Dune Medical Devices' MarginProbe cut the rate of re-excision in breast-conserving cancer surgeries by about 50% in a recent study, more promising results for the company as it awaits FDA approval.
Dune's device is designed to minimize the need for repeat operations after breast-conservation surgeries by detecting the presence of cancer at or near the surface of excised tissue. In a randomized study of patients with ductal carcinoma in situ, 37% of patients needed repeat surgeries using standard methods compared to 13% with MarginProbe, MedPage Today reports. In women with both ductal carcinoma and invasive cancer, the rates were 17% with MarginProbe and 33% without it.
"The difficult part, as a surgeon in the operating room, is we don't have a lot of information to go on to determine whether the edge of the tissue is cancer-free," Dr. Susan Boolbol of Brigham and Women's Hospital told the site. "The device gives us feedback in the operating room, gives us information as to whether there are cancer cells close to one of the margins."
Currently, after a lumpectomy, doctors send the excised tissue to a pathology lab, taking a week or more to get results, according to MedPage Today. In 20% to 40% of cases, pathologists find residual tumor cells in the margins of the tissue, requiring patients to go back for another procedure, the site reports. With MarginProbe, however, patients and physicians can save time, money and anxiety, Boolbol said.
The device is already available in Europe, and Dune filed it with the FDA in 2011, getting a 10-1 recommendation for approval from an agency panel in June. The company has said that it will work closely with the FDA through the rest of the approval process and launch the device in the U.S. as soon as possible.
- read MedPage Today's report