An advisory panel from the U.S. Food and Drug Administration has favorably recommended the U.S. use of a real-time breast cancer detection device that is used in the operating room.
The medical device, manufactured by Dune Medical Devices Ltd. in Framingham, Mass., tests whether all tumor tissue has been removed in surgery, reports Gali Weinreb in Globes online. Called the MarginProbe system, the device should reduce the number of repetitive surgeries among breast cancer patients, the company reports in a press release.
“We are very pleased with the panel’s positive decision on the MarginProbe System for use in the U.S.,” says Dune’s Chief Executive Officer Dan Levangie. “We believe that the MarginProbe System will give surgeons a powerful tool in their fight against breast cancer and provide women a substantially better chance of avoiding additional surgeries. We will work closely with the FDA to complete the approval process and intend to launch the MarginProbe System in the U.S. immediately thereafter.”
The device uses electromagnetic waves to identify possibly cancerous tissue on the edges of a breast tumor, reports Mass Device. The areas where cancer is detected in areas just outside tumors are called positive margins. The company cites studies showing that the device’s detection of positive margins helps cut in half the number of additional procedures to remove residual cancer.
If, when using the device in surgery, it detects no remaining cancerous tissue, doctors may determine that the surgical procedure is completed. If the device finds cancerous tissue after the tumor has been excised, the procedure can continue.
Currently, excised tumors are sent for a biopsy, the results of which often are available a day after the surgery is over. If the biopsy determines that margins of the excised tissue is cancerous, the patient has to have another operation. Dune Medical reports that between 30% and 60% of current breast cancer surgical procedures require additional operations.
The medical device has won approval in the European Union. The company submitted a pre-market approval in the United States based on a 600-patient pivotal study.
Source: “FDA Panel Recommends Dune Medical Breast Cancer Detection System,” Globes online, 6/24/12
Source: “FDA Advisory Panel Votes in Favor of Dune Medical Devices MarginProbe® System,” PR Newswire, 6/22/12
Source: “Dune Medical’s MarginProbe Breast Cancer Detection Device on Track for FDA Approval,” Mass Device, 6/25/12
Image by National Institutes of Health, used under Fair Use: Reporting
Dale McGeehon has been a journalist and editor for more than 25 years, covering chemical regulation and testing for Pesticides and Toxic Chemical News and innovations in material sciences for the National Technology Transfer Center. His writing credits include Omni and College Park magazines and The New York Times.