An FDA advisory panel votes that the CardioMEMs Champion device is safe and that its benefits outweigh its risks, but against its effectiveness.
An FDA panel today issued a mixed recommendation on CardioMEMs Champion permanently implantable pressure measurement system for daily pulmonary arterial pressure measurements, voting against its effectiveness due to confounding factors in the study backing the device’s pre-market approval application but saying it is safe and that its benefits outweigh its risks.
Champion, which wirelessly measures systolic, diastolic, and mean pulmonary arterial pressure, is indicated for measuring pulmonary artery pressures in subjects with New York Heart Assn. Class III heart failure who have been hospitalized for heart failure in the previous year.
The FDA’s Circulatory Systems Devices panel voted 11-0 that Champion is safe and 6 to 4 with 1 abstention that its benefits outweigh its risks. But the committee voted 4-7 on Champion’s effectiveness, citing confounding factors in the study that make it hard to attribute positive study outcomes to the device itself.