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.
Michael R. Abern, M.D., national principal investigator and urologic surgeon at Duke University Hospital, remarked, “The study demonstrated that the Hugo RAS system met the safety and effectiveness endpoints, and the outcomes are consistent with published literature for robotic-assisted urologic surgery.”
Clinical Excellence Validated by Robust Outcomes
The trial featured patients with significant systemic disease (ASA ≥3) and maintained rigorous FDA premarket protocols, including prospective enrollment, independent clinical event adjudication, and a 98% 30-day follow-up compliance rate.
Key findings include:
- Surgical Success Rate: 98.5% — significantly surpassing the 85% performance benchmark (p<0.0001).
- Complication Rates: Well below literature-based targets across procedures:
- Prostatectomy: 3.7% vs. 20%
- Nephrectomy: 1.9% vs. 20%
- Cystectomy: 17.9% vs. 45%
- Low Conversion Rate: Just two cases required conversion — one device-related, one anatomy-related.
The patient cohorts were primarily treated for prostate cancer, renal tumors, or bladder tumors, with all cancer cases set for five-year follow-up monitoring.
Strategic Move Toward U.S. Market Approval
With the U.S. IDE study now meeting its primary endpoints, Medtronic has submitted the Hugo RAS system to the U.S. Food and Drug Administration (FDA) for approval for urologic indications. The FDA filing, made in Q1 2025, marks a pivotal move in Medtronic’s campaign to compete in the U.S. robotic surgery market.
“The Expand URO clinical study provides important clinical evidence about the Hugo RAS system and is an exciting milestone that brings us closer to our goal of offering surgeons in the U.S. long-awaited choice in robotic technology,” said James Porter, M.D., Chief Medical Officer of Robotic Surgical Technologies and Digital Technologies at Medtronic.
This development follows recent enrollment completions in hernia and benign gynecology studies, and the FDA’s approval for a new oncologic gynecology trial — signaling Medtronic’s intent to broaden the Hugo RAS system’s indications.
A Global Vision for Robotic-Assisted Surgery
While awaiting FDA clearance in the U.S., the Hugo RAS system is already in use across more than 25 countries spanning five continents. With over 200 independent clinical papers published, the system is steadily gaining global traction.
Designed in collaboration with hundreds of surgeons and hospital administrators, Hugo offers a modular, flexible architecture and an open surgeon console that enhances team collaboration. It integrates with the Touch Surgery™ ecosystem, creating a connected digital surgical environment aimed at improving patient outcomes and procedural efficiencies.
Driving the Future of Surgical Innovation
As the market for robotic-assisted surgery continues to expand, Medtronic’s Hugo RAS system is poised to reshape the competitive landscape by offering a high-performing, scalable alternative for hospitals and surgical teams. With FDA review underway and global use growing, Hugo is fast becoming a formidable player in the surgical robotics space.
Learn more about the Hugo RAS system and Medtronic’s vision for surgical innovation at medtronic.com/hugo.