Medrobotics said today that its Flex robot-assisted surgery device won CE Mark approval in the European Union, expanding its indication to include colorectal procedures. The Raynham, Mass.-based company claims to be the 1st robotics firm to offer minimally invasive and steerable robotic products for colorectal applications.
“CE Mark for colorectal procedures is significant since it expands the number of patients who can be treated with the Flex robotic system and provides a true platform technology that multiple hospital departments can use,” CEO Samuel Straface said in prepared remarks. “When combined with the unrivaled mobility of the system, European otolaryngology and colorectal surgeons can now perform minimally invasive surgery through the body’s natural orifices, offering the potential for truly scarless surgeries.”
“The Flex Robotic System has been clinically proven to provide access and visualization to surgical targets in difficult to reach locations such as the oropharynx and endolarynx in otolaryngology,” added Dr. Marshall Strome of the Cleveland Clinic Head and Neck Institute and co-chair of Medrobotics’ medical advisory board. “With the new colorectal indication, more European surgeons, hospitals and patients can benefit from minimally invasive procedures.”
Medrobotics, which raised $25 million in November 2015, won 510(k) clearance from the FDA for transoral procedures in July of that year. Last summer the company touted data from an 80-patient post-market study of the Flex device in procedures to treat throat lesions, showing that the system was able to successfully visualize and access the target area in 94% of cases, with 91% resulting in successful biopsy. Fifty-eight percent of the procedures were performed in areas the surgeons considered “difficult to reach,” such as the tongue base and vocal chords.