Conceptus, Inc. (Nasdaq:CPTS), developer of the Essure® procedure, the first and only FDA-approved, non-incisional permanent birth control method available, announced today that new independent study data released at the 35th Annual Meeting of the American Association of Gynecologic Laparoscopists (AAGL) shows the Essure system eliminates risks associated with traditional surgical sterilization for many women not eligible for permanent birth control.
Unlike surgical tubal ligation, which involves cutting, clipping or burning a woman’s fallopian tubes, the Essure procedure does not require any incisions and can be done in a physician’s office under local anesthesia. Tiny, lightweight Essure coils are passed through the cervix and inserted into the fallopian tubes, forming a permanent blockage. Women typically return to normal activity within a day after the Essure procedure, rather than a week or more following tubal ligation surgery.
“Considering the risks associated with tubal ligation, including potential trocar injuries, infections at the incision site and complications associated with general anesthesia, we encourage physicians to educate patients about the benefits of the Essure procedure,” said Mark Sieczkarek, president and chief executive officer of Conceptus. “The studies presented at this year’s AAGL — each of which is a first-of-its-kind undertaking — are further proof of the safety and efficacy of the Essure procedure for all patients, particularly those where a tubal ligation is either contraindicated or where the surgical risks are high.”
One study, Historical Risk Factors, Are They a Contraindication For Office Essure?, presented at AAGL by Mark Levie, M.D., and Scott Chudnoff, M.D., of Albert Einstein College of Medicine at Montefiore Medical Center in New York, showed successful placement of the Essure device among women with historical risk factors that could affect tubal cannulation. More than 92 percent of women in this study successfully had the Essure device placed.
“Women with histories of pelvic inflammatory disease, sexually transmitted disease, termination of pregnancy and cesarean section can still have highly effective placement of the Essure device in an in-office setting,” said Dr. Chudnoff. “These women do not need to undergo the risks of a laparoscopic sterilization procedure under general anesthesia in an operating room simply due to prior risk factors.”
A second study, The Impact of Obesity on Office-Placement of Essure, also conducted by Drs. Levie and Chudnoff, suggests the Essure procedure can be performed on obese women in an office setting with excellent success rates. In this study of women with an average body mass index (BMI) of 36.2, nearly all had a positive experience with the procedure. In the obese group, successful placement of the device was achieved in 74 of 81 (91 percent) obese women, compared with 101 of 110 (92 percent) women in the non-obese group.
“Obese patients are better candidates for the Essure procedure than for a laparoscopic tubal ligation under general anesthesia,” commented Dr. Chudnoff. “There are simply fewer potential complications for these women with an office-based procedure that does not require general anesthesia.”
“The studies present positive news for women in search of permanent birth control who may not be candidates for laparoscopic tubal ligation due to the associated risks,” said Dr. Levie. “With the Essure procedure, risks are minimized. In my experience, this also has contributed to high patient satisfaction.”
A third study, The Essure Micro-Insert System for Hysteroscopic Sterilization in Women with Cardiac Disease: 19 Cases, by Drs. S.A. El-Nashar, M.R. Hopkins, D.J. Driscoll and A.O. Famuyide of the Mayo Clinic in New York, documented 19 women with heart disease, all of whom had successful placement of the Essure device with no intra-procedural complications. The women in this study had cardiac disease, including adult congenital heart disease (ACHD) and valvular or ischemic heart disease (V/HD); factors that would place them in a “high-risk” category for both pregnancy and surgical tubal ligation.
Additional findings from a Dutch study presented at the meeting by Michel Vleugels, M.D., entitled Management of Patients for Essure Sterilization in the Outpatient Department Without Any Anesthesia at All, demonstrates the Essure procedure can be performed successfully with no need for anesthesia. Of the 273 women documented in the study, the placement success rate was 94.1 percent with a very low overall pain score (2.7 on a scale of 0–8).
About the Essure® Procedure
The Essure procedure, approved by the FDA in 2002, 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 (based on four years of follow-up data). 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 more than 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.
Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements, the accuracy of which is necessarily subject to risks and uncertainties. Discussions regarding performance of Essure in the office setting, lower risk associated with Essure and other matters discussed in this release, may differ significantly from the discussion of such matters in the forward-looking statements. Such differences may be based upon factors such as strategic planning decisions by management, re-allocation of internal resources, decisions by insurance companies, scientific advances by third parties, and 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.
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