Eleview™ is an FDA & CE-cleared medical device submucosal injectable composition to be used in endoscopic resection procedures in the upper and lower gastrointestinal tract, such as the esophagus, the stomach, the intestine and the rectum. Eleview™ has a unique and novel mechanism of action (MOA) and is designed to provide a submucosal cushion of optimal height and duration while lowering the risk of perforation, facilitating an easy resection procedure for EMR, hybrid EMR, and ESD.8,9
By design, Eleview™ enables endoscopists to better visualize the target lesion. Eleview™ is injected into the submucosa of the gastrointestinal tract near the lesion to provide a lift of the mucosal layer to form a cushion between the two layers (mucosa and submucosa). The endoscopists can then perform the resection procedure efficiently, leading to better en bloc resection, less piecemeal resection of the large lesion, and helping to decrease the risk of damaging the external muscular layer, which could lead to perforation and hemorrhaging.8,9
The efficacy and safety of Eleview™ were illustrated in preclinical studies (animal models), ex vivo studies, and a clinical study with human subjects. Eleview™ delivers a long-lasting cushion that holds up to 45 minutes, with minimal reduction of cushion height over time,9 and with less injection volume than NS and a comparable safety profile.10 The inclusion of 0.001% methylene blue in the composition of Eleview™ enables endoscopists to better visualize the margins of the target lesion to help reduce damage to external muscular layer, which could lead to perforation.
Eleview™, an emulsion comprising a bulking agent and 0.001% methylene blue, is an alternative injection agent for lifting the submucosa to create a safety cushion during EMR and ESD procedures.
The MOA is accomplished by the presence of poloxamer 188, a polymer which operates as a bulking (or cushioning) agent. Upon injection into the area surrounding targeted lesions, Eleview™ reconfigures to create an “artificial net” to trap water, elevating the mucosal layer from the submucosa and the muscular layer, creating a cushion of optimal height and duration.
The methylene blue dye present in the composition creates a contrast with the natural color of the mucosa, allowing endoscopists to precisely perceive the position of the cutting device, reducing the risk of unwanted parietal perforation.
Therefore, Eleview™ is able to provide a cushion of optimal height and duration and visualization of target lesion margins for successful submucosal resection. The optimal lift allows for endoscopic resection of polyps of a range of sizes and types, in a range of locations (Figure 1)
Interventional endoscopy accessories & solutions
The duration of the cushion effect provided by Eleview™ was evaluated in an ex vivo model by injecting Eleview™ (n=3) into the submucosal layer of a clean porcine stomach. Eleview™ showed a better cushion-forming ability and duration of permanence (up to 45 minutes) compared with the reference NS.
Eleview™ maintained the post-injection cushion height, with a decrease in height from 1.6% to 3.4% over 45 minutes, compared with a 52.9% decrease in cushion height with the reference NS .
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