Breast Biopsy and Tissue Removal System

This new indication has been cleared by the U.S. Food and Drug Administration (FDA).

A biopsy procedure using the Atec system of Suros Surgical Systems, Inc. (Indianapolis, IN, USA), 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 Atec Pearl system is used for biopsy guided by ultrasound or x-ray, while the Atec Sapphire can be used with ultrasound, x-ray, or magnetic resonance (MR) imaging. The typical time required for biopsy is less than one minute.

Surgeons have also used Atec to completely remove fibroadenomas up to 4 cm in one step. Women can now have noncancerous breast lumps diagnosed and completely removed in the convenience of their doctor's office without the trauma and disfigurement of invasive surgery or the need for a surgical incision.

"For many years, I have seen women in our practice who remained concerned about a breast lump despite a prior benign diagnosis by needle biopsy,” noted Dr. Jeffrey Mendel, chairman of radiology at Caritas St. Elizabeth Medical Center of Boston (MA, USA). "The only alternative to them was surgical excision. The Atec system allows us to offer these patients and other women with probably benign lesions diagnosis and treatment with a single procedure.”

Suros notes it is the industry leader in MRI-guided breast biopsy with its Atec system, which has been used in more than 3,000 biopsy procedures in more than 100 U.S. centers.




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