A Food and Drug Administration review of CardioMEMS’ device for treating heart failure found it has met its main safety and effectiveness goals, based on trial results. But the FDA questioned on Monday how clinically significant the findings are for the CardioMEMS Heart Failure Pressure Measurement System, which undergoes an FDA panel review on Thursday. The agency’s staff said they have questions related to the proportion of patients who were hospitalized for heart failure after receiving the device, the number of days alive outside the hospital and their quality of life.
