Ellavi Uterine Balloon Tamponade: A Lifesaving Medical Device Registered by Mangel Klicks Limited for Postpartum Haemorrhage Receives FDA Regulatory Approval in Ghana
Global health nonprofit organization PATH and Sinapi Biomedical, South Africa, announced today that the Sinapi Ellavi uterine balloon tamponade has received regulatory approval from the Ghana Food and Drugs Authority and the Kenya Pharmacy and Poisons Board for use of this medical device in each country. Made in Africa it’s the first low-cost, fully assembled uterine balloon tamponade device to help protect women from the leading cause of maternal death.
Postpartum hemorrhage is the leading cause of maternal mortality and can kill an otherwise healthy woman in a few hours. Women in sub-Saharan Africa face a maternal mortality rate more than 50 times higher than women in high-resource countries. The World Health Organization (WHO) identifies uterine balloon tamponades as important tools for the treatment of severe postpartum hemorrhage when standard drug treatments fail or are not available. National clinical guidelines for treatment of postpartum hemorrhage in both Ghana and Kenya include uterine balloon tamponades. However, use of commercially available devices has been limited, mostly due to the high cost.
SEATTLE, July 29, 2020 /PRNewswire indicated that the product will be distributed in Ghana through Mangel Klicks Company Limited in Ghana.