The CardioMEMS’ heart failure pressure measurement system
By Steven Greer, MD
The CardioMEMS’ heart failure pressure measurement system will be evaluated by an FDA advisory committee next month. The CHAMPION trial, led by Dr. Abraham at Ohio State, demonstrated that the constant pressure monitor implanted in the pulmonary artery can reduce hospitalization rates for congestive heart failure patients, increasing quality of life and decreasing cost.
The device is powered by energy sources outside the body and has no moving parts. Therefore, the device does not need to be replaced and has a low chance of fracturing or causing bodily harm once implanted.
In our video interview, Dr. Abraham answers these questions:
- Can you please summarize the CHAMPION trial?
- What unmet clinical need does the CardioMEMs device meet?
- Which heart failure sub-classes will benefit the most from this device if it is approved by the FDA?
- What might be some reasons this technology would not be adopted by cardiologists?
- Which type of cardiologist will likely care for the patient after the CardioMEMs monitor is implanted?
- Are reimbursement codes established already for the device and procedure?
- Will mortality data be required or will hospitalization be adequate for the FDA and CMS?
- Is too much information a problem? Will the CardioMEMs PA pressure data cause interventions that otherwise would not have been delivered?
- Will new data be presented at the TCT or other upcoming meetings?
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