The U.S. Food and Drug Administration has cleared a new medical device that provides another option for radiation treatment for women who have had a cancerous lump removed from their breast (lumpectomy).

The device, a brachytherapy applicator, is designed to irradiate the surgical site from which the lump has been removed, with minimal irradiation of the surrounding tissue. (Brachytherapy is radiation treatment in which the source of radiation is close to the area being treated.)

The new device is the MammoSite Radiation Therapy System, made by Proxima Therapeutics, Inc., of Alpharetta, Ga. It consists of a hollow catheter to which an inflatable balloon it attached.

The device is implanted into the breast at the site of the lumpectomy, and the balloon is inflated. A radioactive source is then placed into the catheter. The balloon acts to center the radiation source within the wound. After a series of treatments are completed-typically over several days-the catheter is removed.

The device is intended to be used primarily to treat breast cancer in its early stages when there is no need to remove the whole breast. It does not replace whole breast irradiation in women who need that treatment.

FDA cleared the device based on information that showed it was comparable in safety and effectiveness to other devices used to deliver brachytherapy to the breast and other body parts. Such information included clinical data from 25 women at eight medical centers who had the device implanted after lumpectomy. The study showed that this new method of delivering brachytherapy was relatively simple and did not create increased risk to the patient.

As a condition for clearance, FDA is requiring Proxima Therapeutics to include a warning in the product labeling that the safety and effectiveness of MammoSite as a replacement for whole breast irradiation to treat breast cancer has not been established.

SOURCE:
U.S. Food and Drug Administration (http://www.fda.gov)