Media release from CairnSurgical Inc.

The multicentre European clinical monitoring study (PMS study) is being conducted in selected European countries within the framework of the guidelines for custom-made devices of the European Medical Device Regulation (MDR). The study is being conducted at several centres in Europe, including Santa Chiara Hospital, Zollikerberg Hospital and Agaplesion Markus Hospital in Frankfurt am Main. The primary endpoint is the rate of positive margins as assessed by imaging and pathology immediately after surgery.

With current breast-conserving operations (BEO), it is not possible to completely remove the tumour in around 20 percent of cases. This is mainly due to the fact that current procedures for localising the tumour do not provide the information required for precise removal of the entire tumour. According to a recent study on the shape of breast cancer tumours, less than 20 percent are spherical1, so procedures that place implants or wires at one or two central points within the tumour have limited or no value in determining the size, borders and margins of the tumour.

The BCL system reduces the rate of positive margins and improves breast-conserving surgery in three steps. Read more in the CairnSurgical media release.