SenoRx Receives Additional 510(k) Clearance for Its Contura MLB

The FDA has granted 510(k) clearance to SenoRx for a second design of its Contura Multi-Lumen Radiation Balloon (MLB) short-term breast radiation device.

Following breast cancer surgery, the balloon catheter delivers radiation to the tissue surrounding the lumpectomy cavity. The new design can be used in 10 percent to15 percent of patients when a larger balloon is needed, the company said.

The product is being evaluated at several clinical sites and is expected to become available during the third quarter of the year.