms of Use." Please review these terms and conditions before downloading, viewing or otherwise using the Prescribing Information. The Prescribing Information is intended for U.S. doctors only. Like any printed material, it may become out of date over time. If you are a physician and have questions about the Essure procedure or the Patient Information Booklet, please call the Physician Consultation line at 877-ESSURE 2 (877-377-8732), prompt 1.