Medtronic announced 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.
Primary safety and effectiveness endpoints were met, supporting use of the Hugo RAS system in hernia repair procedures.
"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. "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 currently clinically used in more than 30 countries.
In the U.S., the company's submission for a urology indication is under review by the FDA, with a U.S. urology indication expected later in the company's current fiscal year, followed by planned indication expansions into hernia repair and gynecology.
The Medtronic Hugo RAS system is commercially available in certain geographies. Regulatory requirements of individual countries and regions will determine approval, clearance, or market availability. In the EU, the Hugo RAS system is CE marked. In the U.S., the Hugo RAS system is an investigational device not for sale.
