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
|SOURCE Hologic, Inc.|
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