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Hologic Inc., the Bedford-based women’s health care company, has won approval from the federal Food and Drug Administration (FDA) to sell its Adiana permanent contraception system.
Company officials say the system is designed to provide women with a less-invasive alternative to tubal ligation. The procedure does not involve an incision and can be performed in a doctor’s office using local anesthesia. In January 2009, Hologic received European approval for the Adiana system and began marketing and sales in some European countries.
The Adiana procedure is used by women who desire permanent birth control by occlusion of the fallopian tubes.
In the Adiana procedure, a slender, flexible instrument is inserted to deliver a low level of radiofrequency (RF) energy to a small section of each fallopian tube, company officials say. Then a tiny, soft insert — about the size of a grain of rice — is placed in each fallopian tube. During the three months following the procedure, the patient continues to use temporary birth control while new tissue grows in and around the Adiana inserts, eventually blocking the fallopian tubes. At three months, a special X-ray test is performed to confirm the fallopian tubes are completely blocked and the patient may begin relying on Adiana for permanent contraception.
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