Nexpowder™* endoscopic hemostatic system
Indications:
Nexpowder™* is used for most GI bleeding. The device is applied during an endoscopic procedure and can cover ulcer or bleeding sites. The device is not intended for use in patients with variceal bleeding. Note: Do not use this device for any purpose other than stated intended use.
Contraindications:
Because the Nexpowder™* system includes lactose, it is contraindicated in patients who have galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption and they would be at risk of having nausea, bloating and diarrhea. Because the Nexpowder™* system includes Brilliant Blue FCF, it must not be used in patients with known hypersensitivity to brilliant blue FCF.
Potential complications:
Those associated with gastrointestinal endoscopy include, but are not limited to: hemorrhage, perforation, aspiration, fever, infection, allergic reaction and foreign body sensation in the digestive tract.
Warning:
Nexpowder™* has not been approved for use in pregnant women, nursing mothers and pediatric population and there is no safety or efficacy data in these groups.
Patients that are on antithrombotic medication may be at an increased risk of re-bleeding. Take individual patient needs and relevant clinical guidelines into account when managing antithrombotic agents for endoscopic procedures. Consider consulting the physician responsible for the antithrombotic if needed.
This medical device is designed for single use only. Attempts to resterilize and/or reuse may lead to device failure and/or transmission of disease.
Important: Always refer to the Instructions For Use (IFU) packaged with the product for complete instructions, indications, contraindications, warnings and precautions.
