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news.Hologic has reported that the FDA Obstetrics and Gynecology Devices Advisory Panel recommended approval for the pre-market application of Adiana permanent contraception for female sterilization. The panel reached this decision by a vote of 10 to 3.
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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.
The pivotal clinical trial to demonstrate the safety and effectiveness of Adiana in providing permanent contraception was conducted in the US, 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% after 12 months of reliance on Adiana was demonstrated, successfully meeting the trial’s primary endpoint.
Tony Kingsley, president of Hologic, said: “We will work closely with the FDA to address any remaining issues and expedite final approval.”