Dune Medical Devices, as we were expecting, finally received clearance, after a unanimous recommendation from an FDA advisory panel back in June, for its MarginProbe system. The device is designed to assist surgeons performing breast lumpectomies in confirming the removal of the entire tumor.
Cancerous tissue often looks much like the healthy counterpart that it evolved from, but because it has a greater density of vasculature it can be identified by machine. The MarginProbe transmits electrical pulses through tissue under its tip and measures the returning signal, which is attenuated in distinct ways by tumors. The goal is to reduce the recurrence of cancer and minimize currently too-frequent follow-up surgeries.
FDA approval of the MarginProbe System was based on a 664 patient prospective, multi-center, randomized, double arm study to evaluate the effectiveness of MarginProbe in identifying cancerous tissue along the margins of removed breast tissue during initial lumpectomy procedures. MarginProbe, which uses electromagnetic “signatures” to identify healthy and cancerous tissue, was found to be over three times more effective in finding cancer on the margin during lumpectomy, compared to traditional intra-operative imaging and palpation assessment. This enabled surgeons to significantly reduce the number of patients with positive margins following initial surgery.
“The MarginProbe System was developed to address one of the longest standing unmet medical needs in the breast cancer surgical community,” said Daniel Levangie, Chief Executive Officer of Dune Medical Devices. “We have received resounding support from clinicians, advocacy organizations and patients alike, who have recognized the value of MarginProbe and intra-operative, real-time detection of cancer on the margin to potentially improve patient outcomes.”
MarginProbe has been available in Europe since 2008 and is now available in select locations throughout the U.S., with national availability expected in early 2013.
Product page: MarginProbe…