MOUNTAIN VIEW, Calif., Nov. 8, 2011 (GLOBE NEWSWIRE) -- Conceptus, Inc. (Nasdaq:CPTS), developer of the Essure® procedure, the most effective non-surgical permanent birth control method available, announced today that it has received an Approvable Letter from the U.S. Food and Drug Administration (FDA) for labeling changes pertaining to the use of bipolar radio frequency (RF) NovaSure Impedance Controlled Endometrial Ablation following a successful Essure Confirmation Test.
In FDA's Approvable Letter, the agency stated that Conceptus' PMA supplement is approvable subject to concurrence with a post-approval study (PAS).
"Conceptus has worked diligently and collaboratively with the agency to establish the safety of Essure when NovaSure RF endometrial ablation is performed," said Mark Sieczkarek, president and chief executive officer of Conceptus. "This labeling change represents yet another choice for premenopausal women and their physicians to consider while evaluating global endometrial ablation (GEA) technology options to treat menorrhagia. We are pleased with the FDA's decision and look forward to reaching agreement with the agency on the PAS protocol and obtaining final approval of the proposed labeling changes."
In July 2008, Conceptus received the CE Mark approval for similar labeling changes related to the addition of GEA technologies (i.e., NovaSure) that can be used safely and effectively with Essure.
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 99.95% effective based on one year 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 to the patient may be as low as a simple co-pay. Essure has been proven and trusted by physicians since 2002, with approximately 570,000 women worldwide having undergone the Essure 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 Company also promotes the GYNECARE THERMACHOICE® Uterine Balloon Therapy System by ETHICON™ Women's Health & Urology, a division of Ethicon, Inc., in U.S. OB/GYN physician offices.
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.
© 2011 Conceptus, Inc.—All rights reserved. Conceptus and Essure are trademarks or registered trademarks of Conceptus, Inc.
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