FDA clears Medtronic's LigaSure RAS Maryland vessel sealer for Hugo robotic surgery system
核心洞察
Medtronic received FDA clearance for the LigaSure RAS Maryland (搜索) jaw device, the first robotically driven LigaSure instrument, for use with its Hugo robotic-assisted surgery system.
The instrument seals and cuts vessels, thick tissue and lymphatics up to 7 mm in diameter, sealing vessels in about 2 seconds while limiting thermal spread.
The clearance brings to the U.S. a capability already available in Europe, where Medtronic obtained CE mark for the robotic vessel-sealing technology in 2025.
Medtronic has received U.S. Food and Drug Administration clearance for the LigaSure RAS Maryland (搜索) jaw device for use with its Hugo robotic-assisted surgery (RAS) system, expanding the instrument lineup available on the platform for U.S. robotic-assisted procedures. The company announced the clearance on September 16, 2026.
According to Medtronic, the LigaSure RAS Maryland (搜索) is the first robotically driven LigaSure instrument. It is built to work only with the Valleylab FT10 energy platform on the Hugo RAS (搜索) system. The company said the instrument seals and cuts vessels, thick tissue and lymphatics up to and including 7 mm in diameter, sealing vessels in approximately 2 seconds while limiting thermal spread to surrounding tissue.
The vessel-sealing technology incorporated in the instrument has been used in more than 45 million procedures across more than 65 countries over the past two decades, Medtronic said. The instrument was introduced on the Hugo RAS (搜索) system in Europe in 2025 following CE mark.
Regulatory path for Hugo in the U.S.
Medtronic received FDA clearance for the Hugo RAS (搜索) system in urologic surgical procedures (搜索) in December 2025, and the platform is in commercial use at a growing number of health systems and hospitals across the country, according to the company.
In a June 3, 2026 announcement, Medtronic said it had submitted 510(k) filings to the FDA seeking clearance for Hugo system use in general surgery, including hernia repair, and in gynecologic surgery (搜索). That release also disclosed that a 510(k) filing for the LigaSure RAS Maryland (搜索) instrument had been submitted and was pending. The clearance announced on September 16, 2026 covers that instrument.
The June announcement also disclosed FDA 510(k) clearance of ProGrip Advanced (搜索), a self-gripping polypropylene mesh cleared for use in robotic-assisted ventral hernia (搜索) repair. Medtronic said ProGrip meshes have been used in more than 6 million procedures, and that nearly 470,000 ventral hernia repair procedures are performed in the U.S. each year.
Medtronic also reported in June that it had completed enrollment in the Embrace Gynecology Investigational Device Exemption (IDE) clinical study, a prospective multicenter study evaluating the safety and effectiveness of the Hugo RAS (搜索) system in robotic-assisted gynecologic procedures. The study enrolled 70 patients at 5 U.S. hospitals.
Surgeon expectations and global use
Medtronic said that with robotic-assisted surgery adoption growing in the U.S., surgeons increasingly want the same energy instruments in a robotic workflow that they use in open and laparoscopic procedures. The company framed the 510(k) clearance as a way to meet those expectations.
"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," Matthew Kroh, chief medical officer at Medtronic's surgical business, said in a statement. "Bringing that same performance to the Hugo RAS (搜索) system in the U.S. means surgeons carry the confidence and control they already rely on into their robotic-assisted cases."
Outside the U.S., Medtronic said the Hugo RAS (搜索) system has been used with tens of thousands of patients in more than 35 countries, covering more than 50 different surgical procedures across urology, general and gynecology indications. In June, the company said the system had nearly five years of commercial use across more than 35 countries on five continents, with hundreds of independently published scientific papers supporting its safety and effectiveness.
Matt Anderson, senior vice president and president of Medtronic's Surgical business, said in June that the milestones would unlock the company's ability to enhance the value of its partnership in general and gynecologic surgical procedures. Medtronic said it continues to pursue plans to broaden Hugo's U.S. indications to a wide range of soft-tissue procedures, including general and gynecologic surgery (搜索).