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Nexpowder™ is used for hemostasis of nonvariceal gastrointestinal bleeding.

The Nexpowder is used for hemostasis of non-variceal gastrointestinal bleeding. It is a prescription only, single-use device provided with a powder pre-packaged in a vial, and a delivery system, which consists of a spray body, a connector and a delivery catheter is inserted through an endoscope's working channel to deliver the powder to the intended hemostasis target site. Nexpowder is almost identical to the currently marketed device (K202929) and has the same technological characteristics and mechanism of action, but differs in the indications for use, where the subject device is also indicated for lower GI bleeding.

Nexpowder™ is used for hemostasis of non-variceal, upper gastrointestinal bleeding.

The Nexpowder™ is used for hemostasis of non-variceal, upper gastrointestinal bleeding. The Nexpowder™ is a prescription only, single-use device provided with a pre-packaged powder, a vial, and a Delivery System, which consists of a Spray body, a Connector and a Delivery Catheter. The powder vials are provided in a sterile condition with gamma radiation sterilization and the non-sterile external Spray Body delivery system with its sterile Connector and sterile Delivery Catheter. The hemostatic powder agents of the Nexpowder™ are primarily composed of succinic anhydride ({-poly-L-lysine) and oxidized dextran and are endoscopically applied through a catheter channel of the delivery system to control qastrointestinal bleeding in the upper qastrointestinal tract. Utilizing the installed battery power, air pressures are generated from the air pump placed in the spray body of Nexpowder™ delivery system to provide effective physical force to move the hemostatic powder agent into the delivery catheter. The hemostatic agents of the Nexpowder™ ultimately get sprayed onto the hemostasis target site in the gastrointestinal tract. Nexpowder is excreted from the patient's gastrointestinal or digestive system primarily by peristalsis of the human digestive system within the three days.