FDA Clears Flex Robotic System from Medrobotics

Raynham, Mass.-based Medrobotics Corp., a surgical robotics company, received U.S. Food and Drug Administration (FDA) clearance to market the Flex Robotic System. The company is initiating a commercial launch in U.S. hospitals. It received European CE mark clearance in March 2014.

“The FlexRobotic System is the first and only robot-assisted surgical platform with a flexible scope cleared by FDA for use during transoral procedures,” said Samuel Straface, Ph.D., president and CEO of Medrobotics. “The minimally invasive system enables surgical access and visualization in hard-to-reach locations through a single site. Doctors can then complete procedures that might otherwise be difficult, or even impossible, to perform due to inability to visualize or access the site.”

Unlike traditional “line-of-sight” approaches, the Flex Robotic System employs a unique, flexible, robotic scope that precisely moves through the body’s natural twists and turns, company officials claim. Once the surgeon reaches the desired vantage point, the scope becomes rigid to form a stable surgical platform. The on-board, high definition vision system makes it easy to see and operate with a range of flexible surgical instruments. The unique “wristed” 3-millimeter Flex Instruments allow the surgeon to operate precisely in confined spaces.

“The Flex Robotic System provides unparalleled access and visualization of the oropharynx, hypopharynx and larynx,” said Marshall Strome, M.D., professor and chairman emeritus, Cleveland Clinic Head and Neck Institute, and co-chair of the Medrobotics medical advisory board. “When used in combination with the highly adjustable Flex Retractor, surgeons can greatly extend their reach in challenging areas of the mouth and throat. I consider these products transformative.”

University of Pittsburgh Medical Center distinguished professor and emeritus chair of otolaryngology, and co-chair of the Medrobotics medical advisory board, Eugene Myers, M.D., echoed those comments.

“I’ve been a surgeon since 1960 and this technology is one of the most significant operating room advances I’ve seen in decades,” said Myers. “If surgeons can reach a site, they can do some good. The Flex Robotic System makes that possible in a number of head and neck procedures. Further, with this device, the surgeon is positioned close to the patient throughout the procedure. My strong sense is it will also have applications for surgery in other sites.”

Medrobotics is privately held. It manufactures and markets the Flex Robotic System that was developed at Carnegie Mellon University in Pittsburgh, Pa.