Today, FDA granted PMA approval to the MarginProbe System created by Dune Medical Devices Inc. MarginProbe is based on a proprietary technology created by Dune based on RF spectroscopy. By measuring tissue response to an electric field the device creates electromagnetic “signatures” that can be used to identify healthy and cancerous tissue in patients. MarginProbe has been demonstrated to improve surgeons' ability to identify what is called “cancer on the margin” and significantly reduce pathologically positive margins following a patient’s initial lumpectomy surgery.

According to the Journal of the American Medical Association, roughly 60 – 75% of breast cancer patients undergo a lumpectomy procedure, in combination with radiation therapy, as their initial treatment. Tissue removed from a lumpectomy is analyzed for “cancer on the margin” - the presence of cancer cells on the margins of the removed tissue. If cancer is found on the edges of the removed tissue, there is a possibility that cancer still remains in the breast and the patient will have to undergo additional surgery. What becomes particularly critical in this stage is the turnaround time for pathology lab results (roughly one week) - time in which cancer may be continuing to spread.

In a press statement, Dr. Susan K. Boolbol, an investigator for the pivotal clinical trial and chief of breast surgery at Beth Israel Medical Center, says, “Up to this point our ability to assess the microscopic margin status in the operating room has been limited. Frequently, early-stage breast cancers are detected by mammography. This can make the process of achieving negative margins more challenging. Following their breast cancer surgery, telling a patient that they need more surgery can be an emotional issue for doctors and patients. This may result in tremendous anxiety and frustration.”

A FDA study found MarginProbe to be over three times more effective in finding cancer on the margin during lumpectomy, compared to traditional intra-operative imaging and palpation assessment. In a press statement Daniel Levangie, CEO of Dune Medical Devices, says, “The MarginProbe System was developed to address one of the longest standing unmet medical needs in the breast cancer surgical community. 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 in 2008 and is currently in select locations in the U.S. With this new approval Dune Medical Devices expects to have the device nationally available in early 2013.

—Chris Wiltz is the associate editor of MD+DI.