FDA Clears Radiation Balloon

May 24, 2007 – SenoRx recently announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Multi-Lumen radiation balloon applicator, created to provide brachytherapy to the surgical margins following lumpectomy for breast cancer.

SenoRx believes that its Multi-Lumen radiation balloon can play an important role in the paradigm shift from traditional whole breast radiation therapy to localized partial breast radiation therapy. The radiation balloon 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.