New Studies on the Essure(R) Procedure Confirm Safety for High-Risk Women; Research Presented in Tribute to a Pioneer of In-Vitro Fertilization and Hysteroscopic Sterilization
Posted on: Monday, 8 May 2006, 09:10 CDT
Conceptus, Inc. (Nasdaq:CPTS), developer of the Essure(R) non-incisional permanent birth control system, today reports that a study being presented at the 54th Annual Clinical Meeting of American College of Obstetricians and Gynecologists suggests tissue will gradually encapsulate the coils of the Essure micro-insert that trail into the uterine cavity following hysteroscopic sterilization.
The late John F. Kerin, M.D., a pioneer of in-vitro fertilization and hysteroscopic sterilization technology, conducted the study at Flinders Reproductive Medicine in Adelaide, Australia in 2006. Kerin tragically died earlier this year at his farm near South Australia. Dr. David Munday, Senior Visiting Specialist in Gynecology at the Queen Elizabeth Hospital in Adelaide, South Australia and colleague of Kerin will present the new study data at ACOG this week at the new Washington Convention Center in Washington, D.C. "When performed correctly, a small amount of the device trails into the uterus indicating correct placement," said Munday.
The Essure procedure is the first commercially successful permanent birth control method for a woman that does not require incisions. The device received clearance from the FDA in November 2002. Unlike surgical sterilization, the Essure procedure can be done in a gynecologist's office under minimal anesthesia.
A second study conducted by Kerin, suggests the Essure procedure can be performed on women suffering from serious health conditions with a high margin of safety eliminating the risk of complications that commonly follow laparoscopic tubal ligation carried out under general anesthesia. Women in Kerin's study suffered from conditions including massive pelvic adhesions, major complications from previous laparoscopic procedures, severe diabetes and morbid obesity prior to undergoing the Essure procedure.
"The study is positive news for women in search of permanent birth control who may not be candidates for laparoscopic tubal ligation," said Mark Levie, M.D., of the Albert Einstein College of Medicine in Bronx, New York who will present the data in place of Kerin. "Patients are able to return to normal activity shortly after the procedure, which can be done in-office with minimal anesthesia. In my experience, this has contributed to high patient satisfaction with the Essure procedure."
Under Special Interest Group Sessions at the convention, Dr. Rafael Valle of the Department of Obstetrics and Gynecology at Northwestern Medical School will be conducting a session titled Hysteroscopic Sterilization and Innovative Endoscopy in Gynecology.
About the Essure(R) Procedure
The Essure procedure 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. A woman is able to return home about 45 minutes after the procedure is completed. There is a three-month waiting period after the procedure during which women must use another form of birth control. The Essure procedure is 99.80% effective after four years of follow-up. The Essure procedure has been demonstrated in a small portion of the women undergoing clinical studies to be 99.74% effective based on 5 years of follow-up. Five-year follow-up of all patients in clinical trials is ongoing.
About Conceptus
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.
Source: Business Wire
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