Medtronic Initiates Third U.S. IDE Clinical Study of Hugo™ Robotic-Assisted Surgery System in Gynecology

Oct 09, 2025 10:01 CST Updated 10:01

Medtronic

Medical Device Manufacturer

Medtronic announces the launch of a new IDE clinical study (Embrace Gynecology) aimed at evaluating itsHugoSafety and Effectiveness in Gynecological Robot-Assisted Surgery. The first case has been successfully completed.HugoAuxiliaryTotal Hysterectomy.

Embrace Gynecology Becomes Hugo's Third IDE Clinical Study in the U.S. Medtronic has previously completed urology studies in the U.S.Expand URO) and hernia repair (Enable Hernia Repair) two IDE clinical studies, and both have reachedThe required safety and efficacy endpoints. Among them, Medtronic submitted a registration application to the FDA based on the results of the Expand URO clinical study, if all goes well.HugoThis year, it will receive FDA approval for market release (urological indications).

Embrace Gynecology is a prospective multicenter study designed to evaluate the safety and effectiveness of Hugo in hysterectomy procedures (radical, modified radical, or total hysterectomy), including its use in the treatment of malignant tumors. The study will enroll up to 70 patients across up to 5 hospitals in the United States.

PI Evaluation

"We are pleased to initiate this important clinical study aimed at exploring surgical treatment options for women in the United States. In my experience, women facing a gynecological diagnosis have two primary needs: effective treatment of their condition and a swift return to normal life. Robotic-assisted surgery can help achieve these goals."

---Emma Rossi Duke University

Executive Evaluation

"The study, named Embrace, reflects our deep compassion and care for patients, as well as our commitment to providing women with more minimally invasive treatment options. We appreciate the close collaboration with the clinical teams at the research institutions and share their enthusiasm for this rigorous scientific research, which is helping to usher in a new era of choice for patients in the United States."

--- James Porter Chief Medical Officer of Robotic and Digital Technologies, Surgical Business Unit, Medtronic

The U.S. National Cancer Institute estimates that by the end of 2025, nearly 111,000 women in the United States will be diagnosed with gynecological cancers, while hundreds of thousands more will experience benign conditions such as uterine fibroids or abnormal bleeding. Surgery is a common treatment for many of these gynecological conditions and is often the first and primary treatment for certain cancers, such as uterine (endometrial) cancer. As a form of minimally invasive surgery, robot-assisted surgery offers patients fewer complications, shorter hospital stays, and quicker recovery times compared to open surgery.

Hugo

Medtronic R&DHugoThe purpose is to solve the historical cost (a Da Vinci robot costs up to 20 million, and each robotic arm costs up to 100,000) and the usage barriers of 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 program optimization, service, 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

Modular robotic arms can be easily moved, shared, and deployed throughout the hospital to maximize utilization.

Technology Sharing

HugoNot just a surgical robot, but a standalone laparoscopic solution with advanced visualization capabilities.HugoEquipped with all the advanced technologies of traditional laparoscopic and open surgeries, such asStorz endoscope, Valleylab electrosurgical system andTouch Surgery Analysis System.

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

Medtronic, founded in 1949 and headquartered in Minneapolis, Minnesota, USA, is a global leader in medical technology, dedicated to providing lifelong treatment solutions for patients with chronic diseases. Medtronic's main products cover areas such as arrhythmia, heart failure, vascular diseases, heart valve replacement, extracorporeal heart support, minimally invasive cardiac surgery, malignant and non-malignant pain, movement disorders, diabetes, gastrointestinal diseases, urological conditions, spinal disorders, neurological diseases, and surgeries in otorhinolaryngology.