INDIANAPOLIS, IN., Nov. 28 /PRNewswire-AsiaNet/ –
ATEC(R) Breast Biopsy and Excision System and
biopsy site marker receive CE Mark approval
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
SOURCE: Suros Surgical Systems, Inc.
CONTACT: Sue Hetzler,
Director of Communications of Suros Surgical Systems, Inc.,
+1-317-344-7514,
Mobile: +1-317-402-8690,
shetzler@SurosSurgical.com
Web site: http://www.surossurgical.com
November 29, 2005
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