CardioExchange Archive

December 6th, 2011

FDA Reviewers Raise Questions About CardioMEMS CHAMPION Trial Ahead of Advisory Panel

Larry Husten, PHD

FDA reviewers have raised serious questions about the results of the CHAMPION trial of the implantable CardioMEMS HF Pressure Measurement System (HF System), which provides daily pulmonary artery pressure measurements for the purpose of guiding heart failure treatment. On December 8, the FDA’s Circulatory System Devices Panel is scheduled to review the PMA for the device. (Click here […]

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November 23rd, 2011

CardioMEMS CHAMPION Trial Undergoes Scrutiny From Wall Street Ahead of Next Month’s FDA Panel

Larry Husten, PHD

Note to readers: An earlier version of this story stated that the FDA may be concerned about the conduct of the CHAMPION trial. This statement could be construed as an implication of ethical misconduct or negligence on the part of the trial sponsors or investigators. I apologize if I conveyed this impression in the earlier story. […]

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February 9th, 2011

Trial Finds Benefit in Wireless Pulmonary Artery Monitoring in HF

Larry Husten, PHD

Results of a new trial suggest that an implanted device that provides continuous wireless sensing of pulmonary artery pressures can reduce hospitalizations in patients with heart failure (HF). In a report published online in the Lancet, William Abraham and members of the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Patients) Trial Study Group randomized 550 patients […]

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