The U.S Food and Drug Administration provided 510(k) clearance for the new Aer-O-Scope colonoscope system, according to GI View of Ramat Gan, Israel.
The Aer-O-Scope is a self-propelled, disposable colonoscope with a 360-degree view of the colon that is controlled with a joystick.
The new system, which is an improvement on the earlier Aer-O-Scope colonoscope, also FDA approved, will have two working channels in order to provide therapeutic access for standard tools to take biopsies or perform polypectomies. It uses a soft multilumen tube designed to significantly reduce pressure on the colon wall, which may increase patient safety. It is also hydrophilic and reduces the friction between bowel and scope by more than 90%. The system has a self-propelled intubation process, created with balloons and low pressure CO2 gas. And, like all colonoscopes, the Aer-O-Scope provides insufflation, irrigation, and suction.
“The new Aer-O-Scope system with therapeutic access has many significant clinical benefits including enabling physicians to more easily, effectively, and efficiently identify and remove polyps and prevent colon cancer,” said GI View CEO Tal Simchony, PhD, in a press release. “We are now working on U.S. market introduction of the Aer-O-Scope. Postmarket studies are also in the plans.”
Colorectal cancer is one of the biggest causes of cancer death worldwide. It can be prevented by early detection and removal of polyps. Read more about Aer-O-Scope on GI View’s website.