Vacuum-Assisted, Spring-Loaded Core Biopsy Device Developed for the Breast Ultrasound Market

The lightweight design of the handheld 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.

Over the past decade, ultrasound-guided large-core needle biopsy has become an effective and acceptable alternative to surgical biopsy for the classification of breast lesions. According to recent published studies, in France, Germany, Italy, and the United Kingdom alone, ultrasound-guided needle procedures account for more than half of all image-guided breast biopsies.

Hologic, Inc. (Bedford, MA, USA), a leading developer, manufacturer, and supplier of diagnostics, medical imaging systems, and surgical products that serve the healthcare needs of women, has received CE Marking approval for the Celero vacuum-assisted, spring-loaded core biopsy device. Celero is the first U.S. Food and Drug Administration- (FDA)-cleared vacuum-assisted core biopsy device for the breast ultrasound market. The company has also received CE Marking approval for the CeleroMark and CeleroMark-2S biopsy site identifiers, as well as the CeleroIntro-12 introducer, clearing the way for sales in the European Union (EU) and all countries recognizing the CE Marking. Some of the unique features of the Celero device are patented.

Hologic is additionally 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.

More than one million women undergo surgical procedures each year to diagnose an abnormality found during mammography, and more than 700,000 ultrasound-guided core needle biopsy procedures are performed annually, primarily with spring-loaded core devices.

"Over the past year, we have seen a shift toward disposable biopsy devices in Europe, and we are excited to bring the completely disposable and cost-effective Celero device to the international market," said David P.Harding, senior vice president and general manager, Interventional Breast Solutions, Hologic. "Today, clinicians and patients alike look to minimally invasive breast biopsy techniques as a way of reducing the time, cost, and trauma associated with surgery as a diagnostic procedure without sacrificing histological accuracy. We are confident that the international availability of 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."

The Celero device is designed to hold securely 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. Furthermore, 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.

"The Celero device provides physicians with a sophisticated and flexible way to obtain tissue samples without compromising the patient's comfort," said Melcior Sentis, M.D., head of breast imaging at UDIAT Diagnostic Center (Sabadell, Spain). "The coaxial technique is an improvement over existing technologies that enables us to conduct more accurate and less invasive biopsies, and I am confident it will be well received on the international market.”

Hologic's core business units are focused on breast health, diagnostics, gynecologic, surgical, and skeletal health. Hologic provides a comprehensive range of technologies with products for mammography and breast biopsy, radiation treatment for early-stage breast cancer, cervical cancer screening, treatment for menorrhagia, osteoporosis assessment, preterm birth risk assessment, mini C-arm for extremity imaging, and products that cover molecular diagnostic reagents for a variety of DNA and RNA analysis applications.

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