Using radiography or ultrasound guidance, the SAVI SCOUT reflector will be placed percutaneously up to 7 days prior to the scheduled excisional procedure. During surgical excision, the SAVI SCOUT system will be used to locate the reflector, which will be removed along with the surrounding breast tissue.
Final data analysis will be completed within 1 month after the last patient is treated.
Final assessment of the surgical results will be completed by the surgeon during a routine follow-up visit within 1 month following the surgical excision or lumpectomy procedure.
Main Objective: to show that the SAVI SCOUT technique can be used to safely and effectively locate a non-palpable breast lesion during a localized excisional biopsy or lumpectomy procedure.
Up to 10 sites and 150 patients will be enrolled.
