Hugo robot-assisted surgery system launches on US market

The first US commercial surgical case using the Hugo robot-assisted surgery (RAS) system has been completed following the device’s recent clearance by the FDA for urologic procedures, Medtronic announced in a news release.¹

According to a company, the procedure was completed by Jihad Kaouk, MD, professor and chair of the Glickman Urologic Institute and the Zegarac-Pollock Endowed Chair in Robotic Surgery at Cleveland Clinic in Cleveland, Ohio. Kaouk performed a robot-assisted prostatectomy using the device, and the patient was discharged on postoperative day 1.

"This case exemplifies Cleveland Clinic's mission to lead surgical innovation and expand access to minimally invasive surgery," Kaouk noted in the news release.¹ "The new technology allows us to customize the approach for each patient case."

Data on the Hugo System

The milestone follows FDA clearance of the Hugo RAS system in December 2025 for use in minimally invasive urologic surgical procedures, including prostatectomy, nephrectomy, and cystectomy.² The clearance was supported by data from the Expand URO Investigational Device Exemption (IDE) study (NCT05696444), which met its primary efficacy and safety end points, supporting use of the Hugo System in patients undergoing urologic procedures.^3,4

In total, the study enrolled 137 patients who underwent a urologic procedure with the Hugo RAS system. Of these, 55 underwent prostatectomy, 29 underwent cystectomy, and 53 underwent partial (n = 36) or radical (n = 17) nephrectomy. The average age of participants was 63 years. Most patients (72.3%) were classified as American Society of Anesthesiologists category 3 or greater, indicating that they had severe systematic disease or a condition impacting their overall health.

The primary effectiveness end point for the study was surgical success rate, defined as no conversion (the case did not switch to another FDA-cleared robot-assisted device, laparoscopy, or open surgery following the first incision). The primary safety end point was the rate of patients with grade 3 or higher Clavien-Dindo complications from incision to 30 days following surgery.

Overall, the trial met its primary end points. The surgical success rate was 98.5% (95% CI, 94.8% to 99.8%), which exceeded the performance goal of 85% (P < .0001). There were a total of 2 conversions, both of which occurred in the renal cohort.

The study also met its safety end point, demonstrating low rates of grade 3 or higher Clavien-Dindo complications across all 3 procedures. Specifically, the rate of grade 3 or higher complications was 3.7% (95% CI, 0.5% to 12.7%; P = .0006) in the prostatectomy arm, 17.9% (95% CI, 6.1% to 36.9%; P = .0025) in the cystectomy arm, and 1.9% (95% CI, 0.0% to 10.3%; P = .0001) in the nephrectomy arm, all which fell below their performance goals of 20%, 45%, and 20%, respectively.

About the Hugo System

The Hugo system features modular arms, which may help address operating room scheduling challenges and infrastructure limitations, according to Medtronic. The system also builds on the company’s other surgical offerings such as the Touch Surgery ecosystem, which is an AI-powered solution that enables recording and analysis of surgical videos. 

The Hugo System is currently available for use in more than 35 countries around the world. Medtronic has indicated plans to pursue additional indications for the device in gynecologic and general surgery, including hernia repair.

"We are excited that the first commercial case in the US using the Hugo RAS system has been successfully completed by Dr. Kaouk and his team. Their pioneering spirit and collaboration reflect our shared vision that with new technology, like Hugo, more patients can access the benefits of minimally invasive surgery," said Rajit Kamal, vice president and general manager of Robotic Surgical Technologies within the Surgical business of Medtronic, in the news release.¹ "The future of surgery isn't about robotics as a separate modality, it's about technology that enables surgical teams to deliver the best possible care for every patient. Medtronic is uniquely positioned to do that as the only company in the world that can partner with surgeons and hospitals across open, laparoscopic, and robotic-assisted surgery."

REFERENCES

1. Medtronic announces first surgery with Hugo™ robotic-assisted surgery system in the U.S. performed at Cleveland Clinic. News release. Medtronic. February 17, 2026. Accessed February 17, 2026. https://news.medtronic.com/2026-02-17-Medtronic-announces-first-surgery-with-Hugo-TM-robotic-assisted-surgery-system-in-the-U-S-performed-at-Cleveland-Clinic

2. Medtronic announces FDA clearance of Hugo™ robotic-assisted surgery system for urologic surgical procedures. News release. Medtronic. December 3, 2025. Accessed February 17, 2026. https://news.medtronic.com/2025-12-03-Medtronic-announces-FDA-clearance-of-Hugo-TM-robotic-assisted-surgery-system-for-urologic-surgical-procedures

3. Abern M, Wiklund P, Goh AC, et al. A prospective, multi-center study assessing effectiveness, safety, and performance of the HUGO robotic-assisted surgery system in the US urologic population: Primary results from the Expand URO IDE study. J Urol. 2025;213(5S2):e4. doi:10.1097/01.JU.0001111604.90306.91.07

4. Medtronic Expand URO U.S. clinical trial meets safety and effectiveness primary endpoints for Hugo™ robotic-assisted surgery system. News release. Medtronic. April 26, 2025. Accessed February 17, 2026. https://news.medtronic.com/2025-04-26-Medtronic-Expand-URO-U-S-clinical-trial-meets-safety-and-effectiveness-primary-endpoints-for-Hugo-TM-robotic-assisted-surgery-system