Having received unanimous recommendation from its Circulatory System Devices Advisory Panel to grant a humanitarian device exemption to the Berlin Heart Excor Pediatric Ventricular Assist Device (VAD), the FDA did just that.
Here are some details from our earlier post about the study that led to the approval:
The sponsors of the VAD presented data from a recent prospective, non-randomized, multi-center, single arm study assessing the safety and probable benefit of the device. 48 children were enrolled in the trial and their outcomes were compared to those receiving ECMO (extracorporeal membrane oxygenation), which is considered the standard of care for bridging children to transplant. Regardless of a 29% stroke rate, 90% of the children survived to transplant or were successfully weaned off the VAD. The overall rate of serious adverse events was less in the Excor group versus the ECMO group. Although the committee wants further investigation of the stroke rates with better-defined outcomes and causes, they do suggest this can be done in the setting of post-approval studies.
Company homepage: Berlin Heart…
Flashbacks: FDA Advisory Panel Recommends Humanitarian Device Exemption for the Berlin Heart Excor Pediatric Ventricular Assist Device; German-made Heart Pump for Children Needing Heart Transplants; Berlin Heart EXCOR