IRELAND – Medtronic plc, the global leader in medical technology, announced today that the Hugo robotic-assisted surgery (RAS) system has received CE (Conformité Européenne) mark, allowing it to be sold in Europe.
CE Mark approval is only available for urologic and gynecologic procedures, which account for roughly half of all robotic procedures performed today.
Hugo RAS system plays a critical role in bringing the benefits of minimally invasive surgery, the first-ever in the world using the Hugo RAS system.
CE Mark approval follows major milestones in the Hugo RAS system global launch, including the first urological and gynecological procedures in Latin America and India, which marked the start of the Hugo RAS system global patient registry.
The Hugo RAS system is a modular, multi-quadrant platform designed for a wide range of surgical procedures.
It combines wristed instruments, 3D visualization, and a cloud-based surgical video capture option in Touch Surgery Enterprise with dedicated support teams specializing in robotics program optimization, service, and training.
Hugo RAS joins a portfolio of gynecological products designed to allow for less invasive surgical treatment of a variety of conditions such as abnormal uterine bleeding, uterine fibroids, and endometrial cancer.
Hugo RAS was created to address the historic cost and utilization barriers that have stifled robotic surgery adoption for the past two decades.
Despite the benefits of minimally invasive surgery — fewer complications, shorter hospital stays, and faster return to normal activities — robotic surgery is only used in about 3 percent of surgeries worldwide.
In Western Europe, approximately 2 percent of procedures are performed robotically, while the majority, approximately 65 percent are open surgeries. The rest are standard minimally invasive surgeries.
“Robotics and artificial intelligence are the undeniable future of healthcare, with incredible potential to not only advance patient care, but increase access to these benefits,” said Rob ten Hoedt, executive vice president and president of the Europe, Middle East, and Africa (EMEA) region at Medtronic.
Hugo RAS is a commercially available system in certain geographies. Individual countries’ and regions’ regulatory requirements will determine its approval, clearance, or market availability.
Following the EU approval, Hugo RAS will be eligible for sale in the UE market. Meanwhile, the Hugo RAS system is an investigational device that is not for sale in the United States.