Dune Medical Devices' MarginProbe system, designed for the detection of breast cancer, has obtained premarket approval (PMA) from the US Food and Drug Administration (FDA).
The system is an intra-operative tissue assessment tool which uses electromagnetic signatures to distinguish healthy and cancerous tissue and prevent repeat surgeries to remove cancerous tissue that was not detected following an initial lumpectomy.
Repeated surgeries are carried out because cancerous cells are found to be present on the rim or edge of the removed tissue, according to the company.
The approval was based on a 664 patient prospective, multi-center, randomized, double arm trial to study the effectiveness of the MarginProbe system, which demonstrated to be over three times more effective in finding cancer on the margin during lumpectomy.
Beth Israel Medical Center breast surgery chief pivotal clinical trial investigator Dr Susan Boolbol said following the breast cancer surgery, telling a patient that they need more surgery can be an emotional issue for doctors and patients.
"This may result in tremendous anxiety and frustration," Boolbol added.
"I believe that the MarginProbe System can help advance the field of breast surgery."
The breast cancer detection system, which is available in Europe and in selected locations of the US, is expected to be launched throughout the nation in early 2013.
