Another big endorsement by the FDA Circulatory System Devices Advisory Panel took place on July 21, 2011. The committee overwhelmingly agreed (16 to 0 vote) that the Berlin Heart Excor Pediatric Ventricular Assist Device (VAD) be granted a humanitarian device exemption (HDE). The device, as reported prior on Medgadget, provides mechanical circulatory support as a bridge to heart transplantation in pediatric patients suffering from severe isolated left ventricular or biventricular dysfunction. 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.
The FDA provides HDE for devices that diagnose or treat conditions affecting relatively few people in the US. The level of evidence needed to obtain HDE is less than regular market application approval. In general, the device must demonstrate probable benefit and not carry a significant risk for HDE status.
The average wait time for a pediatric heart transplant in the United States is between six and eight weeks.
FDA advisory panel: Brief Summary of the Circulatory System Devices Panel Meeting – July 21, 2011…
Berlin Heart’s Sponsor Executive Summary presented to FDA Advisory Committee…
Flashbacks: Berlin Heart EXCOR; German-made Heart Pump for Children Needing Heart Transplants
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