US FDA clears new breast cancer treatment option

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US FDA clears new breast cancer treatment option

Last Updated: 2002-05-07 9:57:59 -0400 (Reuters Health)

WASHINGTON (Reuters) - US regulators on Monday approved a device that

provides a new treatment option for women who have had a cancerous

breast lump removed.

The MammoSite Radiation Therapy System is designed to send radiation

directly to the site where the lump was taken out, with minimal

radiation to surrounding tissue, the Food and Drug Administration said.

The device, a hollow catheter with an inflatable balloon attached, is

made by privately-held Proxima Therapeutics Inc. of Alpharetta, Georgia.

Doctors must implant the device into the breast at the lumpectomy site

to deliver doses of radiation. Treatment lasts one to 5 days, the

company said. The implant is removed after radiation therapy is

completed.

The product is intended mainly to treat early-stage breast cancer when

there is no need to remove the whole breast, the FDA said. The agency

said the new device does not replace whole-breast radiation for women

who need it.