Medtronic (NYSE: MDT) has secured US Food and Drug Administration clearance for its LigaSure RAS Maryland instrument on the Hugo robotic-assisted surgery system, giving surgeons operating on the platform their first robotic-driven bipolar vessel-sealer inside the United States.
The first robot-native LigaSure lands on Hugo
The LigaSure RAS Maryland is designed to seal and cut vessels, thick tissue and lymphatics up to 7 mm in diameter in roughly two seconds while limiting thermal spread to adjacent structures. The instrument runs on the Valleylab FT10 energy platform that already powers open and laparoscopic LigaSure devices, so hospitals adopting the robotic version do not have to swap out their generators. The device was cleared in Europe last year following CE Mark approval, and this clearance opens the US installed base to the same workflow.
Why it matters for Hugo
Hugo is Medtronic's answer to Intuitive Surgical's dominant da Vinci franchise. In the US the system is cleared for urologic procedures and running at a growing set of leading health systems, with general and gynaecologic indications lined up next. Outside the US, Hugo is now in more than 35 countries and used across 50-plus surgical procedures — but until this clearance, US surgeons on Hugo had to fall back to laparoscopic LigaSure for vessel sealing during hybrid steps. Bringing the robotic-driven version onto the platform gives Medtronic a tighter answer to a persistent Hugo pitch friction point.
An installed base built on 45 million procedures
LigaSure has been used in more than 45 million procedures across 65 countries over the last two decades, according to Medtronic, and the RAS Maryland variant carries the same core sealing algorithm forward. "Vessel sealing sits at the centre of how surgeons work through the most demanding moments of a procedure, and surgeons have trusted LigaSure to do it across open and laparoscopic surgery for decades," said Dr. Matthew Kroh, chief medical officer of Medtronic Surgical, adding that a robot-native option extends that trust into more indications.
What comes next
Medtronic said it is preparing follow-on Hugo instrument clearances as it works toward broader indications. The company's competitive push against Intuitive is expected to intensify through 2027 as Hugo's expanded instrument catalogue reaches the field. Analysts covering surgical robotics see the LigaSure RAS Maryland clearance as one of the most operationally meaningful additions to Hugo in the US since the platform's first urology nod.
Reporting based on coverage from BioSpace, Medtronic and MedTech Dive.