US FDA grants Humanitarian Use Device status for Xeltis pulmonary valve


The US Food and Drug Administration (FDA) has granted Humanitarian Use Device designation for Xeltis’ bioabsorbable cardiac pulmonary valve, for the correction or reconstruction of right ventricular outflow tract (RVOT).

Humanitarian Use Device status 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 Humanitarian Use Device 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” states Laurent Grandidier, Xeltis chief executive officer.