Suros breast biopsy system gains EC approval

Indianapolis, USA. Suros Surgical Systems, Inc. has received European CE Mark approval for its ATEC Breast Biopsy and Excision System and ATEC TriMark biopsy site identification system. The company expects to sell its first ATEC system for use with stereotactic (x-ray) and ultrasound-guided breast biopsy in January 2006.

The Full Quality Assurance certificate issued by the British Standards
Institute (BSI) provides Suros with the ability to use the CE Mark and sell its minimally invasive breast biopsy system and biopsy marker system in any of the 28 countries in the European Community and other countries who recognize the CE Mark. The ATEC system was also approved by Health Canada in July for use in performing diagnostic breast biopsy and partial or complete removal of visible evidence of benign breast disease.

The ATEC system includes the Pearl and Sapphire console units, all biopsy devices and the ATEC TriMark marker deployment system for post-biopsy site identification. The ATEC Pearl is designed specifically for stereotactic and ultrasound-guided breast biopsy; the ATEC Sapphire is the first ever all-in-one unit compatible with any of the three primary diagnostic imaging modalities of stereotactic, ultrasound and magnetic resonance imaging (MRI). Suros pioneered vacuum assisted breast biopsy using MRI-guidance in 2002 and has multiple patents pending with breast biopsy in this imaging modality.

MRI-guided breast biopsy is now widely accepted as the preferred secondary screening tool for women at high risk of developing breast disease or cancer. More than 200 hospitals and breast centres across North America currently use the MRI ATEC system exclusively for their MRI-guided breast biopsy needs.

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