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FDA approves breast cancer detection device
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The FDA has approved a surgical tool that can detect cancerous tissue on the margins of removed breast tissue during lumpectomy procedures in real time, according to a press release.
The MarginProbe System, developed by Dune Medical Devices Inc., uses electromagnetic “signatures” to identify healthy and cancerous tissue.
The FDA based its premarket approval on a prospective, multicenter, randomized, double-arm study of 664 patients.
The trial examined the device’s effectiveness in identifying cancerous tissue along the margins of removed breast tissue during initial lumpectomy procedures.
In the trial, the MarginProbe System was found to be at least three times more effective in finding cancer on the margin during lumpectomy compared with traditional intraoperative imaging and palpation assessment, according to the press release.
Susan K. Boolbol
“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 in New York City. “Frequently, early-stage breast cancers are detected by mammography. This can make the process of achieving negative margins more challenging. Following their breast cancer surgery, telling a patient that they need more surgery can be an emotional issue for doctors and patients. This may result in tremendous anxiety and frustration. I believe that the MarginProbe System can help advance the field of breast surgery.”
On June 22, the FDA advisory panel voted 10-1 to approve the MarginProbe System.
MarginProbe has been available in Europe since 2008 and is now available in select locations throughout the United States.