Medtronic's Hugo Robotic System Achieves 100% Success Rate in Hernia Repair Trial

Medtronic has announced the results of its Enable Hernia Repair clinical study, which evaluated the performance of the Hugo robotic-assisted surgery system in inguinal and ventral hernia repair procedures. The study included 193 patients and achieved a 100% success rate, exceeding the pre-specified performance goal of 85%. The surgical site event rate was 0% for inguinal patients and 2.1% for ventral patients, both significantly lower than the performance goal of 30%. The mean length of hospital stay was 4.7 hours for inguinal patients and 6.7 hours for ventral patients.

Medtronic plc (NYSE: MDT) has reported promising results from its Enable Hernia Repair clinical study, which evaluated the performance of its Hugo robotic-assisted surgery (RAS) system in hernia repair procedures. The study, presented at the American Hernia Society annual meeting in Nashville, Tennessee, achieved a 100% surgical success rate, significantly exceeding the targeted performance goal of 85% [1].

The study, which is the first-ever Investigational Device Exemption (IDE) clinical study for robotic-assisted hernia surgery in the United States, included 193 patients undergoing either inguinal or ventral robotic hernia repair with the Medtronic Hugo™ RAS system. The study met all primary safety endpoints, with a surgical site event (SSE) rate of 0.0% for inguinal hernias and 2.1% for ventral hernias, both meeting the pre-determined performance goals of 30% [1].

The study's success highlights the potential of robotic-assisted surgery in hernia repair, a common procedure with nearly 1.5 million surgeries performed annually in the United States [2]. The Hugo RAS system's ability to achieve high success rates and low complication rates could make it a valuable addition to existing surgical options.

Medtronic's commitment to advancing minimally invasive surgical options is evident in the development of the Hugo RAS system, which is clinically used in over 30 countries on five continents. The company's submission for a urology indication in the United States is currently under review by the Food and Drug Administration, with further indication expansions into hernia repair and gynecology planned [1].

The study's findings are significant for Medtronic, as it aims to compete with Intuitive Surgical for the hernia market. The Hugo system's modular design allows for flexibility in the number of arms used during procedures, potentially offering advantages over existing robotic systems.

References:
[1] https://news.medtronic.com/2025-09-04-Study-of-Medtronic-Hugo-TM-robotic-assisted-surgery-system-in-hernia-repair-meets-safety-and-effectiveness-endpoints
[2] https://finance.yahoo.com/news/study-medtronic-hugo-robotic-assisted-161500972.html