Dune Medical Devices announced that an FDA Advisory Panel voted 10 to 1 in favor of Dune’s MarginProbe System for use in breast cancer surgery, as an adjunct to current standard methods of intraoperative surgical margin assessment. Dune submitted a Premarket Application (PMA) in April 2011 based on data from a 600-patient pivotal study conducted primarily in the United States.
The MarginProbe System enables real time detection of cancer at or near the surface of excised tissue specimens during surgery for breast cancer. The simple and immediate assessment of the surgical margins allows surgeons to immediately excise additional tissue, significantly reducing the potential for positive margins remaining after the initial lumpectomy.
The pivotal trial data shows that by using The MarginProbe System during the first operation, in conjunction with standard methods, surgeons will have the ability to significantly reduce the rate of positive margins following the initial surgery. ■