CMR Surgical received Europe’s CE mark and Great Britain’s UKCA mark for its Versius robotic system in pediatric surgery, the company said Thursday.
The approval for abdominal surgery in patients under the age of 18 is the company’s first regulatory clearance for treating children, opening a significant new market segment in Europe, CMR said.
The Cambridge, England-based company said the robot’s modular arms, which mimic the human arm, and small-diameter instruments are well suited to the anatomy of children. The modular design means surgeons use only the number of arms needed for a given procedure.
“We look forward to extending the benefits of our minimally invasive technology to this important patient population,” Co-founder and Chief Medical Officer Mark Slack said in a statement.
Robotics market leader Intuitive Surgical’s da Vinci 5 system is also CE marked for pediatric use, as is Beijing-based Surgerii Robotics’ single port system.
CMR obtained the CE mark for Versius in 2019. In the U.S., an updated version of the robot, Versius Plus, gained Food and Drug Administration clearance in December with an initial indication for gallbladder removal, about a year after the first system won de novo authorization.
About 40,000 cases have been performed with Versius worldwide to date, in specialties including urology, general surgery, gynecology and thoracic surgery.
SS Innovations adds smaller instruments
SS Innovations International this week said it completed development of five new surgical instruments for use with its SSi Mantra robotic system in procedures involving small anatomical structures, including in pediatric, cardiac, and head and neck surgery.
The 5-millimeter surgical instruments are a spatula cautery, hook cautery, needle driver, bipolar forceps and grasping forceps.
“We aim to make robotic surgery more accessible to pediatric patients with new, smaller surgical instruments,” Vishwa Srivastava, CEO for Asia Pacific, said in a statement. “Moving forward, we will continue to focus on developing differentiated surgical robotic technologies, such as these instruments, for the benefit of a larger segment of patients globally.”
The India-based company, which filed for FDA clearance for the SSi Mantra system in December, said its robot has been used in more than 7,800 procedures, including over 120 telesurgeries and 400 cardiac surgeries, to date. At the end of December, the installed base of SSi Mantra robots totaled 168 systems across 10 countries.
