WASHINGTON and FRAMINGHAM, Mass., April 29, 2011 /PRNewswire/ -- Dune Medical Devices, Inc. today announced that the landmark, 664-patient pivotal trial evaluating the MarginProbe™ System met its primary endpoints. The MarginProbe System provides surgeons with a real time, intraoperative technology to detect microscopically-positive margins on excised tissues. Top-line data from the study were presented at the 12th Annual Meeting of the American Society of Breast Surgeons (ASBS) in Washington, DC. Results showed that, when using MarginProbe in addition to standard of care techniques, there was greater than a three-fold increase in surgeons' ability to identify and immediately resect all positive lumpectomy margins, compared to standard of care techniques alone. This improvement led to a 57 percent reduction in patients who were candidates for re-excision (additional surgery) due to positive margins left un-resected on the lumpectomy specimen.
A successful lumpectomy requires cancer-free margins at the edges of excised tissue. However, intraoperative methods currently available to surgeons are limited in their ability to identify microscopically positive margins. Because of this, patients frequently require re-excision when positive margins are found during pathological examination, normally occurring 2-4 days following lumpectomy. Re-excision rates for positive margins are reported as high as 30 percent.
Patients participating in the international, multi-center, controlled trial underwent lumpectomy surgery and were randomized in the operating room to receive either the standard of care (control group), or the standard of care plus MarginProbe (device group). In the device group, MarginProbe was used to measure each margin of the excised lumpectomy specimen. If the device registered a positive reading, additional tissue was immediately resected from the adjacent breast cavity surface.
A primary end
|SOURCE Dune Medical Devices, Inc.|
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