Despite voting for approval, I was surprised by a lot of negative comments by the FDA panel. This may cause the FDA to reject this or at a minimum an expensive and rigorous post-approval study.
Here are some of the negative comments:
And panelist Dr Gregory Dehmer (Texas A&M University, Temple) said the trial's data "has more holes than Swiss cheese."
But he (panel chair, Dr Richard L Page) slammed what he and others saw as a poorly conducted ADVANCE trial, calling its data "a mess."
But others slammed the lack of a real, contemporaneous comparator group in ADVANCE and seemed ready to send the device-maker (also called HeartWare) back to get more direct comparative safety data. Dr John C Somberg (Rush University Medical Center, Lake Bluff, IL), said the admittedly small stroke rate in ADVANCE was still "worrisome" and "you can't judge safety" without a direct comparator group.
Read my post below, the FDA told HTWR to use the registry that had missing data, was NOT HTWR's fault. The expert panel doesn't know this and HTWR isn't going to stand up and say it was the FDA that fudged up, letting them save face.