FDA Approves Revolutionary Bioengineered Blood Vessel for Trauma Treatments

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The U.S. Food and Drug Administration (FDA) has approved a groundbreaking bioengineered blood vessel aimed at addressing the needs of trauma patients. Developed by North Carolina-based Humacyte, this vessel is designed to integrate with a patient’s body over time, providing a solution for individuals who have suffered severe injuries that impede blood circulation, particularly in cases of amputation. According to founder and CEO Laura Niklason, traditional treatments using veins are often inadequate, especially when patients cannot provide usable options from their own bodies.

The FDA approval follows extensive testing involving 51 civilian and 16 military patients, revealing that nearly 92% of the engineered vessels remained functional after 30 days, compared to 79% for synthetic alternatives. Additionally, the infection rate for the bioengineered vessels was under 1%, significantly lower than the over 8% rate associated with synthetic grafts, as published in the journal JAMA Surgery.

While the approved application is limited to trauma cases, Humacyte is exploring additional uses for its technology, including potential applications in kidney dialysis and peripheral artery disease.

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