Clinical safety and efficacy of a fully automated robot for magnetic resonance imaging-guided breast biopsy

Background Magnetic resonance imaging (MRI)-guided biopsies are an accurate, but technically challenging, method for screening and diagnosis of breast lesions. This study assesses the safety and efficacy of an Image Guided Automated Robot (IGAR) in performing breast biopsies compared to manual procedures. Methods Safety was determined from adverse events (AEs) and device deficiencies. Efficacy was assessed using targeting accuracy, number of successful biopsies, pain and scar scores, patient discomfort, and radiologist-determined ease-of-use. Results All seven procedures in phase I were successfully and safely completed with no AEs and one device deficiency. The 23 IGAR biopsies in phase II outperformed the 18 manual biopsies in 1-week pain scores (p = 0.027), scarring at 1-week (p = 0.035), 1-month (p = 0.004), and components of comfort and ease-of-use. Phase II had seven and three AEs in the IGAR and manual groups, respectively (p = 0.317), with no serious AEs and nine device deficiencies. Conclusions The IGAR system is safe and effective for breast biopsy procedures. The results from these trials indicate the IGAR system as a potentially viable alternative to manual breast biopsy procedures.