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."

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