BEDFORD, Mass., Dec. 13 /PRNewswire-FirstCall/ -- Hologic, Inc. (Nasdaq: HOLX) announced today that the FDA Obstetrics and Gynecology Devices Advisory Panel recommended that the pre-market application for Adiana(R) Permanent Contraception for female sterilization is Approvable. The panel reached this decision by a vote of 10 to 3.
The FDA is not required to accept, but traditionally follows the recommendations of its advisory panels. The panel recommended approval of the device contingent upon several conditions, including long-term follow up of current pivotal trial patients, a new post approval study of new patients and physicians, and more specific labeling recommendations.
"Women are looking for choices for their long-term contraceptive needs," said Ted Anderson, M.D., Ph.D., Associate Professor of Obstetrics and Gynecology at Vanderbilt University Medical Center, and clinical investigator of the pivotal clinical trial for Adiana. "Adiana provides a novel, safe and effective permanent transcervical alternative to tubal ligation. The procedure takes approximately 15 minutes to perform without the risky and uncomfortable side effects experienced with a more invasive surgical procedure but with comparable efficacy in avoiding pregnancy as underscored by the results of the clinical trials where the device was evaluated in more than 600 women."
Bilateral tubal ligation -- commonly referred to as "getting your tubes tied" -- is the most common form of contraception used throughout the world. Approximately 700,000(1) tubal ligation surgical procedures are performed annually in the U.S. alone. The surgery is typically performed in a hospital operating room under general anesthesia and requires the physician to make one or two incisions in the abdomen. This usually requires approximately four to five days of recuperation.
In contrast, Adiana is a minimally-invasive, non-incisional alternative. This procedure uses hysteroscopy, generally requires only local anesthesia, and can be performed in a physician's office. Patients are typically able to return to work or resume their everyday activities within a day.
"Contraception is obviously a critical decision for any woman," said Sue Knapton, a 46-year-old woman who participated in the clinical trial of Adiana. "This seemed to me to be the better choice than more invasive surgery or long- term use of oral contraceptives. I am glad I was able to participate in the Adiana trial and hope other women will benefit from Adiana in the future."
"Today represents a tremendous milestone in enabling us to realize our goal in making Adiana a viable and better alternative for women looking for permanent contraception. We will work closely with the FDA to address any remaining issues and expedite final approval. We are confidently on course to provide women with an important new treatment option," said Tony Kingsley, President, Hologic GYN Surgical Products.
The pivotal clinical trial to demonstrate the safety and effectiveness of Adiana in providing permanent contraception was conducted in the U.S., Australia, and Mexico. As part of the clinical trial, 645 women between the ages of 21 and 45 had treatment attempted with Adiana. The procedure showed a strong safety profile, with very high device placement success, patient tolerance, comfort and satisfaction. A pregnancy prevention efficacy rate of 98.9 percent after 12 months of reliance on Adiana was demonstrated, successfully meeting the trial's primary endpoint. This efficacy result also compares favorably with the results of the CREST Study (U.S. Collaborative Review of Sterilization), which examined the long-term failure of tubal ligation for sterilization.
About Adiana Permanent Contraception
Adiana is a novel, two-step approach to permanent contraception. First, a catheter is positioned immediately inside the opening of the patient's fallopian tube using a hysteroscope, eliminating the need for any incisions. The catheter applies a very low-level of bi-polar radiofrequency (RF) energy to remove just a thin layer of cells that line a 1cm section of the inside of the fallopian tube. The catheter then delivers an implantable, soft polymer, called a "matrix," which remains within the prepared section of the tube. The matrix is smaller than a grain of rice. The procedure is then repeated on the other fallopian tube. Healthy tissue will grow into the matrix, creating a complete blockage of each tube. A confirmatory dye test called a hysterosalpingogram (HSG) is conducted at three months post-procedure to ensure the fallopian tubes are completely blocked and that the woman can begin relying on Adiana for permanent contraception.
About Hologic, Inc.
Hologic, Inc. is a diversified medical technologies company specializing in diagnostic imaging products and interventional devices dedicated to serving the healthcare needs of women. Historically, the Company has developed, manufactured and marketed products focused on mammography, breast care and osteoporosis assessment. In October 2007, Hologic completed its business combination with Cytyc Corporation, a company that develops, manufactures and markets complementary products covering a range of cancers and women's health indications, including cervical cancer screening, treatment of excessive menstrual bleeding, prenatal diagnostics and partial breast radiation therapy.
This press release contains forward-looking information that involves
risks and uncertainties, including statements regarding Hologic's plans,
objectives, expectations and intentions. Such statements include, without
limitation, statements regarding the future approval by the FDA of the
premarket application for Adiana Permanent Contraception for female
sterilization and the benefits realizable by using the Adiana Permanent
Contraception procedure. The Company cannot assure when or if FDA approval
will be granted or that the anticipated efficacy of the Adiana Permanent
Contraception procedure will be realizable. Factors that could adversely
affect Hologic's business and prospects are described in the Company's
filings with the Securities and Exchange Commission. Hologic expressly
disclaims any obligation or undertaking to release publicly any updates or
revisions to any such statements to reflect any change in the Company's
expectations or any change in events, conditions or circumstances on which
any such statement is based.
(1) Westhoff C, Davis A. Tubal sterilization: focus on the U.S.
experience. Fertil Steril. 2000;73(5):913-922.
Jane Hauser or Sarah Belkner
Director, Investor Relations
|SOURCE Hologic, Inc.|
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