While its Hugo surgical robot undergoes review at the FDA, Medtronic presented clinical data from its U.S. trial demonstrating success in hernia repairs—notably with zero mid-procedure conversions to traditional surgical methods, or switches to another robotic platform.
The prospective study, dubbed Enable Hernia Repair, included 193 participants split between inguinal and ventral procedures and met its primary endpoints in safety and effectiveness.
Among those undergoing inguinal hernia repairs, zero patients reported major complications or surgical site infections, either during the procedure or in the 30 days that followed. In the ventral repair cohort, 2.1% of patients recorded an event; both arms were well below the study’s cutoff of 30%.
“The Enable Hernia Repair clinical study didn't just meet primary endpoints, it far surpassed them,” said the trial’s principal investigator, Jacob Greenberg, chief of the division of minimally invasive surgery at Duke University Hospital. The results were presented at the annual meeting of the American Hernia Society held in Nashville.
In addition, inguinal patients saw an average hospital stay of 4.7 hours, with ventral patients taking 6.7 hours. Medtronic estimates that nearly 1.5 million hernia repair surgeries are performed each year in the U.S., ranking them among the most common procedures.
“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,” the general manager of Medtronic’s robotic surgery business, Rajit Kamal, said in a statement.
Earlier this year, Hugo also delivered positive results in a urology study that evaluated its ability to remove prostate, kidney and bladder tissue among patients with cancer. The Expand URO trial saw a 98.5% surgical success rate, or two mid-procedure conversions out of 137 treated patients.
Urology will serve as Hugo’s entry point for the U.S. market, as it’s the first indication the company applied for at the FDA in the first quarter of this year. Medtronic has also received a green light from the agency to conduct a clinical study in benign gynecological procedures.
With its separate, cart-based robotic arms, Hugo is designed to be a more flexible fit for hospital operating rooms and surgical centers. Outside the U.S., Hugo is being used in more than 25 countries, spanning Europe, Canada, Japan and South America, including in urology, gynecology and general soft-tissue surgery.