MOUNTAIN VIEW, Calif., Feb. 29, 2012 (GLOBE NEWSWIRE) -- Conceptus, Inc. (Nasdaq:CPTS), developer of the Essure® procedure, the leading non-surgical permanent birth control method, announced today that the U.S. Food and Drug Administration (FDA) approved labeling changes pertaining to the use of bipolar radio frequency (RF) NovaSure® Impedance Controlled Endometrial Ablation System(1) following the placement of Essure inserts and a successful Essure Confirmation Test. The expanded label change followed the Company and the FDA reaching an agreement on the post-approval study (PAS) protocol.
The Essure procedure is now approved to be safe and compatible with all the major global endometrial ablation (GEA) technology options that treat menorrhagia. The Essure procedure U.S. Instructions for Use (IFU) will add NovaSure®(1) to its existing list of compatible GEA procedures that includes GYNECARE THERMACHOICE® Uterine Balloon Therapy System(2) and Hydro ThermAblator® System(3). Pregnancy following ablation can be dangerous for both mother and fetus, therefore effective permanent birth control is a vital solution for patients preparing to undergo a GEA procedure.
"This important FDA approval effectively removes a major barrier for physicians to use the NovaSure procedure with the market-leading Essure, the most effective form of permanent birth control. The positive change also builds upon our win last year when the FDA approved the removal of the nickel hypersensitivity contraindication from our IFU," said Keith Grossman, president and chief executive officer of Conceptus.
"Our competitive advantage and leadership in the permanent birth control market has been significantly strengthened by this upgraded label," added Mr. Grossman. "We will be communicating the change to the OB/GYN community, and especially to those physicians who have used the competitor's hysteroscopic sterilization product with NovaSure."
(1) Registered trademark of Hologic, Inc.
(2) Registered trademark of ETHICON™ Women's Health & Urology, a division of Ethicon, Inc.
(3) Registered trademark of Boston Scientific Corporation
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 public and private 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 more than 600,000 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.
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.
The Conceptus, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=7961
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, the accuracy of which is subject to known and unknown risks and uncertainties. These forward-looking statements include, without limitation, discussions regarding expected benefits from FDA-approved changes to the Essure procedure U.S. Instructions for Use (IFU) that expands Essure indications for use, our competitive positioning as a result of the expanded Essure procedure U.S. IFU label, our ability to market effectively to physicians and prospective patients, and the expected attainment of strategic initiatives intended to grow the business. These discussions and other forward-looking statements included herein may differ significantly from actual results. Such differences may be based upon factors such as changes in strategic planning decisions by management, re-allocation of internal resources, changes in the impact of domestic and global macroeconomic pressures, reimbursement decisions by insurance companies and domestic and foreign governments, scientific advances by third parties, litigation risks, attempts to amend or repeal all or part of the Patient Protection and Affordable Care Act of 2010 as amended, and the introduction of competitive products, as well as those factors set forth in the Company's most recent Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q, and other filings with the Securities and Exchange Commission. These forward-looking statements speak only as to the date on which the statements were made. We undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events, or otherwise.
© 2012 Conceptus, Inc.— All rights reserved.
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