Hologic notches U.K. approval win

September 28, 2009 by MassDevice staff

Hologic Inc. notched an approval win in the United Kingdom, clearing the way for that nation's National Health Service to cover its Adiana female sterilization treatment.

The U.K.'s National Institute for Health and Clinical Excellence approved the procedure, which involves threading an endoscope through the vagina, cervix and uterus into the fallopian tubes, where radiofrequency energy is applied to small sections of the tube.

The catheter delivers about 3 watts of energy for roughly 60 seconds in order to create a tiny, shallow lesion in the fallopian tube. A small, silicon matrix plug with a solid core is then inserted at the site to block ova from contact with sperm.

Adiana won CE Mark approval in the European Union in January and landed FDA approval in July.

Tony Kingsley, Hologic's SVP of gynecological surgical products, said the ruling is "an important milestone" for Hologic, adding that more than 50 British surgeons have been trained to perform the procedure.

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