Dune Medical Devices has a date with the FDA to review its pre-market approval application for the MarginProbe breast cancer detection device.
The watchdog agency’s general & plastic surgery devices advisory panel scheduled a hearing for June 21 to review the PMA data for the device, which uses electromagnetic waves to characterize human tissue in real time and "provides intra-operative information on the malignancy of the surface of the ex vivo lumpectomy specimen," according to the FDA.
Last week Dune Medical touted 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," according to a press release.
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.
A nod from the advisory panel won’t assure approval of MarginProbe, but the FDA usually follows its panels’ guidance.
