SenoRx' breast brachytherapy tool:
This article was originally published in Clinica
Executive Summary
The US FDA has given SenoRx 510(k) clearance to market its Multi-Lumen Radiation Balloon Applicator for providing brachytherapy to the surgical margins following lumpectomy for breast cancer. The device uses vacuum to remove excess fluid and to adhere closely to often irregularly shaped lumpectomy cavities in order to deliver precise radiation dosing through multiple seed lumens. "Certain patients who are presently candidates for balloon therapy are currently excluded because of the location of the lesion relative to their breast size," claimed Lloyd Malchow, the Aliso Viejo, California firm's president and CEO. "Our multi-lumen approach offers a solution to this problem."