Medtronic gets USFDA clearance of Hugo robotic assisted surgery system for urologic surgical procedures

The U.S. leads the world in robotic surgery adoption, yet hospitals continue to face challenges in capacity and access.

"This is an incredibly exciting day for healthcare in the United States. FDA clearance of the Hugo RAS system means there is now choice for hospitals looking to expand their robotic programs and increases access for patients," said Rajit Kamal, vice president and general manager of Robotic Surgical Technologies within the Surgical business of Medtronic. "As we begin our purposeful launch of the Hugo RAS system in the U.S., our focus is on building a strong foundation with leading hospitals through our differentiated approach to partnership, rooted in our enduring commitment to provide an excellent customer experience and enable surgical teams to deliver the best possible outcomes for their patients."

Thoughtfully designed with input from surgeons and hospital administrators to shape the future of surgery, the Hugo RAS system includes three main differentiators:

• Modular Design: The Hugo RAS system's innovative modular design means the robotic arms can be easily moved, shared, and deployed across any care setting — helping to maximize utilization and providing surgeons flexibility to customize their approach to optimize anatomical access for each patient's unique needs. The open design of the surgeon console provides greater situational awareness and visualization, reduces physical strain, and creates enhanced training opportunities for surgical teams — enabling better bedside communication and team integration.
  
• Digital Ecosystem: The Hugo RAS system connects seamlessly with the Touch Surgery ecosystem, which provides pre-operative training tools, remote tele-proctoring capabilities, and AI-powered post-operative case insights.† Surgeons may securely access case videos seconds after a procedure is completed, supporting continuous improvement and collaboration among hospital teams and with their peers in the global surgical community.
  
• Differentiated Partnership: Medtronic is the first and only company that can meet surgeon needs across all surgical modalities — open, laparoscopic, and robotic-assisted. The addition of the Hugo RAS system provides surgical teams access to world-class robotic training, deep clinical and technical expertise, and choice when determining the best surgical approach for each patient's unique needs, with the opportunity to use trusted Medtronic technologies and instruments as technology advances.

"The Hugo RAS system represents a new and exciting approach to robotic-assisted surgery," said Dr. James Porter, a urologic surgeon and chief medical officer for Robotic Surgical Technologies and Digital Technologies within the Surgical business at Medtronic. "We're excited for surgical teams in the U.S. to experience the differentiated technology and partnership from Medtronic, which supports them at every stage of their robotic surgical journey."

With FDA clearance, the Hugo RAS system is indicated for use in minimally invasive urologic surgical procedures including prostatectomy, nephrectomy, and cystectomy — common procedures that account for about 230,000 surgeries per year in the U.S.

The Expand URO investigational device exemption clinical study demonstrated that the Hugo RAS system met primary safety and effectiveness endpoints in urologic surgical procedures, with outcomes that are consistent with published literature.

Outside the U.S., the Hugo RAS system has been used in tens of thousands of urologic, gynecologic, and general surgery procedures in more than 30 countries across 5 continents. Medtronic intends to expand the Hugo RAS system's use in the U.S. to additional surgical specialties over time, with indications for general and gynecologic surgical procedures expected to follow the initial urology clearance.

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