From HealthImaging.com

Dune Medical Devices said it is launching a clinical study of a margin-detection system after securing an investigational device exemption approval from the FDA. The MarginProbe system, which uses radio-frequency spectroscopy to assess the malignancy of breast-tumor margins during surgery, will be tested on more than 600 female patients in U.S. hospitals.



Dune Medical Devices has initiated a clinical trial of the MarginProbe intraoperative, real-time, positive margin detection system, following FDA investigational device exemption (IDE) approval of its protocol during breast cancer surgery.

With the FDA IDE approval in place, Dune said it is launching a nationwide U.S. clinical trial of MarginProbe, which uses radiofrequency (RF) spectroscopy to characterize breast tissue during surgery to determine the malignancy status of tumor margins. The study will involve more than 600 women in more than a dozen leading medical centers in New York City, Baltimore, Washington D.C., Allentown Pa., and Los Angeles, according to the Caesarea, Israel-based company.

The Dune MarginProbe system comprises a sterile handheld probe and portable console. When the probe tip is applied to an excised lumpectomy segment, RF signals are transmitted into the tissue and reflected back to the console, where they are analyzed using a specialized algorithm to determine tissue status, Dune said.

October 30, 2008