Medtronic (NYSE:MDT) announced today that it completed the first patient procedure with the Hugo robotic-assisted surgery system.
Fridley, Minn.–based Medtronic said in a news release that urological surgeon Dr. Ruben Olivares performed the robotic prostatectomy on June 19 at Clínica Santa Maria in Santiago, Chile. The procedure marks the beginning of the Hugo RAS system patient registry, which will collect clinical data as the company seeks various global regulatory submissions.
“I’m proud to have performed the very first clinical procedure with the Hugo RAS system,” Olivares said in the release. “From the open console and modular platform to the instrumentation I know and trust, this innovative system is truly a partner in the OR.”
Hugo, which last month garnered FDA investigational device exemption, offers a modular, multi-quadrant platform designed for a broad range of surgical procedures with wristed instruments, 3D visualization and surgical video capture option in Touch Surgery Enterprise.
The system has not yet received clearance or approval in the U.S. or Europe. Medtronic said the regulatory requirements of individual countries and regions will determine its availability, approval and/or clearance timelines. At the same time, Touch Surgery Enterprise is not intended to direct surgery or aid in the diagnosis of or treatment for a disease or condition.
“Today, with the start of our Hugo RAS system patient registry, we’re taking an exciting step forward to bring the benefits of robotic-assisted surgery to more patients in more places,” president of Medtronic’s surgical robotics business Megan Rosengarten said. “That’s possible thanks to our shared vision with Clínica Santa Maria, 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 in support of our patient registry.”