Hugo RAS System Demonstrates Safety and Efficacy Far Exceeding Targets in Largest Robotic-Assisted Urologic Surgery Trial to Date

Medtronic Announces Successful Achievement of Primary Safety and Effectiveness Endpoints in its Expand URO Investigational Device Exemption (IDE) Clinical Study at AUA2025 – The Largest Robotic-Assisted Urological Surgery Study to Date. This prospective, multicenter, single-arm IDE study enrolled 137 patients using...HugoPatients undergoing urological surgery with surgical robots.

Research Data

• Safety:The incidence of Grade 3 or higher complications was significantly lower than the preset target (Prostatectomy 3.7% vs. 20%, p=0.0006; Nephrectomy 1.9% vs. 20%, p=0.0001; Cystectomy 17.9% vs. 45%, p=0.0025), with the target values set based on a systematic review of literature for the three types of surgeries.

• EffectivenessThe surgical success rate was 98.5%, far exceeding the preset goal of 85% (p<0.0001). Only 2 cases were converted to open surgery, 1 related to equipment and 1 due to the patient's anatomical structure.

The data of this study wereRated by the American Urological Association (AUA) as "Clinical Trials with Transformative Significance (P2 Level) in the Field of Urology" research data.

PI Evaluation

"The study confirmed that the Hugo RAS system met the endpoints for safety and effectiveness, with results consistent with published data in the literature on robot-assisted urological surgery. As the operator of the first surgical case in the Expand URO clinical study, I am extremely gratified to see the achievements of this rigorous and significant research in the field of robotic surgery."

---Michael R. Abern Duke University Hospital

Executive Evaluation

"The Expand URO study provides critical clinical evidence for the Hugo RAS system, marking an important step toward our goal of offering long-awaited robotic technology options to surgeons in the United States. Robotic technology, empowered by minimally invasive approaches and innovative science, is reshaping the future of surgery and helping doctors deliver better treatment outcomes for patients."

---James Porter Chief Medical Officer of Robotic Surgery and Digital Technology, Medtronic Surgical Business

CurrentlyHugoHas been clinically applied in more than 25 countries across five continents globally, with over 200 independent papers published cumulatively.By adopting a modular design, an open console, and intelligent connectivity with the Touch Surgery ecosystem, it creates a flexible and collaborative surgical experience, aiming to enable more patients to benefit from minimally invasive technology.

Announced simultaneously that it has submitted to the FDAHugoRegistration Application (Urology Indications), and is well-prepared to enter the world's largest robotic surgery market. In addition, last year Medtronic completed patient enrollment for hernia and benign gynecology (GYN) studies, and received approval to initiate a new clinical study including gynecological oncology surgeries, paving the way for future expansion in the U.S.HugoIndications lay the foundation.

According to the previous registrationIf things go quickly, it could be approved for market release by the end of this year or early next year. Once approved, it will be...Another Milestone in the History of Soft Tissue Surgical Robots.

HugoIt is a modular multi-quadrant surgical platform designed for a wide range of soft tissue surgeries. It combines wristed instruments, 3D visualization, and Touch Surgery Enterprise (a cloud-based surgical video capture and management solution).Powered by artificial intelligence, enabling surgeons to seamlessly record, analyze, and share Hugo case footage.), as well as a dedicated support team specializing in robotic procedure optimization, services, and training.

Hugo Advantages

• Designed by surgeons - Built for surgeons

HugoIt was co-designed with surgeons around the world to make robotic-assisted surgery possible.

• Modular and Portable

• Technology Sharing

• Safe and Seamless Video Recording Options

Analyze and improve the surgical process anytime, anywhere through touch surgery

• Function Optional

Aimed at reducing the total cost of ownership and optimizing robot utilization.

Medtronic