Background / Objective: For several years, head and neck surgery has incorporated transoral robot assisted surgery (TORS) as a new approach in the management of pharyngeal and supraglottic cancer. In contrast to well-known systems originally designed for large cavity surgery the new Flex® Robotic System (Medrobotics Corporation, Raynham, MA, USA) was developed in order to enhance the spectrum of TORS and to overcome existing limitations by being specifically tailored to the needs of head and neck surgeons.

The Flex® Robotic System is an operator controlled computer assisted flexible endoscope that enables the physician to easily access and visualize structures within the oropharynx and laryngopharynx down to and including the vocal cords. Like other endoscopes, visualization is provided by a digital camera incorporated in the distal end of the scope.  The Flex® Robotic System endoscope also provides 2 accessory channels for various compatible flexible instruments which are easily viewed when extended from the distal end of the scope.

The objective of our study was the evaluation of the Flex® Robotic System in transoral robotic head and neck surgery.

Study Design / Material and Methods: This prospective, single-arm, open-label, European post-market clinical follow-up study was performed at four European sites from 16 July 2014 to 26 October 2015 and assessed the safety and effectiveness of the Flex® Robotic System when used to provide surgeons with visualization and surgical access to benign as well as malignant lesions in the oropharynx, hypopharynx, and larynx. A total of 80 subjects were enrolled. The lesions could be accessed and visualized in 79 subjects and a total of 78 subjects went on to have a surgical procedure performed with the Flex® Robotic System. The system was evaluated for adjustability, maneuverability, visualization, and resectability of the tumor.

Results: We were able to expose, visualize and access the palatine tonsil area, the base of tongue area, the epiglottis, the posterior pharyngeal wall, and the false vocal cords in more than 94% of cases (75 of 79 subjects). In addition, a variety of surgical procedures and biopsies in the oropharynx, hypopharynx and larynx could successfully be completed in 91% of procedures (72 of 79 subjects), with 58% (42 of 72 procedures) performed in areas of the anatomy considered difficult to reach (i.e. base of tongue, pharynx, piriform sinus, posterior pharyngeal wall, false vocal cords, and vocal cords). There were no serious or unanticipated device-related adverse events identified to be caused by the Flex® Robotic System.

Conclusion: The Flex® Robotic System was specifically developed for TORS: The combination of a robot assisted flexible endoscope with flexible instruments allowed for excellent maneuverability and tactile feedback. All relevant anatomic structures of the pharynx and larynx could be well exposed, visualized and accessed. Lesions especially in different to reach regions could be successfully resected thus making it a safe and effective tool in transoral robotic surgery.