January 7, 2008 – Dune Medical Devices announced new clinical developments of its breast cancer assessment probe, currently in investigational use, stating that results from a recent randomized clinical trial in 11 medical centers in Israel have underscored the safety and clinical benefit of the system in the intraoperative detection of tumors at the resection margins (positive margins) in specimens of patients undergoing breast conserving surgery.
The study compared the performance of 35 surgeons operating on patients with and without the MarginProbe. Use of the system resulted in a reduction in repeat surgeries, which are typically performed in order to surgically correct positive margins found following a patient’s initial lumpectomy. The effect of the MarginProbe is pronounced in patients with nonpalpable lesions.
Preliminary results for more than 110 patients with nonpalpable lesions showed a 60 percent reduction in repeat surgeries in the study arm that allowed use of the MarginProbe. These results reflect initial data from the first 200 patients recruited and analyzed in the study. Final results from the entire 300 patient cohort are scheduled for presentation at the annual meeting of the American Society of Breast Surgeons (ASBS) in May 2008 in New York City.
The MarginProbe consists of a sterile, hand-held probe and portable console. When the probe tip is applied to an excised lumpectomy segment, radio frequency signals are transmitted into the tissue and are reflected back to the console where they are analyzed using a specialized algorithm to determine tissue status.
For more information: www.dunemedical.com
April 24, 2024 
