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FDA clears Fischer MammoTest Breast Biopsy System as platform for Interstitial Breast Brachytherapy

ChicagoWednesday, December 1, 2004, 08:00 Hrs  [IST]

Fischer Imaging Corporation has received clearance from the Food and Drug Administration (FDA) for use of the MammoTest Breast Biopsy System as a platform for Interstitial Breast Brachytherapy, a promising new treatment for breast cancer offering a less invasive, four day alternative to the traditional six week external beam radiation therapy, here at the 90th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA). Developed by Robert Kuske, professor of radiation oncology at the University of Arizona, Interstitial Brachytherapy involves the precise, Xray guided insertion of catheters to irradiate and control malignant tumours in the breast using the MammoTest digital imaging system. While traditional external beam radiation therapy irradiates the entire breast and can last up to six weeks, brachytherapy lasts only 4-5 days and involves only the tissue within two centimetres of the lumpectomy site. "Interstitial Brachytherapy has demonstrated excellent tumour control over 13 years with a three percent reoccurrence rate in breast cancer compared to traditional radiation therapy utilizing external beam, which has about a 10 per cent reoccurrence. The therapy is effective because it extends intense treatment an additional two centimetres around the lumpectomy site to include the tissue that is at the greatest risk for relapse," said Dr. Kuske, a radiation oncologist at the Scottsdale offices of the Arizona Oncology Services and Foundation for Cancer Research. "The MammoTest breast imaging system is very important to the effectiveness of the procedure as surgeons must have high quality, high resolution images to accurately place the catheters in a prone position. The MammoTest system provides the best images I have seen," he added. According to Dr. Kuske, phase II trial results were so promising that the National Cancer Institute recently approved a Phase III trial to compare brachytherapy and external radiation therapy for the treatment of breast cancer. Involving more than 3,000 patients, it is the largest North American breast cancer radiation trial. "If the results of this trial maintain the same level of tumour control with low reoccurrence rates, I strongly expect brachytherapy to rapidly become one of the leading breast cancer treatments because it is easier on patients with better cosmetic outcomes and fewer side effects," he said. The MammoTest Stereotactic imaging system was originally introduced and is primarily used at the diagnostic stage of breast cancer screening. When suspicious calcifications are found using traditional screening mammograms radiologists order a higher resolution image of the suspicious area. In some cases, cancer is ruled out at this stage. In others, a biopsy is performed using the MammoTest imaging system to precisely locate a biopsy needle and extract the tissue in question for testing. Fischer Imaging Corporation designs, manufactures and markets medical imaging systems for the screening and diagnosis of disease. One company focus is women's health, particularly the diagnosis and screening of breast cancer through the application of innovative digital imaging technologies.

 
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