Medtronic's Hugo Robotic System Achieves 100% Surgical Success Rate in Pivotal Hernia Repair Trial, Exceeding Expectations

Medtronic Announces its Soft Tissue Surgical Robot---HugoClinical Research Results (Enable）。Study shows: Achieved primary safety and efficacy endpoints, supportingHugoApplication in hernia repair surgery.

Enable is a prospective, multi-center, single-arm pivotal study, enrolling 193 patients who underwent robotic inguinal or ventral hernia repair using the Medtronic Hugo.

Specific Research Results

• Primary Efficacy Endpoint:

The success rate of the surgery reached 100%, surpassing the preset performance goal of 85% (p<0.0001).

• Primary Safety Endpoint:

Inguinal Hernia Group: Among 92 analyzable patients, the incidence of Surgical Site Events (SSE) was 0.0%, significantly lower than and meeting the preset performance goal of 30% (p<0.0001).

Abdominal Wall Hernia Group: Among 94 evaluable patients, the SSE incidence rate was 2.1%, significantly lower than and met the preset 30% performance goal (p<0.0001); the two recorded SSE events were managed without complications.

• Others:The average hospital stay for inguinal hernia patients is 4.7 hours, and for abdominal wall hernia patients, it is 6.7 hours.

PI Evaluation

"Enable Hernia Repair Clinical Study Not Only Met the Primary Endpoint, But Far Exceeded Expectations. It Is an Honor to Advance the Clinical Research of Robot-Assisted Surgery, Bringing Benefits to Patients in the U.S. and Around the World."

---Jacob Greenberg  Duke University Hospital

"Hugo's addition brings innovative opportunities to the field, advancing robotic technology while safeguarding the interests of patients, surgeons, and hospital systems, and significantly delivering the clinical outcomes we expect from robot-assisted surgery."

---David Chen  UCLA

Executive Evaluation

"We are deeply honored to collaborate with the clinical team to treat this common and often painful condition for millions of patients worldwide. Adding a digital robotic-assisted surgical system to the foundation of laparoscopic and open surgical solutions provides surgeons with more options and enables patients to receive the care they need—this is undoubtedly a win-win situation for all parties involved."

---Rajit Kamal  Vice President and General Manager of Medtronic Surgical Robotics

The United States performs nearly 1.5 million hernia repair surgeries annually, making it one of the most common procedures for adult men and women. Hernia repair surgery aims to treat the condition where the intestine protrudes through weakened abdominal muscles. If left untreated, it may lead to pain, digestive issues, swelling, or infection. Currently, surgical repair is the most effective treatment method, with innovations in minimally invasive techniques, including mesh technology, driving advancements in patient care.

HugoLetHernia RepairSurgery becomes more efficient, with an increased success rate and a reduction in adverse events.

This study will be used forHugoApply for registration in the United States. Medtronic has currently submitted to the FDAHugoRegistration application (indication: urology) is expected to be approved for marketing this year. Medtronic will also submit a registration application for the indication of hernia repair to the FDA.

Medtronic R&DHugoThe purpose is to address the historical cost (a Da Vinci robot costs up to 20 million, and each robotic arm costs up to 100,000) and the barriers to using surgical robots in the future.

HugoIt is a modular multi-quadrant surgical platform designed for a wide range of soft tissue surgeries. It combines wristed instruments, 3D visualization, and Touch Surgery Enterprise (a cloud-based surgical video capture and management solution).Powered by artificial intelligence, enabling surgeons to seamlessly record, analyze, and share Hugo case footage.), as well as a dedicated support team specializing in robotic procedure optimization, services, and training.

Hugo Advantages

• Designed by surgeons - Built for surgeons

HugoIt was co-designed with surgeons around the world to make robotic-assisted surgery possible.

• Modular and Portable

• Technology Sharing

• Safe and Seamless Video Recording Options

Analyze and improve the surgical process anytime, anywhere through touch surgery

• Function Optional

Aimed at reducing the total cost of ownership and optimizing robot utilization.

Medtronic