Authors Greenberg JA, Malcher F, Panchal A, Bianco F, Petro C, Hopson S, Docimo S, Wilson E, Giulianotti P, Rosen M, Berndtson J, Beffa L, Michaels A, Irwin A, Larue R, Chen DC.
Journal Annals of Surgery
Published date May, 2026
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Medtronic summary

This publication describes a prospective, multi-center, single-arm, FDA-approved investigational device exemption study of the first use of the Hugo™ robotic-assisted surgery (RAS) system to treat inguinal and ventral hernias in the United States.

The primary effectiveness endpoint of this study was the rate of surgical success, which was defined as the procedure not being converted from the use of the Hugo RAS system to another approach (i.e., open surgery, laparoscopy, other robotic systems). The primary safety endpoint was the rate of patients with one or more procedure- and/or device-related surgical-site events up to 30 days post-operation. Secondary outcome measures included 30-day readmission and reoperation.

Across 193 patients who had inguinal or ventral hernia repair with Hugo™ RAS system, no conversions to other surgical approaches occurred (surgical success rate of 100%). No surgical-site events occurred in the inguinal cohort; 2 (2.1%) occurred in the ventral cohort.

Post-operative readmission occurred for 1 patient in the inguinal cohort (N = 92) and 4 patients in the ventral cohort (N = 94); reoperation occurred in only 1 patient in the ventral cohort. The patient readmitted in the inguinal cohort was for a seroma (Clavien–Dindo [CD] Class II); the readmissions in the ventral cohort were for an incision-site abscess (CD II), a port-site hematoma (CD I), abdominal pain (CD II), and one case of small bowel obstruction (CD IIIb, requiring reoperation).

 

Contact Office of Medical Affairs:

rs.surgicaloma@medtronic.com​

 

Disclosure:

  1. Hugo™ RAS has not been approved by the FDA for hernia repair, and the safety and effectiveness of Hugo™ RAS for hernia repair has not been established in the US.
  2. The FDA-cleared use for Hugo™ RAS is in minimally invasive urologic surgical procedures including prostatectomy, nephrectomy, and cystectomy.
  3. The FDA-required labeling for Hugo™ RAS states that “[t]he potential adverse events associated with the use of robotically assisted surgical devices include, but are not limited to: arrhythmia, bleeding, blunt trauma, bowel perforation, burns (varying degrees, bowel, thermal), crushing injury, delay of treatment (prolonged procedure), electric shock, foreign body in patient, infection, inflammation, tissue damage/trauma, toxicity, or vessel perforation.”
  4. A copy of the FDA-required labeling.
  5. Jacob A. Greenberg, Flavio Malcher, Ajay Panchal, Francesco Bianco, Clayton Petro, Steven Hopson, Salvatore Docimo, Erik Wilson, Pier Giulianotti, Michael Rosen, Jeffrey Berndtson, Lucas Beffa, Alex Michaels, and David C. Chen were consultants to Medtronic while writing, editing, and contributing to this publication.
    Chris Irwin and Ruben Larue were employees of Medtronic while writing, editing, and contributing to this publication.
  6. “Inguinal and Ventral Hernia Repair with the Hugo Robotic-Assisted Surgery System: A Prospective, Single-arm, Clinical Trial; published May 11, 2026.