The Ellavi UBT is the first and only low-cost, fully assembled UBT designed specifically for use in low-resource health facilities, with the unique capability of directly controlling uterine pressure. The Ellavi UBT addresses the challenges of cost, assembly, and safety of current UBT devices and puts a lifesaving technology in the hands of health care workers to ensure mothers who experience PPH live beyond the day they give birth.
The Ellavi UBT takes a well-known and proven technology for managing PPH, and makes it available in a low-cost manner for resource-scarce settings. Sinapi Biomedical (Pty.) Ltd developed an easy to use uterine balloon tamponade unit that contains the unique features of the surgical glove balloon. The design makes use of an open system that allows water to be expelled from the balloon to reduce the volume and allow the physiological process of contraction and retraction of the myometrium to occur. Furthermore, the device’s open gravity-fed system allows the intra-uterine pressure to be controlled whereby if the pressure inside the uterus corresponds to the patient’s systolic blood pressure arterial bleeding from the placental implantation site into the uterus will be stopped. This design also supports the treatment of PPH when additional surgical measures are required where it has been successfully used following a caesarean section and with compression sutures in place. Using a UBT once compression sutures have been inserted to keep the uterus contracted requires control of the amount of pressure exerted in the uterus to prevent uterine necrosis.
Key Features of Ellavi Uterine Balloon Tamponade.
Deploys Quickly – Ellavi UBT is pre-assembled, fills in under one minute, and acts swiftly to stop bleeding. It is easy to use and, once trained, any maternal health care provider should
be able to insert it.
Free-Flow System – Water moves freely between the balloon and the bag. As soon as the uterus regains its ability to contract, the water is pushed back towards the bag. This provides a visual indication of improved uterine contractility and facilitates faster balloon removal.
Vertical Pressure – Simply lifting the bag allows water to fill the balloon. Adjusting the vertical height of the bag controls pressure between the balloon and the uterus. This pressure needs to be slightly higher than the blood pressure in the uterus to stop bleeding.
UBT & PPH Statistics
-14 million annual cases of PPH. Abou-Zahr C. The Global burden of maternal death and disability. Br Med Bull.
-800,000 estimated annual cases where uterotonics are ineffective. Herrick T, Mvundura M, Abu-Haydar E. (Running
title) Modeling potential health impact of a low-cost UBT on maternal mortality and morbidity in sub-Saharan Africa. April
-Between 115-120,000 estimated annual deaths from PPH. 99 % of these deaths occur in low income
countries.- World Health Organization. WHO maternal mortality fact sheet N°348 [Internet]. Geneva: WHO; 2015 [updated
November 2015; cited 20 January 2016]. Available from: http://www.who.int/mediacentre/factsheets/fs348/en/.
-11,000 hysterectomies could be averted in one year – sub-Saharan Africa: Norad, Bill & Melinda Gates Foundation,
United States Agency for International Development, PATH. The Ic2030 Report. Reimagining global health: 30 high-impact
innovations to save lives. Seattle: PATH; 2015. Available at http://ic2030.org/wp-content/uploads/2015/07/ic2030-report-
-Women who survive severe PPH are significantly more likely to die in the year following PPH. Impact International.
Measuring and Addressing Outcomes After Pregnancy: A Holistic Approach to Maternal Health. Impact International:
Aberdeen, United Kingdom; February 2007. Available at: www.prb.org/pdf07/Outcomes.pdf. Accessed September 26, 2012.
-12 % of women who survive PPH will have long-term debilitating health conditions. WHO. Maternal Health and Safe
Motherhood Programme. Mother-baby package: implementing safe motherhood in countries. WHO/FHE/MSM/94.11. Geneva:
-The success rates for the control and management of PPH with a UBT range between 70 – 100 %. Doumouchtsis S,
Papageorghiou A, Arulkumaran S. Systematic review of conservative management of postpartum hemorrhage: What to do
when medical treatment fails. Obstetrical and Gynecological Survey. 2007:62(8):540–547.
-Global effort to save 169,000 lives by 2030: Norad, Bill & Melinda Gates Foundation, United States Agency for
International Development, PATH. The IC2030 Report. Reimagining global health: 30 high-impact innovations to save lives.
Seattle: PATH; 2015. Available at http://ic2030.org/wp content/uploads/2015/07/ic2030-report-2015.pdf.