IRELAND – Medtronic has received European approval for its Hugo surgical robot, paving the way for the system to make its debut in multiple countries across the continent.
Hugo performed its first human procedure this summer in Santiago, Chile: a minimally invasive prostatectomy.
It has since expanded to Latin America, beginning with a series of initial gynecological surgeries in Panama City, Panama.
The robotic platform, which is comprised of modular surgical arms mounted on wheeled carts, has also completed its first operation in the Asia-Pacific region, a prostatectomy in Chennai, India.
All of the company’s systems are linked to a global patient registry, which monitors outcomes and feeds that information back into the platform.
In Europe, the CE mark now covers urologic and gynecologic procedures such as hysterectomies and uterine fibroids removal.
According to Medtronic, the green light allows access to roughly half of all robotic surgeries performed today.
“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,” Megan Rosengarten, president of Medtronic’s surgical robotics business, said in a statement.
The CE mark largely follows a timeline first laid out by the company in late 2019, which had its sights set on Europe before pursuing FDA regulatory approvals and broader soft-tissue surgery indications.
The Hugo system is intended to lower the barrier to entry for hospitals looking to expand their robotic surgery capabilities.
In comparison to platforms like Intuitive Surgical’s flagship Da Vinci system—a large, multiarm machine that is typically installed as the centerpiece of an operating room—Hugo can be customized with up to four independent arms and rolled to different locations within a hospital as needed.
The ultimate goal of Medtronic is to provide robot-assisted procedures at a cost comparable to manual laparoscopy.
According to the company, only about 3% of procedures are performed robotically today, with the vast majority still being performed through open surgery.
“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, Medtronic’s Europe, Middle East and Africa regional president.
“We’ve had strong interest from leading surgical centers across Europe and expect to move quickly with multiple installations in several countries.”
To begin, clinicians will receive hands-on training at Medtronic surgical centers, including two flagship sites in Ghent, Belgium, and Strasbourg, France, at the Orsi Academy and the IRCAD laparoscopic training center.
The Hugo system also includes 3D visualization and cloud-based video capture technology via the company’s Touch Surgery platform, which is used to train surgeons and students outside of the operating room.
Hugo will compete in Europe against CMR Surgical’s Versius robot, which has its own cart-based, modular design.
Versius received its first CE mark in 2019 and is currently being reviewed by the FDA, with approval possible this year.