FDA
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GI Supply Notes EverLift Submucosal Lifting Agent is 1st Submucosal Lifting Agent in a Pre-filled 5mL Syringe Receives FDA Clearance

July 14, 2020

GI Supply today announced the FDA clearance of EverLift™ Submucosal Lifting Agent , 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 devices.

GI Supply advises it is conveniently packaged in the market’s first pre-filled 5mL syringe, potentially reducing costs to hospitals and ambulatory surgery centers by not requiring the purchase of 10mL units. The pre-filled syringe eliminates the time and expense associated with mixing and preparing the agent.

The new EverLift device provides margin delineation of the lesions with a darker blue color than that offered by other manufacturers1. The darker color is intended to enable the safe and complete resection of polyps.

EverLift™ Submucosal Lifting Agent formulation is cellulose based, making it hypertonic. This results in a lifting agent that is specially formulated with water-retaining properties, which causes a slower rate of absorption because of osmotic resistance. With an absorption rate slower than other currently available agents2, EverLift provides gastroenterologists with a longer lift during their resection procedures.

According to the latest recommendations by the US Multi-Society Task Force on Colorectal Cancer (Kaltenback et al.), “…the ideal submucosal injection should be a widely available inexpensive solution that provides a sustained lift to facilitate safe and efficient piecemeal resection.”

“This is an effective lifting agent for endoscopic resection that is offered in convenient and cost-effective packaging,” said Dr. Douglas Rex, Director of Endoscopy at Indiana University Hospital in Indianapolis.

“GI Supply has been an expert in the field of submucosal injection agents for 20 years with our Spot® and Spot®Ex endoscopic tattoos. The launch of EverLift expands our portfolio as lifting agents and endoscopic tattooing are often used together to lift lesions and mark their location,” said GI Supply CFO and Interim CEO Kristi Dahlke.

References

  1. Survey conducted at DDW, 2019
  2. Based on ex-vivo bench top studies and not in clinical use.
SourceGI Supply Inc.

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