Hugo Robotic-Assisted Surgery System receives European CE Mark approval – Medtronic

Medtronic plc announced it has received CE (Conformité Européenne) Mark for the Hugo robotic-assisted surgery (RAS) system, authorizing the sale of the system in Europe. CE Mark approval is for urologic and gynecologic procedures, which make up about half of all robotic procedures performed today.

The Hugo RAS system was designed to address the historic cost and utilization barriers that have stifled robotic surgery adoption for two decades. Globally, about 3% of surgeries are performed robotically, despite offering patients the benefits of minimally invasive surgery — fewer complications, shorter hospital stays, and faster return to normal activities. In Western Europe, about 2% of procedures are done robotically while the majority, approximately 65%, are open surgery. The remainder are traditional minimally invasive surgery.

These hospitals will be the first in Europe to join Medtronic’s Partners in Possibility Program, a group of pioneering institutions that will be among the first in the world to use the Hugo RAS system and participate in the global patient registry. Clinicians from these hospitals will participate in hands-on training at Medtronic Surgical Robotics Experience Centers, including two flagship sites operated in partnership with the ORSI Academy in Ghent, Belgium, and IRCAD in Strasbourg, France.

CE Mark approval comes on the heels of major milestones in the Hugo RAS system global launch, including the first urological and gynecological procedures, which took place in Latin America and India and marked the start of the Hugo RAS system global patient registry. A modular, multi-quadrant platform designed for a broad range of surgical procedures, the Hugo RAS system 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.

The Hugo RAS system is commercially available in certain geographies. Regulatory requirements of individual countries and regions will determine approval, clearance, or market availability. In the EU, the Hugo RAS system is CE marked. In the U.S., the Hugo RAS system is an investigational device not for sale. Touch Surgery Enterprise is not intended to direct surgery, or aid in diagnosis or treatment of a disease or condition.