Medtronic initiates U.S. IDE study of Hugo robotic-assisted surgery system

Medtronic (MDT) announced the start of the Embrace Gynecology investigational device exemption U.S. clinical study to evaluate the safety and effectiveness of its Hugo robotic-assisted surgery system in robotic-assisted gynecological procedures. The first procedures, total hysterectomies, were successfully completed at AHN West Penn Hospital in Pittsburgh, PA, by Dr. Sarah Crafton and Dr. Eirwen Miller, Embrace Gynecology study surgeons at Allegheny Health Network. Embrace Gynecology is a prospective multicenter study to evaluate the safety and effectiveness of the Hugo RAS system when used during hysterectomy procedures, inclusive of those being treated for malignancies. The study will enroll up to 70 patients across up to 5 U.S. hospitals.