FDA approves Dune Medical Devices

Dune Medical Devices recently announced that the U.S. Food and Drug Administration approved its MarginProbe System for use in breast cancer surgery. Use of the system could potentially improve patient outcomes while cutting costs for hospitals.

The FDA's Advisory Panel voted 10-1 in favor of the system that is an alternative to traditional surgery methods. The application for approval was submitted by the medical device company in April 2011 after reviewing data from a study conducted with 600 patients in the United States.

According to a Dune press release announcing the MarginProbe approval, about 30 to 60 percent of breast conservation surgery patients undergo additional surgeries as a result of doctors failing to achieve negative margins. The MarginProbe system is designed to reduce the number of follow-up surgeries by improving initial surgery results, adding efficiency to the hospital system and improving quality of care.

"We are very pleased with the panel's positive decision on the MarginProbe System for use in the U.S.," said Dan Levangie, Dune's chief executive officer. "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."