First patient enrolled in U.S. clinical trial for Hugo robotic-assisted surgery system
Medtronic plc announced the first patient enrolled in the Expand URO U.S. clinical trial for the Hugo robotic-assisted surgery (RAS) system
The robotic-assisted prostatectomy procedure was performed by Dr. Michael R. Abern at Duke University Hospital in Durham, N.C.
Minimally invasive surgery, including robotic-assisted surgery, offers fewer complications, shorter hospital stays, faster return to normal activities, and smaller scars. Urologic procedures are one of the most commonly performed with the assistance of a surgical robot. The Hugo RAS system is intended to be used in this study for urologic surgical procedures including radical prostatectomy, radical cystectomy, and nephrectomy (partial or radical) procedures at sites in the U.S.
The Expand URO clinical trial is being conducted pursuant to an Investigational Device Exemption from the FDA. Up to 122 patients will be enrolled in the study at six sites in the U.S. Dr. James Porter, a urologic surgeon at Swedish Medical Center in Seattle, WA, is the principal investigator of the U.S. Expand URO study.
The Hugo RAS system, combined with Touch Surgery Enterprise, offers a smart, digitally enabled surgical experience. Outside the U.S., it is in use at hospitals across three continents in a range of procedures within urology, gynecology, and general surgery.
The Hugo RAS system is commercially available in certain geographies. Regulatory requirements and status in individual countries and regions will determine market availability of the Hugo RAS system and approved indications. In the U.S., the Hugo RAS system is an investigational device not for sale.
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