GALWAY, September 18 — Medtronic announced this week that the U.S. Food and Drug Administration has cleared the LigaSure RAS Maryland jaw device for use with the company’s Hugo robotic-assisted surgery system, expanding the instruments available to U.S. surgeons on the platform. The clearance, dated Sept. 16, brings Medtronic’s LigaSure vessel-sealing technology into robotic-assisted procedures in the United States. The company describes the LigaSure RAS Maryland as the first-ever robotic-driven LigaSure instrument.
It is designed exclusively for use with the Valleylab FT10 energy platform on the Hugo RAS system, and it seals and cuts vessels, thick tissue, and lymphatics up to and including 7 mm in diameter — sealing vessels in approximately 2 seconds while minimizing thermal spread to surrounding tissue. For patients, the practical question is what a surgeon can do inside the body with steadier, more controlled tools.
LigaSure vessel-sealing technology, according to Medtronic, has been used in more than 45 million procedures across 65-plus countries.
A surgeon’s view from inside Medtronic
Dr. Matthew Kroh, chief medical officer within the Surgical business at Medtronic and a practicing surgeon, said in a company statement that vessel sealing sits at the center of how surgeons work through the most demanding moments of a procedure, and that surgeons have trusted LigaSure across open and laparoscopic surgery for decades. He added that 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.
The Hugo RAS system is currently cleared for use in urologic surgical procedures in the U.S. and is in commercial use at a growing number of leading health systems and hospitals across the country, Medtronic said. The company said it is continuing to progress plans to expand Hugo indications to a broad range of soft-tissue surgical procedures in the U.S., including general and gynecologic surgical procedures.
Where Hugo already operates
Outside the U.S., the Hugo RAS system has positively impacted the lives of tens of thousands of patients across more than 35 countries, spanning more than 50 different surgical procedures within urology, general, and gynecology indications, according to the company. The announcement was made via PR Newswire from Galway, Ireland, where Medtronic is headquartered. The company trades on the New York Stock Exchange under the ticker MDT.
Medtronic disclosed no financial terms or specific pricing for the LigaSure RAS Maryland instrument, and it did not provide a specific timeline for when the instrument would be commercially available in the U.S. or when additional Hugo indications might be cleared. The clearance represents a step in Medtronic’s efforts to compete in the growing robotic-assisted surgery market, where the company is positioning Hugo as a platform that integrates its established energy devices.
It follows Medtronic’s ongoing strategy to expand its surgical robotics footprint and leverage its LigaSure franchise, which the company says is trusted in open and laparoscopic surgery. What to watch next: whether Medtronic sets a U.S. commercial launch date for the LigaSure RAS Maryland instrument, and whether the FDA clears the broader soft-tissue indications — general and gynecologic procedures — that would widen the pool of patients whose operations could be performed on Hugo. Consult your doctor for medical advice.
