CardioMEMS, the company developing a wireless implantable sensor for heart failure patients, has recently announced the results of its nearly three year-long CHAMPION trial. One of the topline results from the trial: The number of hospitalizations for heart failure patients reduced by 38 percent over the the full duration of the study.
CHAMPION stands for: CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Patients.
This class of patients experience symptoms of heart failure with only mild exertion, according to the company. This group represents about 1.5 million of the six million heart failure patients in the US and accounts for about 50 percent of all heart failure hospitalizations.
Trial background: The CHAMPION Trial included 550 patients who had been hospitalized for heart failure in the previous year. The patients were spread across 63 heart centers in the US and each subject received a CardioMEMS CHAMPION HF sensor as a permanent pulmonary artery implant. Prior to the trial, these patients each received optimal drug, device and disease management therapy.
Results: The reduction in the risk of a heart failure related hospitalization at 6 months was 30% and the impact on hospitalizations continued to increase over time, reaching 38% per year over the full duration of the trial, according to the company. The average patient follow-up was 15 and 1/2 months. The safety profile of the device was positive: none of the implanted sensors needed to be removed or replaced and all were functioning throughout the course of the trial, according to CardioMEMS.
For more on CardioMEMS, read the press release here.