Medtronic's Hugo Robotic Surgical System Receives European Approval
Medtronic has received CE (European conformity) certification in Europe for its Hugo robotic surgical system. The Medtronic CE mark covers urological and gynecological procedures, which account for roughly half of all robotic procedures performed today.
Hugo, which received an FDA exemption for investigational devices in May 2021, is a modular multi-quadrant platform designed for a wide range of surgical procedures using hand-held instruments, 3D visualization, and the ability to create surgical video in Touch Surgery Enterprise. In June 2021, Medtronic announced the first clinical procedure with Hugo in Chile.
“This day has been a long time coming, not only for Medtronic but also for the surgeons and hospital executives who have become our partners on this journey to bring the benefits of robotic surgery to more patients around the world. We know our solution matters more because of their insight. With the Hugo RAS system in the hands of our European customers and our dedicated team alongside them, we will together redefine what is possible in robotic surgery”
Several hospitals will be among the first in Europe to join the Medtronic Partners in Possibility program to use the Hugo system and take part in the global patient registry. Physicians from the hospitals will take part in hands-on training at Medtronic's surgical robotics centers of excellence, in particular two centers in Ghent (Belgium) and Strasbourg (France).
“Robotics and artificial intelligence are the undeniable future of healthcare, with incredible potential not only to improve patient care but also to expand access to these benefits. The Hugo RAS system is built on our leadership in minimally invasive surgery, and we are excited to provide hospitals across Europe with a robotic surgery system thoughtfully designed to meet their needs today and in the future. Leading surgical centers across Europe have shown strong interest, and we expect to move quickly with several installations in multiple countries”
First Procedure with Hugo
On June 19, 2021, urologic surgeon Ruben Olivares performed a robotic prostatectomy at Santa Maria Clinic in Santiago, Chile. This procedure marked the start of the Hugo RAS patient registry, which will collect clinical data as the company pursues various international regulatory submissions.
“I am proud to have performed the very first clinical procedure with the Hugo RAS system. From the open console and modular platform to the instrumentation I know and trust, this innovative system will truly become my partner in the operating room”
It is also worth noting that Touch Surgery Enterprise, an intelligent operating room computer with built-in AI capabilities that provides secure and easy access to surgical videos and delivers post-operative analytics, is not intended to directly perform surgery, assist in diagnosis, or treat disease. Medtronic introduced Hugo about two years ago with the goal of lowering costs and expanding the use of robotic surgery for minimally invasive procedures.
“Today, with the launch of our Hugo RAS system patient registry, we are taking an exciting step forward to bring the benefits of robotic surgery to more patients in more places. This is made possible by our shared vision with Santa Maria Clinic, the first institution to join our Partners in Possibility program, a group of pioneering hospitals that will be among the first in the world to use the Hugo RAS system to support our patient registry”
Medtronic is one of the world's largest medical technology, services, and solutions companies, alleviating pain, restoring health, and extending life for millions of people around the world. The company employs more than 90,000 people who serve physicians, hospitals, and patients in more than 150 countries. Medtronic aims to collaborate with stakeholders worldwide to advance healthcare together.
The company says its core mission is: «To contribute to human welfare by application of biomedical engineering in the research, design, manufacture, and sale of instruments or appliances that alleviate pain, restore health, and extend life. To direct our growth in biomedical engineering where we can make the greatest use of our strengths and capabilities, to gather together people and things which tend to enlarge these fields, to continually develop these fields through education and the acquisition of knowledge, and to avoid participation in those areas where we cannot make a unique and worthwhile contribution».
