Lifesaving medical device for postpartum hemorrhage receives regulatory approval in Ghana and Kenya
Made in Africa: The first low-cost, fully assembled uterine balloon tamponade device to help protect women from the leading cause of maternal death
SEATTLE, July 29, 2020 /PRNewswire/ -- Global health nonprofit 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.
The Sinapi Ellavi uterine balloon tamponade is a CE-marked preassembled device used in multiple countries to manage postpartum hemorrhage and costs a fraction of currently available regulatory-approved uterine balloon tamponade devices.
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.
President of the International Federation of Gynecology and Obstetrics Dr. Anne B. Kihara, stated, "In Sub-Saharan Africa, where the need is greatest, an affordable, preassembled uterine balloon tamponade that is easy for health providers to use in emergencies from refractory postpartum hemorrhage caused by uterine atony can help mainstream management and improve health outcomes for women."
The World Health Organization 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. Regulatory approvals in Ghana and Kenya will help to improve access to the low-cost Ellavi. The product is distributed through Mangel Klicks in Ghana and Prota Limited in Kenya.
Unlike condom catheter uterine balloon tamponades that are assembled at the point of care, the Ellavi device is fully assembled and uses a pressure-controlled mechanism of action to address some of the limitations of fixed-volume condom catheters. The Ellavi was designed by Sinapi Biomedical to begin working in minutes and is manufactured in their International Organization for Standardization (ISO)–certified factory in Stellenbosch, South Africa. Sinapi Biomedical provides Ellavi from the factory to the public sector in low- and lower-middle-income countries at US$7.50, which does not include varying distribution costs and country-specific tariffs.
The Ellavi was clinically tested in 4 hospitals in South Africa between 2016 and 2017 and in additional clinics in 2018 and 2019, with support from the South African Medical Research Council and the Global Health Innovation Accelerator. Study results demonstrated high acceptability, safety, and efficacy. In the first 6 months after launch, the Ellavi was adopted by more than 30 South African hospitals across 5 provinces.
PATH, in collaboration with Ghana Health Service and the Ministry of Health and University of Nairobi in Kenya, will work with leading local researchers to conduct implementation studies to integrate the Ellavi into existing national postpartum hemorrhage management programs. Evidence generated will be disseminated to help inform public-sector programs and maternal delivery care packages aimed at reducing preventable maternal deaths.
This project is funded by UK aid from the British people. Previous funding was provided by the Bill & Melinda Gates Foundation and the US Agency for International Development.
Sinapi Biomedical's work on the Ellavi UBT introduction has been supported by the South African Medical Research Council, the Every Woman Every Child Innovation Marketplace, and Grand Challenges Canada.
About PATH
PATH is a global organization that works to accelerate health equity by bringing together public institutions, businesses, social enterprises, and investors to solve the world's most pressing health challenges. Learn more at www.path.org.
About Sinapi Biomedical
Sinapi Biomedical (Pty) Ltd manufactures and commercializes the Ellavi UBT device. Sinapi Biomedical, an ISO 13485–accredited company, is registered with the US Food and Drug Administration as a contract manufacturer and regularly exports products globally. Learn more at https://sinapibiomedical.com/.
View release online here.
Media contact: Lindsay Bosslet | PATH | media@path.org
Arabic, English, and French-speaking spokespeople available
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