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The GliaSite RTS with Cesitrex, (Liquid 131CsCl), is intended to deliver intracavity radiation therapy (brachytherapy) in patients with malignant brain tumors following tumor resection surgery.

The GliaSite® RTS is a radiation therapy system that includes the GliaSite Catheter Tray, GliaSite Access Tray, and Iotrex®, (125)-HBS) or Cesitrex, (liquid 131CsCI) Radiotherapy Solutions. The GliaSite Catheter Tray includes the GliaSite catheter and accessories to assist with the implantation of the catheter. The GliaSite catheter is a double balloon applicator that positions the radiation source within the resected cavity for radiation delivery. The GliaSite RTS Catheters are provided in three balloon sizes: 2 cm, 3 cm, and 4 cm. The GliaSite RTS Access Tray contains the items needed for the afterloading and retrieval of the Iotrex or Cesitrex. Iotrex and Cesitrex radiotherapy solutions are the radiation sources that can be used with the GliaSite RTS.

The IsoRay Medical, Inc. Cesium-131 Implant Devices are indicated for the treatment of malignant disease (e.g., head and neck, brain, breast, prostate, etc.), and may be used in surface, interstitial, and intracavitary applications for tumors with known radiosensitivity. These devices may be used as a primary treatment or in conjunction with other treatment modalities, such as external beam radiation therapy, chemotherapy or as treatment for residual disease after excision of primary tumors. The Cesium-131 Implant Devices have the same indications for use as the original device, the IsoRay Medical, Inc. Cs-131 Brachytherapy Seed, Model CS-1.

The IsoRay Medical, Inc. Cesium-131 Strand, Model PL-1, contains absorbable seeding spacers and Cs-131 Brachytherapy Seeds enclosed in a bio-absorbable brachytherapy sleeve and sterilized using ethylene oxide. The seeds and spacers are arranged according to a treatment plan provided by a physician or medical physicist. For the IsoRay Medical, Inc. Cesium-131 Strand Preload, Model PL-2, each Cesium-131 Strand, Model PL-1, is placed in a brachytherapy needle which is pre-plugged with bone wax to hold the strand in position. The arrangement of the seeds and spacers and the strands in the needles is dictated by the treatment plan. The strands are sterilized after loading into needles using ethylene oxide. The IsoRay Medical, Inc. Cesium-131 Preload, Model PL-3, contains absorbable seeding spacers and Cs-131 Brachytherapy Seeds within a brachytherapy needle which is pre-plugged with bone wax to keep the seeds and spacers in position. The arrangement of the seeds and spacers in each needle is dictated by the treatment plan. The preloaded needles are then sterilized using ethylene oxide. The IsoRay Medical, Inc. Cesium-131 S-Cartridge, Model PL-4 contains Cs-131 Brachytherapy Seeds, loaded into Mick® cartridges and sterilized by either steam or ethylene oxide. Note: The above-listed devices may be assembled using components with equivalent composition and function that are FDA-cleared for the same intended use or otherwise determined to be exempt or pre-amendment devices.

IsoRay, Inc. Lawrence CSERION seeds are indicated for the treatment of malignant disease (e.g., head and neck, brain, breast, prostate, etc.) and may be used in surface, interstitial, and intracavitary applications for tumors with known radiosensitivity. The seeds may be used as a primary treatment or in conjunction with other treatment modalities, such as external beam radiation therapy, chemotherapy or as treatment for residual disease after excision of primary tumors.

The IsoRay, Inc. Lawrence CSERION Model CS-1 is a small, cylindrical sealed source which contains the low energy gamma (X-ray) emitting radionuclide, cesium-131, adsorbed onto an internal inorganic substrate. The nominal external seed dimensions (4.5 mm length and 0.8 mm diameter) and patient-contacting material (titanium) are identical to predicate device(s).