An FDA review found CardioMEMS’ Champion heart failure pressure measurement system safe and effective, but questioned the logic of clinical trials supporting the device’s bid for pre-market approval.
While the company’s research met its goals, the watchdog agency raised questions about heart failure therapies that were administered by nurses during the clinical trials, potentially complicating the study as look at the value of the device alone.
"FDA is concerned is that this study tested a treatment strategy of device plus heart failure recommendations vs. optimal medical therapy alone, which was not FDA’s understanding of the original intent of this trial," according to an agency document.
The agency review, provided in advance of Thursday’s Circulatory System Devices Panel meeting to discuss the future of the Champion device, also outlines interactions between national study investigators and local investigators that "was
inconsistent with FDA’s expectations based on the protocol."
The preliminary review warns that study results may be biased in certain areas as some groups got drug therapies not given to the control group patients. The agency also questioned whether the level of involvement from national investigators was a reasonable corollary for how the device would be managed should the Champion system make it to the U.S. market.
CardioMEMS did not immediately return calls for comment.