Medtronic's landmark clinical trial for its robotic-assisted surgery system has achieved a significant milestone, potentially paving the way for a new competitor in the U.S. robotic surgery market. The company announced today that its Expand URO Investigational Device Exemption (IDE) clinical study successfully met both primary safety and effectiveness endpoints for the Hugo™ robotic-assisted surgery (RAS) system.
The prospective, multi-center, single-arm IDE study included 137 patients who underwent urologic procedures and represents the largest such study for robotic-assisted urologic surgery ever conducted in the United States. The American Urologic Association (AUA) described the trial as a "practice-changing, paradigm-shifting (P2) clinical trial in urology."
Dr. Michael R. Abern, the study's national principal investigator and urologic surgeon at Duke University Hospital, presented the findings at the AUA annual meeting in Las Vegas. "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," said Dr. Abern. "Having performed the first case in the Expand URO clinical study, it's incredibly rewarding to see the results of this rigorous and important study in the field of robotic surgery."
Study Design and Patient Population
The Expand URO clinical study enrolled patients with an average age of approximately 63 years who were classified as American Society of Anesthesiologists (ASA) category ≥3, indicating they had severe systematic disease or conditions impacting their overall health.
Eleven surgeons across six U.S. hospitals performed three types of urologic procedures:
- Prostatectomies (prostate removal) in 55 patients
- Nephrectomies (kidney removal) in 53 patients
- Cystectomies (bladder removal) in 29 patients
The common patient cohorts included prostate cancer patients undergoing prostatectomy, renal tumor patients undergoing nephrectomy, and bladder tumor patients undergoing cystectomy.
The study was conducted with rigorous methodology consistent with FDA premarket requirements, including prospective enrollment and data collection, independent event adjudication by a Clinical Events Committee, data monitoring, and excellent follow-up compliance with approximately 98% of patients completing the 30-day follow-up. All cancer patients in the study will be followed for five years.
Impressive Safety and Effectiveness Results
The safety endpoint results were particularly notable. The rates of grade 3 or higher complications were significantly below the performance goals established based on systematic review of published literature:
- Prostatectomy: 3.7% vs. 20% goal (p=0.0006)
- Nephrectomy: 1.9% vs. 20% goal (p=0.0001)
- Cystectomy: 17.9% vs. 45% goal (p=0.0025)
For effectiveness, the study demonstrated a 98.5% surgical success rate, well above the performance goal of 85% (p<0.0001). There were only two conversions during the study: one related to the device and one related to patient anatomy.
"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 Dr. James Porter, Chief Medical Officer of Robotic Surgical Technologies and Digital Technologies within Medtronic's Surgical business. Dr. Porter, who is also a urologic surgeon at Swedish Medical Center in Seattle, added, "Surgeons want to deliver the best care to our patients and robotic technology is key to making that possible today by enabling minimally invasive surgery and leveraging technology that is shaping the future of surgery."
FDA Submission and Market Expansion Plans
Medtronic confirmed it has submitted the Hugo RAS system to the U.S. Food and Drug Administration (FDA) for a urologic indication in the first quarter of calendar 2025. This submission represents a significant step toward the company's planned entrance into the U.S., which is the world's largest robotic surgery market.
The company is not limiting its focus to urology. In February, Medtronic completed enrollment in both its hernia and benign gynecology (GYN) studies and received approval to start a new clinical study including oncologic GYN procedures—all supporting planned FDA submissions for additional indications beyond urology for the Hugo RAS system in the U.S.
Outside the United States, the Hugo RAS system is already in clinical use in more than 25 countries across five continents, with a growing body of evidence including more than 200 independent papers published to date.
Innovative Design and Future Potential
Medtronic developed the Hugo RAS system through collaboration with hundreds of surgeons and hospital leaders globally, aiming to expand access to minimally invasive care worldwide. The system features a flexible, modular form factor and an open surgeon console that supports communication among the surgical team.
When paired with the Touch Surgery™ ecosystem, the Hugo RAS system offers what Medtronic describes as a "smart, connected surgical experience" that could shape the future of surgery. The Touch Surgery ecosystem is designed for education and training purposes, not for directing surgery or aiding in diagnosis or treatment.
The Hugo RAS system is currently an investigational device not for sale in the U.S., with regulatory requirements varying by country and region determining approval, clearance, or market availability.
Potential Market Impact
If approved, the Hugo RAS system would introduce significant competition into the U.S. robotic surgery market, potentially offering surgeons and hospitals an alternative to existing platforms. The system's modular design and open console approach represent a different philosophy compared to some current market offerings.
The positive clinical results from the Expand URO study suggest that Medtronic's entry into this space could accelerate adoption of robotic-assisted surgery for urologic procedures while potentially reducing costs through increased market competition.
As robotic surgery continues to evolve, the introduction of new platforms like the Hugo RAS system may help address current limitations in access to minimally invasive surgical options, potentially benefiting more patients requiring urologic and other surgical procedures.
