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FDA Approval for Intraoperative Assessment Tool for Breast Cancer

doi: 10.1097/01.COT.0000427347.26172.57


The Food and Drug Administration has granted Premarket Approval (PMA) for the MarginProbe System, an intraoperative tissue assessment tool for early stage breast cancer surgery that improves surgeons' ability to identify cancer on the margin and significantly reduces pathologically positive margins following a patient's initial lumpectomy surgery. Information from the manufacturer, Duane Medical Devices, notes that the device uses electromagnetic “signatures” to differentiate healthy from cancerous tissue.

“Up to this point our ability to assess the microscopic margin status in the operating room has been limited,” said Susan K. Boolbol, MD, Chief of Breast Surgery at Beth Israel Medical Center and investigator for the device's clinical trial to establish safety and effectiveness. Between 30 and 60 percent of early-stage breast cancer patients who have initial lumpectomy will undergo a repeat surgery, according to recent estimates, she noted. “Frequently, early-stage breast cancers are detected by mammography. This can make the process of achieving negative margins more challenging.”

The approval was based on a prospective, multi-center, double-arm, randomized study of 664 patients who received lumpectomy. The MarginProbe System, which has been available in Europe since 2008, was used to identify cancerous tissue along the margins of removed breast tissue, and was found to be more than three times more effective in finding cancer on the margin during the procedure compared with traditional intraoperative imaging and palpation assessment.

© 2013 Lippincott Williams & Wilkins, Inc.
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