Lifesaving medical device for postpartum hemorrhage receives regulatory approval in Ghana and Kenya
Lifesaving medical device for postpartum hemorrhage receives regulatory approval in Ghana and Kenya

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 AcceleratorStudy 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.