FDA clears LigaSure RAS Maryland instrument for use with Hugo robotic surgery system

The FDA has granted clearance to the LigaSure RAS Maryland jaw device for use with Medtronic’s Hugo robotic-assisted surgery (RAS) system, expanding access to LigaSure vessel-sealing technology within robotic surgical workflows.¹

The instrument is designed to seal and cut vessels, thick tissue, and lymphatic tissue up to and including 7 mm in diameter. According to Medtronic, it is intended for use exclusively with the Valleylab FT10 energy platform on the Hugo RAS system.

The LigaSure RAS Maryland instrument received CE mark approval in Europe in 2025.

"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," said Matthew Kroh, MD, FACS, FASMBS, FASGE, chief medical officer within the Surgical business at Medtronic and a practicing surgeon at Cleveland Clinic, Cleveland, Ohio, in a news release from the company.¹ "Bringing that same performance to the Hugo RAS system in the US means surgeons carry the confidence and control they already rely on into their robotic-assisted cases."

Instrument expands Hugo RAS energy capabilities

The LigaSure RAS Maryland device is the first robotic-driven LigaSure instrument, combining tissue dissection, vessel sealing, and cutting within a robotic-assisted surgical workflow. Medtronic reported that the device can seal vessels in approximately 2 seconds and is designed to limit thermal spread to surrounding tissue. The company also noted that the instrument can deliver consistent burst pressure performance of 360 mmHg (3 times systolic blood pressure) and effective blunt dissection.²

FDA clearance of the LigaSure device follows the FDA’s December 2025 clearance of the Hugo RAS system for adult minimally invasive urologic surgical procedures. US commercial launch of the platform was subsequently announced in February 2026.

Related: James R. Porter, MD, discusses Hugo RAS’s learning curve, modular design

The company is also planning to file for expanded indications of the Hugo RAS system across a range of soft-tissue surgical procedures, including general and gynecological surgical procedures.

REFERENCES

1. Medtronic announces FDA clearance for LigaSure™ RAS Maryland instrument on the Hugo™ RAS system. News release. Medtronic plc. September 16, 2026. Accessed September 16, 2026. https://news.medtronic.com/2026-09-16-Medtronic-announces-FDA-clearance-for-LigaSure-TM-RAS-Maryland-instrument-on-the-Hugo-TM-RAS-system

2. LigaSure technology is now on the Hugo robotic-assisted surgery (RAS) system. Medtronic. Accessed September 10, 2026. https://www.medtronic.com/en-us/healthcare-professionals/specialties/surgical-robotics/hugo-robotic-assisted-surgery/products-and-system/ligasure-ras-maryland.html?cid=VURL:MIX:Learn-More:LigaSure-RAS