After the bell:
>>SAN CARLOS, Calif.--(BUSINESS WIRE)--Nov. 4, 2002 Conceptus, Inc. (NASDAQ NM: CPTS - News) today announced that Essure(TM) has received approval by the United States Food and Drug Administration (FDA) for women who desire permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes.
Essure is the first alternative to tubal ligation for women seeking permanent birth control in the US. It is currently marketed in Australia, Europe, Singapore and Canada.
"Conceptus is extremely proud to have developed Essure and to provide this breakthrough option to women seeking permanent birth control," said Steve Bacich, President and Chief Executive Officer of Conceptus, Inc. "We are fully committed to making Essure the standard of care in this area. Our 37-person sales and professional education organization is in place and has been trained. We look forward to making Essure available to women nationwide in the coming months, allowing them to meet their need for effective permanent birth control without unduly interrupting their lives."
Currently, an estimated 700,000 American women undergo tubal ligation each year, making it the most common form of contraception in the United States. Unlike tubal ligation, which requires an abdominal incision and is typically done under general anesthesia, Essure requires no incisions and can be performed without general anesthesia. Data from the Pivotal trial of Essure showed that 92 percent of Essure patients who were employed outside the home returned to work in one day or less after the day of the procedure and most patients were back to their regular physical activities within one to two days.
"Several studies show that there is a need for new contraception technologies," said Jay M. Cooper, MD, founder and medical director of Women's Health Research, Phoenix, Arizona, and principal investigator in the Essure Pivotal trial. "I believe the approval of Essure is tremendously significant and will have an enormous impact on women looking for alternatives for permanent birth control."
"We at Conceptus have been very impressed with the FDA's dedication, professionalism, and thorough and thoughtful review of the Essure PMA, and are appreciative for the valuable input we have received from FDA during the six years of product development for Essure," said Cindy Domecus, Senior Vice President, Clinical Research and Regulatory Affairs at Conceptus.
Pivotal Trial Data Results
The FDA approval was based on data from two separate clinical trials involving over 600 women who relied on the current Essure design for one to two years. There were no pregnancies among these women while relying on Essure for contraception. Fully 99 percent of women who have relied on Essure for birth control rated their long-term comfort as `good' to `excellent'. In the second study, 96 percent of patients stated they would recommend the procedure to a friend.
Placement of the Essure device was attempted in 518 women in the Pivotal trial. Bilateral placement was achieved in 86 percent on first attempt, increasing to 90 percent when a second attempt is included. Of the women with bilateral placement, 97 percent were ultimately able to rely on Essure for contraception.
Like all birth control methods, Essure is not expected to be 100 percent effective, and pregnancies are expected. There is a three-month waiting period after the procedure during which women must use another form of birth control.
Tubal Ligation Most Prevalent Birth Control Choice
According to the United States Centers for Disease Control and Prevention, tubal ligation continues to be the most prevalent form of birth control in the U.S., with 41 percent of women age 35 - 39 and 50 percent of women age 40 - 44 choosing tubal sterilization. Tubal ligation remains the most popular form of birth control worldwide despite the fact that it is invasive and costly. About 93 percent of the laparoscopic female sterilization procedures in the U.S. are performed in a hospital or surgi-center under general anesthesia, typically requiring four to six days of recovery before returning to regular activities.
About Essure
Essure deploys a soft micro-insert into the fallopian tube through the cervix using a minimally invasive transcervical tubal access catheter. Once in place, the device is designed to elicit tissue growth in and around the micro-insert to form an occlusion or blockage in the fallopian tube. An Essure procedure does not require cutting or penetrating the abdomen and can be performed in a less costly procedure setting without general anesthesia. Accordingly, a woman is expected to return home about 45 minutes after the procedure is completed. <<
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Cheers, Tuck |
