Medtronic announced that its Hugo robotic-assisted surgery (RAS) system has met safety and effectiveness benchmarks in the Enable Hernia Repair clinical study.
Enable Hernia Repair is a prospective, multi-centre, and single arm study that enrolled 193 patients undergoing robotic hernia repair using the Hugo RAS system.
It is the first investigational device exemption (IDE) study for robotic-assisted hernia surgery in the US and supports the Hugo system’s use in both inguinal and ventral hernia repairs.
The study achieved its primary effectiveness endpoint with a 100% surgical success rate, surpassing the pre-set target of 85%.
It has also achieved primary safety endpoint for two cohorts, evaluated separately.
The inguinal cohort of 92 patients showed no surgical site event (SSE) rate, and the ventral repair cohort of 94 patients showed a 2.1% SSE rate, both below the 30% target.
The study also noted that the average hospital stay was 4.7 hours for inguinal patients and 6.7 hours for ventral patients, highlighting the efficiency of the procedure.
Medtronic said that the study findings supplement to the growing evidence supporting the Hugo RAS system, which is also backed by nearly 300 independent publications.
Enable Hernia Repair study national principal investigator Jacob Greenberg said: “The Enable Hernia Repair clinical study didn’t just meet primary endpoints, it far surpassed them.
“I am proud to have had the opportunity to advance clinical research in robotic-assisted surgery for the benefit of patients in the United States and around the world.”
The Hugo RAS system is a modular, open-console robotic surgical platform currently used in over 30 countries. It is CE marked in the European Union (EU) and remains an investigational device in the US.
Medtronic is seeking the US Food and Drug Administration (FDA) review for a urology indication, with plans to expand the system into hernia repair and gynaecology.
Medtronic robotic surgical technologies vice president and general manager Rajit Kamal said: “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.
“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.”
