Sam Brusco, Associate Editor02.23.21
The U.S. Food and Drug Administration (FDA) has approved EndoClot Plus Inc.’s (EPI) EndoClot Polysaccharide Hemostatic System (EndoClot PHS), which assists gastroenterologists to rapidly and reliably stop bleeding. EndoClot PHS is expected to be released in the U.S. by May.
The single-use device, including a starch-based powder hemostat, is applied to the bleeding site via flexible endoscope. The firm’s proprietary Absorbable Modified Polymer (AMP) powder quickly concentrates the blood to accelerate normal clotting.
A gelled matrix forms when the AMP powder contacts blood or fluid in the GI tract to provide a mechanical barrier to further control bleeding. EndoClot PHS is a nonthermal, nontraumatic, method for achieving hemostasis with GI bleeds.
“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,” Steve Heniges, president of EPI told the press.
Heniges further stated, “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.”
The single-use device, including a starch-based powder hemostat, is applied to the bleeding site via flexible endoscope. The firm’s proprietary Absorbable Modified Polymer (AMP) powder quickly concentrates the blood to accelerate normal clotting.
A gelled matrix forms when the AMP powder contacts blood or fluid in the GI tract to provide a mechanical barrier to further control bleeding. EndoClot PHS is a nonthermal, nontraumatic, method for achieving hemostasis with GI bleeds.
“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,” Steve Heniges, president of EPI told the press.
Heniges further stated, “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.”