This client engaged us to develop a first of its kind cardiac pump controller to work with a balloon catheter for therapy delivery to patients who have acute decompensated heart failure.
This project began as a concept but has since become a multiple generation project, beginning with a First in Human system, pivotal study design and commercially viable product spanning multiple software enhancements as identified by the client during limited market release.
The Complexity
Integrated pump and pressure transducer interface for balloon catheter-controlled inflation and deflation
Monitoring occlusion through precise pressure changes
Algorithm for inflation and deflation patterns
Touch screen console with single board computer
Battery backup for mobility of system without therapy disruption
Specific criteria for system shutoffs to ensure patient safety
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