IsoRay has received FDA clearance for its GliaSite radiation therapy system, a balloon catheter device for the delivery of brachytherapy in brain cancer patients. IsoRay recently acquired the GliaSite technology from Proxima Therapeutics, which already had FDA and CE approval for it since 2001.
The catheter has a dual balloon system, with the inner balloon designed to hold a liquid radioactive source and the outer balloon providing an extra safety layer in case of damage to the inner balloon. It is inserted into the surgical cavity after tumor removal and inflated with radioactive liquid. This way, high doses of radiation can be delivered locally at the tumor site and its surroundings where recurrence is most likely, while saving the rest of the brain from excessive radiation as happens in external beam-radiation. The radioactive liquid is inserted approximately one week after surgery and remains in place for several days.
Currently, Iotrex (iodine-125) is used as the liquid radiation source, however the company plans to market the GliaSite with its proprietary isotope cesium-131 (Cs-131). Cesium-131 is already available in seed form for the treatment of various types of cancer, but the liquid form still awaits FDA clearance. It has a five times shorter half-life (9.7 days) than iodine-125 (59.4 days), resulting in dose deposition over a shorter period, possibly making tumor recurrence less likely.
Press release: FDA Clears IsoRay’s GliaSite Treatment For Brain Cancer…
Video of brain tumor surgery followed by GliaSite implantation: ORLive…
Product page: IsoRay GliaSite…