Medtronic shared results from the Enable Hernia Repair study evaluating its Hugo robotic-assisted surgery (RAS) system in inguinal and ventral hernia repair procedures.

Enable Hernia Repair, according to the company, is the first investigational device exemption (IDE) study completed for robotic-assisted hernia surgery in the U.S. Medtronic announced primary safety and effectiveness endpoints were met, backing Hugo’s use in hernia repair procedures.

The prospective, multi-center, single-arm pivotal study had 193 patients undergoing either inguinal or ventral robotic hernia repair with Hugo.

The surgical success rate was 100%, which surmounted the performance goal of 85%. For inguinal hernia, surgical site event (SSE) rate was zero among 92 patients available for analysis, beating the goal of 30%. Among 94 ventral hernia patients available for analysis, the SSE rate was 2.1%—below the goal of 30%. Two SSEs were recorded and resolved without complication, Medtronic reported.

Mean length of hospital stay was 4.7 hours for inguinal patients and 6.7 hours for ventral patients.

“The addition of the Hugo platform to our field introduces exciting new opportunities to innovate and advance robotics in the best interests of patients, surgeons, and hospital systems while clearly offering the clinical results we expect from robotic-assisted surgery,” said Dr. David Chen, a general surgeon at UCLA and lead presenter of the Enable Hernia Repair data at the American Hernia Society (AHS) meeting in Nashville, Tenn.

Medtronic’s U.S. submission for a urology indication is under review by the U.S. Food and Drug Administration (FDA). The indication is expected later in the company’s fiscal year, followed by planned indication expansions into hernia repair and gynecology.

“We’re grateful for the opportunity to partner with clinical teams to treat this common and often painful condition for millions of patients around the world,” said Rajit Kamal, vice president and general manager of Robotic Surgical Technologies within the Surgical business of Medtronic. “Adding a digitally-powered robotic-assisted surgery system to our laparoscopic and open surgery solutions for hernia repair gives surgeons more choice and patients greater access to the care they need—and we believe that’s a win for everyone.”

In July, the company received CE mark approval for its LigaSure RAS vessel-sealing technology, expanding its Hugo robotic-assisted surgery (RAS) system capabilities for gynecologic, general, and urologic procedures in Europe.