TransEnterix, a medical device company that is pioneering the use of robotics and flexible instruments to improve minimally invasive surgery, announced the submission of its 510(k) application with the US Food and Drug Administration (FDA) for clearance of the company’s SurgiBot System.
"TransEnterix is pleased to deliver on our commitment to file for 510(k) clearance for the SurgiBot System by mid-2015," said TransEnterix President and CEO, Todd M. Pope.
"Robotically enhanced laparoscopy with the SurgiBot System represents the first surgical platform designed to address economic and clinical challenges associated with current laparoscopic and robotic options."
The SurgiBot System is the first patient-side, robotically enhanced laparoscopy platform. Our goal is to usher in the next wave of minimally invasive surgery by delivering excellent instrument dexterity and precision, surgeon comfort, and minimize patient incisions.
The system is also designed to be mobile, minimize reliance on additional staff, and be cost-effective for many types of surgical facilities.
The surgical approach and motions used with the SurgiBot are intended to mimic established laparoscopic surgical techniques.
The system utilizes flexible instruments through articulating channels controlled directly by the surgeon, with robotic assistance, from within the sterile field. The flexible nature of the system allows multiple instruments to be introduced and deployed through a single incision.