Device Dossier

TheraSleeve - Radionuclide source, therapeutic, brachytherapy, manual, permanent implant

Device Dossier for TheraSleeve - Radionuclide source, therapeutic, brachytherapy, manual, permanent implant (Radionuclide source, therapeutic,…

Intended purpose

AgX100 seeds with an activity range of 0.198 mCi to 0.898 mCi are indicated for permanent interstitial treatment of localized prostate cancer. The seeds may be used as primary treatment as monotherapy, or combined with other modalities such as external beam radiation therapy and/or androgen deprivation therapy.

Functional description

The device consists of implanted seeds that deliver localized radiotherapy by passively emitting low-energy ionizing radiation from an Iodine-125 (I-125) source. Once implanted at the treatment site, the seeds emit photons that interact with surrounding tissue, causing cellular damage through ionization and inhibiting cell replication to achieve the intended therapeutic effect.

TGA Public Summary