FDA panel votes in favor of HeartWare's VAS
The panel vote is a recommendation, but FDA usually votes in accordance with the panel. The agency will consider device approval in a review of the premarket approval application that HeartWare submitted in December 2010.
During the meeting, panel members reviewed data from the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) trial, which evaluated the non-inferiority of the proportion of study patients alive, transplanted or explanted for recovery at 180 days to the same number of those in the INTERMACS registry cohort.
The FDA found that the trial’s 180-day observed ischemic stroke rate was 8 percent and the event rate of hemorrhagic stroke was 3 percent. The panelists were asked to comment on neurological event rates and patient outcomes during the meeting.
Additionally, the panel voted on whether the HeartWare VAS system was safe for patients who meet certain criteria and whether the system is effective. While the panel unanimously voted that the device was effective, panel members were split eight to three in terms of the device's safety.
Lastly, the panel addressed whether the benefits of the system outweighed the potential risks, with a final vote of nine to two.
“The Advisory Committee meeting outcome represents an important step toward approval of the HeartWare VAS in the U.S., and we look forward to continuing our dialogue with the FDA as it finalizes its review of our PMA,” Doug Godshall, CEO and president of HeartWare said in a statement. “HeartWare remains committed to optimizing outcomes for patients with end-stage heart failure and looks forward to expanding the clinical experience for the device in the future.”