Boy: (in a rush). Mr. Godot told me to tell you he won’t come this evening but surely tomorrow. (Samuel Beckett, Waiting for Godot)
The US fate of the Sapien transcatheter aortic heart valve remains unknown this Halloween night. Despite previous statements from Edwards Lifesciences that projected an October US launch of their TAVI device, no word has yet been received concerning approval of the device in the US.
Earlier in Ocrober Jeffrey Borer, a member of the FDA advisory panel that gave a positive recommendation for Sapien, said that FDA approval of the device would be delayed until April. Other observers have said Borer was wrong. At the time Edwards said that it still expected approval in October. Here’s what an Edwards’ spokesperson told me today:
We are fully prepared to begin U.S. launch of SAPIEN for inoperable patients and expect FDA approval any day.
It is worth noting here that unlike drugs, which have firm PDUFA dates, devices do not have the same sort of absolute deadlines for FDA decisions. As best I can tell, although the FDA may reach agreements with companies about deadlines, neither the companies not the FDA are obligated to disclose this information.
Estragon: I can’t go on like this.
Vladimir: That’s what you think. (Waiting for Godot)
Note: CardioBrief will update this story as developments occur.