Healthcare Industry News: permanent birth control
News Release - November 19, 2007
Three New In-Office Studies on Essure(R) Procedure Presented at AAGL Meeting, Including First Study on Third-Generation SystemEase of Administration of Third-Generation System Shown During Live Demonstration
Conceptus Participated in Boston Scientific Symposium on Integrating Endometrial Ablation and Hysteroscopic Sterilization into an Office Setting
WASHINGTON--(HSMN NewsFeed)--Conceptus, Inc. (NASDAQ: CPTS ) today announced positive results from three clinical studies that were presented at the American Association of Gynecological Laparoscopists (AAGL) 36th Annual Congress. The studies reported high patient satisfaction, successful placement rates and efficient administration with the Essure® permanent birth control system in an in-office setting. As demonstrated by one of the studies, placement of the Essure device can be successfully achieved despite historical risk factors of traditional surgical sterilization.
Approved by the U.S. Food and Drug Administration (FDA) in 2002, the Essure permanent birth control system is the first and only female sterilization procedure to have zero pregnancies in the clinical trials. Unlike tubal ligation, the Essure procedure does not require incisions and can be performed in the comfort of a physician’s office in less than 15 minutes with a local anesthetic. Most women are able to return to work or other activities within a day following their Essure procedure.
According to one multi-center study presented by Mark Levie, MD, Director of the Department of Obstetrics & Gynecology and Women's Health at the Montefiore Medical Center in New York, 98 percent of the 253 women who had the Essure procedure were extremely satisfied with their choice and would recommend it to a friend. Women who participated in the study also indicated that the discomfort experienced during the procedure was less than or equal to what is felt during a regular menstrual cycle.
Levie and his colleagues presented a second study assessing the placement and occlusion rates of the Essure procedure, and found an overall 94 percent successful placement rate in 348 patients. Additionally, there were no adverse reactions or hospitalizations, and the average in-office recovery time was less than 30 minutes. The investigators recorded historical risk factors traditionally associated with surgical sterilization, such as a high body mass index (BMI), prior sexually transmitted diseases, pelvic inflammatory disease, termination of pregnancy and cesarean sections and found no correlations with the non-incisional Essure procedure.
“The study supports that office-based Essure placement can be accomplished effectively irrespective of historical risk factors,” said Levie. “The majority of patients can have this minimally invasive office procedure and avoid visiting the operating room for laparoscopic sterilization under general anesthesia.”
Rafael F. Valle of Northwestern University Medical School in Chicago presented the first study of Conceptus’ third-generation Essure system, the ESS305, which received FDA clearance in June. Results of the study show the new third-generation device offers a simpler placement and deployment method, resulting in an average reduction in procedure time by approximately six minutes without compromising placement success rates.
In an effort to demonstrate the ease of administering the third-generation Essure device, Peter Rothschild, MD of Northern Virginia Gynecologists Inc., performed a procedure via live telecast from Alexandria, Virginia. The broadcast was shown in the exhibit hall of the AAGL Congress.
“I am excited to be given the opportunity to teach other physicians how easy this new generation of the Essure procedure is to perform,” said Rothschild. “I hope that my demonstration will allow physicians to see for themselves how simple, safe and effective the Essure procedure is compared to surgical tubal ligation for patients seeking permanent birth control.”
Also at AAGL, Conceptus, Inc. was invited by Boston Scientific Corporation to participate in a symposium addressing successful strategies of integrating two rapidly growing procedures, endometrial ablation and hysteroscopic sterilization, without I.V. sedation, into a typical gynecological office setting. More than 170 physicians attended the symposium.
About the Essure Procedure
The Essure procedure, approved by the FDA in 2002, is a permanent birth control procedure that replaces tubal ligation for women. In the comfort of a physician’s office and in about 10 minutes, the soft micro-inserts are placed into the Fallopian tubes through the cervix eliminating the need for incisions. 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 tubes.
The Essure confirmation test is performed three months after the procedure to confirm that the micro-inserts are in the correct location, the tubes are blocked and that the woman can discontinue temporary birth control. The Essure procedure is 99.80% effective with 4 years of data and is the first and only FDA approved female sterilization procedure to have zero pregnancies in clinical trials.
Conceptus, Inc. manufactures and markets the Essure permanent birth control system, an innovative medical device and procedure designed to provide a non-incisional alternative to tubal ligation, which is currently the leading form of birth control worldwide. The availability of the Essure procedure in the U.S. is expected to open up a market currently occupied by incisional tubal ligation and vasectomy, which combined account for over 1 million procedures annually.
Additional information about the Essure procedure is available at www.essure.com or by calling the Essure Information Center at 1-877-ESSURE1. Additional information about Conceptus is available at www.conceptus.com or by calling 1-877-ESSURE2.
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