Medtronic plc has received official approval for the sale of its robotic-assisted surgery (RAS) system in Europe.
European CE Mark approval of its Hugo system is for urologic and gynecologic procedures, which make up around half of all robotic procedures performed today.
Megan Rosengarten, president of the firm’s surgical robotics division, said: “This day has been a long time coming, not just for Medtronic, but for the surgeons and hospital leaders who have partnered with us on this journey to bring the benefits of robotic-assisted surgery to more patients around the world.
“We know our solution is more meaningful because of their insights. With the Hugo RAS system in our European customers’ hands and our dedicated team by their side, together we will redefine what is possible in robotic-assisted surgery.”
The Hugo RAS system was designed to address the historic cost and utilisation barriers that have stifled robotic surgery adoption for two decades.
Globally, around three per cent 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 two per cent of procedures are done robotically while the majority, approximately 65 per cent, are open surgery. The remainder are traditional minimally invasive surgery.
Rob ten Hoedt, executive vice president and president of the Europe, Middle East, and Africa (EMEA) region at Medtronic said: “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.
“The Hugo RAS system builds on our leadership in minimally invasive surgery, and we’re thrilled to provide hospitals across Europe a robotic-assisted surgery system that is thoughtfully designed to meet their needs today and tomorrow. We’ve had strong interest from leading surgical centres across Europe and expect to move quickly with multiple installations in several countries.”
These hospitals will be the first in Europe to join Medtronic’s Partners in Possibility Program, a group of 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 training at Medtronic Surgical Robotics Experience Centres, including two flagship sites operated in partnership with the ORSI Academy in Ghent, Belgium, and IRCAD in Strasbourg, France.
CE Mark approval follows 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.