EVALUATION OF THE INDEPENDENT TEMPORARY EFFECTS OF INTELECT® RPW2 (RADIAL PRESSURE WAVE) AND CEFAR TENS (NMES) TREATMENTS ON THE LOCAL CIRCULATION OF HEALTHY VOLUNTEERS

Aims: This study evaluated the haemodynamic changes in the lower limbs resulting from the use of two non-invasive medical devices: radial pressure wave (RPW) therapy via the Intelect® RPW2 device and neuromuscular electrical stimulation (NMES) via the CEFAR TENS device. Conducted as a Post-Market Clinical Follow-Up (PMCF), the study aimed to assess whether stimulation of the calf muscles using either device produces a local and temporary increase in venous return.Methods: Twenty healthy adult volunteers participated in a prospective, single-centre PMCF study. Each subject received both treatments, RPW and NMES, on opposing calf muscles in a randomised sequence, with RPW administered first. Duplex Doppler ultrasound was used to assess haemodynamic parameters at baseline, during treatment, and at 1-, 2-, 5-, and 10-minutes post-treatment. The primary endpoint used was peak venous velocity (PV, cm/s), with secondary endpoints included ejected volume (EV, mL), time-averaged mean velocity (TAMV, cm/s), and volume flow (VF, mL/min). Safety was assessed through direct observation, participant reporting, and a one-week follow-up.Results: Both devices produced statistically significant increases in PV, with corresponding improvements in secondary haemodynamic endpoints compared to baseline. Intelect® RPW2 generated an immediate and marked elevation in PV during treatment, while CEFAR TENS was associated with sustained increases in TAMV and VF following stimulation. No adverse events or device-related complications were reported.Conclusion: The findings support the hypothesis that both Intelect® RPW2 and CEFAR TENS induce temporary enhancements in lower limb venous haemodynamics. These results support their use in both clinical and home settings to promote local circulatory benefit.