Medtronic PLC ( MDT ) released on Thursday 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.

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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.

Enable Hernia Repair is the first-ever Investigational Device Exemption (IDE) clinical study completed for robotic-assisted hernia surgery in the U.S.

Primary safety and effectiveness endpoints were met. Key findings included that the surgical success rate was 100%, surpassing the pre-specified performance goal of 85%.

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The study met the primary safety endpoint for both cohorts, which were analyzed independently.

Among 92 inguinal patients available for analysis, the surgical site event (SSE) rate was 0.0%, which is significantly lower than and meets the pre-determined performance goal of 30% (p