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