Journal of Vascular Medicine & Surgery

Abstract

A Prospective, Cross-Sectional, Multicenter Pilot Study to Assess the Efficacy of NerveVue: A Non-Invasive, Multi-Site Diagnostic Tool for Peripheral Artery Disease

Rakesh Chaitanya, Anuhya Choda and Gayathri Choda*

Peripheral Artery Disease (PAD) remains significantly underdiagnosed even among high-risk populations particularly in primary care and underserved settings due to the dependency on doppler-based Ankle-Brachial Index (ABI) measurements, which is time-consuming, need a trained personnel and specialized equipment. NerveVue is a novel, portable diagnostic system that integrates Photoplethysmography (PPG) and piezoelectric sensors to capture arterial pressure wave form signals from all four limbs simultaneously. Designed for use by low-skill operators, NerveVue enables rapid, infrastructure-light PAD screening suitable for decentralized and outreach environments. 

Methods: A prospective, cross-sectional, multicenter clinical study was conducted involving 299 adults across standard middle- age to older-age ranges. Ankle-Brachial Index (ABI) values derived from the NerveVue device (ABI_NV) were compared against the reference Handheld Doppler method (ABI_Ref). Diagnostic performance metrics including sensitivity, specificity, and predictive values were computed. Subgroup analyses were performed for participants with diabetes, hypertension, and smoking history. Agreement between ABI_NV and ABI_Ref was assessed using Pearson correlation coefficients and concordance. Results: NerveVue demonstrated an overall accuracy of 91.6%, with a sensitivity of 84.6% and specificity of 94.7% compared to Handheld Doppler-based ABI measurements. The correlation between ABI_NV and ABI_Ref was strong, with Pearson’s r=0.991 (right limb) and r=0.992 (left limb), both statistically significant (p<0.00001). Subgroup analysis showed consistent performance, with enhanced sensitivity among diabetic participants (90%) and perfect sensitivity among smokers (100%). The system enabled rapid PAD assessment within five minutes using low-skill operators, making it suitable for decentralized screening environments. 

Conclusion: NerveVue provides a reliable and accurate alternative to Doppler-based ABI for the detection of Peripheral Artery Disease (PAD), demonstrating high diagnostic agreement and robust performance across diverse risk groups. Its simultaneous multi-site measurement and ease of use by low-skill operators, position it well for largescale deployment in community screenings, primary care, diabetic clinics, and preventive health programs. NerveVue has the potential to bridge current diagnostic gaps and enable earlier intervention in vascular disease management.

Published Date: 2026-12-16; Received Date: 2025-12-17