Access to atrial flow regulators for implantation in critically ill children via the US Food and Drug Administration's emergency use pathway.

OBJECTIVES

The authors conducted a review of the US Food and Drug Administration's (FDA) emergency use authorization (EUA) pathway as a mechanism to use the Occlutech Atrial Flow Regulator (AFR) (Occlutech International AB) for critically ill pediatric patients with congenital heart disease.

METHODS

The authors describe 8 pediatric patients in whom the EUA pathway was activated to permit AFR implantation and provide potentially lifesaving therapy.

RESULTS

Emergency authorization was granted for each of the 8 cases with successful implantation of the AFR. There were 2 cases in which the patient required a repeat catheterization for thrombus on the device, but all 8 patients were able to progress their care. These cases demonstrate the feasibility of the EUA pathway to access emerging technologies for pediatric patients.

CONCLUSIONS

The Occlutech AFR may provide an important therapeutic option for critically ill children with congenital heart disease. The EUA pathway can facilitate timely access to unapproved but potentially beneficial technologies when no satisfactory approved alternatives exist.