Life-Saving Healthcare Device Granted FDA Approval

BOSTON, November 13, 2019 (Newswire.com) - The United States Food and Drug Administration (FDA) has granted approval of a life-saving medical device used to prevent unnecessary deaths of mothers around the world. 

The device, called the Every Second Matters - Uterine Balloon Tamponade (ESM-UBT), is a highly cost-effective solution to stop life-threatening postpartum hemorrhage (PPH) in mothers during childbirth. ESM-UBT is one of several disruptive healthcare solutions supported by the Ujenzi Charitable Trust, a 501(c)(3) organization. After years of scientific testing, ESM-UBT has been approved by the FDA, clearing the way for the global distribution of the devices. 

“FDA approval adds a layer of credibility that opens doors within nations and healthcare systems where the devices can make a huge impact,” Dr. Thomas F. Burke, Chief of the Division of Global Health Innovation at the Massachusetts General Hospital and founder of the Ujenzi Charitable Trust, said. “We can now set our sights on a more comprehensive, robust distribution plan that will create real change for mothers and their families.”

Postpartum hemorrhage is one of the leading causes of preventable deaths in the world, accounting for 35% of all maternal deaths according to the World Health Organization. In developing countries, that figure can jump to nearly 60%. The Ujenzi Charitable Trust works to reduce these statistics by supporting the ESM-UBT package and aiding in the provision of the packages to healthcare professionals caring for vulnerable populations in developing countries.

The ESM-UBT device provides an ultra-low-cost solution to PPH-related deaths. The functionality of the device is comparable to other Western PPH solutions, such as the Bakri Balloon, but at a far lower price point. ESM-UBT can be provided at a price point of around $5, while the Bakri Balloon has a retail listing of around $400. ESM-UBT offers a solution that will be accessible within lower and middle-income countries that cannot afford a more expensive alternative.

“Maternal death during childbirth is the greatest inequality on earth,” Geoff Cudd, Head of Marketing at the Ujenzi Charitable Trust, said. “Up until now, solutions to address postpartum hemorrhage have been largely inaccessible in developing nations.  The device has already had a dramatic impact on the communities where it has been used in, and now we can reach significantly greater populations of mothers in need.”

Over the past few years, thousands of lives have been saved by innovative medical solutions supported through The Ujenzi Charitable Trust. As ESM-UBT continues to grow in prominence, Ujenzi will continue to seek donations, sponsors, and supporters to aid in the continued provision of these healthcare solutions to developing countries around the world.

Source: The Ujenzi Charitable Trust

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