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PR Newswire
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FDA Clears Use of Fischer MammoTest Breast Biopsy System as Platform for Interstitial Breast Brachytherapy

Finanznachrichten News
CHICAGO, Nov. 29 /PRNewswire-FirstCall/ -- Fischer Imaging Corporation (FIMG:PK), announced it 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), Nov. 28 - Dec. 2, 2004.

Developed by Robert Kuske, MD, professor of radiation oncology at the University of Arizona, Interstitial Brachytherapy involves the precise, Xray guided insertion of catheters to irradiate and control malignant tumors 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 centimeters of the lumpectomy site.

"Interstitial Brachytherapy has demonstrated excellent tumor 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 percent reoccurrence. The therapy is effective because it extends intense treatment an additional two centimeters 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."

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 tumor 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."

Also this week at the RSNA meeting, Dr. Kuske is presenting an abstract, titled "Use of the Stereotactic Breast Core Biopsy Table to Perform Image- Guided Breast Brachytherapy (BT) in the Prone Position for Select Carcinomas of the Breast." In his educational exhibit, Dr. Kuske demonstrates the integral role of the MammoTest biopsy table to the reproducibility and broad accessibility of the breakthrough therapy.

According to the American Cancer Society, breast cancer is the most frequently diagnosed cancer in US women, with 211,300 invasive cases expected in 2003, accounting for nearly one in every three cancers diagnosed. Each year, more than one million women undergo breast tissue biopsies. Statistics currently indicate that 80 percent of breast biopsies result in benign, or non-cancerous findings, reinforcing the need for minimally invasive techniques.

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.

"We are proud to work with Dr. Kuske, an internationally renowned cancer researcher, on the development of this breakthrough treatment for breast cancer," said Harris Ravine, Fischer Imaging president and CEO. "Clearance from the FDA for use of the MammoTest digital imaging system as a platform for Interstitial Breast Brachytherapy marks a significant step in offering women who suffer from breast cancer a breakthrough therapy that carries excellent tumor control and minimal side effects."

About Fischer Imaging

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. The company also produces equipment designed for Emergency, Radiology, Surgical, and certain Cardiovascular needs. Fischer Imaging began producing general- purpose x-ray imaging systems in 1910 and is the oldest manufacturer of x-ray imaging devices in the United States. For more information, visit http://www.fischerimaging.com/.

Fischer Imaging Corporation
© 2004 PR Newswire
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