Jul 15, 2025

Medtronic shaping future of surgery, secures CE Mark for LigaSure™ technology on Hugo™ robotic-assisted surgery system

The company also announces plans to share new gynecologic data
for the Hugo™ RAS system and conduct a telesurgery demo at the
Society of Robotic Surgery 2025 Annual Meeting in Strasbourg, France

Medtronic plc, a global leader in healthcare technology, today announced it has received CE Mark for the LigaSure™ RAS vessel-sealing technology, expanding Hugo™ robotic-assisted surgery (RAS) system capabilities for gynecologic, general, and urologic procedures in Europe.

As the first-ever robotic-driven LigaSure™ instrument, this milestone represents the beginning of a new era for the vessel-sealing technology that has been used in more than 35 million procedures across 65+ countries over the last two decades.

“Today, with CE Mark for LigaSure™ RAS, Medtronic is fulfilling a promise to customers to integrate our trusted vessel-sealing technology onto the Hugo™ RAS system,” said Matt Anderson, senior vice president and president of the Surgical business, which is part of the Medical Surgical Portfolio at Medtronic. “More than fulfilling a commitment, this regulatory approval is a big step forward as we continue to shape the future of surgery with surgical teams who share our passion and commitment to deliver the best possible care to every patient.”

Dr. Miguel Caceres of Pacifica Salud Hospital in Panama was one of the first surgeons in the world to use LigaSure™ RAS with the Hugo™ RAS system.

“LigaSure™ technology is one of the most important advances for minimally invasive surgery because it provides sealing and cutting in a way that is very, very secure for the performance of the surgeon and the security of the patient,” said Dr. Caceres. “As a robotic surgeon, we want LigaSure™ technology because it gives us confidence in the security of the seal. We are already seeing the benefits in our cases with the Hugo™ RAS system.”

Powered by the Valleylab™ FT10 energy platform and for use exclusively with the Hugo™ RAS system, the LigaSure™ RAS Maryland instrument is indicated for sealing and cutting vessels, thick tissue, and lymphatics up to and including 7 mm in diameter. The device reliably seals vessels in approximately 2 seconds while minimizing thermal spread to surrounding tissue.

This week at SRS: LigaSure™ RAS initial experience, Hugo™ GYN data and telesurgery demo

Dr. Caceres, who has been using the Hugo™ RAS system four years, will discuss his initial experience with LigaSure™ RAS during a Medtronic-sponsored symposium at the Society of Robotic Surgery (SRS) 2025 Annual Meeting, July 16-20 in Strasbourg, France.

SRS also includes a presentation on preliminary outcomes of hysterectomy for benign gynecologic conditions — a Medtronic-sponsored study of 112 Hugo™ RAS procedures across eight sites in Europe and Asia. Dr. Francesco Fanfani, associate professor at Agostino Gemelli University Polyclinic, will present the data.

Looking ahead to the next frontier of surgery, Medtronic will demo telesurgery capabilities on the Hugo™ RAS system from the nearby IRCAD facility — one of its strategic training partners. The demo will be followed by a panel discussion, including authors of Technical Guidelines for Remote Robotic-Assisted Surgery, which was recently published in the Journal of World Surgery.

The paper is a foundational piece to support safe and scalable telesurgery, reinforcing Medtronic’s commitment to innovation powered by human connection.

These announcements come amid growing momentum for the Hugo™ RAS system, which is now in use across 30+ countries on five continents, with over 270 independent publications supporting its clinical use across urology, gynecology, and general surgery procedures.

In the U.S., the company’s submission for a urology indication is under review by the Food and Drug Administration, with an expected U.S. entrance later in the company’s current fiscal year, followed by planned indication expansions into hernia and gynecology.

The Medtronic Hugo™ RAS system is commercially available in certain geographies. Regulatory requirements of individual countries and regions will determine approval, clearance, or market availability. In the EU, the Hugo™ RAS system is CE marked. In the U.S., the Hugo™ RAS system is an investigational device not for sale.

For more information, visit medtronic.com/hugo.

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.

Contacts:
Gary Jeanfaivre
Public Relations
+1-203-556-0777

Ryan Weispfenning
Investor Relations
+1-612-839-4549