Medical isotope developer IsoRay Medical of Richland, WA, has received additional U.S. Food and Drug Administration (FDA) 510(k) clearance for its Proxcelan cesium-131 brachytherapy seeds.
The new clearance will allow the company to preload cesium-131 into flexible braided strands and surgical mesh, expanding the applications for treating prostate cancers that are beyond the scope of current products.
While the cesium-131 seeds themselves have been cleared for this indication since 2003, this FDA 510(k) clearance allows the seeds to be delivered in a new sterile format that can be implanted without additional seed loading by the facility.
IsoRay plans to use the product to treat lung, head and neck, and other organ tumors.
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