FDA advisory panel issues positive opinion for Dune's MarginProbe System

Dune Medical Devices announced today that a U.S. Food and Drug Administration (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 U.S.

"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."

Historically, between 30%-60% of women who undergo breast conservation surgery have to undergo additional surgeries because doctors fail to achieve negative margins during the first surgery. 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.

SOURCE Dune Medical Devices