Cardiovascular Disease Testing |
Cardiovascular disease is the leading cause of death of men and women in the United States, and accounts for more than one-third (34.3%) of all U.S. deaths
Clinical studies have demonstrated that cardiovascular disease and damage to the vascular system starts years before it can be detected with current testing methods, (such as blood pressure, lipid panels, EKG or angiograms); this damage impairs vascular health and eventually makes its presence known later as high blood pressure and elevated cholesterol levels; after significant damage has already been done to the vascular system.
What is AngioDefender?
The AngioDefender by Everist Genomics is the world’s first non-invasive CVD testing system. With breakthrough technology combining non-invasive sensor technology with a sophisticated software algorithm, the AngioDefender is able to quickly and cost-effectively help physicians assess the presence of early stage CVD and atherosclerosis in asymptomatic patients. The most effective way to prevent more serious forms of CVD such as severe hypertension, atherosclerosis, congestive heart failure and stroke, is early diagnoses and treatment
Coronary Heart Disease
17.6 million people alive today have a history of myocardial infarction (acute heart attack) , or angina pectoris (chest pain or discomfort caused by reduced blood supply to the heart muscle)
LEARN MORE >>Stroke
Approximately 6.4 million people alive today have had a stroke. About 795,000 people suffer a new or recurrent stroke each year.
LEARN MORE >>Frequently Asked Questions
Blood vessels play a vital role in maintaining cardiovascular health and atherosclerosis. A single layer of cells called the endothelium lines the walls of every blood vessel and capillary in the body. Along with a layer of elastic tissue, the endothelium comprises what is called the intima. Endothelial cells are also referred to as the “brain" of the vascular system. Healthy endothelial cells play an important role in maintaining blood vessel flexibility, (or compliance} and influences a number of important aspects of vascular health.
Endothelial cells provide a dynamically-controlled structural barrier between the circulating blood and surrounding tissues and organs, they also produce signaling molecules that influence vasodilation and vasoconstriction. Vasodilation causes blood vessels to relax allowing for greater blood flow. This reduces blood pressure. Vasoconstriction causes blood vessels to tighten reducing blood flow and causing blood pressure to increase.
Independent research suggests that endothelial cells are the controlling factor in the regulation of blood pressure. They produce both nitric oxide which is the most potent vasodilator and endothelin-1 the most potent vasoconstrictor.
The proper production of nitric oxide is fundamental to maintaining normal blood pressures because it maintains basal tone by relaxing the vascular smooth muscle cells.
Early identification of thickening of the arteries (atherosclerosis) is a vital part of aiding physicians in the prevention (or regression) of cardiovascular disease.
- Sub-clinical vessel damage starts years before it can be detected with current testing methods (such as blood pressure and lipid panel tests).
- As illustrated in the exhibit below, despite advances in diagnosis and treatment, no diagnostic tool is available for early detection of blood vessel damage.
Although the clinical value of endothelial testing has been demonstrated as a key biomarker of atherosclerosis and coronary heart disease, current diagnostic testing methods (such as Brachial Artery Ultrasound, ‘BAUI’) are costly, difficult and complex to use.
The BAUI method has major limitations; it requires access to expensive ultrasound equipment, a specialized ultrasound probe and a highly trained technician. Brachial artery ultrasound is highly dependent on the skill of the individual technician and varies greatly from one user to the next. Consequently, the cost, complexity and time required to perform ultrasound based measurement of Flow Mediated Dilation (‘FMD’) of the brachial artery has confined its use to research applications.
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 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.
Subject to the required regulatory clearances, Everist Genomics plans for AngioDefender systems to be available to physicians in the following countries, commencing in 2012:
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AngioDefender
Clinical validation of the AngioDefender device has been completed1 in 6 clinical evaluations around the world and has demonstrated a strong correlation to the current gold-standard, BAUI.
- The AngioDefender procedure is non-invasive.
- The AngioDefender testing can be performed and results reported in about 15 minutes. It can be used in a hospital, clinic or physician office by a doctor, nurse or technician.
- AngioDefender testing is applicable to any patient, regardless of age, gender, ethnicity or pre-existing conditions.
- AngioDefender test results are not dependent on user technique or operator proficiency.
For more information on AngioDefender, please
- 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 i n 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)