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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.

PuraStat is intended for hemostasis of mild and moderate bleeding post ESD or EMR, as an adjunct, bridge, prophylactic or rescue therapy for intraprocedural venous bleeding or prophylactic therapy to prevent post procedure bleeding, and for primary non-variceal gastrointestinal (GI) bleeding. PuraStat is not indicated for arterial Forrest 1a bleeding.

PuraStat is a sterile gel composed of a synthetic peptide and sterile water for injection. It is provided as a prefilled syringe (2.5% peptide content) ready for use as a hemostat. The gel is delivered to the intended application site(s) via a commercially available endoscopic catheter that is attached to the gel-filled syringe via the polypropylene adapter (Class 1 - 510k Exempt) also commercially available (Class 1, 510k Exempt). PuraStat is completely non-animal and non-plant derived and contains no preservatives that might present a risk of allergic reaction or skin irritation. Exposure to physiological fluids such as blood causes the peptide solution to quickly form a transparent gel without expansion in volume. PuraStat achieves hemostatic effects by forming a hydrogel matrix barrier that blocks the flow of blood at the site of application.

PuraStat is intended for hemostasis of mild and moderate bleeding post ESD or EMR, as an adjunct, bridge, prophylactic or rescue therapy for intraprocedural venous bleeding or prophylactic therapy to prevent post procedure bleeding, and for primary non-variceal gastrointestinal (GI) bleeding. PuraStat is not indicated for arterial Forrest 1a bleeding.

PuraStat is a sterile gel composed of a synthetic peptide and sterile water for injection. It is provided as a prefilled syringe (2.5% peptide content) ready for use as a hemostat. The gel is delivered to the intended application site(s) via a commercially available endoscopic catheter that is attached to the gel syringe via the polypropylene adapter. PuraStat is completely non-animal and non-plant derived and contains no preservatives that might present a risk of allergic reaction or skin irritation. Exposure to physiological fluids such as blood causes the peptide solution to quickly form a transparent gel without expansion in volume. PuraStat achieves hemostatic effects by forming a hydrogel matrix barrier that blocks the flow of blood at the site of application.

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.

PuraStat-GI is intended for hemostasis of mild and moderate bleeding post ESD or EMR, as an adjunct, bridge, prophylactic or rescue therapy for intraprocedural venous bleeding or prophylactic therapy to prevent post procedure bleeding.

PuraStat-GI is a sterile gel composed of a synthetic peptide and sterile water for injection. It is provided as a prefilled syringe (2.5% peptide content) ready for use as a hemostat. The gel is delivered to the intended application site(s) via a commercially available endoscopic catheter that is attached to the gel syringe via the polypropylene adapter. PuraStat-GI is completely non-animal and non-plant derived and contains no preservatives that might present a risk of allergic reaction or skin irritation. Exposure to physiological fluids such as blood causes the peptide solution to quickly form a transparent gel without expansion in volume. PuraStat-GI achieves hemostatic effects by forming a hydrogel matrix barrier that blocks the flow of blood at the site of application.

EndoClot® PHS is used for hemostasis of nonvariceal gastrointestinal bleeding, excluding Forrest Ia classification of bleeding.

EndoClot® Polysaccharide Hemostatic System (EndoClot® PHS) is a sterilized single use medical device that is composed of Absorbable Modified Polymer (AMP®) particles in a PE bellow and an EndoClot® Applicator (K162197). The device contains no human or animal components. AMP® particles are biocompatible, non-pyrogenic and derived from plant starch.

The COOK Hemospray device is intended for hemostasis of non-variceal bleeds in the GI (gastrointestinal) tract. It is for prescription use only.

Hemospray is an inert, bentonite powder developed for endoscopic hemostasis. The powder is delivered by use of a carbon dioxide powered delivery system and through a catheter inserted through the working channel of an endoscope which provides access to the bleed. Each device contains approximately 20g of powder.

The COOK Hemospray® Endoscopic Hemostat is used for hemostasis of non-variceal gastrointestinal bleeding.

The Hemospray® Endoscopic Hemostat is a prescription use device consisting of a hemostatic agent and a delivery system. The hemostatic agent is (b) (4) | bentonite powder, a naturallysourced aluminum phyllosilicate clay. The delivery system is an endoscopic accessory used for spraying the powder onto the bleeding surface. The delivery device consists of a 220cm polyethylene application catheter, a handle with a pressurized CO2 cartridge, and a powder chamber containing approximately 20g of the Hemospray® material is propelled through the application catheter by release of CO2 from the cartridge located in the device handle. A trigger valve with an activation button allows the physician to control the amount of powder delivered to the affected area. Each actuation of Hemospray® delivers of CO2 and (b) gram of (b) (4) bentonite. Use of the complete 20-gram canister can produce a volume increase within the lumen of the bowel of 3 liters. In the presence of blood, the (b) (4) bentonite may swell 10-15% in volume. The delivery system is offered in two configurations (i.e., two different outer diameters of the powder delivery catheter). The HEMO-7 version is used with a 2.8mm endoscope accessory channel, and the HEMO-10 version is used in a 3.7mm endoscope accessory channel.