Everist Health™ has approval to market the AngioDefender™ System in over 30 countries
The AngioDefender™ system is a CE-marked device and meets additional requirements in India, the United Arab Emirates, and Canada. Everist Health is currently seeking FDA approval of the AngioDefender™ system in the United States.
The AngioDefender™ system is statistically equivalent to the gold standard
The AngioDefender™ system represents the most innovative solution to the technical, clinical, ease of use and cost challenges relating to assessment of endothelial dysfunction. These advantages position AngioDefender™ testing to become part of the standard screening methodology applied by physicians to their patients; as an important part of helping physicians to assess early-stage cardiovascular disease and atherosclerosis particularly in asymptomatic patients.
A 2010 comparison study reveals that AngioDefender™ is statistically equivalent to the gold standard BAUI technique as used to measure %FMD. Each of twenty-two subjects with a range of CVD risk factors underwent testing with both procedures, separated by a one hour interval, with each test administered in random order.
Figure 1. Passing and Bablok regression plot showing statistical equivalence of 2 techniques.
Figure 1 illustrates a Passing and Bablok regression of the data, showing a close matching of the regression line with the line-of-identity (Pearson correlation coefficient = 0.84, p<0.0001).
Study conducted at the Moscow Medical Academy