PATH and Sinapi Biomedical announced today at the Women Deliver 2019 Conference that the Ellavi uterine balloon tamponade (UBT) has achieved CE marking, signifying that the medical device meets European regulatory requirements. The low-cost, fully assembled Ellavi UBT is now cleared for sales in Europe, a pivotal step to mainstreaming use of this lifesaving emergency intervention in countries with high maternal mortality rates. In many developing countries, such as those in sub-Saharan Africa, CE marking can streamline procurement of this device.
Excessive bleeding after childbirth, or severe postpartum hemorrhage (PPH), is the number one killer of women during childbirth, and can kill an otherwise healthy woman in less than two hours if she does not receive adequate care. The current World Health Organization recommendations identify the UBT as an emergency intervention for PPH when drug treatment fails or is unavailable. However, UBT products that have been used for decades in hospitals in high-resource countries cost hundreds of dollars each—putting them out of reach of many health facilities in low-resource countries. Instead, these health facilities rely on improvised balloon tamponades that are assembled on the spot with supplies such as a male condom or latex glove and a catheter pieced together with a string.
This access gap is significant, as developing countries account for 99 percent of all maternal deaths. “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,” said Elizabeth Abu-Haydar, UBT Product Manager at PATH. “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.”
PATH and Sinapi Biomedical developed the Ellavi UBT with input from physicians, midwives, and maternal health experts. Once the Ellavi balloon is positioned in the uterus by a health care provider, the balloon fills in less than one minute with water from a supply bag. “Unique design innovations include our pressure-controlled, free-flow system that applies optimal pressure to the uterine wall to arrest bleeding in minutes, allowing the woman’s uterus to contract and relax when its normal function is restored,” says Chris De Villiers, Managing Director at Sinapi Biomedical. “We designed Ellavi to be intuitive to use by providers during the most critical moments of their job.”
The device is manufactured in Sinapi’s factory in Stellenbosch, South Africa, which is certified by the International Organization for Standardization (ISO). Sinapi provides Ellavi at the ex-factory price of US$7.50 for the public sector in low- and lower-middle-income countries. The price to end users will vary based on country-specific tariffs and distribution costs.
PATH, Sinapi Biomedical, and the South African Medical Research Council are introducing the Ellavi UBT into key markets in sub-Saharan Africa. The United Kingdom’s (UK) Department for International Development (DFID) is supporting country-led, evidence-based implementation research in Kenya and Ghana as part of the Devices, Diagnostics, and Drugs to Address Women’s Needs Product Development Partnership (D3AWN PDP). This work, led by Dr. Patricia Coffey, D3AWN PDP Project Director at PATH, aims to help country stakeholders in sub-Saharan Africa—where maternal mortality rates can average 500 per 100,000 live births—reach their targets for Sustainable Development Goal 3.1: by 2030, reduce the global maternal mortality ratio to less than 70 per 100,000 live births.
This project is funded with UK aid from the British people. Previous funding was provided by the Bill & Melinda Gates Foundation and the US Agency for International Development (USAID).