Breast radiologist Paige Huber MD
prepares to biopsy with the
Suros Celeroâ„¢
Hologic Subsidiary Launches Core Biopsy Device
April 11, 2007
INDIANAPOLIS, Indiana - Suros Surgical Systems, Inc., a subsidiary of women's imaging leader, Hologic, Inc, (NASDAQ: HOLX), has launched the Suros Celero™ - the first U.S. FDA-cleared spring loaded, vacuum assisted core biopsy device for the breast ultrasound market. With the option of firing inside or outside the breast, the 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 and its highly echogenic needle provide smooth penetration to lesions while reducing deflection and offer a clearly visible aperture location for target verification under ultrasound imaging prior to tissue acquisition. Celero securely holds the tissue sample in place while acquiring large cores.
"Early Celero clinical findings show that only two to three samples are needed for a diagnosis and DCIS [ductal carcinoma in situ] staging with only two samples," said Paige Huber MD, a radiologist with AnMed Health, a healthcare provider in Anderson, South Carolina. "While many physicians are accustomed to 6-10 needle insertions for spring loaded core biopsies, Celero needs only 2-3 insertions to gain the same results.
One benefit to firing and collecting tissue in two separate steps is that it allows for confirmation. "I can place and confirm the aperture is where desired before firing the outer cannula and taking the sample," Dr. Huber said. "When we think about what this could mean to patients, the Suros Celero device is a very exciting emergence to the breast biopsy market. This is a good thing for women."
In her clinical evaluation of Celero, Dr. Huber targeted a node 15cm deep into the axilla and resting on the pectoralis muscle. "The high echogenicity of the needle and trocar tip gave me the confidence to enter this sensitive region. Until now, I had not sampled lymph nodes because of the sensitivity of the region and because of the limitations of the devices available. I would not have done this procedure with any other device on the market."
Dr. Mary Nicholson, fellowship-trained breast radiologist at Women's Diagnostic Center, Community Healthcare System in Munster, Indiana had a similar experience with Celero. "One of my first cases was an abnormally enlarged, low-lying axillary lymph node deep within the tissue," said Dr. Nicholson. "In four passes, I had gathered plenty of tissue and was done, without complications. This translates into faster and more compassionate patient care. For me, it means I can expect the samples coming back from pathology with a definitive diagnosis."
Dr. Huber and Dr. Nicholson were among more than a dozen radiologists from across the country that participated in the initial clinical evaluations of Celero. Detailed profiles of the experiences of Dr. Huber and Dr. Nicholson are posted on the Suros website - www.SurosSurgical.com. Many of the hospitals and breast centers that participated in the pre-launch program have adopted the Celero for their spring loaded core procedures.
Suros President, Jim Pearson, believes that larger core samples mean the procedure will be faster for the patient, less traumatic due to fewer needle insertions, and able to provide improved diagnostic information in pathology. Pearson says, "The Celero is designed to replace current ultrasound-guided spring loaded core biopsy devices. Like spring loaded core needles, it is just as easy to use for physicians and technologists, but we believe our product offers a better clinical solution."
More than 550,000 ultrasound guided core needle biopsy procedures are performed annually, primarily with spring loaded core devices. The number of diagnostic breast biopsies is increasing every year. A report in the September 2006 issue of the Journal of the American College of Radiology indicates a 61 percent increase in biopsy procedures and procedure volumes going up by 101 percent among radiologists compared to surgeons. "With 80 percent of those biopsies resulting in a negative diagnosis," Pearson says, "there is no reason why women should undergo procedures that are painful or traumatic."
About Suros Surgical Systems, Inc.
Suros Surgical Systems, Inc., a subsidiary of women's imaging leader, Hologic, Inc, (NASDAQ: HOLX), is a leading innovator in the field of devices used for minimally invasive breast biopsy and tissue excision. At Suros, we believe patients are better served with a minimally invasive approach to biopsy or surgery. That's why we specialize in fast, safe and easy interventional breast biopsy products for biopsy, tissue removal and biopsy site marking. Suros designs, manufactures and markets patient-focused and physician-inspired "Compassionate Technologies" through its ATEC® (Automated Tissue Excision and Collection) product line compatible with stereotactic x-ray, ultrasound and magnetic resonance imaging (MRI) systems and its ultrasound only Celero device. 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. For more information visit www.SurosSurgical.com.
About Hologic, Inc.
Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostic and medical imaging systems dedicated to serving the healthcare needs of women, and a leading developer of innovative imaging technology for digital radiography and breast imaging. Hologic's core business units are focused on mammography and breast biopsy, osteoporosis assessment, and mini C-arm and extremity MRI imaging for orthopedic applications. For more information visit www.hologic.com.