CairnSurgical, Inc., in Lebanon, has treated the first patient in its U.S. trial of the Breast Cancer Locator (BCL) System at Massachusetts General Hospital. The BCL system is designed to eliminate the guesswork in breast cancer surgery by providing a blueprint of the tumor and a surgical guide to achieve clear margins.
Current breast-conserving surgery is unsuccessful at removing the entire tumor about 20 percent of the time, primarily because current tumor localization techniques do not provide the information required to achieve precise removal of the disease.
The BCL System is designed to reduce positive margin rates, and to improve the process of BCS, using three steps.
- A supine MRI image is first performed, with the breast positioned in its surgical position, providing detail on the size, shape, depth, edges, and 1-centimeter margin for each tumor. This imagery is used to analyze the tumor and construct a three-dimensional tumor model that serves as the basis for two surgical tools.
- A 3D-printed form – the Breast Cancer Locator, or BCL – is produced to fit the unique shape of the patient’s breast, with ports for several central and bracketing wires to be placed under anesthesia in the operating room immediately prior to surgery. The wires guide the surgeon to the tumor boundaries and margins.
- An interactive 3D image – the Visualizer – is provided to the surgeon. The Visualizer offers interactive views of the tumor and quantifies the closest distance from the tumor to the skin and chest wall – information that provides valuable references for the surgeon during the procedure.
“Breast cancer surgery today leaves disease in the breast in more than one in five cases – as a surgeon myself, that’s just unacceptable. Re-excision surgery to go back into the breast is bad for the patient - it’s expensive and it’s painful," says Richard Barth, Jr., MD, Chief of General Surgery, Dartmouth-Hitchcock Medical Center, Professor of Surgery, Geisel School of Medicine at Dartmouth, and Co-Founder, CairnSurgical.
We developed the Breast Cancer Locator with the vision to provide improved clinical outcomes in order to reduce the positive margin rate. We want surgeons to be able to remove the entire tumor the first time, every time. Our pilot studies are demonstrating that, by providing surgeons with a detailed blueprint of the tumor in the supine position, which we have never had before, we can reduce positive margins and enable surgeons to do more precise excisions.”
CairnSurgical, Inc. is a clinical-stage medical device company developing patient-specific surgical guides using patient imaging data and state-of-the-art 3D printing technologies. CairnSurgical’s Breast Cancer Locator System enables precise tumor localization and excision and has been tested in both single-arm and randomized clinical trials. The Breast Cancer Locator is considered an investigational device in the U.S. and is limited by U.S. law to investigational use only. It is not approved for sale in any region.