Medtronic announces first surgery with Hugo robotic-assisted surgery system in the U.S. performed at Cleveland Clinic

Medtronic announces first surgery with Hugo robotic-assisted surgery system in the U.S. performed at Cleveland Clinic

Newly FDA-cleared system helps expand patient access to minimally invasive surgery

Cleveland Clinic joins nationally recognized academic medical centers including Atrium Health Wake Forest Baptist High Point Medical Center as first hospitals in the U.S. to install Hugo RAS system

Medtronic today announced that the first U.S. commercial surgical case using its recently FDA-cleared Hugo™ robotic-assisted surgery (RAS) system has been successfully performed by Jihad Kaouk, MD, professor and chair of the Glickman Urologic Institute and the Zegarac-Pollock Endowed Chair in Robotic Surgery at Cleveland Clinic.

Dr. Kaouk successfully completed a robotic-assisted prostatectomy, and the patient was discharged the day after surgery.

"This case exemplifies Cleveland Clinic's mission to lead surgical innovation and expand access to minimally invasive surgery," said Dr. Kaouk. "The new technology allows us to customize the approach for each patient case."

Urology has led the way in adoption of robotic technology, with about 80% of urologic abdominal surgeries in the U.S. today conducted with the assistance of a robotic system. This high adoption rate has created a community of surgeons highly experienced in robotic-assisted procedures available to support training as new technology like the Hugo RAS system becomes available, which is important as robotic-assisted approaches are increasingly common across many specialties and hospitals are looking for solutions to address capacity challenges.

The Hugo RAS system's mobile footprint with modular arms may help address operating room scheduling challenges and infrastructure limitations, enabling more patients access to the well-documented benefits of minimally invasive care — including reduced blood loss, shorter hospital stays, decreased recovery time, and less postoperative pain.†,1-3

Cleveland Clinic actively researches and implements new robotic approaches. Their team, led by Dr. Kaouk as the Principal Investigator, was part of the Expand URO Investigational Device Exemption (IDE) clinical study — the largest ever completed for multi-port robotic-assisted urological surgery in the U.S. Expand URO demonstrated that the Hugo RAS system met primary safety and effectiveness endpoints in urologic surgical procedures, with outcomes that are consistent with published literature.

"We are excited that the first commercial case in the U.S. using the Hugo RAS system has been successfully completed by Dr. Kaouk and his team. Their pioneering spirit and collaboration reflect our shared vision that with new technology, like Hugo, more patients can access the benefits of minimally invasive surgery," said Rajit Kamal, vice president and general manager of Robotic Surgical Technologies within the Surgical business of Medtronic. "The future of surgery isn't about robotics as a separate modality, it's about technology that enables surgical teams to deliver the best possible care for every patient. Medtronic is uniquely positioned to do that as the only company in the world that can partner with surgeons and hospitals across open, laparoscopic, and robotic-assisted surgery."

In addition to Cleveland Clinic, Duke University Hospital and Atrium Health Wake Forest Baptist High Point Medical Center are among the first hospitals in the U.S. to install the Hugo RAS system. Atrium Health Wake Forest Baptist High Point Medical Center is the first hospital in the country to install the Hugo RAS system that was not part of the IDE clinical study.

The Hugo RAS system represents an advancement in surgical robotics in the U.S., offering surgeons a flexible, accessible alternative that prioritizes choice, collaboration, and efficiency in the operating room. The Hugo RAS system is available for use in more than 35 countries around the world. The introduction of the Hugo RAS system in the U.S. builds on Medtronic's broad surgical offering, including the Touch Surgery™ ecosystem, to deliver a connected, integrated operating room — today and in the future.

The company plans to follow its initial urology indication for the Hugo™ RAS system with indication expansion into gynecologic and general surgery procedures, including hernia repair.

For more information, visit medtronic.com/hugoishere.

†Compared to open surgery.

  1. Fitch K, Engel T, Bochner A. Cost differences between open and minimally invasive surgery. Managed Care. 2015;24(9):40–48.
  2. Tiwari MM, Reynoso JF, High R, Tsang AW, Oleynikov D. Safety, efficacy, and cost effectiveness of common laparoscopic procedures. Surg Endosc. 2011;25(4):1127-1135.
  3. Roumm AR, Pizzi L, Goldfarb NI, Cohn H. Minimally invasive: minimally reimbursed? An examination of six laparoscopic surgical procedures. Surg Innov. 2005;12(3):261–287.

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

Ingrid Goldberg
Investor Relations
1-763-505-2696

Dr. Jihad Kaouk, professor and chair of the Glickman Urologic Institute and the Zegarac-Pollock Endowed Chair in Robotic Surgery at Cleveland Clinic, was the first surgeon in the United States to perform a commercial surgical procedure using the Hugo™ RAS system, following the system's FDA clearance for urologic surgical procedures in December 2025. Credit: Cleveland Clinic

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