ARTSENS® Pen – portable easy-to-use device for carotid stiffness measurement: Technology validation and clinical-utility assessment

OBJECTIVE The conventional medical imaging modalities used for arterial stiffness measurement are non-scalable and unviable for field-level vascular screening. The need for an affordable, easy-to-operate automated non-invasive technologies remains unmet. To address this need, we present a portable image-free ultrasound device-ARTSENS® Pen, that uses a single-element ultrasound transducer for carotid stiffness evaluation. APPROACH The performance of the device was clinically validated on a cohort of 523 subjects. A clinical-grade B-mode ultrasound imaging system (ALOKA eTracking) was used as the reference. Carotid stiffness measurements were taken using the ARTSENS® Pen in sitting posture emulating field scenarios. MAIN RESULTS A statistically significant correlation (r > 0.80, p < 0.0001) with a non-significant bias was observed between the measurements obtained from the two devices. The ARTSENS® Pen device could perform highly repeatable measurements (with variation smaller than 10%) on a relatively larger percentage of the population when compared to the ALOKA system. The study results also revealed the sensitivity of ARTSENS® Pen to detect changes in arterial stiffness with age. SIGNIFICANCE The easy-to-use technology and the automated algorithms of the ARTSENS® Pen make it suitable for cardiovascular risk assessment in resource-constrained settings.