The US Food and Drug Administration (FDA) has granted premarket approval (PMA) to Dune Medical Devices’ intra-operative tissue assessment tool for breast cancer detection, based on a 664-patient prospective, multi-centre, randomised, double-arm study.
Using electromagnetic signatures, the MarginProbe system distinguishes healthy and cancerous tissue and prevents 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.
Beth Israel Medical Centre 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 said.
"I believe that the MarginProbe System can help advance the field of breast surgery."
The study, which assessed the effectiveness of MarginProbe in identifying cancerous tissue along the margins of removed breast tissue, showed the device to be over three times more effective in finding cancer on the margin during lumpectomy.
Dune Medical Devices chief executive officer Daniel Levangie said; "We have received resounding support from clinicians, advocacy organisations and patients alike, who have recognised the value of MarginProbe and intra-operative, real-time detection of cancer on the margin to potentially improve patient outcomes."
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.