Eleview® is an injectable composition, patented by Cosmo, intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions prior to excision with a snare or other endoscopic device.
The objective is to allow endoscopists with a faster and less risky excision of gastrointestinal lesions (e.g. adenomas or polyps) during endoscopy in the gastrointestinal tract. The composition is injected in the submucosal space beneath the lesion to be excised, providing a submucosal cushion of optimal height and duration, which lifts the lesion above the mucosa allowing for an easy and safe resection procedure. The submucosal cushion persists up to 45 minutes from injection, thereby giving the endoscopist sufficient time to excise the lesion while reducing the risk that the organ is perforated during the procedure.
The composition is stained with Methylene Blue which allows for a clear differentiation of the tissues and for a better visualisation of the lesion margins and of the surgical area by the endoscopist.
A post-market randomized, double-blind trial clinical study was conducted in U.S. and EU to assess the efficacy and safety of Eleview® in resection procedures of large (more than 20 mm) colorectal lesions as compared to saline solution. The use of Eleview® was associated with a lower volume needed to perform the resection, lower average volume per lesion size, lower mean procedure time and a trend for lower number of resection pieces and higher rate of complete resections in the Eleview® arm as compared to saline solution. The rate of adverse events was similar between the study groups. In the study, Eleview® appeared to be a more effective and equally safe submucosal agent for EMR injection than saline solution1.
Eleview® is classified as a class II medical device in the U.S. and Europe.
Eleview® is approved in the U.S., EU, Canada and Japan:
The FDA approved the product in September 2015.
In the EU, the product was approved in June 2016.
Approved by Health Canada in 2019,
November 2020 it was approved by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
Eleview® was launched in the U.S. in May 2017 and is the only commercially available device approved by the FDA for the removal of polyps and lesions in the colon. Eleview® is supplied and distributed worldwide by Medtronic with the exception of Canada, where the product is licensed to Pendopharm, a division of Pharmascience Inc.
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1Repici et al. Gastrointest Endosc. 2018. 88(3): 527-535