Medtronic Hugo RAS study in hernia repair meets safety, effectiveness endpoints

Medtronic (MDT) announced results from the Enable Hernia Repair clinical study evaluating the performance of the Hugo robotic-assisted surgery system in inguinal and ventral hernia repair procedures. Enable Hernia Repair is the first-ever Investigational Device Exemption 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. The surgical success rate was 100%, surpassing the pre-specified performance goal of 85%. 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 rate was 0.0%, which is significantly lower than, and meeting, the pre-determined performance goal of 30%. 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%; two SSEs were recorded and resolved without complication. “The Enable Hernia Repair clinical study didn’t just meet primary endpoints, it far surpassed them,” said Dr. Jacob Greenberg, national principal investigator of the Enable Hernia Repair study and gastrointestinal surgeon at Duke University Hospital.