IsoRay, Inc. announced that it has received clearance from the FDA for its Premarket Notification, [510(k)] for Proxcelan™ Cesium-131 Brachytherapy Seeds enabling the company to preload Cesium-131 into flexible braided strands and surgical mesh. This FDA clearance allows IsoRay to market Cesium-131 seeds for use in the treatment of cancers well beyond the current prostate market.
This order 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, convenient and sterile format that can be implanted without additional seed loading by the facility. The 510(k) also clears the application of the braided strands onto a bioabsorbable mesh matrix to further facilitate implant procedures.
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