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Dune Medical's MarginProbe™ Demonstrates Increased Positive Margin Identification Leading to Reduction in Patients Indicated for Re-excision in Landmark Lumpectomy Surgery Trial
Date:4/29/2011

point of the study was Complete Surgical Resection (CSR), which measured the surgeons' ability to identify and resect all positive margins when present.  Roughly 50 percent of patients had one or more positive margins on the lumpectomy specimen (later determined by pathology), and CSR was successful when all margins were identified and completely resected.  For the device group, the rate of successful CSR was 72 percent, compared to 22 percent in the control group (P<0.0001). Patients who did not achieve successful CSR were considered candidates for re-excision procedures, 42 in the device group compared to 98 in the control group (57 percent reduction, P<0.0001). Of these candidates, 30 patients in the device group and 62 patients in the control group had a re-excision.

"The results of the study are very encouraging," said International Principal Investigator Lorraine Tafra, MD, FACS, Medical Director of Anne Arundel Breast Center, Annapolis, MD. "The ability to accurately identify cancer immediately in the operating room, and have a marked impact on the number of patients who return from surgery with clear margins, suggests that the MarginProbe System has the potential to significantly improve traditional breast cancer surgery outcomes."

Readmissions for re-excision to obtain clear margins have been shown to increase cost and emotional distress for patients, as well as have the potential for more scarring and deformation at the surgical site.  

"Despite best efforts, achieving microscopically-clear surgical margins in the operating room has been a persistent challenge," said Dune Medical CEO, Bill Densel. "We are extremely pleased with the positive outcome of the study. These results confirm that our breakthrough technology can benefit patients by providing physicians with the ability to detect cancerous tissues during procedures and immediately react."

Pivotal Study Details

664 women aged 18 years an
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SOURCE Dune Medical Devices, Inc.
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