Hologic, Inc. announced that the FDA Obstetrics and Gynecology Devices Advisory Panel recommended the pre-market application for Adiana Permanent Contraception for female sterilization as approvable in a panel vote of 10 to 3.

The FDA is not required to accept the panel’s decision, but traditionally follows their recommendations. 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.

Bilateral tubal ligation — commonly referred to as “getting your tubes tied” — is the most common form of contraception used throughout the world. 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.

 

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 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.

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