Medtronic’s Expand URO Study Demonstrates Strong Safety and Efficacy Results for Hugo™ Robotic-Assisted Surgery System
SHERIDAN, WYOMING – May 5, 2025 – Medtronic has announced a major milestone for its Hugo™ robotic-assisted surgery (RAS) system, as the Expand URO U.S. clinical trial met both primary safety and effectiveness endpoints. The results position the company for strategic market entry into the U.S. robotic-assisted surgery sector, the largest of its kind globally, and were presented as a late-breaking session at the American Urologic Association (AUA) annual meeting in Las Vegas.
Landmark Trial Sets New Benchmark in Robotic Urologic Surgery
The Expand URO study is the largest Investigational Device Exemption (IDE) trial conducted in the U.S. for multi-port robotic-assisted urologic procedures. Designed as a prospective, multi-center, single-arm study, it involved 137 patients across six hospitals. Participants underwent one of three common urologic surgeries — prostatectomy, nephrectomy, or cystectomy — using the Hugo RAS system.
