EverLift Submucosal Lifting Agent
EverLift Submucosal Lifting Agent
FDA
1 min.Read

EverLift Submucosal Lifting Agent in a 10mL Syringe Receives FDA Clearance

October 23, 2020

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, has received FDA clearance. The news was announced today by GI Supply.

EverLift Submucosal Lifting Agent is the only pre-filled Submucosal Lifting Agent in the market available in two presentations, 5mL and 10mL, providing physicians the 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 manufacturers1. 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.” – 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 continuing to invest in innovation and this launch is another proof of our continuous investments,” said GI Supply CFO and Interim CEO Kristi Dahlke.

More here.

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

Hot this week

Cartessa Aesthetics Partners with Classys to Bring EVERESSE to the U.S. Market

0
Classys, which is listed on the KOSDAQ, is one of South Korea's most distinguished aesthetic technology manufacturers, with devices distributed in 80+ markets globally. This partnership marks Classys's official entry into the American marketplace, with Cartessa Aesthetics as the exclusive distributor for EVERESSE, launched under the Volnewmer brand in current global markets.

Stryker Launches Next-Generation of SurgiCount+

0
Now integrated with Stryker's Triton technology, SurgiCount+ addresses two key challenges: retained surgical sponges and blood loss assessment. Integrating these previously separate digital solutions provides the added benefit of a more efficient, streamlined workflow for hospitals notes Stryker.

Nevro Receives CE Mark In Europe for It’s HFX iQ™ Spinal Cord Stimulation System

0
Nevro notes HFX iQ is the first and only SCS system with artificial intelligence (AI) technology that combines high-frequency (10 kHz) therapy built on landmark evidence that uses ongoing cloud data insights to deliver personalized pain relief

Recor Medical Reports: CMS Grants Distinct TPT Device Code and Category to Recor Medical for Ultrasound Renal Denervation

0
The approval of TPT offers incremental reimbursement payments for outpatient procedures performed with ultrasound renal denervation for Medicare fee-for-service beneficiaries. It becomes effective January 1, 2025, and is expected to remain effective for up to three years notes Recor Medical.

Jupiter Endovascular Reports | 1st U.S. Patient Treated with Jupiter Shape-shifting Thrombectomy Device

0
“Navigation challenges during endovascular procedures are often underappreciated and have led to under-adoption of life-saving procedures, such as pulmonary embolectomy. We have purpose-built our Endoportal Control technology to solve these issues and make important endovascular procedures accessible to more clinicians and their patients who can benefit from them,” said Carl J. St. Bernard, Jupiter Endovascular CEO. “This first case in the U.S. could not have gone better, and appears to validate the safety and performance we are seeing in our currently-enrolling European SPIRARE I study.”

About us

Medical Device News Magazine

Welcome to Medical Device News Magazine, a digital publication providing up to the minute medical device news and biotechnology news.

Need to know more?

Contact us

Navigation

Florida, New York
United States
Phone Number: 1.561.316.3330