Medtronic Receives FDA Clearance for Vessel-Sealing Instrument for Robotic Surgery

As robotic-assisted surgery expands across U.S. hospitals, teams increasingly seek energy instruments with the familiarity and performance of tools used in open and laparoscopic procedures. Rapid, reliable vessel sealing with limited thermal spread is essential during demanding surgical steps. Supporting this need, a newly cleared device brings established vessel-sealing technology to a major robotic surgical system in the United States.

Medtronic has received U.S. Food and Drug Administration (FDA) clearance for the LigaSure RAS Maryland instrument for use with the Hugo robotic-assisted surgery (RAS) system. The clearance expands the instrument options on Hugo and introduces the company’s vessel-sealing technology to U.S. surgeons performing robotic procedures. In the U.S., the Hugo RAS system is cleared for use in urologic surgical procedures and is in commercial use at a growing number of health systems and hospitals.

Designed exclusively for the Valleylab FT10 energy platform on the Hugo RAS system, the LigaSure RAS Maryland instrument seals and cuts vessels, thick tissue, and lymphatics up to and including 7 mm in diameter. The device seals vessels in approximately two seconds while minimizing thermal spread to surrounding tissue. It is the first robotic-driven instrument in the LigaSure portfolio, which has been used in more than 45 million procedures across more than 65 countries over the last two decades.

The LigaSure RAS Maryland instrument was introduced on the Hugo system in Europe in 2025 following CE Mark. Outside the U.S., the Hugo RAS system is in use across more than 35 countries and supports more than 50 surgical procedures within urology, general surgery, and gynecology. In the U.S., the company is continuing to progress plans to expand Hugo indications to a broader range of soft-tissue procedures, including general and gynecologic surgery.

“Vessel sealing sits at the center 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. Bringing that same performance to the Hugo RAS system in the U.S. means surgeons carry the confidence and control they already rely on into their robotic-assisted cases,” said Dr. Matthew Kroh, chief medical officer within the Surgical business at Medtronic and a practicing surgeon.