EndoClot Plus this week announced that it has received FDA approval for its EndoClot Polysaccharide Hemostatic System (PHS).
EndoClot PHS is a nonthermal, nontraumatic method for achieving hemostasis with GI bleeds and is designed to help gastroenterologists stop bleeding rapidly and reliably.
The single-use device has a starch-based powder hemostat that is applied directly to the bleeding site through a flexible endoscope. The powder quickly concentrates the blood to accelerate the normal physiological clotting process. The gelled matrix that forms when the powder contacts blood or fluid in the GI tract provides a mechanical barrier to further control bleeding.
“The FDA clearance of EndoClot PHS represents a significant milestone in advancing the care of the GI patient. This technology will drive a paradigm shift in the treatment of upper and lower GI bleeding as we have already seen outside the U.S. for many years,” president Steve Heniges said in a news release. “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.”