FDA panel OKs Dune Medical's MarginProbe breast cancer detection tool
An FDA advisory panel recommends approval for Dune Medical's MarginProbe breast cancer detection device.
An FDA advisory panel recommended approval for Dune Medical Devices' MarginProbe breast cancer detection device today.
The federal watchdog agency's general & plastic surgery devices advisory panel met to mull whether the device, which uses electromagnetic waves to identify possibly cancerous tissue on the edges of a breast tumor in real time during surgical procedures, ought to be approved for the U.S. market.
The panel voted 11-0 that the device is safe, 8-1 with 2 abstentions that it is effective and 10-1 that its benefits outweigh its risks.
The company has emphasized data from several studies showing "a substantial reduction in repeat surgeries needed for breast cancer patients, the ease of integration of the MarginProbe System into routine practice, and a substantial economic benefit to device use" in press releases issued ahead of today's meeting.
The MarginProbe system, which won CE Mark approval in the European Union in 2006, is Framingham, Mass.-based Dune Medical's first commercial product. The company cites studies showing that the device's detection of "positive margins" – the cancer found at the edges of excised breast tissue – contributes to a 50 percent reduction in the necessity for additional procedures to remove residual cancer.
The nod from the advisory panel doesn't assure approval of MarginProbe, but the FDA usually follows its panels' guidance.