The SAVI Applicator Kit is intended for use as an accessory to commercially available remote afterloading equipment used during brachytherapy procedures. The multiple lumens of the SAVI Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.
The safety and effectiveness of the SAVI Applicator Kit for breast brachytherapy as a replacement for whole breast irradiation in the treatment of breast cancer has not been established.
The SAVI SCOUT Reflector is intended to be placed percutaneously in breast tissue to mark (>30 days) a biopsy site or a lumpectomy site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (SAVI SCOUT System) the SAVI SCOUT Reflector is located and surgically removed with the target tissue. The SAVI SCOUT System is intended only for the non-imaging detection and localization of the SAVI SCOUT Reflector that has been implanted in a breast biopsy site or a lumpectomy site intended for surgical removal.