FDA Approves Suros ATEC for Complete Removal of Breast Tissue

The FDA gave clearance to medical device manufacturer Suros Surgical Systems to provide partial or complete removal of breast tissue with the ATEC breast biopsy system.

The ATEC system is compatible with the three most common imaging modalities used in breast biopsy: ultrasound, stereotactic and magnetic resonance imaging (MRI). Under ultrasound guidance, Timothy Goedde, surgical oncologist at the Midwest Breast Center in Indianapolis, has completely removed fibroadenomas up to 4 cm in one step. Typical biopsy time using the ATEC system is less than one minute to remove a 1-cm fibroadenoma -- less time than it takes to perform an ultrasound-guided core biopsy.

A biopsy procedure using the ATEC system involves a one-time needle insertion in the breast near or at the site where the lump was found. No stitches are required following the biopsy procedure and most women can resume normal daily activity immediately. The Suros ATEC Pearl system is used for biopsy guided by ultrasound or X-ray and the ATEC Sapphire can be used with ultrasound-, X-ray- or MRI-guided breast biopsy.