Author(s): Andrew Luhrs, MD
EvoEndo Inc. received FDA approval for EvoEndo Single-use Endoscopy System on February 14, 2022.
The EvoEndo Model LE Gastroscope is a sterile, single use gastroscope intended to perform oral or transnasal diagnostic endoscopy in adult and pediatric patients. It has a 3.5mm outer diameter, 2mm working channel (compatible with standard accessories), and a 1.1 m working length. The device allows for high-definition visualization of the esophagus, stomach, and duodenal bulb. This device allows physicians to control the distal tip with 4-way deflection capabilities and has a 120° field of view. Additionally, due to its small outer diameter this device allows for unsedated transnasal upper gastrointestinal examination, which has been shown to be safe and effective and eliminates the risk of associated anesthesisa, lowers cost, and reduces procedure times1.
The EvoEndo Controller is able to process image and video capture and adjustments and outputs the endoscopes image feed to any medical monitor or computer system via USB or HDMI output.
The EvoEndo Single-use Endoscopy System has been shown to be safe, effective, and biocompatible in nonclinical testing. The FDA had determined this device to be substantially equivalent to the Fujinon Model EG-530N Transnasal Insertion and the Boston Scientific EXALT Controller.
The EvoEndo Model LE Gastroscope is intended for oral or transnasal endoscopic observation, diagnosis and treatment in the esophagus, stomach and duodenum in patients over five years of age.
The EvoEndo Controller is intended for use with an EvoEndo Endoscope for endoscopic diagnosis, treatment and endoscopic observation.
The devices is contraindicated in children less than 5 years of age or if there is an absolute contraindication to endoscopy or endoscopic surgery.
1. Nguyen N, Mark J, Furuta GT. Emerging Role of Transnasal Endoscopy in Children and Adults. Clin Gastroenterol Hepatol. 2022 Mar;20(3):501-504. doi: 10.1016/j.cgh.2021.11.021. Epub 2021 Dec 16. PMID: 34921762.