The Toronto-based company said that it completed a system engineering confidence build for all the components in the robotic platform, including a new camera system and design enhancements to its surgeon workstation and patient cart, which act as the two primary components of the system.
The Sport surgical system is a single-incision, advanced robotic surgical system featuring multi-articulated instruments with single-use replaceable tips. The platform uses 3D high-def visualization through a flat-screen monitor along with an open workstation and a single-arm mobile patient cart, according to the company’s website.
“I extend congratulations to Dr. Perry Genova, our senior vice president of research and development, and our engineering team for achieving this significant development milestone on an aggressive schedule during the fourth quarter of 2018. We are proud of their accomplishments and are thrilled with our substantial progress in 2018, and note that timely completion of this build is a critical step in preparation to file for regulatory clearances in the U.S. and the European Union. We are also grateful to the visionary surgeons who performed 45 preclinical studies with our earlier Sport system prototype, including 14 different procedures within four surgical disciplines, providing key input to our design team. As a result, our single-port robotic system now incorporates multiple important and patent-pending enhancements specifically intended to improve surgical performance and ease of use, which will better position us in the rapidly-expanding surgical robotics market,”prez & CEO David McNally said in a press release. “We welcome viewers to our website where we have posted video of the Sport system enhancements, which include a completely redesigned unique dual-camera system with a 3D high-definition steerable endoscopic camera for use during surgery, as well as a 2D high-definition wide-angle camera integrated into the camera insertion tube for visualization of instrument insertions, which also serves as a backup camera for safety. The engineering team has also designed a more compact and significantly lighter patient cart, with a reduced footprint designed to optimize portability, minimize set-up time and facilitate unencumbered assistance of surgical staff at the patient bedside. Further, we have improved the surgeon interface at the workstation with a more comfortable handle design, a new 4K monitor and upgraded haptic feedback with image overlays to assist the surgeon with the positioning of the instruments for optimal performance. We are excited to move into 2019 with this next-generation single-port robotic surgical system, with a focus on meeting our regulatory milestones.”
Yesterday, said that it expects to file for 510(k) clearance in the U.S. and CE Mark clearance in the E.U. by the end of 2019 for its Sport robotic surgical system.