Medtronic has received CE mark approval for the Hugo robotic-assisted surgery (RAS) system to be used in general surgery procedures in Europe.
The Hugo RAS system received CE mark for urologic and gynaecologic procedures in October 2021. Those indications, combined with general surgery, cover about 80% of all robotic-assisted surgeries performed globally today.
Dr. Carla Peron, chief medical officer of the Surgical Robotics business in Medtronic’s Medical Surgical portfolio, shared the announcement during a podium presentation at the European Hernia Society’s annual international congress in Manchester, England.
Dr Peron said: “Robotic-assisted surgery is key to opening access to quality care and improved outcomes. The general surgery indication for Hugo is a major step in expanding the benefits of minimally invasive surgery to patients around the world. Our team is looking forward to partnering with more customers to build and grow their robotic surgery programs in this hugely important area of healthcare.”
The Hugo RAS system was designed to address barriers to robotic surgery adoption. Globally, about 4% of surgeries are performed with the assistance of a robot, 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.
The CE mark for general surgery spans several specialties including hernia, colorectal, and bariatric. Hernia surgery is the fourth most common operation around the world and represents the fastest-growing procedural area for robotic-assisted surgery. It is also a space where Medtronic has long had market-leading positions with its portfolio of access, dissection, mesh, and fixation products.
Dr. Filip Muysoms, president of the European Hernia Society, said: “Robotic-assisted surgery represents an exciting opportunity for hernia procedures, transforming the patient experience. We are thrilled to collaborate with Medtronic, our long-term partner, on this announcement and continue to shape the future of hernia treatment together.
CE mark approval comes alongside regulatory milestones for Hugo RAS system, including a Health Canada licence for general surgery, and Ministry of Health, Labor, and Welfare (MHLW) approval for use in gynaecology and urology in Japan. Outside the EU, the Hugo RAS system has been used in general surgery procedures at hospitals in Asia Pacific and Latin America. The procedures range from common to more complex and include cholecystectomy, inguinal hernia repair, gastric bypass, and lower anterior resection.
A modular, multi-quadrant platform designed for a broad range of surgical procedures, the Hugo RAS system combines wristed instruments, 3D visualisation, and a cloud-based surgical video capture option in Touch Surgery Enterprise with dedicated support teams specialising in robotics program optimisation, service, and training.
Touch Surgery Enterprise is a first-of-its-kind AI-powered platform that makes sharing surgical video simple and provides surgeons with a powerful new training tool to improve performance. Used together, the Hugo RAS system and Touch Surgery Enterprise provide insight into procedure time, cost, and process, which has the potential to reduce burdens on healthcare systems.
The Hugo RAS system is commercially available in certain geographies. Regulatory requirements and status in individual countries and regions will determine market availability of the Hugo RAS system and approved indications. In the U.S., the Hugo RAS system is an investigational device not for sale.
