September 5, 2025- Medtronic plc announced results from the Enable Hernia Repair clinical study evaluating the performance of the Hugo™ robotic-assisted surgery (RAS) system in inguinal and ventral hernia repair procedures. Enable Hernia Repair is the first-ever Investigational Device Exemption (IDE) clinical study completed for robotic-assisted hernia surgery in the United States. Primary safety and effectiveness endpoints were met, supporting use of the Hugo RAS system in hernia repair procedures.
Enable Hernia Repair is a prospective, multi-center, single-arm pivotal study that included 193 patients undergoing either inguinal or ventral robotic hernia repair with the Medtronic Hugo™ RAS system. Key findings include:
- The study met the primary effectiveness endpoint:
̵ The surgical success rate† was 100%, surpassing the pre-specified performance goal of 85%. (p<0.0001) - The study met the primary safety endpoint for both cohorts, which were analyzed independently:
̵ Inguinal: Among 92 patients available for analysis, the surgical site event‡ (SSE) rate was 0.0%, which is significantly lower than, and meeting, the pre-determined performance goal of 30% (p <0.0001).
̵ Ventral: Among 94 patients available for analysis, the SSE rate was 2.1%, which is significantly lower than, and meeting, the pre-determined performance goal of 30% (p <0.0001); two SSEs were recorded and resolved without complication.