#United States #Nashville #Medtronic #Hernia Repair #Hugo RAS

Results of Hugo™ Robotic-Assisted Surgery Study

In a groundbreaking development in the realm of surgical interventions, Medtronic plc recently announced the successful results of its Enable Hernia Repair clinical study. This research marks the first Investigational Device Exemption (IDE) clinical study focused on robotic-assisted surgery for hernia repair in the United States. Conducted on a significant array of participants, the study evaluated the performance of the Hugo™ robotic-assisted surgery (RAS) system, demonstrating its potential in performing inguinal and ventral hernia repair procedures.

Study Overview

The Enable Hernia Repair study comprised 193 patients who underwent either inguinal or ventral robotic hernia repair with the Hugo™ RAS system. According to Dr. Jacob Greenberg, the national principal investigator of the study and a gastrointestinal surgeon at Duke University Hospital, the results were nothing short of extraordinary. The study met its primary effectiveness endpoint with a surgical success rate of 100%, far exceeding the initial performance benchmark of 85% (p<0.0001).

Safety and Effectiveness

Notably, the study also achieved its primary safety endpoint, examining surgical site events (SSE) across its two cohorts. In the inguinal hernia group, comprising 92 patients, the SSE rate stood at an impressive 0.0%, significantly lower than the predetermined goal of 30% (p <0.0001). Meanwhile, in the ventral hernia cohort, which included 94 patients, an SSE rate of 2.1% was recorded, again surpassing the established safety threshold (p <0.0001). Both incidences were handled without complication, affirming the system’s robust safety profile.

Advancements in Robotic Surgery

Surgeons and clinical teams participating in the study have welcomed the integration of the Hugo platform into surgical procedures, as it opens doors for innovative practices aimed at enhancing patient care. Dr. David Chen, a general surgeon at UCLA and lead presenter of the study findings at the American Hernia Society (AHS) meeting, expressed optimism regarding the potential of robotic-assisted surgeries to redefine traditional surgical methodologies. He remarked, “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.”

With approximately 1.5 million hernia procedures conducted annually in the U.S., there exists a significant opportunity to improve patient outcomes using advanced technology like the Hugo RAS system. Hernia repair, a procedure that addresses the protrusion of organs through weakened muscles, is essential, as untreated hernias can lead to severe complications such as pain, infections, and digestive issues. The innovative approach of using robotic assistance allows for minimally invasive techniques, thus potentially improving recovery time and patient satisfaction.

Research Impacts and Future Directions

The findings from the Enable Hernia Repair study contribute to a growing body of evidence supporting the safety and effectiveness of the Hugo system. In addition to this study, Medtronic has previously conducted the Expand URO clinical study, which also yielded positive results in terms of safety. There are nearly 300 independent publications by practitioners utilizing the Hugo RAS system, indicating a thriving ecosystem of research and clinical feedback surrounding this technology.

Born out of Medtronic's 75-year tenure in healthcare innovation, the Hugo RAS system aims to broaden access to minimally invasive surgical options globally, collaborating closely with clinical partners. Currently, the system is already in clinical use across more than 30 countries.

In the United States, Medtronic is actively pursuing FDA approval for additional therapeutic indications, including urology and gynecology, leveraging the notable performance recorded in its hernia studies. The commercialization of such advanced surgical systems is poised to reshape the landscape of hernia repairs, enhancing surgical methodologies while ensuring patient safety and satisfaction.

Overall, as Medtronic continues to pioneer advancements in robotic-assisted surgery, the medtech landscape anticipates further innovations that promise to transform how common surgical procedures are performed, benefitting countless patients each year.