Dune Medical, a healthcare products manufacturer based in Framingham, Massachusetts, received approval from the United States Food and Drug Administration (FDA) for its MarginProbe breast cancer screening tool. According to a press release by the company, the MarginProbe can be used by surgeons to quickly determine if all cancerous tissue has been removed during breast cancer procedures.

The FDA approval follows a clinical trial of 664 patients. The clinical trial evaluated the device’s efficacy at identifying cancerous tissue at the edge of breast cancer tissue that had been removed during lumpectomy operations.

Results from the clinical trial were positive. The MarginProbe system was 300 percent more effective at identifying cancerous tissue when compared to traditional imaging and assessment techniques.

The MarginProbe cancer screening tool uses electromagnetic pulses to identify cancerous tissue at the edge of a tumor in real time. This gives physicians and healthcare providers the ability to quickly and easily identify lingering cancerous tissue during a lumpectomy or a mastectomy. In addition, this reduces the need for exploratory or repeat surgeries to remove cancerous tissue.

According to information from Dune Medical, an estimated 30 to 60 percent of women with breast cancer undergo repeat lumpectomies.

In prepared remarks, MarginProbe trial investigator Dr. Susan Boobol said, “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.” With MarginProbe, surgeons can achieve a threefold reduction in repeat lumpectomies.

References

www.multivu.com/mnr/58891-dune-medical-devices-fda-approval-marginprobe-...