MOUNTAIN VIEW, Calif.,(GLOBE NEWSWIRE) -- Conceptus, Inc, developer of the Essure(R) procedure, the leading non-surgical permanent birth control method, today announced that it has begun patient enrollment in a 60-patient clinical trial at two medical centers in Canada and Mexico with its next-generation Essure device. The new Essure device is designed to offer not only all the advantages of the current Essure procedure, but also immediate, permanent contraception without a three-month waiting period or 90-day confirmation test.
In most cases a non-invasive transvaginal ultrasound is all that will be required to confirm placement immediately following the new Essure procedure. Like the Essure procedure itself, this test may be performed in the physician's office. A satisfactory confirmation of proper placement will provide the patient the ability to rely upon Essure for immediate permanent contraception without the need for a secondary method of contraception for the first three months of wear.
The clinical trial will evaluate the safety of the next-generation Essure device placement procedure and the three-month effectiveness of the new contraception technology. Data from the clinical trial will be used to initiate the IDE and CE Mark studies in 2013 for U.S. PMA supplement and CE Mark applications.
The first placement of the new Essure device was performed on July 3,
2012 by John Thiel, M.D., principal investigator, at Regina Central Hospital in Canada. "We are pleased to be involved in the clinical efforts to evaluate a device that could address an unmet need for immediate, highly reliable permanent birth control."
"While still early, this next-generation Essure device is designed to offer an even more compelling value proposition for female permanent birth control, particularly as compared to surgical tubal ligation,"
said D. Keith Grossman, president and chief executive officer of Conceptus. "Immediate contraception and the elimination of a 90-day confirmation test will dramatically strengthen our competitive positioning and enable us to further penetrate the permanent birth control market for years to come. If successful, this will be an important achievement as we advance our vision of making Essure the standard of care in permanent birth control and position Conceptus for long-term growth."
About the Essure(R) Procedure
The Essure procedure, FDA approved since 2002, is the first permanent birth control method that can be performed in the comfort of a physician's office in less than 10 minutes (average hysteroscopic time) without hormones, cutting, burning or the risks associated with general anesthesia or tubal ligation. Soft, flexible inserts are placed in a woman's fallopian tubes through the cervix without incisions. Over the next three months, the body forms a natural barrier around and through the inserts to prevent sperm from reaching the egg. Three months after the Essure procedure, a doctor is able to perform an Essure Confirmation Test to confirm that the inserts are properly placed and that the fallopian tubes are fully blocked, allowing the patient to rely upon Essure for permanent birth control.
The Essure procedure is 99.83% effective based on five years of follow up with zero pregnancies reported in clinical trials, making it the most effective form of permanent birth control on the market. Essure's 10-year commercial data tracks closely with its five-year clinical results, and Essure has been proven and trusted by physicians since 2002. The Essure procedure is covered in the U.S. by most public and private insurance plans and more than 625,000 women worldwide have undergone the procedure.
About Conceptus(R), Inc.
Conceptus, Inc. is the leader in the development of innovative device-based solutions in permanent birth control. The Company manufactures and markets the Essure procedure, which is available in the United States, Europe, Australia, New Zealand, Canada, Mexico, Central and South America and the Middle East.