New system for precise localisation of breast cancer used commercially for the first time

The US medical technology company Cairn Surgical has announced the first commercial use of its Breast Cancer Locator (BCL) system. The innovative procedure is designed to improve the accuracy of breast-conserving operations. It also utilises 3D printing.

Prof. Dr Hisham Fansa, Head of the Breast Centre and Plastic Surgery at Zollikerberg Hospital in Zurich, performed the procedure. ‘In this first commercial case, we have achieved a negative margin, which indicates complete removal of the tumour,’ explained Fansa. He emphasised the benefits of the detailed, individualised information about each tumour that the system provides.

The BCL system uses a special MRI image of the breast in the supine position, i.e. in the position in which surgery is performed. A patient-specific 3D-printed mould is created from the image data, which serves as a guide for the surgeon during the procedure. An interactive 3D representation of the tumour is also available in real time.

David Danielsen, CEO of Cairn Surgical, sees the technology as an important advance: ‘We offer breast surgeons detailed information and 360° views of each tumour that they didn’t have before.’ The company plans to further expand access to this technology once the US approval trial has been completed.

Initial clinical data from previous studies, published in the journals ‘Annals of Surgical Oncology’ and ‘Surgical Oncology’, show promising results. Tumour-free resection margins were achieved in all patients, with the resection volumes matching the target volumes.

A larger clinical trial is currently underway in the USA with 448 patients at up to 25 centres. It is intended to support FDA approval and the market launch in the USA. The primary endpoint is the rate of positive resection margins. Other endpoints include the resection volume, the rate of additional resections, the re-excision rate, the tumour localisation rate, the operation time and the treatment costs.