The MARGINPROBE System is an adjunctive diagnostic tool for identification of cancerous tissue at the margins (less than 1mm) of the main ex-vivo lumpectomy specimen following primary excision and is indicated for intraoperative use, in conjunction with standard methods (such as intraoperative imaging and palpation) in patients undergoing breast lumpectomy surgery for previously diagnosed breast cancer.
A sterile electronic probe intended to be connected to a system analyser (not included) for tissue surface analysis and characterization using radio-frequency spectroscopy, to identify cancerous tissue at the cut-lines (margins) during a lumpectomy procedure. It includes a handpiece with a tissue contact tip and a cable which may include a suction line to allow complete tip/tissue contact. It is intended for systematic analysis of the tissue sample, whereby surfaces identified by the analyser as cancerous correspond to margins which may require further excision. This is a single-use device.