An advisory panel of the FDA has voted nearly unanimously to recommend approval of Dune Medical‘s MarginProbe, a device that helps surgeons make sure that all cancerous tissue is removed around a breast cancer site. The company, which has offices in US, Israel and Switzerland, has been adapting RF spectroscopy for use in differentiating tissue types.
The MarginProbe emits an electric field and senses the returning signal from tissue under evaluation. Because tumors exhibit greater vascularization, a different polarization of cell membranes, and other anatomical differences over healthy tissue, the electromagnetic signature is different as well. The device is used to detect the characteristic signature of cancer, helping surgeons to make sure they removed everything unwanted around the margin of the tumor.
Historically, between 30%-60% of women who undergo breast conservation surgery have to undergo additional surgeries because doctors fail to achieve negative margins during the first surgery. The pivotal trial data shows that by using The MarginProbe System during the first operation, in conjunction with standard methods, surgeons will have the ability to significantly reduce the rate of positive margins following the initial surgery.
The MarginProbe System enables real time detection of cancer at or near the surface of excised tissue specimens during surgery for breast cancer. The simple and immediate assessment of the surgical margins allows surgeons to immediately excise additional tissue, significantly reducing the potential for positive margins remaining after the initial lumpectomy.
Product page: MarginProbe…