November 13, 2008 - Hologic Inc. received CE Mark approval for the Celero vacuum-assisted, spring loaded core biopsy device, the first U.S. FDA-cleared vacuum-assisted core biopsy device for the breast ultrasound market.
The company has also received CE Mark approval for the CeleroMark and CeleroMark-2S biopsy site identifiers, as well as the Celero Intro-12 introducer, clearing the way for sales in the European Union (EU) and all countries recognizing the CE Mark.
As ultrasound-guided large-core needle biopsy has become a reliable and acceptable alternative to surgical biopsy for the classification of breast lesions, the company hopes the Celero device can help increase the number of women who can avoid surgery and opt for a minimally invasive biopsy procedure to diagnose breast lesions Hologic is further registering the Celero device in markets in Latin and South America, the Middle East and Asia. The Celero device was approved by the FDA in April 2007.
With the option of firing inside or outside the breast, the Celero device is designed to access hard-to-reach lesions in the axilla, near the chest wall, near implants or behind the nipple. The lightweight design of the handheld Celero device and its highly echogenic needle provides smooth penetration to lesions while reducing deflection and offers a visible aperture location for target verification under ultrasound imaging prior to tissue acquisition. The Celero device is designed to securely hold the tissue sample in place while acquiring large cores. Research shows that with the Celero device, only two to three samples are needed for a diagnosis In addition, the Celero device requires only two to three insertions to gain the same results, as opposed to more needle insertions for other spring loaded core biopsies.
For more information: www.hologic.com