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Mammotome Nets 510(k)

RSNA-2010-Radiological socitey of North America annual meeting., a division of Devicor Medical Products, announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Mammotome MI (Molecular Imaging) System, used to conduct minimally invasive, vacuum-assisted breast with molecular imaging guidance. It is the first device of its kind to receive FDA clearance and it is commercially available to healthcare facilities specializing in breast cancer screening and diagnosis.

The Mammotome Biopsy System has been available for use with traditional imaging modalities, including stereotactic x-ray, ultrasound, and MRI. The new Mammotome MI System facilitates minimally invasive breast biopsy guided by molecular imaging techniques such as Positron Emission Mammography (PEM) and Breast Specific Gamma Imaging (BSGI) to localize lesions.

“The introduction of the Mammotome MI Breast Biopsy System takes the advancements made in molecular imaging to the next level by allowing clinicians to obtain diagnostic tissue samples,” said Kathy Schilling, M.D., Medical Director of and Intervention at the Center for Breast Care, Boca Raton Community Hospital in Florida. “This has great potential to help radiologists and surgeons diagnose and stage breast cancer accurately and early, especially in women who are hormonally active or with dense breast tissue which may result in limitations with other imaging modalities.”

In traditional screening or diagnostic imaging of the breast, clinicians look at the breast for anatomical changes. With molecular imaging, however, the clinicians look for unusual metabolic activity in the breast. This is accomplished by injecting the patient with a small amount of radiopharmaceutical tracer. These radioactive substances circulate and get trapped in abnormal cells creating a unique “hot spot” which can be imaged and biopsied with the Mammotome MI Breast Biopsy System.

More about Mammotome Biopsy System

A procedure with the Mammotome Biopsy System involves a single insertion of a needle equipped with a vacuum system into a ¼-inch incision. The system gently vacuums, cuts and removes suspicious breast tissue for analysis and diagnosis. Since the incision is so small, no stitches are required.

Instead, only an adhesive bandage is needed and most patients can return to normal activity immediately following the procedure. The outpatient procedure typically takes less than an hour, and scarring is minimal.

Since the Mammotome Biopsy System’s introduction in 1995, more than 3.4 million women have had a minimally invasive breast biopsy in stereotactic, ultrasound, or MRI-guidance imaging using the system.

The technology will be on display in the South Building, Hall A, Booth 4409, during the 2010 RSNA conference.

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