GI Supply Receives CE Mark for its EverLift® Submucosal Lifting Agent
New EverLift® medical device now available to physicians in Europe
December 13, 2021 | Mechanicsburg, PA
GI Supply Inc. today announced its EverLift® Submucosal Lifting Agent has been awarded a CE Mark and is now available for use by physicians across Europe. EverLift is GI Supply’s first medical device to be awarded a CE Mark under the new EU Regulation 2017/745 on Medical Devices (MDR). EverLift is a new device for the lift of polyps, adenomas, early-stage cancers and other gastrointestinal lesions prior to excision with a snare or other appropriate endoscopic devices1. EverLift gained FDA clearance in October 2020.
EverLift is the only pre-filled Submucosal Lifting Agent on the market available in two presentations, 5mL and 10mL, providing physicians with the flexibility to use only what they need and potentially reducing costs to hospitals. In addition, the pre-filled syringe eliminates the time and expense associated with mixing and preparing the agent.
EverLift provides margin delineation of the lesions with a darker blue colour than that offered by other manufacturers2. The darker colour is intended to enable safe and complete resections of polyps.
“Lifting agents aid in safer resections for patients. EverLift provides a pliable yet reliable cushion for resection and darker blue hues. The single serve dosing helps reduce waste for everyday polypectomies.” – Dr. Taavi Reiss, Assistant Professor of Clinical Medicine LSU Health and Director of Interventional GI Metropolitan Gastroenterology Associates.
EverLift’s formulation is cellulose based, making it hypertonic. This results in a slower rate of absorption because of osmotic resistance. With an absorption rate slower than other currently available agents3, EverLift provides gastroenterologists with a long lift during their resection procedures.
“This is an effective lifting agent for endoscopic resection that is offered in convenient and cost-effective packaging.” – Prof. Douglas Rex, Director of Endoscopy at Indiana University Hospital, Indianapolis.
“The CE Mark for EverLift enables us to reach more physicians around the world. Many gastroenterologists will be familiar with our Spot® Ex Endoscopic Tattoo, and we have used our extensive experience in injection solutions to develop a unique lifting agent which will enhance their ability to safely resect lesions,” said GI Supply Senior Marketing Manager Simon Humphrey-Adam.
About GI Supply
As a physician-founded company, we strive for deep clinical input into all that we do. GI Supply is broadening our portfolio with solutions that allow physicians to perform more-advanced procedures safely, efficiently and economically. We help doctors do their jobs faster, safer and simpler. For more information visit www.gi-supply.com.
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1. EverLift Instruction for Use G55-006 Rev 08, Nov 2021; G59-007 Rev 07, Nov 2021
2. Survey conducted at DDW, 2019
3. Based on ex-vivo bench top studies and not in clinical use. Data on file