The system is indicated for use in minimally invasive urologic surgical procedures including prostatectomy, nephrectomy, and cystectomy.
Medtronic announced the US 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 robotic-assisted platform to US surgeons and health systems seeking to expand soft-tissue robotic surgery programs.
“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,” says Rajit Kamal, vice president and general manager of robotic surgical technologies within the surgical business of Medtronic, in a release.
With FDA clearance, the Hugo RAS system is indicated for use in minimally invasive urologic surgical procedures including prostatectomy, nephrectomy, and cystectomy, procedures that account for about 230,000 surgeries per year in the US.
“The Hugo RAS system represents a new and exciting approach to robotic-assisted surgery,” says Dr James Porter, a urologic surgeon and chief medical officer for robotic surgical technologies and digital technologies within the surgical business at Medtronic, in a release. “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.”
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 consistent with published literature.
Outside the US, the Hugo RAS system has been used in tens of thousands of urologic, gynecologic, and general surgery procedures in more than 30 countries across five continents, according to a release from Medtronic. Medtronic intends to expand the Hugo RAS system’s use in the US to additional surgical specialties over time, with indications for general and gynecologic surgical procedures expected to follow the initial urology clearance.
Photo caption: The Hugo RAS system
Photo credit: Medtronic
