Women's imaging vendor Hologic of Bedford, MA, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the company's MammoSite ML breast brachytherapy system.
With its multilumen design, the device is intended to give 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 was first cleared by the FDA in 2002 as a single-lumen device. MammoSite devices consist of an inflatable balloon catheter in which a radioactive source is introduced for therapy delivery. The inflatable balloon is inserted into the surgical cavity and remains after removal of the tumor.
The local placement of the balloon provides for therapeutic delivery of a five-day course of radiation to the tissue most likely to contain residual cancerous cells following surgery, while reducing radiation exposure to adjacent healthy tissue.
Hologic expects to commercially launch MammoSite ML in the fourth quarter of 2009.
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Hologic grows revenue in fiscal Q1, February 3, 2009
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