Hologic says FDA cleared more flexible design of MammoSite radiation seeding system

Hologic: FDA approves new radiation therapy system

BEDFORD, Mass. — Hologic Inc. said the Food and Drug Administration approved a new version of its MammoSite system, which delivers radiation seeds to prevent recurrences of breast cancer.

The agency approved the MammoSite ML radiation therapy system, which allows physicians to better target specific areas of tissue than the original MammoSite system, the company said. MammoSite devices include balloon catheters that are inserted into the body after a tumor has been removed. Inside the catheter is a pellet of radioactive material.

The radiation seed is left inside the body for five days, delivering radiation to the areas the cancer is most likely to return, Hologic said. The treatment is intended to prevent a recurrence while not harming healthy tissue.

Hologic, which makes medical diagnostic products for illnesses affecting women, said the new version of the device will allow therapists to treat patients who are not otherwise good candidates for radiation seeding. It said it will also be usable in more typical cases.

The company said it plans to launch the MammoSite ML by Dec. 26, the end of its fiscal fourth quarter. The original MammoSite device was approved in 2002.

In aftermarket trading, Hologic stock rose 50 cents, or 3 percent, to $16.70. The shares finished at $16.20 Tuesday.