January 7, 2013 — FDA on Wednesday gave premarket approval to a probe that allows surgeons performing breast lumpectomies to immediately test if removed tissue has cancer-free edges, also known as "clean margins," Medical News Today reports (Paddock, Medical News Today, 1/3).
Current margin-testing procedures typically involve sending the removed tissue to a pathology lab and waiting up to a week for results, requiring a second surgical procedure if any cancerous cells are detected (Weisman, Boston Globe, 1/2).
Dune Medical Devices' MarginProbe System comprises a single-use probe attached to a console containing detection software. The probe uses radio frequency energy to determine whether the "electromagnetic signatures" of tissue is cancerous or healthy within 20 minutes of removal by comparing it to stored tissue samples. During clinical trials, the system was found to be three times more effective at finding cancer on the margin than traditional methods.
According to Dune Medical Devices, MarginProbe can significantly reduce the number of patients with positive margins following an initial lumpectomy (Medical News Today, 1/3).
MarginProbe will cost health care providers about $2,000. However, Daniel Levangie, CEO of Dune Medical Devices, says that the aim of the product is to eliminate second surgeries, which now occur in more than 20% of lumpectomies and cost roughly $7,000 each (Boston Globe, 1/2).
MarginProbe has been available since 2008 in Europe (Medical News Today, 1/3).
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