December 9th, 2011
FDA Advisory Panel Votes Against Implantable CardioMEMS HF Pressure Measurement System
Members of the FDA Circulatory System Devices Panel on Thursday 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.”