IsoRay has received FDA 510(k) clearance for its premarket notification for Proxcelan Cesium-131 brachytherapy seeds, allowing the company to preload Cesium-131 into flexible braided strands and surgical mesh.
The FDA clearance allows IsoRay to market Cesium-131 seeds for use in the treatment of cancers beyond the current prostate market, according to the Richland, Wash.-based company. The approval clears the product for commercial distribution for treatment of lung and head and neck tumors, as well as tumors in other organs.
While Cesium-131 seeds themselves have been cleared for this indication since 2003, this current 510(k) allows Cesium-131 to be delivered in a new sterile format that can be implanted without additional seed loading by the facility, IsoRay said. The 510(k) also clears the application of the braided strands onto a bioabsorbable mesh matrix to further facilitate implant procedures.