Medtronic announces FDA clearance for LigaSure™ RAS Maryland instrument on the Hugo™ RAS system

Trusted vessel-sealing technology used in more than 45 million procedures worldwide is now cleared for robotic-assisted surgery in the U.S.

GALWAY, Ireland, Sept. 16, 2026 /PRNewswire/ -- Medtronic (NYSE: MDT), a global leader in healthcare technology, today announced the U.S. Food and Drug Administration (FDA) has cleared the LigaSure™ RAS Maryland jaw device for use with the Hugo™ robotic-assisted surgery (RAS) system. The clearance expands the instruments available on the Hugo RAS system and brings Medtronic's trusted vessel-sealing technology to U.S. surgeons performing robotic-assisted procedures.

As robotic-assisted surgery adoption grows in the U.S., surgeons increasingly expect the same trusted energy instruments in a robotic workflow that they rely on in open and laparoscopic settings. The LigaSure RAS Maryland instrument meets that expectation, pairing a versatile robotic platform with vessel-sealing technology surgeons already know.

"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 Dr. Matthew Kroh, chief medical officer within the Surgical business at Medtronic and a practicing surgeon. "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 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. The company is continuing to progress its plans to expand Hugo indications to a broad range of soft-tissue surgical procedures in the U.S., including general and gynecologic surgical procedures. 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.

Designed exclusively for use with 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, sealing vessels in approximately 2 seconds while minimizing thermal spread to surrounding tissue. As the first-ever robotic-driven LigaSure™ instrument, it incorporates vessel-sealing technology used in more than 45 million procedures across 65+ countries over the last two decades. The LigaSure RAS Maryland instrument was introduced on the Hugo™ RAS system in Europe in 2025 following CE Mark.

The addition of the LigaSure™ RAS Maryland instrument reflects Medtronic's commitment to meeting surgeons' needs across open, laparoscopic, and robotic-assisted surgical modalities, giving surgeons and health systems the choice and partnership to meet each patient's unique needs and build successful surgery programs.

Learn more at medtronic.com/LigaSureOnHugo.

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow on LinkedIn.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

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SOURCE Medtronic plc