Frequently Asked Questions
Frequently Asked Questions
Get answers and learn more about Eleview®, a long-lasting submucosal injection agent for easy and safe GI resection procedures.
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What is Eleview®?
Eleview® is an injectable liquid composition that is intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers, or other gastrointestinal mucosal lesions, prior to removal with a snare or endoscopic device. It facilitates examinations in the upper and the lower gastrointestinal tracts, such as the esophagus, the stomach, the intestine, and the rectum.
Eleview® is a colored (blue), sterile, clear emulsion used as a submucosal injection composition that helps clarify the area where it is injected. It assists the endoscopist in visualizing the margins of the target lesion and performing the resection procedure, thereby decreasing the risk of damage to the external muscular layer and potential perforation.1
How is Eleview® supplied?
Eleview® comes in a 10-mL polypropylene ampoule with a female Luer-lock closure that can easily be connected to a suitable disposable plastic or glass syringe with a male Luer-lock connection fitting.
Eleview® can be extracted and then injected through an endoscope via a normal, commercially available endoscopic injection needle (eg, a 2.3 mm x 230 cm endoscopic injection needle) having a 23-gauge (23G) to 26-gauge (26G) diameter (not provided with the device).
How does Eleview® work?
Eleview® is designed to elevate the mucosal layer and the tissue to be excised from the submucosal and the muscular layers, thereby allowing the endoscopist an easy and safe mucosal resection (EMR), hybrid EMR, or endoscopic submucosal dissection (ESD).1
How long does Eleview® last?
Eleview® is designed, upon injection, to reconfigure and occupy the interstitial space, creating a submucosal cushion of optimal height and duration that allows for an easier resection procedure.1 As demonstrated in an animal study, Eleview® separates the mucosal layers for up to 45 minutes.2
What is contained in Eleview®?
The emulsion consists of water for injection, medium-chain triglycerides (the oily phase), poloxamer 188 (the bulking/cushioning agent), polyoxyl-15-hydroxystearate (the surfactant), sodium chloride (osmotic agent), and methylene blue (a dye).
Why does Eleview® contain methylene blue?
Eleview® includes methylene blue to help in visualizing the lesion and performing the resection procedure, thereby helping to minimize the risk of perforation.1 In addition, the staining of the submucosal layer will help facilitate the identification of muscle injury.3
What is the procedure for the preparation of Eleview® for injection?
Preparation of Eleview® for injection is as follows:
- Open the aluminum pouch, detach one ampoule from the strip, and then open the ampoule by twisting off the cap following the arrow direction.
- Screw a disposable, sterile plastic or glass syringe with male Luer-lock connection fitting (not provided with the device) directly to the ampoule.
- Turn the ampoule upside down and extract the whole volume of the emulsion.
- Unscrew the disposable, sterile plastic or glass syringe from the ampoule and expel the air from the syringe until some drops of the emulsion pour out of the tip.
- Securely screw the filled Luer-lock syringe to a suitable sterile endoscopic injection needle (not provided with the device).
- Fill the endoscopic injection needle with the emulsion and expel any air.
- Infuse a small quantity of the emulsion to determine the amount of force needed to inject the material.
- Retract the needle.
- Introduce the endoscopic injection needle through the working channel of the endoscope.
- Inject Eleview® immediately beneath the lesion to be excised in one or in a series of injections around the base of the lesion.
- Discard the empty ampoule and store the unused ampoules inside the aluminum pouch in the folding box.
Does Eleview® require any special apparatus or equipment?
No. Eleview® does not require any special apparatus or equipment, and it is designed to be used with the most common endoscopic resection devices.1 Eleview® can be injected through an endoscope via a normal, commercially available endoscopic injection needle (eg, a 2.3 mm x 230 cm endoscopic injection needle) having a 23-gauge (23G) to 26-gauge (26G) diameter. (Needle is not provided with the device.)
What size needle can Eleview® pass through?
A normal, commercially available endoscopic injection needle can be used. For example, a 2.3 mm x 230 cm endoscopic injection needle having a needle diameter of 23 gauge (23G) to 26 gauge (26G) (not provided with Eleview®) can be used.
How much Eleview® should be injected?
The dose to be administered is determined based on the dimensions of the lesion to be removed. Inject enough Eleview® to form a submucosal cushion of optimal height and shape for the lesion to be removed. Do not exceed 50 mL per patient, either in single or multiple injections, during one endoscopic procedure.1
Can I reuse an opened ampoule of Eleview® on another patient?
No. Eleview® is provided in ampoules that are intended for single use only. Any emulsion in an opened ampoule that was not injected should not be used for another patient.1
If I order Eleview®, how many ampoules will I receive in one order?
In one package, there are 5 individual ampoules each containing 10 mL of Eleview®.
How is Eleview® packaged?
Eleview® is sold as a five (5)-ampoule pack carton, with each ampoule containing 10 mL of product in a protective foil pouch. Eleview® second-level packaging has 5 sales units (with 5 ampoules each) in a secondary carton. Eleview® case-level packaging has 4 secondary packing cartons, containing 20 sales units in each case.
What is the barcode/GTIN (UDI) number for Eleview®?
Following are the GTIN (UDI) numbers for Eleview®:
|Package Level||Description||GTIN (UDI)|
|Base Unit||Individual 10-mL ampoule||5391530190008|
|Inner Pack||Folding box containing 1 foil pouch of 5 ampoules||5391530190015|
|Case||Inner box containing 5 folding boxes||5391530190022|
|Case||Outer box (contains 4 inner boxes) = 20 folding boxes||5391530190039|
How do I store Eleview®?
Eleview® should be protected from light and stored between 35.6°F (2°C) and 77°F (25°C).
The temperature indicator in my box is green. What does this mean?
If the center dot is green, then the product is usable. Please continue to store the product within the labeled temperature range.
Are there any contraindications to using Eleview®?
Patients with any known sensitivity or allergy to any of the components contained in Eleview® should not receive the product.1
Are there any warnings and precautions I should know about?
- The endoscopist injecting Eleview® must be experienced in the administration technique.1
- The safety of Eleview® has not been established in pregnant or lactating women, or in children under 18 years of age.1
- Eleview® is provided in single-use ampoules. Eleview® should not be reused after the first opening. Any emulsion not injected during the procedure should not be reused for another endoscopic procedure.1
- Do not use if the primary packaging (ampoule) or secondary packaging (aluminum pouch) is damaged.1
- Do not use if the twist-off cap is damaged.1
- Do not use if the emulsion is not clear, shows any signs of opalescence, or contains floating or precipitated visible particles.1
- The product compatibility with other substances has not been tested.1
What adverse events have been observed with Eleview®?
Rarely, local bleeding and/or inflammatory reaction could occur which may or may not be associated with Eleview®.1
For adverse event reports:
Does Eleview® interact with other drugs?
The interaction of Eleview® with other drugs has not been tested.1
How do I report a device-related adverse event or product complaint related to Eleview®?
Please call our toll-free customer service number at +1-888-274-3708.
How can I obtain additional medical information on Eleview®?
Please call our toll-free customer service number at +1-888-274-3708 for medical information.
Download a complete PDF of Eleview® Frequently Asked Questions.