Medtronic's Hugo robotic-assisted surgery system has demonstrated exceptional performance in hernia repair procedures, achieving a 100% surgical success rate in the first-ever Investigational Device Exemption clinical study for robotic-assisted hernia surgery in the United States. The Enable Hernia Repair study results, presented at the American Hernia Society annual meeting, significantly exceeded pre-specified performance goals and met all primary safety and effectiveness endpoints.
Study Design and Patient Population
The Enable Hernia Repair study was a prospective, multi-center, single-arm pivotal study that included 193 patients undergoing either inguinal or ventral robotic hernia repair with the Medtronic Hugo RAS system. The study represents a significant milestone in advancing robotic-assisted surgical options for one of the most common surgical procedures performed in the United States.
"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."
Exceptional Effectiveness Results
The study achieved remarkable effectiveness outcomes, with the surgical success rate reaching 100%, substantially surpassing the pre-specified performance goal of 85% (p<0.0001). Surgical success was defined as procedures that did not require conversion from the robotic-assisted approach using the Hugo RAS system to laparoscopy, open surgery, or alternative robotic-assisted systems.
The mean length of hospital stay was notably brief, with inguinal patients averaging 4.7 hours and ventral patients averaging 6.7 hours, suggesting the potential for same-day discharge in many cases.
Outstanding Safety Profile
The study demonstrated exceptional safety outcomes across both patient cohorts, which were analyzed independently. Among 92 inguinal patients available for analysis, the surgical site event rate was 0.0%, significantly lower than the pre-determined performance goal of 30% (p<0.0001). For the ventral cohort, among 94 patients available for analysis, the surgical site event rate was 2.1%, also significantly below the 30% threshold (p<0.0001). Only two surgical site events were recorded in the ventral group, both of which resolved without complication.
Surgical site events were defined as a composite endpoint of surgical-site occurrences and surgical-site infections related to the device or procedure from the first incision through 30 days post-procedure.
Clinical Significance and Market Impact
Nearly 1.5 million hernia repair surgeries are performed annually in the United States, making hernia repair one of the most common surgeries for adult men and women. Hernia repair addresses conditions where part of the intestine bulges through weakened abdominal muscles. Left untreated, hernias can lead to pain, digestive troubles, swelling, or infection, with surgical repair currently representing the leading effective treatment.
"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 meeting.
Regulatory Pathway and Global Availability
The Hugo RAS system is currently commercially available in certain geographies and is clinically used in 30+ countries across five continents. In the European Union, the Hugo RAS system is CE marked. In the United States, the system remains investigational and not for sale.
Medtronic's submission for a urology indication is currently under review by the Food and Drug Administration, with a U.S. urology indication expected later in the company's current fiscal year. The company plans indication expansions into hernia repair and gynecology following the initial approval.
"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."
The study builds on the growing body of evidence for Hugo, including the Expand URO U.S. clinical study, which also met safety and effectiveness endpoints, and nearly 300 independent publications by surgeons using the Hugo RAS system worldwide.
