The US Food and Drug Administration (FDA) has cleared Medtronic’s Hugo robotic-assisted surgery (RAS) system for use in urologic surgical procedures. With FDA clearance, the Hugo RAS system is indicated for use in about 230,000 minimally invasive urologic surgical procedures per year in the US.
Earlier this year, the company published the Expand URO investigational device exemption clinical study – the largest study ever completed for multi-port robotic-assisted urological surgery in the US. The study demonstrated that the Hugo RAS system met primary safety and effectiveness endpoints in urologic surgical procedures, with outcomes that were consistent with published literature.
Rajit Kamal, Vice President and General Manager of Robotic Surgical Technologies within the Surgical business of Medtronic, said: “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.
“As we begin our purposeful launch of the Hugo RAS system in the US, 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.”
More than 30 countries
Dr James Porter, a urologic surgeon and chief medical officer for Robotic Surgical Technologies and Digital Technologies within the Surgical business at Medtronic, said the announcement represented “a new and exciting approach to robotic-assisted surgery”.
“We’re excited for surgical teams in the US to experience the differentiated technology and partnership from Medtronic, which supports them at every stage of their robotic surgical journey,” Dr Porter said.
To date, the Hugo system has been used in more than 30 countries across five continents. It is expected that indication for the system will expand to include general and gynaecologic procedures.
The system connects 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.
