Pression Wave PRO External Counter-Pulsation System

The Pression Wave PRO External Counter-Pulsation System is a portable medical device that wraps around a patient's calves with inflatable sleeves. During the heart's relaxation phase (diastole), the sleeves inflate sequentially from ankle to knee, compressing the legs in sync with the cardiac cycle to increase blood flow to the heart and reduce heart workload. It is indicated for treating chronic stable angina refractory to medication and for improving vasodilation and blood flow in healthy adults.

The Wave PRO uses calf-only sleeves with five sequential bladders, whereas predicate devices use cuffs on calves, thighs, and buttocks. It operates at 41–50 kPa (automatically set) versus the predicate's 13–41 kPa (manually set). The device is highly portable at 34 kg compared to stationary or much heavier predicates. It employs a PPG finger sensor for cardiac cycle detection and modern software validated per FDA's 2023 guidance, versus older predicate validation standards.

IEC 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 62304 (software lifecycle), ISO 10993-1 (biocompatibility), ISO 14971 (risk management), and ISO 15223-1 (symbols). The device underwent compression accuracy, electrical safety, EMC testing, software verification, service life validation, reprocessing validation, and summative usability testing.

The WaveCRESST clinical study demonstrated non-inferiority to the predicate ACS Model NCP-2 on the primary endpoint of diastolic augmentation ratio (DA ratio 0.83 vs. 0.57, p<0.0001), with the Wave PRO actually exceeding the predicate's performance. Both devices use the same fundamental ECP mechanism, operate in the same regulatory class and product code (DRN), and address the same intended use for chronic stable angina. No adverse events occurred in clinical testing, confirming safety equivalent to the predicate.