Merit Medical Systems recently enrolled the first patient in a prospective study for its Scout breast localization system.
Scout is a wireless, radar-guided localization system used to assist breast surgeons in identifying biopsied tumors for removal during breast-conserving surgery. The study aims to enroll 500 patients to add to current literature supporting the use of the Scout system by improving efficiency in patient care between biopsy and surgery.
Merit said the study will include patients with high-risk breast lesions categorized as BI-RADS 4C or 5. Outcomes will be assessed from the initial placement of the Scout reflector during biopsy to its removal.
Pathology reports following this will include Scout's impact on the number of patient visits for invasive procedures between biopsy and surgery, as well as additional postmarket data on the system's safety and efficacy. The company added that patient and clinician satisfaction with the device will also be evaluated.