MOUNTAIN VIEW, Calif., April 11, 2012 (GLOBE NEWSWIRE) -- Conceptus, Inc. (Nasdaq:CPTS), developer of the Essure® procedure, the leading non-surgical permanent birth control method, announced today that the U.S. Food and Drug Administration (FDA) has approved inclusion of 10 years of data on Essure effectiveness in commercial settings in the Essure procedure U.S. Instructions for Use (IFU) and Patient Information Booklet (PIB). In addition, the FDA has approved inclusion of the full five-year clinical study results and effectiveness rate of 99.83% in the IFU and PIB, which brings to a close the Essure clinical trials that began in 1998. The Essure procedure has maintained its unprecedented record of zero pregnancies among clinical trial subjects over five years.
During the 10-plus years that Essure has been available commercially worldwide, Conceptus has collected records of all reported pregnancies from commercial use of the Essure procedure and their causes. Based on these reports, the Essure procedure's 10-year commercial pregnancy experience tracks closely with its new five-year clinical rate of 99.83%. Pregnancies that occurred in commercial use primarily stemmed from patient non-compliance or misinterpreted confirmation tests.
"Our Essure commercial experience data and new five-year clinical efficacy rate represent additional positive developments in Essure's decade of use. Along with a successful 10-year track record, Essure offers key advantages to multiple audiences. More than two-thirds of Essure procedures in the U.S. are performed in a physician's office, resulting in greater safety and convenience for patients, increased operating efficiency for physicians and cost savings for payors," said D. Keith Grossman, president and chief executive officer of Conceptus. "These milestone data points support our continuing efforts to define the Essure procedure as the best choice for permanent birth control for patients, physicians and providers."
About the Essure® 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 600,000 women worldwide have undergone the procedure.
About Conceptus®, Inc.
Conceptus, Inc. is a leader in the design, development and marketing of innovative solutions in women's healthcare. The Company manufactures and markets the Essure procedure. The Essure procedure is available in the United States, Europe, Australia, New Zealand, Canada, Mexico, Central and South America and the Middle East.
The Conceptus, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=7961
Please visit www.essure.com for more information on the Essure procedure. Patients may call the Essure Information Center at 1-877-ESSURE-1 with questions or to find a physician in their area.
© 2012 Conceptus, Inc.— All rights reserved.
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