Medtronic Submits FDA Application for Hugo Robotic-Assisted Surgery System in Urology with Strong Clinical Data from Expand URO IDE Study

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# Progress as Expected

In November 2024, during the company's second-quarter earnings call, Medtronic Chairman and CEO Geoff Martha announced that the application for the Hugo surgical robot is expected to be submitted to the FDA in the first quarter of 2025.

Martha stated, "We will continue to increase our investment in the Hugo platform. The company has completed the data collection required for urology indications, andExpected to submit relevant documents to the FDA in the first quarter of 2025."The company inHernia and GynecologyIndication StudyCNAchieved Rapid Patient"Enrollment."

In addition, heIntroduced its latest launchTouch Surgery Digital Surgical System Live Streaming Function。

• Two Clinical Studies

Clinical trials in the United States include Duke University Hospital in DurhamRobot-Assisted Bilateral Inguinal Hernia Repair Surgery, conducted by the national principal investigator of the trial, Dr. Jacob Greenberg. Medtronic alsoHas obtained the launch of a project includingGynecological Oncology SurgeryApproval of new clinical trials.

• More Function Integration

# Expand URO Research

Expand URO is aA prospective, multi-center, single-arm IDE study enrolled a total of 137 patients who received Hugo.RAS System-Assisted Urological Surgery.

As the principal investigator, Dr. Michael Abern, a urologist at Duke University Hospital, presented the findings at the American Urological Association (AUA) Annual Meeting in Las Vegas.

Research Design

Performed by 11 surgeons across 6 hospitals in the United States, a total of 3 types of urological surgeries were conducted, including prostatectomy (55 cases), nephrectomy (53 cases), and cystectomy (29 cases). Approximately 98% of the patients completed the 30-day follow-up.

Research Data

• Safety:The incidence rates of grade 3 and above complications for prostatectomy, nephrectomy, and cystectomy are respectively3.7%, 1.9%, and 17.9%, all below the set targets (20%, 20%, and 45% respectively), reaching the primary safety endpoint of the study.

• Effectiveness:The success rate of the surgery has reached98.5%, higher than the set 85% (p<0.0001). Only 2 cases were converted to open surgery, one related to equipment and the other related to the patient's anatomy.

Outside the United States, the Hugo RAS system has been deployed in more than 20 countries across five continents, with a growing body of clinical evidence, including over 200 independent published papers.

# Hugo Surgical Robot

Hugo is a soft tissue surgical robot developed by Medtronic.Adopting a modular design,Composed of an open surgical console with a 3D-HD display, a patient operating platform, and more.

Surgical Console:There is a head above the open monitor.A tracking device that locks the master controller automatically (to prevent misoperation) when the surgeon is not looking at the screen, as determined by tracking the reflective markers on the 3D glasses worn by the chief surgeon.

Master Hand:The two master hands translate the doctor's hand movements into the movements of instruments or endoscopes. When the robotic arms or instruments reach the boundary of the working space, the master hands will prevent the doctor’s hand movements to serve as a reminder.

The controller at the end of the Hugo master handle is gun-grip styled, with added buttons for controlling the stapler activation and reset, as well as a hand detection sensor (located at the base of the thumb, functioning similarly to head tracking; when the doctor's hand is not detected, the master handle locks).

Task Simulator：Transform the surgeon's console into a 3D HD simulation environment, allowing surgeons to learn and practice skills such as instrument control, needle threading, and suturing.

• Product Features

Modular Design:Hugo robot adopts a modular design,Able to flexibly select the required robotic arms based on specific surgical procedures and individual patient needs, robotic systemCan be flexibly moved within the operating room,Effectively optimize the utilization efficiency of operating rooms.

Three-arm and four-arm configurations are suitable for robot-assisted surgery;Single-arm configuration can assist in standard laparoscopic surgery.

Technology Integration:Independent Laparoscopic Solution with Advanced Visualization Features，Integrating advanced technologies of traditional laparoscopic surgery and open surgery, including Storz endoscopes, Valleylab electrosurgical systems, etc.,Doctors can more flexibly choose tools suitable for specific situations.

Video Recording:Provide safe and seamless video recording options, allowing doctors to review and analyze surgical videos anytime, anywhere, continuously improving the surgical process.

Intelligent Recognition:Able to identify and label key anatomical structures, provide information that may not be visually observable, making the surgical process more precise and controllable, reducing potential human errors, and improving the success rate of surgeries.

Teaching Assistant:Through the integration of digital surgery and artificial intelligence, HugoThe RAS system provides "driver assistance" functionality, allowing doctors with less experience in specific surgeries to receive guidance and advice from top experts.

In July 2024, Medtronic announced that its Touch Surgery digital surgical system had updated its live streaming feature, including 14 new AI algorithms that can enhance postoperative analysis functions.Provide AI-based surgical insights for laparoscopic surgical robots and other robot-assisted surgeries.

Related Reading:In-Depth Analysis: What Are the Similarities and Differences Between the Hugo Surgical Robot and da Vinci? (Part 1)

In-Depth Analysis: What Are the Similarities and Differences Between the Hugo Surgical Robot and da Vinci? (Part 2)

# The Road to Development

In June 2021, a hospital in Chile completed the world's first robotic prostatectomy using the Hugo RAS system.

July 2021,Hugo RAS System Successfully Used to Complete 6 Gynecological (GYN) Surgeries, Including Hysterectomy and Myomectomy.

In September 2021, the first case in the Asia-Pacific region using HugoThe clinical surgery of the RAS system was performed in India by Dr. N Ragavan, a consultant urologist, urological oncologist, and robotic surgeon.

In the fourth quarter of 2021, Medtronic began selling the Hugo RAS system outside the United States and generated revenue.

In February 2022, Medtronic announced the first surgery in Europe using the Hugo RAS system.

In October 2022, Medtronic announced significant progress in the regulatory approval of the Hugo RSA surgical robot:In Europe, it is approved for general surgery; in Canada, it is approved for general laparoscopic surgery; in Japan, it is approved for urological and gynecological related surgeries.

In June 2023, Guy's and St Thomas' Hospital in London, UK, became the first medical institution in the UK to introduce the Medtronic Hugo robot.

In October 2023, at the 6th CIIE, Medtronic announced that the Hugo RAS robotic-assisted surgery system had beenTaiwan, China Establishes Training Center to Provide Precision Minimally Invasive Surgery Training for Surgeons in the Asia-Pacific Region and Locally.

Medtronic's Hugo Soft Tissue Surgical Robot has achieved significant commercial progress in Europe, Latin America, and Asia. It is expected to challenge the market position of the Da Vinci Surgical Robot globally in the future.

# About Medtronic

Medtronic is a global leading medical technology company, founded in 1949, with its headquarters located in Minnesota, USA. The main product lines of Medtronic areThe four major businesses of cardiovascular, surgery and critical care, neuroscience, and diabetes cover a product and service system in the treatment areas of arrhythmia, heart failure, cardiac intervention, heart valve replacement, diabetes, gastrointestinal diseases, urinary system diseases, spinal diseases, neurological diseases, and ENT.

As a technology company, Medtronic is also committed to researching and developing new medical technologies to improve patients' quality of life. The company has numerous R&D centers and production bases worldwide, with a total workforce of over 90,000 employees. Medtronic's business spans more than 150 countries and regions globally.