Members of the FDA Circulatory System Devices Panel today recommended against approval of the implantable CardioMEMS HF Pressure Measurement System. Although panel members agreed that the device was safe by a 9-1 vote, they voted 7-3 that the device had not been shown to be effective and 6-4 that the benefits did not outweigh the risks.
Panel discussion focused on the CHAMPION trial. In an extraordinary addendum to its main review of the trial, the FDA reviewers raised serious concerns that “the conduct of the trial may have biased the study results.” An audit of the trial by FDA inspectors determined that the sponsor or the principal investigators “routinely contacted investigational sites and made specific therapeutic recommendations for some Treatment Group study subjects.”
As previously reported here and here, Wells Fargo analyst Larry Biegelsen was the first to uncover the news that the FDA would raise serious questions about the CHAMPION trial at the advisory panel. These initial charges were dismissed by Jay Yadav, the cardiologist who founded the company, but the concerns about CHAMPION now appear to be valid.