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FDA Panel Gives Nod to Novel LVAD
MedPageToday, 2012-- An FDA advisory committee has voted 9-2 to recommend approval of an experimental left ventricular assist device (LVAD) used as a bridge to transplant in very sick heart failure patients.
The FDA's Circulatory System Devices panel voted Wednesday that the benefits of HeartWare's ventricular assist system outweigh its risks, despite pointing to missing data and concern over how the company managed its clinical trial.
Unlike other so-called bridge-to-transplant devices, HeartWare is inserted directly into the pericardium and does not require a pump pocket.
The panel based its decision on HeartWare's main clinical trial -- known as the trial -- which compared outcomes from 137 advanced heart failure patients implanted with its HeartWare system with outcomes from a registry of patients who have received a different type of mechanically assisted circulatory support.
HeartWare had a success rate of 90.7%, compared with 90.1% of the control group ( P <0.0001), meaning the HeartWare system had bridge-to-transplant success rates comparable to currently approved devices.
One panelist called it a huge advance over existing technology, and the panel's chairman praised the HeartWare system as a "masterpiece in engineering."
However, they weren't as effusive about the safety of the device, voting 8-3 that the HeartWare system is safe.
Throughout Wednesday's meeting, panelists struggled with determining what sort of safety comparisons could be made between the HeartWare arm and the registry arm of the trial.
That was particularly evident when it came to comparing stroke rates between HeartWare patients and the control group.
Eleven patients who received the HeartWare device had an ischemic stroke within 180 days (27% of whom died or else were no longer eligible for a heart transplant) and four patients died of a hemorrhagic stroke.
But whether 11 ischemic strokes is a high or low number is unclear, because stroke data wasn't tracked in the registry.