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The Isoray Medical, Inc. Cs-131 Implant Devices with SiriusTM MRI Markers are indicated for the treatment of malignant prostatic disease. These devices may be used as a primary treatment or in conjunction with other modalities. The MRI Markers are used to facilitate the anatomical localization of seeds after they have been implanted.

The Isoray Medical, Inc. Cs-131 Implant Devices with Sirius™ Markers are a combination of two commercially available devices: The Isoray Medical Cs-131 Implant Devices, and the Sirius™ MRI Markers. They come in two configurations and listed below: - Isoray Medical, Inc. Cs-131 PL-7 Preloaded Strands with Sirius™ Markers - Isoray Medical, Inc. Cs-131 PL-8 Preloaded Strands with Sirius™ Markers in 18G Needles ● The Sirius™ MRI Markers combined with the Isoray Cesium-131 Implant Devices will be used to facilitate the anatomical location of seeds after they have been implanted in the prostate of a patient with confirmed prostatic malignancy. The Cs-131 Implant Devices are a small, cylindrical, sealed source that consists of a welded pure titanium capsule containing the low energy gamma (x-ray) emitting isotope, Cesium-131 (Cs-131), adsorbed onto an internal inorganic substrate. The external seed dimensions are 4.5 mm length and 0.8 mm diameter and the only patient-contacting material is commercially pure titanium. The Sirius™ MRI markers consist of a sealed polyether ether ketone (PEEK) polymer capsule containing a cobalt chloride: N-Acetylcysteine solution. The Sirius™ MRI Marker is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuclide brachytherapy seeds containing one of the following isotopes: lodine-125, Palladium-103 or Cesium-131. The Sirius™ MRI Markers combined with the Isoray Cesium-131 Brachytherapy Seeds will be used to facilitate the anatomical location of seeds after they have been implanted. The spacers are used to maintain the exact locations and separation distances between the seeds as indicated on the treatment plan prepared by the physicist. They are made of PLA/PGA copolymer and are absorbable. The spacer length is variable since it is a function of how many seeds are required by the patient treatment plan. The spacers are 0.8mm in diameter. The Cs-131 Implant Devices with MRI Markers comes in two (2) configurations as listed in the table below. The seeds, spacers, and Sirius™ MRI markers are arranged in a precise pattern in order to maintain the exact locations and separation distances between the seeds as indicated on the treatment plan prepared by the physician or medical physicist. There are no product specific guidance documents or product specific standards for brachytherapy seeds. The subject devices are EtO sterilized and are a single-use device.

The GliaSite RTS 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, Iotrex™ Radiotherapy Solution, and the GliaSite RTS Access Tray. 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 is provided in three balloon sizes: 2 cm, 3 cm, and 4 cm. lotrex is an 129 radiotherapy solution and is the radiation source to be used with the GliaSite RTS. The GliaSite RTS Access Tray contains the items needed for the afterloading and retrieval of the lotrex Radiotherapy Solution.

Proxcelan™ (Cesium-131) Implant Devices containing cesium-131 brachytherapy seeds are indicated for the treatment of malignant disease (e.g. head and neck, brain, breast, lung, prostate, eye, etc.) and may be used in surface, interstitial, and intracavity 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 a treatment for residual disease after excision of primary tumors.

The Proxcelan (Cesium-131) Implant Devices are single use, prescription devices consisting of IsoRay Model CS-1 Brachytherapy Seeds that are combined with bioabsorbable spacers and preloaded into bioabsorbable hollow strands or 18 gauge brachytherapy needles for implant. The Implant Devices are designed to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for the treatment of malignant disease. These Implant Devices are described as follows: PL-1 Cs-131 Preloaded Strands, PL-2 - Cs131 Preloaded Strands in 18 Gauge Needles, PL-3 - Cs131 Preloaded 18 Gauge Needles.

Proxcelan™ (Gesium-131) Implant Devices, Model PL-5 – Cs-131 Preloaded Braided Strands, containing cesium-131 brachytherapy seeds are indicated for the treatment of malignant disease (e.g. head and neck, brain, breast, lung, prostate, eye, etc.) and may be used in surface, interstitial, and intracavity applications for tumors with known radiosensitivity. These devices may be used as a rimary treatment or in conjunction with other treatment modalities, such as external beam radiation therapy, chemotherapy or as a treatment modalites, after excision of primory tumore after excision of primary tumors.

The Proxcelan (Cesium-131) Implant Devices, Model PL-5 – Cs-131 Preloaded Braided Strands are single use, prescription devices, will consisting of IsoRay Model CS-1 Brachytherapy Seeds that are preloaded into into a body series of the Implant Devices are designed to be preloaded into into a body cavity or tissue as a source of nuclear radiation for the treatment of malignant disease. The PL-5 – Cs-131 Preloaded Braided Braided Strands consist of a series of Proxcelan (Cesium-131) Brachytherapy Seeds held in place within a bioabsorbable braided sleeve (or strand). The seeds are arranged in a precise pattern in order to maintain the exact locations and separation distances between the seeds as indicated on a treatment plan prepared by the physician or medical physicist for an individual patient. If required by the treatment plan, the braided strands containing the brachytherapy seeds may be woven into a bioabsorbable mesh supplied as a kit component for implant. A (non-patient contact) needle may also be provided either attached or unattached to the braided strand to attach it to the mesh.