Improved labeling for 3rd generation device is a plus . . .
Press Release Source: Conceptus Inc. On Tuesday May 18, 2010, 4:18 pm
MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Conceptus Inc. (NASDAQ: CPTS - News), developer of the Essure(R) procedure, the first and proven non-surgical permanent birth control method, announced today that the third generation (ESS305) of the Essure procedure has received FDA-approval for an improved bilateral placement rate of 96.9%. Improvement in the hysteroscopic time of 9 minutes is an additional benefit.
The bilateral placement rate, at first attempt, has increased from 94.6% to 96.9%; and the hysteroscopic time decreased from thirteen to nine minutes based on a clinical study in a commercial setting with 94 physicians treating 612 patients. The post-approval study was designed to evaluate bilateral placement rate and ease-of-use of the ESS305 after its July 2007 introduction. This improved labeling offers patients and physicians with even more security of placing the micro-inserts properly the first time and ease of performing the procedure.
“The announcement of an increased bilateral placement rate and faster procedure time illustrates the continued commitment of Conceptus to improve an already simple procedure for both the benefit of physicians and patients,” said Dr. Mark Levie, an OB/GYN based in New York City. “In my opinion, Essure continues to be the choice for physicians and women seeking a permanent birth control solution.”
During the procedure, a physician places two soft, flexible micro-inserts into each fallopian tube through the cervix without incisions. Essure is 99.74% 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.
Mark Sieczkarek, president and chief executive officer of Conceptus Inc. states, “The improvements to our product were a direct response to customer input. The objective to provide an even simpler and faster procedure was met as shown by FDA approval of our updated labeling. Conceptus continues to be dedicated to providing ‘best in class’ innovative solutions in women’s healthcare.”
About the Essure Procedure:
The Essure procedure, FDA approved since 2002, is a permanent birth control method that can be performed in the comfort of a physician’s office in about 9 minutes (average hysteroscopic time) without hormones, cutting, burning or the risks associated with general anesthesia or tubal ligation. Small, flexible micro-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 the micro-inserts to prevent sperm from reaching the egg. Essure is 99.74% 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. The procedure is covered by most insurance plans, and when it is performed in a doctor’s office the cost may be as low as a simple co-pay.
Three months after the Essure procedure, a doctor performs an Essure Confirmation Test to confirm that the fallopian tubes are fully blocked, and that the patient can rely on Essure for permanent birth control. Essure has been proven and trusted by physicians since 2002, with more than 400,000 women worldwide having undergone the Essure procedure.
Essure and Conceptus are registered trademarks of Conceptus Inc. (NASDAQ:CPTS)<<
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