The CardiSense CS1 medical device
The CS1 device combines known technology for use as a temporary cardiac pacemaker electrode (TME) when connected to a standard external pacemaker, with an integrated accelerometer that allows measurement of myocardial contractility to monitor cardiac function when connected to the external accessory CB1. The device enables sensing of the electrical impulses of the heart, and application of pacing pulses to be delivered to the heart from standard commercially available external pacemakers when needed to restore normal cardiac rhythm.
To utilize the pacing feature, the CS1 must be connected to a standard external pacemaker. To utilize the cardiac contractility measurement feature, the CS1 must be connected to the proprietary external accessories CB1 and an acquisition unit with CM software. The CB1 accessory further connects to a standard electrocardiogram (ECG) patient monitor to allow synchronization of the CS1 accelerometer data with the heart cycle.
The lead of the CS1 device will be placed and removed in the same manner as existing temporary pacing leads that are used following open-heart surgeries. No additional action for placement is required by the surgeon over what is currently done with existing leads
The CS1 device is pending regulatory approval
CM Software and accessory CB1
The CM Software acquires, displays and stores CS1 acceleration data together with the patient ECG data provided by the accessory CB1 to enable continuous heart function monitoring. The software is running on a 10" medical touch panel computer that allows flexible mounting options. The CB1 accessory provides power to CS1 and allows heart motion data transfer when connected to the acquisition unit. A standard analogue ECG signal from the patient monitor must be connected to CB1 to allow heart cycle synchronization of the CS1 data.
The CB1 accessory and CM Software is pending regulatory approval