INDIANAPOLIS, Nov. 28 /PRNewswire/ -- Medical device maker Suros Surgical Systems, Inc. announced today that it has received European CE Mark approval for its ATEC(R) Breast Biopsy and Excision System and ATEC TriMark(TM) biopsy site identification system. The company expects to sell its first ATEC(R) 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(R) 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(R) system includes the Pearl(TM) and Sapphire(TM) console units, all biopsy devices and the ATEC TriMark(TM) marker deployment system for post- biopsy site identification. The ATEC Pearl(TM) is designed specifically for stereotactic and ultrasound-guided breast biopsy; the ATEC Sapphire(TM) 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. The company is considered to be the worldwide leader in MRI-guided breast biopsy, now widely accepted as the preferred secondary screening tool for women at high risk for developing breast disease or cancer. More than 200 hospitals and breast centers across North America currently use the MRI ATEC(R) system exclusively for their MRI-guided breast biopsy needs.
The ATEC(R) Breast Biopsy and Excision System and the ATEC TriMark(TM) are patented and FDA-cleared. This year, more than 3 million women around the world will undergo a diagnostic breast biopsy. The Suros ATEC(R) system offers these women with a fast, safe and easy alternative to open surgery.
About Suros Surgical Systems, Inc.
Suros is an Indiana-based medical device manufacturer of minimally invasive biopsy and tissue excision products. The company designs, manufactures and markets patient-focused and physician-inspired "Compassionate Technologies" through its ATEC(R) (Automated Tissue Excision and Collection) product line compatible with stereotactic x-ray, ultrasound and magnetic resonance imaging (MRI) systems. Suros is viewed worldwide as the pioneer and market leader in MRI-guided breast biopsy technology, and is the fastest growing choice in vacuum-assisted breast biopsy. Since becoming available in 2001, the ATEC(R) breast biopsy system has been installed in more than 450 hospitals and breast centers across North America and more than 80,000 procedures have been successfully performed. For more information about Suros, visit http://www.SurosSurgical.com .
Suros Surgical Systems, Inc.
CONTACT: Sue Hetzler, Director of Communications of Suros SurgicalSystems, Inc., +1-317-344-7514, Mobile: +1-317-402-8690,shetzler@SurosSurgical.com