americanpharmaceuticalreviewOctober 26, 2020
Tag: GI Supply , FDA , EverLift
GI Supply announced the FDA clearance of EverLift™ Submucosal Lifting Agent in a 10mL syringe, 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.
EverLift is the only pre-filled Submucosal Lifting Agent in the market available in two presentations, 5mL and 10mL, providing physicians flexibility to use only what they need and potentially reducing costs to hospitals and ambulatory surgery centers. Also, 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 manufacturers. The darker color is intended to enable safe and complete polyp resections.
"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," said Dr. Gary "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 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 long lift during their resection procedures.
"The launch of EverLift 10mL completes our offering as now we have two separate presentations of lifting agents in a 5mL and 10mL syringe, to give physicians more flexibility. We are committed to continue to invest on innovation and this launch is another proof of our continuous investments," said GI Supply CFO and Interim CEO Kristi Dahlke.
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