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FDA clears Aer-O-Scope with therapeutic access
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The FDA has granted 510(k) clearance for the new Aer-O-Scope disposable colonoscopy system, which now includes working channels for therapeutic intervention during colorectal cancer screening, the manufacturer announced.
Aer-O-Scope (GI-View) is a single-use self-propelled colonoscope system that is the first to provide a 360 degree omni-directional view of the colon for detecting polyps behind folds, according to a press release. The update to the new system includes two working channels that provide therapeutic access using standard biopsy and polypectomy tools.
“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,” Tal Simchony, PhD, EE, CEO of GI-View, said in the press release. “We are now working on U.S. market introduction of the Aer-O-Scope. Post-market studies are also in the plans.”
The system is disposable, so there is no risk of contamination or disease transmission between patients, and it is controlled by a user-friendly joystick that requires minimal training, according to the press release. It uses a soft, hydrophilic, multi-lumen tube that reduces pressure on the colon wall and reduces friction by more than 90%, and the system’s self-propelled intubation using balloons and low pressure CO2 gas increases ease of use and patient safety and comfort. The system also provides standard insufflation, irrigation and suction, according to the press release.
Disclosures: Simchony is employed by GI-View