Device typeExternal counterpulsation system, stationary: A noninvasive, stationary assembly of devices intended to assist the blood circulation of an adult patient suffering from heart disease through the electrocardiogram (ECG) synchronized inflation of pressure cuffs worn around the extremities/buttocks. It includes a patient bed with inflatable cuffs, an air pump, ECG cables, and either a control unit or software for use with a personal computer (PC); it may include a pulse oximeter probe. The cuffs are intended to inflate from the most distal to the most proximal during diastole and deflate during systole to increase preload/decrease afterload. The system is intended to be operated by a professional in a clinical setting.
FDA categoryDevice, counter-pulsating, external
Device ID00817980020948
Catalog numberV23-0003
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information