The FDA’s Circulatory System Devices Advisory Panel voted Dec. 8 against approval of CardioMEMS’ implantable pressure measurement system in heart failure patients. The FDA had asked the panel to review clinical trial results to determine if the Champion heart failure monitoring system was safe and effective.
The committee voted nine to one in favor of the device’s safety but the majority did not find sufficient evidence of the system’s effectiveness. The FDA will review the panel’s decision to determine whether or not to grant premarket approval. The agency typically follows the advisory panel's recommendations.
Jay Yadav, MD, CardioMEMS CEO and founder, called the decision a "disappointment," but added the company would continue discussions with the FDA. “We believe this technology is a significant step forward in the management of heart failure patients," he said in a statement.
CardioMEMS designed the wireless system for remotely monitoring New York Heart Association Class III heart failure patients by gauging pulmonary artery pressure and heart rate. In an executive summary for advisory panel members, the FDA had questioned the clinical significance of the findings in the CHAMPION trial and cautioned that a monitoring division reported potential biases in the results.
Atlanta-based CardioMEMS is a medical device company that specializes in wireless sensing and communication technology.