We evaluated the usefulness and safety of a handheld vacuum-assisted biopsy system (VACORA®) in 253 lesions suspected to be malignant. Biopsy samples were successfully obtained from 252 lesions, and no complications occurred that required other treatments during or after the biopsy. The definitive diagnosis rate using VACORA / ®was 89.3% (226/253). For 27 lesions, biopsy using Mammotome®or open biopsy was performed because a diagnosis could not be made with the VACORA® system, despite a category 4 result on ultrasonography. The lesions that were diagnosed as benign using the VACORA® system did not manifest malignant features during the observation period (1-36 months). We considered the VACORA® biopsy system as an effective technique that has both convenience and high diagnostic accuracy.