Medrobotics said today it won FDA 510(k) clearance for its Flex robotic transoral surgery system and is launching the system in the U.S.
The Flex system uses a flexible robotic endoscope, a range of flexible instruments and a high-definition vision system for use in accessing and visualizing structures in the mouth and throat, Raynham, Mass.-based Medrobotics said.
“The Flex robotic system is the 1st and only robot-assisted surgical platform with a flexible scope cleared by FDA for use during transoral procedures. 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,” CEO Samuel Straface said in a prepared statement.
“The Flex Robotic System provides unparalleled access and visualization of the oropharynx, hypopharynx and larynx. 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,” Medrobotics medical advisory board co-chair Dr. Marshall Stromeof the Cleveland Clinic Head and Neck Institute said in a press release.
After the operating physician positions the robotic scope at the necessary vantage point, the scope can become rigid to provide a more stable operating platform for the surgeon, Medrobotics said.
“I’ve been a surgeon since 1960 and this technology is one of the most significant operating room advances I’ve seen in decades. 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 medical advisory board co-chair Dr. Eugene Myers of the University of Pittsburgh Medical Center said in prepared remarks.
Last July, Medrobotics celebrated the world’s 1st cancer surgeries performed with its Flex surgical robot in a pair of procedures conducted at a hospital in Germany. Surgeons used the Flex system to successfully remove lesions from a pair of patients, effectively launching Medrobotics’ postmarket clinical trial, which will enroll up to 80 patients in Germany and Belgium.
The Flex system won CE Mark approval in the European Union last March.