MOUNTAIN VIEW, Calif., May 2, 2011 (GLOBE NEWSWIRE) -- Conceptus, Inc. (Nasdaq:CPTS), developer of the Essure® procedure, the most effective permanent birth control method available, today introduced the Essurance Promise™ Program, the industry's first-ever patient reliance warranty program, at the American College of Obstetricians and Gynecologists 59th Annual Clinical Meeting.
The Essurance Promise™ Program is an exclusive "out-of-pocket" payment assistance program for the Essure Confirmation Test. After a patient has had the Essure procedure and both inserts are successfully placed, she returns for her Essure Confirmation Test three months later. If she is told by her physician that the Essure procedure requires more time to be effective or she cannot rely on Essure for permanent birth for any reason at that time, the Company will pay her uncovered costs for the Essure Confirmation Test, up to a maximum of $150 per test, and in accordance with certain conditions.
Conceptus is uniquely able to offer such a warranty program because the Essure procedure's clinical and real-world commercial performance is unsurpassed among all other permanent birth control options, including tubal ligation, vasectomy and the only other competing hysteroscopic sterilization product. For nearly a decade of clinical trial follow-up, there have been zero reported pregnancies with the Essure inserts when properly placed. Results in the commercial setting over this same time period are equally compelling and continue to reflect the Essure procedure's superb clinical performance.
No other method of permanent birth control works better than the Essure procedure and no company other than Conceptus backs up their procedure with a reliance warranty, which gives women full confidence in this birth control choice.
"The Essurance Promise™ Program is an innovative solution demonstrating our conviction that patients can rely upon Essure for permanent birth control. The warranty supports both physicians and patients by giving them peace of mind when they choose the Essure procedure, while emphasizing the importance of the Essure Confirmation Test," said Mark Sieczkarek, president and chief executive officer of Conceptus. "This program further advances our leadership role in the hysteroscopic permanent birth control market that we pioneered more than a decade ago."
The Essure procedure is the market leader between two competing hysteroscopic sterilization procedures and has been trusted by more than half a million women since 2002. Following the introduction of the competitor's product last year, the market may have experienced confusion and lack of clarity regarding the differences between the two products. The Essurance Promise Program underscores Essure's unparalleled performance, including the fact that the competitor product's failure rate is 10 times higher than Essure's failure rate, based on three-year clinical data. In addition, Essure clinical trial patients have experienced zero reported pregnancies, while the competitor's product has resulted in 12 pregnancies in patients followed for five years. The Essure procedure has a proven clinical and commercial track record, but the competitor's product has yet to establish and report its long-term clinical and real-world, commercial safety and effectiveness.
A key competitive advantage of the Essure insert is its stainless steel/Nitinol inner/outer coil design, which is radiopaque and allows for visual confirmation of each insert's proper placement both during the procedure and during the Essure Confirmation Test. The competitor's insert is neither visible during the procedure nor during the confirmation test.
"The Essurance Promise Program is unprecedented for a permanent birth control procedure. Essure is backed by a growing body of scientific data validating the optimal design characteristics and clinical performance of Essure's Nitinol coil insert, both in the FDA trials and the clinical evidence reported in the literature over the past decade," said Barbara Levy, M.D., Medical Director for Conceptus. "I highly recommend that OBGYNs talk to their patients about the Essure procedure and the Essurance Promise Program."
Additional information on the Essurance Promise™ Program
Federal Law prohibits any company from offering this kind of program to Medicaid or Medicare patients and is also restricted where prohibited by law. Complete program details can be found on the Conceptus physician website www.essuremd.com.
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 the fallopian tubes are fully blocked, giving the patient reliance on 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 more than 500,000 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, Essure, Essurance Promise and Your Family is Complete. Your Choice is Clear are registered trademarks and service marks of Conceptus, Inc.
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