EndoClot Plus, Inc. (EPI) received clearance for the EndoClot® – Polysaccharide Hemostatic System (PHS) from the Food and Drug Administration (FDA) in January 2021.
The EndoClot® PHS is a single use medical device consisting of Absorbable Modified Polymers (AMP®) and a specific powder delivery system (applicator). It is intended to control non-variceal bleeding in the upper and lower GI tracts. This product is manufactured by EndoClot Plus, Inc based in Santa Clara, California. This privately held medical company belongs to EndoClot Plus Co., Ltd. (Suzhou, China).
The AMP® are hydrophilic particles that instantly create a gel barrier when they come into contact with blood or GI fluids. AHP particles contain no human or animal components, they are biocompatible, non-pyrogenic and derived from plant starch. These particles are very adhesive to assist in maintaining the clot formation as they create a matrix, which provides a mechanical barrier to seal and protect the wound for several days. The particles are not degradable by human enzymes. They are eliminated from the gastrointestinal tract with stool. The delivery system enables application through an endoscope. The specially-designed applicator consists of a delivery catheter with a powder/air mixing chamber that is connected to the powder dispenser and the EndoClot® Air Compressor.
During an upper or lower endoscopic procedure, the delivery catheter is inserted in the endoscope and positioned toward the lesion in the gastrointestinal tract. Pressure coming from the air compressor propels the powder through the catheter directly to the designated area. The system has an anti-reflux design to prevent occlusion.
This product has been shown to be effective for large, minor to moderate bleeding wounds, such as ulcer bleeding and bleeding associated with endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD). It is capable of being applied to lesions that may be located in hard to reach areas. It is also useful in prevent re-bleeding following EMR/ESD and can be used as an add-on therapy to control bleeding with any other conventional techniques.
The product is not indicated for Forrest Ia classification bleeding (acute hemorrhage – active spurter).
AMP® product (particles) and applicator
EndoClot® Air compressor
EndoClot® being used after ESD.