A global healthcare organization, Sinapi Biomedical, a company based in South Africa and PATH has just received the European Union’s CE mark of approval, Ellavi, a uterine balloon tamponade (UBT). Though intended for Europe, the CE mark is recognized in many countries outside the continent, so the new clearance gives the Ellavi device broad access to where it’s most needed.
Wholesaler costing is only $7.50, the Ellavi can provide regular, safe pressure onto the interior of the uterus within two minutes of opening the package. You only need tap water, and it is used to fill up the tamponade once it is inserted. A free-flow system helps to make sure that the pressure is even, proper, and stable over the interior of the uterus. This helps to stop the bleeding and motivates the uterus to relax and halt the bleeding on its own thanks to its cross-linked anatomy.
“PPH can happen to any pregnant woman, anywhere in the world. These deaths can be prevented; however, the mothers who are most likely to die from PPH are those living in sub-Saharan Africa, reflecting the inequities in access to health care and appropriate technologies, we championed an innovative solution that could prevent the deaths of thousands of pregnant women—a low-cost UBT that performs to the same high standards as those used to save lives in high-resource hospitals, yet is affordable and preassembled for ease of use in health facilities in resource-poor communities, " Elizabeth Abu-Haydar, UBT Product Manager at PATH.
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Photo by: Sinapi BioMedical
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