Study of Medtronic Hugo™ robotic-assisted surgery system in hernia repair meets safety and effectiveness endpoints

Core Insights - Medtronic announced the results of the Enable Hernia Repair clinical study, the first Investigational Device Exemption (IDE) clinical study for robotic-assisted hernia surgery in the U.S. [1][2] Company Overview - Medtronic plc is a leading global healthcare technology company headquartered in Galway, Ireland, with over 95,000 employees across more than 150 countries [11]. - The company focuses on innovative technologies that address various health conditions, including surgical robotics, and aims to alleviate pain, restore health, and extend life [11]. Clinical Study Findings - The Enable Hernia Repair study included 193 patients undergoing robotic hernia repair, achieving a surgical success rate of 100%, exceeding the pre-specified goal of 85% [8]. - The study met primary safety endpoints, with a surgical site event (SSE) rate of 0.0% for inguinal patients and 2.1% for ventral patients, both significantly lower than the predetermined performance goal of 30% [8]. - The mean length of hospital stay was reported as 4.7 hours for inguinal patients and 6.7 hours for ventral patients [5]. Market Context - Approximately 1.5 million hernia repair surgeries are performed annually in the U.S., making it one of the most common surgeries for adults [4]. - The introduction of the Hugo robotic-assisted surgery system aims to enhance surgical options and improve patient care in hernia repair [6][3]. Future Prospects - Medtronic is currently under review by the FDA for a urology indication, with plans for further expansions into hernia repair and gynecology [9]. - The Hugo RAS system is already clinically used in over 30 countries, indicating a strong international presence [7].