CE Mark and UKCA Marks for Versius Surgical System in paediatric surgery – CMR Surgical

CMR Surgical  the global surgical robotics business, announce that it has received CE and UKCA Marks for its Versius Surgical System (Versius) in paediatric surgery, marking the Company’s first regulatory clearance for treating children. The approval has been received for abdominal surgery in children and infants under the age of 18.

Versius’ uniquely compact and modular design allows the system to be set up in a way that enables optimal access for the surgeon and surgical teams. With a compact instrument diameter and maximal dexterity, the system is optimally designed for the paediatric anatomy. The system’s portability allows it to seamlessly integrate into virtually any operating room and be easily moved between departments.

Mark Slack, Chief Medical Officer at CMR Surgical, commented: “Securing CE Mark approval for Versius in paediatric surgery is an important milestone for CMR Surgical and for the future of robotic-assisted minimally invasive surgery. The approval opens a new, high value segment of the market, whilst validating the strength and flexibility of our technology and we look forward to extending the benefits of our minimally invasive technology to this important patient population.”

Ewan Brownlee, Consultant Paediatric Urologist at Southampton Children’s Hospital and Chief Investigator for the Versius Paediatric Trial, said: “As a paediatric surgeon, I’m delighted that Versius can now benefit more children in the UK and internationally. In our study, its modular arms and small instruments proved well suited to paediatric anatomy, and we have already completed almost 150 procedures across three centres in patients from just a few months old upwards. With approval for use in under-18s, we will be able to extend the benefits of minimally invasive surgery to a wider patient population.”

Versius is a unique, versatile and adaptable surgical robot designed to seamlessly and easily integrate into any operating room and hospital workflow. The system has performed c.40,000 surgical cases to date and is being used across a broad range of specialties including urology, general surgery, gynaecology, and thoracic surgery in leading hospitals around the world. Versius can be easily moved between departments, making it suitable for any care setting from low acuity, high-volume cases to the most complex oncological surgical procedures