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RadioMed™ Soft Tissue Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.

The RadioMed™ Soft Tissue Marker is a non-sterile device, in the form of a gold coil that ranges in OD between 0.75mm and 1.2mm. The RadioMed™ Soft Tissue Marker is packaged non-sterile, single use, and is to be sterilized by the end user in accordance with a validated sterilization process. Sterilization is achieved by exposure to steam autoclave. The RadioMed™ Soft Tissue Marker will be manufactured, labeled, and packaged in accordance with the current FDA QSR. To ensure compliance to specifications, upon completion of the manufacturing process the device will be inspected and tested in accordance with RadioMed standard operating procedures. The RadioMed™ Soft Tissue Marker will be delivered using either a 17 gauge or 18 gauge needle and stylet.

The RadioMed"10 Source with activities from 0.1 to 5.0mCi per centimeter is indicated for temporary or permanent interstitial implantation or surface application to treat selected localized turnors. They can be used either as primary treatment (such as for prostate cancer or unresectable tumors) or as treatment for residual disease after excision of primary or recurrent tumors. The Pd-103 sources may be used concurrently with or following treatment with other interventions, such as external beam therapy, hyperthermia, or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate and other accessible tumors are commonly treated.

The RadioMed™ source utilizes Pd-103 as the radionuclide for brachytherapy. The RadioMed The Source exists in the form of a coiled rhodium wire. The rhodium matrix also provides the radiopacity of the device. The RadioMed™ Source is a naturally sealed source in the form of a wire. The RadioMed The Source is packaged non-sterile, single use, and is intended to be sterilized by the end user in accordance with a validated sterilization process. Sterilization is accomplished by exposure to steam autoclave. The RadioMed" Source will be manufactured. labeled and packaged under GMP controls. Upon completion of the manufacturing and assembly process the device will be inspected to assure compliance to specifications. The devices will be tested in accordance with Standard Operating Procedures. The sources are delivered in the same manner as brachytherapy seeds currently on the market, i.e. a 17 or 18-gauge needle and stylet.