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US FDA clears new breast cancer treatment option
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.
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