Medtronic has announced the U.S. Food and Drug Administration (FDA) has cleared the Hugo robotic-assisted surgery (RAS) system for use in urologic surgical procedures. The Hugo RAS system’s clearance brings a versatile robotic-assisted platform to U.S. surgeons and health systems seeking to expand soft-tissue robotic surgery programs and access to minimally invasive care.
The introduction of the Hugo RAS system in the U.S. helps address a gap in robotic surgery adoption in the U.S., offering an innovative approach to robotic-assisted surgery and bringing choice to hospitals and surgeons across the country says Medtronic.
“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.”
The system’s innovative modular design means the robotic arms can be easily moved, shared, and deployed across any care setting, helping to maximise utilisation and providing surgeons flexibility to customise their approach to optimise anatomical access for each patient’s unique needs according to the company.
Medtronic claims the open design of the surgeon console provides greater situational awareness and visualisation, reduces physical strain, and creates enhanced training opportunities for surgical teams, enabling better bedside communication and team integration.
The Hugo RAS system is compatible with the Touch Surgery ecosystem, which provides pre-operative training tools, remote tele-proctoring capabilities, and AI-powered post-operative case insights. Surgeons may also securely access case videos minutes after a procedure is completed.
Medtronic claims it is the first and only company that can meet surgeon needs across all surgical modalities – open, laparoscopic, and robotic-assisted. The addition of the system provides surgical teams access to ‘world-class’ robotic training, deep clinical and technical expertise according to the company, alongside 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 surgeries.
The Expand URO investigational device exemption clinical study, the largest ever completed for multi-port robotic-assisted urological surgery in the U.S., 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.The introduction of the Hugo RAS system in the U.S. builds on Medtronic’s broad surgical offering, including the Touch Surgery ecosystem, to deliver a connected, integrated operating room, today and in the future.
