The US FDA granted Humanitarian Use Device (HUD) designation for Xeltis’ first bioabsorbable cardiac pulmonary valve, for the correction or reconstruction of right ventricular outflow tract (RVOT). HUD designation is granted to medical devices that may help people with rare diseases or conditions, to provide an alternative pathway for market approval in the USA. “FDA HUD designation represents an important step for Xeltis and may help expedite the time when bioabsorbable valves become a real, available treatment option for patients that need RVOT reconstruction in the USA” – stated Laurent Grandidier, Xeltis CEO.
US FDA granted Humanitarian Use Device for Xeltis pulmonary valve
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