More than 3.0 million women have had successful breast biopsies using the Mammotome® Biopsy System worldwide since 1996. The Mammotome Biopsy System is offered in approximately 2,500 hospitals, breast centers and physician offices. Breast biopsies using the Mammotome Biopsy System are performed in an outpatient setting or doctor's office under local anesthesia. Patients can return to normal daily activity immediately following a breast biopsy using the Mammotome Biopsy System. Approximately 95% to 99% of all health insurance plans cover breast biopsies using the Mammotome Biopsy System. The Mammotome Biopsy System can be used to biopsy breast abnormalities in x-ray, ultrasound and MRI imaging modalities Tissue samples collected using the Mammotome Biopsy System are as reliable as open surgical biopsies and more accurate than core needle biopsies in the diagnosis of conditions associated with early breast cancer. The Mammotome Biopsy System is suitable for sampling breast abnormalities including microcalcifications, spiculated masses, asymmetric densities, multifocal disease and diffuse tissue. In 2003, the Mammotome Biopsy System also received clearance for fibroadenomas (non-cancerous breast lumps). Millions of women can now receive care in a doctor's office with the Mammotome Biopsy System rather than having the lump removed by invasive surgery in an operating room.
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