FDA Recommends Adiana Approval
In a a vote of 10 to 3 the FDA's Ob/Gyn specialty panel recommended that the pre market application for Adiana(R) Permanent Contraception for female sterilization is Approvable.
If you recall, Adiana is a new female birth control method in the Sterilization group, a novel, two-step approach to permanent contraception. Here's how it works:
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.