AgX100 I-125 TheraStrand - Radionuclide source, therapeutic, brachytherapy, manual, permanent implant

Intended purpose

Intended to treat localized, unresectable tumors with low to moderate radiosensitivity. Tumors may be recurrent, or residual following external beam or excision of primary tumor.

Functional description

The Medical Device contains custom loaded strands of I-Seed AgX100 seeds and spacers embedded within bioabsorbable suture into brachytherapy needles. The I-Seed AgX100 is a titanium capsule containing I-125 adsorbed onto a silver rod. The seed carrier helps stabilize the seeds in the treated tissue to provide the desired dosimetry and minimize seed migration post implant. The maximum number of seeds and spacers in a strand is 12