RF Device Detects Breast Cancer Margins During Surgery

A novel detection system characterizes breast tissue during surgical procedure to determine the malignancy status of tumor margins throughout breast cancer surgery.

The Dune MarginProbe is an intraoperative, real-time, radiofrequency (RF) spectroscopy system that assists surgeons to positively detect tumor margins. The system is comprised of a sterile, disposable, hand-held probe and a portable console. When the probe tip is applied to an excised lumpectomy segment, RF signals are transmitted into the tissue and reflected back to the console, where they are analyzed using a specialized algorithm to determine tissue status. The system does not require any contrast agents or assistance from a radiologist or a pathologist. Each measurement performed by the MarginProbe scans a coin-shaped volume of tissue 7 mm wide by 1 mm deep. The streamlined operation and the ability to receive instantaneous results are designed to help with an easy integration into the existing surgical workflow. A recent study involving a 300-patient, prospective, randomized, controlled clinical trial of the MarginProbe compared surgeons' ability to detect and remove positive margins during an initial lumpectomy and the resulting reduced rate of repeat procedures. In the MarginProbe group, surgeons applied the probe to the excised lumpectomy specimen and shaved additional tissue according to the device's readings, resulting in a 56% reduction in repeat lumpectomies. The study was published in the October 2008 issue of The American Journal of Surgery.

The MarginProbe is a product of Dune Medical Devices (Caesarea, Israel), which has recently received an investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA). Dune will be launching a clinical trial of the MarginProbe in the United States, which will involve more than 600 women in over a dozen leading medical centers in New York City, Baltimore, Washington DC, Allentown, and Los Angeles.

"Based on the strength of our ongoing studies and their validation of the benefits of MarginProbe, we look forward to the device's acceptance within the surgical community,” said Dr. Dan Hashimshony, founder and CEO of Dune Medical Devices. "Soon thereafter, we hope to help ease the difficulties experienced by women who receive multiple surgeries for breast cancer.”

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