December 14, 2007 – Hologic Inc. announced today the FDA Obstetrics and Gynecology Devices Advisory Panel recommended that the pre-market application for Adiana Permanent Contraception for female sterilization is approvable, 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.
The FDA is not required to accept, but traditionally follows the recommendations of its advisory panels.
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 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, nonincisional 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.
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.
For more information: www.hologic.com