The U.S. Food and Drug Administration (FDA) recently sanctioned Hologic’s (HOLX) application for pre-market approval (PMA) for the Adiana permanent birth control system. The Adiana system offers women a minimally-invasive, non-hormone and non-incision option to conventional permanent contraception measures.
The Adiana procedure can be conducted in a doctor’s chamber using local anesthesia. Patients can resume their work or daily activities within a day. While conventional procedures – such as tubal ligation – are more invasive and performed in a hospital using general anesthesia. Usually, patients take 4-5 days to recover.
The Adiana system is a perfect choice for women who want permanent contraception but are not fit for surgery. As per iData Research (U.S. Markets for Women’s Health Devices – January 2009), roughly 70,000 female transcervical contraception procedures were performed in the U.S. last year.
Earlier in January this year, Hologic obtained European (CE mark) approval for the Adiana system and began marketing and sales of this product in some countries of the Europe.
Hologic closed at $13.04 on Wednesday. We maintain our Hold recommendation for the company.
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