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The Food and Drug Administration (FDA) has approved EndoClot® Polysaccharide Hemostatic System (EndoClot® PHS; EndoClot Plus, Inc) to control bleeding in both the upper and lower gastrointestinal (GI) tract.
EndoClot® PHS is a single-use medical device that consists of absorbable modified polymers (AMP®) and a powder delivery system. Using a flexible endoscope, the starch-based powder hemostat is applied directly to the bleeding site in the GI tract where it quickly concentrates the blood to accelerate the clotting process. Once applied, a gelled matrix forms to provide a mechanical barrier to further control bleeding.
According to the Company, EndoClot PHS may be used to control large, oozing to moderate bleeding wounds (eg, bleeding related to ulcers, tumors, and endoscopic submucosal dissection [ESD]/endoscopic mucosal resection [EMR]). “Since 2011, when EPI was the first to launch a powder hemostat for GI endoscopic applications in Europe, EndoClot® PHS has proven to be an effective technique to treat GI bleeding especially for those lesions located in hard-to-reach areas and where the source of the bleeding is not easily identifiable,” said Steve Heniges, President of EPI.
EndoClot PHS may also be used to prevent re-bleeding following ESD/EMD and as an add-on therapy to control bleeding with other conventional techniques.
The product is expected to be commercially available by May 2021. The recommended gas source for the powder delivery system is the EndoClot® Air Compressor.
For more information visit endoclot.com.
References
- FDA approves EndoClot® Hemostat to manage GI bleeding. [press release]. Santa Clara, CA: EndoClot Plus, Inc.; February 23, 2021.
- EndoClot: New GI Therapeutic Solutions. Products: EndoClot® PHS. http://endoclot.com/products.html. Accessed February 23, 2021.
