Medtronic has secured EU CE mark approval for LigaSure RAS, a vessel-sealing instrument for use with the company’s Hugo robotic-assisted surgery (RAS) system.

LigaSure is indicated for sealing and cutting vessels, thick tissue, and lymphatics up to 7mm in diameter and expands Hugo’s capabilities in areas such as gynaecologic and urologic procedures. According to Medtronic, LigaSure seals vessels within two seconds and minimises thermal spread to surrounding tissue.

Medtronic senior vice-president Matt Anderson said: “With CE mark for LigaSure RAS, Medtronic is fulfilling a promise to customers to integrate our trusted vessel-sealing technology onto the Hugo RAS system.

“More than fulfilling a commitment, this regulatory approval is a big step forward as we continue to shape the future of surgery.”

Hugo has been in use in Europe since 2022 and was recently recommended by the National Institute for Health and Care Excellence (NICE) as one of 11 surgical robots set to be used across the UK National Health Service (NHS).

While Hugo is not yet available in the US, Medtronic’s submission for a urology indication for the robot is currently under review with the US Food and Drug Administration (FDA), with US market entry expected later this year.

In anticipation of Hugo’s approval with the FDA, Medtronic is currently building out its training provision for the RAS system following the introduction of live streaming to its Touch Surgery Ecosystem (TSE) last year. The broad aim of Medtronic’s surgical training provision is to enhance and democratise surgical education on a global scale, removing barriers to training such as geographic location.

With its da Vinci surgical robot, Intuitive Surgical currently holds the largest share of the global robotic surgery market at almost 60%, according to GlobalData analysis. The market is forecast to reach a valuation of $9.2bn by 2034, up from around $2.9bn in 2024.

Due to Medtronic’s size, the Hugo is expected to pose the main challenge to Intuitive’s da Vinci robot once the former is approved in the US.

According to GlobalData analyst Grayson Vigneux, due to Intuitive’s 20-year head start in the US robotic surgery market, its vast installed base and long-standing reputation, Hugo is “more likely to capture new customers rather than immediately displace Intuitive’s existing market”.