FDA Clears Hologic's MammoSite® ML Radiation Therapy System For The Treatment Of Early-Stage Breast Cancer

Hologic, Inc. (Hologic or the Company) (Nasdaq: HOLX), a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, today announced the U.S. Food and Drug Administration (FDA) cleared the Company's 510K application for the MammoSite((R)) ML radiation therapy system. With its multi-lumen design, this new device gives radiation oncologists the ability to shape the radiation dose for typical cases and treat patients who are otherwise not appropriate candidates for traditional brachytherapy.

Hologic's MammoSite therapy system, first cleared by the FDA in 2002 as a single-lumen device, is the most widely used form of accelerated partial breast irradiation (APBI) in the United States. It has been used to treat more than 50,000 breast cancer patients in the U.S.

By employing the MammoSite system, the physician can deliver targeted radiation therapy directly to the area where cancer is most likely to recur,(i) allowing a full course of radiation to be delivered in just five days. Additionally, targeted therapy of the breast limits radiation exposure to normal, healthy tissue. This targeting helps minimize side effects such as skin discoloration and scarring, burning, fatigue, and damage to surrounding organs.

source: Hologic