GI Supply Receives CE Mark for its EverLift® Submucosal Lifting Agent

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MECHANICSBURG, Pa, Jan. 11, 2022 /PRNewswire/ -- 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.

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PR NewswirePR Newswire
Retrieved on: 
Tuesday, January 11, 2022
Information
Tags: 
Use, EU, Extrapyramidal system, CE marking, Patient, MDR, Injury, Endoscopy, Medical device, Gastroenterology, Indiana University Health University Hospital, Submucosal, Polyp, ESD, Solution, Assistant, Cellulose, Medicine, Time, Health, Lifting, Endoscopic mucosal resection, Intervention, Risk, EMR, Infection, FDA, LSU Health Sciences Center New Orleans, Adenoma, Physician, Syringe, Pharmaceutical industry
Geotags: 
BELGIUM, SWITZERLAND, PENNSYLVANIA, INDIANAPOLIS, PA, EUROPE
Organisation: 
GI SUPPLY INC.
Summary
Key Points: 
  • MECHANICSBURG, Pa, Jan. 11, 2022 /PRNewswire/ -- 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 facilitates endoscopic resection procedures such as endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD), during examinations in the upper and the lower gastrointestinal tract.
  • 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 the only pre-filled Submucosal Lifting Agent available in both 5mL and 10mL syringes, providing physicians with the flexibility to use only what they need whether lifting small or large lesions.


GI Supply Receives CE Mark for its EverLift® Submucosal Lifting Agent

MECHANICSBURG, Pa, Jan. 11, 2022 /PRNewswire/ -- 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 a new device for the lift of polyps, adenomas, early-stage cancers and other gastrointestinal lesions prior to their excision with a snare or other appropriate endoscopic device1.

EverLift facilitates endoscopic resection procedures such as endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD), during examinations in the upper and the lower gastrointestinal tract.

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 gained FDA clearance in October 2020.

EverLift is the only pre-filled Submucosal Lifting Agent available in both 5mL and 10mL syringes, providing physicians with the flexibility to use only what they need whether lifting small or large lesions. In addition, the sterile pre-filled syringe reduces the time and infection risk associated with preparing a hospital-mixed solution.

The darker blue colour of EverLift is used to identify the perimeter of lesions enabling a safe and complete resection, reducing the risk of recurrent lesions. Following resection of a lesion, the darker colour helps endoscopists identify potential injuries to the muscle layer.

"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 is cellulose based, creating a hypertonic solution with an absorption rate slower than other currently available agents2. EverLift provides gastroenterologists with a long and stable 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 or to locate a distributor visit www.gi-supply.com.

1.  EverLift Instruction for Use G55-006 Rev 08, Nov 2021; G59-007 Rev 07, Nov 2021

2.  Based on ex-vivo bench top studies and not in clinical use. Data on file

G-1951-02

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