Clinical Validation of AngioDefender
To address the limitations of the BAUI technique, Everist Health has developed a non-invasive diagnostic device (AngoDefender) for the assessment of Endothelial Dysfunction (‘EDF’) via Flow Mediated Dilation (‘FMD’) of the Brachial Artery (‘BA’).
The procedure is non-invasive and employs neither ultrasound nor Doppler flow analysis. The AngioDefender device uses a novel, proprietary software algorithm to analyze pulse wave data collected before and after BA occlusion by an upper arm sphygmomanometric cuff.
Clinical validation of the AngioDefender device has been completed in 6 clinical studies around the world and has demonstrated a strong correlation to the current gold-standard, BAUI.
AngioDefender identifies otherwise asymptomatic patients, presenting within normal blood pressure ranges, which are at risk of developing CVD and atherosclerosis.
By way of example, this capability was demonstrated in a recently completed evaluation conducted at Manipal Hospital, Bangalore, India:
- The Manipal Hospital evaluation demonstrated that the AngioDefender device rapidly produces (test time <15 minutes) accurate, easy to perform and clinically valuable assessment of Flow Mediated Dilation.
- There were zero instances of device malfunction or software crashes
- As illustrated in the data table below; AngioDefender identifies otherwise asymptomatic patients, presenting within normal blood pressure ranges, that are at risk of developing CVD and atherosclerosis.
- Twenty out of twenty-five patients (refer to the exhibit below) tested presented within normal blood pressure ranges.
- However, AngioDefender identified that eighteen of the patients that tested within normal blood pressure ranges had %FMD scores which identified them with early-stage CVD and at risk of developing more serious forms of CVD and atherosclerosis
- AngioDefender generated CVD clinical insight and risk stratification that blood pressure measurement or lipid testing alone are unable to produce
Summary of Manipal Hospital AngioDefender Evaluation Results
*Note: Patients DN-008 and YS-024 were tested twice.
- AngioDefender Correlation with Brachial Artery Ultrasound: Conducted at the Moscow Medical Academy. This evaluation produced a strong correlation (R=0.84) between %FMD by AngioDefender with Brachial Artery Ultrasound; AngioDefender Study of Reproducibility: Conducted in Japan to demonstrate reproducibility. The study demonstrated the ability of AngioDefender to deliver highly reproducible results; R=0.88' AngioDefender Correlation Study With BAUI in Indian Population: Conducted at Medanta, Medical City, high degree of correlation between BAUI and AngioDefender (R=0.77)