Is the Adiana Transcervical Sterilization System used to place a silicone implant into each fallopian tube? Can endothelial damage provided by the RF energy be controlled to encourage tissue ingrowth response? Can the release mechanism of the catheter reliably actuated to deploy the matrix after the thermal dose is delivered?
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…The Adiana system is designed to provide a minimally-invasive, non-incisional alternative to traditional, surgical means of female sterilization.
The Adiana procedure utilizes hysteroscopy, generally requires only local anesthesia, and can be performed in a physician’s office. Patients are normally able to return to work or resume their everyday activities within a day. In contrast, bilateral tubal ligation — commonly referred to as “getting your tubes tied” — 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.
CE marking approval allows Hologic to market the Adiana system in the 27 countries of the European Union (EU) and three of the four member states of the European Free Trade Association (EFTA). CE marking is recognized in many countries outside the European Economic Area giving Hologic the ability to supply systems to a number of markets internationally. In the United States, the pre-market approval (PMA) application for the Adiana permanent contraception system is currently under Food and Drug Administration (FDA) review. Hologic is also in the process of registering the Adiana system in Canada and Australia…
