Author(s): Sharona Ross MD FACS & Heather DeReus
Medrobotics Corporation received FDA approval for Flex Robotic System and Flex Colorectal Drive on May 4, 2017.
The Flex Robotic Colorectal System is comprised of the Flex Robotic System and the patient-contacting portion called the Flex Colorectal Drive. The Flex Robotic Colorectal System is a video endoscope controlled through a console based physician handle. It combines the benefit of a rigid endoscope with the benefit of a computer coordinated controller to allow for visualization and access to the anus, rectum, and distal colon. This endoscope features two channels for insertion of additional flexible instruments.
Three animal studies were conducted to determine safety of the Flex Robotic System and Flex Colorectal Drive. It was found that in comparison to the colonoscope control, the Flex Colorectal Drive was not associated with an increased level of abrasion. It was also shown that the visualization and access by use of the Flex Robotic System to the colorectal space were acceptable. Another study showed that the Flex Robotic System stabilizes and allows the surgeon to perform surgical procedures including excision, suturing, and bleeding control. Additionally, a study on 6 human cadavers showed that together the Flex Robotic System and Flex Colorectal Drive allow for trans-anal entry, maintenance of insufflation, along with visualization and access necessary for resection and closure of trans-anal tissue.
The Flex Robotic System and Flex Colorectal Drive have been deemed substantially equivalent to the NeoGuide Navigator Endoscopy System.
- The Medrobotics Flex Robotic System is intended for use in adults 22 years of age and older. It provides robot-assisted control of the Flex Colorectal Drive. The Flex Colorectal Drive is intended for robot assisted visualization of and surgical site access to the anus, rectum and distal colon. The Flex Colorectal Drive also provides accessory channels for compatible flexible instruments used in surgical procedures.
- Age younger than 22 years