Medtronic (NYSE:MDT) announced today that it enrolled the first patient in its Expand URO U.S. clinical trial for the Hugo surgical robot.
Dr. Michael R. Abern at Duke University Hospital (Durham, North Carolina) performed the procedure. He used the Hugo robotic-assisted surgery (RAS) system for a robotic-assisted prostatectomy procedure.
“This is an exciting moment,” said Dr. Abern. “Robotic-assisted surgery provides many benefits within my specialty of urology, and I’m proud to have performed the first U.S. clinical trial case with the Medtronic Hugo RAS system.”
Medtronic intended for the use of Hugo in the study across a range of urologic surgical procedures. That includes radical prostatectomy, radical cystectomy, and nephrectomy (partial or radical) procedures at sites in the U.S.
The study, conducted pursuant to an FDA investigational device exemption (IDE), will enroll up to 122 patients. It includes six sites across the U.S. Dr. James Porter, a urologic surgeon at Swedish Medical Center in Seattle, serves as principal investigator. He expects to perform his first cases under the trial this month.
“This is an exciting time for healthcare in the United States and around the world, as we have the opportunity to expand robotic-assisted surgery treatment options to more patients,” said Dr. Porter. “Backed by a growing body of clinical evidence, robotic-assisted surgery is the preferred approach within urology given the anatomical access, precision, and ergonomic advantages it enables.”
More about the Hugo surgical robot
Hugo combines with Medtronic’s Touch Surgery Enterprise to offer a smart, digitally enabled surgical experience. Itcombines wristed instruments and 3D visualization in one platform. Touch Surgery Enterprise, Medtronic’s cloud-based surgical video capture and management solution, helps to offer a multi-quadrant platform designed for a wide range of soft tissue procedures.
The system earned European approval in October 2021. Currently, hospitals across three continents use it in a range of procedures within urology, gynecology and general surgery.
Medtronic announced the first urologic and gynecology procedures with Hugo in Latin America and Asia-Pacific over the past year. The first patient procedure took place in Chile in June 2021. It soon performed the first procedure in Europe in February 2022, following its CE mark.
Hugo remains investigational in the U.S. as the clinical trial continues.
“Scientific evidence is the bedrock of healthcare technology innovation and adoption. It creates and builds trust among clinicians and patients,” said Dr. Carla Peron, M.D. CMO of the Surgical Robotics business at Medtronic. “We’re proud to further that important pursuit with the Hugo RAS system in partnership with hospitals and surgical teams in the United States who share our commitment to patients.”