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Medtronic Secures FDA Approval for Hugo™ Robotic Surgery System

In a significant milestone for robotic-assisted surgery, Medtronic (NYSE: MDT), a major player in surgical innovation, has announced that its Hugo™ robotic-assisted surgery (RAS) system has received FDA clearance for urologic surgical procedures. With this approval, hospitals across the United States are poised to enhance their surgical capabilities, particularly in the area of minimally invasive procedures.

Expanding Surgical Options

The approval of the Hugo RAS system signifies a step forward in providing surgeons with advanced tools for soft-tissue robotic surgery. This platform is designed to address the growing demand for robotic surgeries in a market that already leads globally in robotic surgery adoption. Hospitals often suffer from capacity and access issues; the introduction of the Hugo RAS system aims to mitigate these challenges.

Rajit Kamal, Medtronic's Vice President and General Manager of Robotic Surgical Technologies, expressed enthusiasm for the development, stating, "This is an incredibly exciting day for healthcare in the United States. FDA clearance of the Hugo RAS system means there is now choice for hospitals looking to expand their robotic programs and increases access for patients."

Key Features of the Hugo RAS System

The Hugo RAS system has been thoughtfully designed with input from surgeons and healthcare administrators, featuring several innovative components that set it apart from others in the field, including:

1. Modular Design

The system's modular design allows for dynamic usage. The robotic arms can be transported, shared, and adapted across various healthcare settings. This flexibility not only maximizes the utilization of the system but also gives surgeons the freedom to customize their approach for each patient, optimizing anatomical access tailored to individual needs. Additionally, the open design of the surgeon console enhances situational awareness and minimizes physical strain, contributing to better communication and teamwork during procedures.

2. Digital Ecosystem

Hugo seamlessly integrates with the Touch Surgery™ ecosystem, which provides tools for pre-operative training, remote tele-proctoring, and post-operative case insights powered by artificial intelligence. Surgeons can access case videos shortly after procedures, promoting continuous improvement and fostering collaboration among medical teams and with peers globally.

3. Comprehensive Partnership Approach

What makes Medtronic unique is its ability to meet surgeon needs across all surgical modalities, including open, laparoscopic, and robotic-assisted surgeries. The introduction of the Hugo RAS system enhances access to world-class training and clinical expertise, allowing surgical teams to select the best surgical method for their patients while utilizing trusted Medtronic technologies.

Dr. James Porter, a urologic surgeon and Chief Medical Officer at Medtronic, commented, "The Hugo RAS system represents a new and exciting approach to robotic-assisted surgery. We're excited for surgical teams in the U.S. to experience the differentiated technology and partnership from Medtronic."

Advancing Minimally Invasive Surgery

The FDA has approved the Hugo RAS system for a range of minimally invasive urologic surgeries, which include procedures such as prostatectomy, nephrectomy, and cystectomy. These common surgical procedures account for approximately 230,000 operations performed annually in the U.S. The clinical study, Expand URO, showcased the effectiveness of the Hugo RAS system, achieving safety and effectiveness benchmarks that align with existing literature.

Globally, the Hugo RAS system has already been deployed in thousands of urologic, gynecologic, and general surgeries across more than 30 countries over five continents. Medtronic’s future plans include expanding the system’s applications in the U.S. to additional surgical specialties, with expectations of approvals for general and gynecologic surgeries following the current clearance for urology.

The introduction of the Hugo RAS system exemplifies Medtronic's dedication to integrating advanced technology with surgical practice, enhancing the connected operating room environment and improving patient outcomes.

For further information on Medtronic’s innovations in surgery, visit medtronic.com/hugoishere.

About Medtronic
Medtronic is a leading global healthcare technology company headquartered in Galway, Ireland. Committed to alleviating pain and restoring health, the company employs over 95,000 individuals across more than 150 countries. Their innovative technologies touch the lives of millions, addressing around 70 health conditions through a broad portfolio of products, ranging from cardiac devices to surgical robotics. Medtronic remains focused on delivering improved healthcare outcomes while fostering insightful and patient-centered care.