AngioDefender

AngioDefender - The CVD Breakthrough

AngioDefender – aiding physicians in diagnosis of early-stage cardiovascular disease in asymptomatic patients:

AngioDefender is the world’s first non-invasive device that successfully combines patent protected non-invasive sensor technology and a sophisticated software algorithm to quickly and cost effectively assesses Endothelial Cell Dysfunction (‘EDF’) and flow mediated dilation (‘FMD’) of the Brachial Artery (‘BA’).

The AngioDefender Testing System

The AngioDefender 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 completed¹ in 6 clinical studies around the world and has demonstrated a strong correlation to the current gold-standard, BAUI.
• 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

At the end of the AngioDefender testing procedure (~15 minutes), the maximal relative post-occlusion change in the diameter of the BA relative to baseline is calculated and expressed as a percentage of flow mediated dilation (‘%FMD).  Based on independently conducted BAUI clinical study² the following categories of ‘Risk of Cardiovascular Disease and Atherosclerosis’ relative to measured % FMD scores, are recommended:

AngioDefender CVD Risk Stratification

	% FMD Score	Risk of CVD & Atherosclerosis
	< 6.0% FMD	High CVD Risk
	6.1% to 9.9%	Moderate CVD Risk*
	10.0% +	Low CVD Risk

Note *:  A score between 6.1% FMD to 7.4% FMD may be considered a ‘Higher’ Moderate Risk score.  A score between 8.5% FMD to 9.9% FMD may be considered is a ‘Lower’ Moderate Risk score

AngioDefender reports 24 elements of the patient record and test parameters for each patient (illustrated below) including the ‘AngioDefender Cardiovascular Risk Score’, flow mediated dilation of the brachial artery (to assess endothelial cell function), maximum dilation of the brachial artery, time to maximum dilation, pulse rate, mean blood pressure, systolic and diastolic blood pressure and cuff pressure

Actual AngioDefender Test Report

AngioDefender Test Report; Recorded	10:17AM May 16th, 2011	Physician Name	Dr. Peter Lenehan
Patient Name	Ms.  YYYY XXXX	Patient Gender	Female
Patient DOB	October 23, 1980	Patient Age	30
Blood Pressure Risk Factor	Normal Range	AngioDefender CVD Risk Score	High- Moderate Risk
Patient Height	1 meter 57 cm	Patient Weight	51 Kg.
Family CVD History	Yes; Father HTN, MI angina	Patient Diagnosed HTN	No
Patient Diagnosed Diabetic	No	Patient Diagnosed Other CVD	No
Patient Smoker	None	Patient Alcohol Consumption	None
Arterial Systolic Pressure (mmHg)	121	Arterial Diastolic Pressure (mmHg)	7575 Systolic Pressure (mmHg)
Mean	90	Pulse Rate	82
Cuff Pressure	90	Occlusion Time	300 seconds
Change in  Arterial Diameter	6.1%	Time to Maximum Dilation	72.8 seconds

AngioDefender is positioned to become a major aid to physicians in their diagnosis of early-stage cardiovascular disease in asymptomatic patients:

1. AngioDefender helps assess endothelial cell function; independent clinical studies have demonstrated that endothelial cell dysfunction is a key biomarker of atherosclerosis and CVD; it is also the earliest detectable sign of atherosclerosis³.
2. Treatment of CVD is most effective at the earlier stages of CVD; early diagnosis and treatment prevents more serious forms of CVD such as severe hypertension, atherosclerosis, congestive heart failure and stroke⁴.

 

AngioDefender:  Clinical Utility

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 important part of helping physicians to assess early-stage cardiovascular disease and atherosclerosis particularly in asymptomatic patients.  It is hoped that AngioDefender will help Physicians to diagnose early-stage CVD and atherosclerosis through:

1. Identification of asymptomatic patients with early-stage CVD within normal blood-pressure and lipid ranges but which may have sub-clinical atherosclerosis and CVD as determined by their AngioDefender test score
2. Periodic health assessment of patients
3. Screening asymptomatic patients with AngioDefender identified as at-risk because of family history or concomitant illness
4. Help in the assessment of the merits of prescribing pharmaco-therapy and life style modification

AngioDefender represents an additional means of monitoring response to therapy and life-style modification, helping physicians to create personalized dosage and treatment regimens

AngioDefender Smartphone, Tablet and Mobile Applications:

Everist Genomics are developing mobile applications for AngioDefender to further enhance the clinical and economic value of the AngioDefender system.  Smartphones, tablets & mobile applications enable healthcare professionals to access patient diagnostic and therapeutic information throughout the day and from any location.  This improves quality of care and reduces the cost of patient care.

 

 

Footnotes:

1. 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)
2. Journal of the American College of Cardiology Vol. 42, No. 7, 2003; The Clinical Implications of Endothelial Dysfunction; Michael E. Widlansky, MD, Noyan Gokce, MD, FACC, John F. Keaney, JR, MD, FACC, Joseph A. Vita, MD, FACC; Boston, Massachusetts; Carotid Intima-Media Thickness (i.e. the endothelial cells) and Coronary Artery Disease: an Indian Perspective, published in Noninvasive Cardiology, Escorts Heart Institute and Research Center, New Delhi, India; Gupta Hansa MD, Kartikeya Bhargava MD, Manish Bansal MD, Sharad Tandon MD, Ravi Kasliwal DM, 2003, Vol 11, No. 3
3. Sources:  Journal of the American College of Cardiology Vol. 42, No. 7, 2003; The Clinical Implications of Endothelial Dysfunction; Michael E. Widlansky, MD, Noyan Gokce, MD, FACC, John F. Keaney, JR, MD, FACC, Joseph A. Vita, MD, FACC; Boston, Massachusetts; Journal of the American College of Cardiology Vol. 42, No. 7, 2003; The Clinical Implications of Endothelial Dysfunction; Michael E. Widlansky, MD, Noyan Gokce, MD, FACC, John F. Keaney, JR, MD, FACC, Joseph A. Vita, MD, FACC; Boston, Massachusetts; Carotid Intima-Media Thickness (i.e. the endothelial cells) and Coronary Artery Disease: an Indian Perspective, published in Noninvasive Cardiology, Escorts Heart Institute and Research Center, New Delhi, India; Gupta Hansa MD, Kartikeya Bhargava MD, Manish Bansal MD, Sharad Tandon MD, Ravi Kasliwal DM, 2003, Vol 11, No. 3
4. Sources:  Research conducted by Psyma International Medical Marketing Research Gmbh and commissioned by the ESC & the Cardiovascular Round Table (CRT) Task Force 4.  The research was performed in 6 countries (France, Germany, Italy, Spain, Poland & UK) Centers for Disease Control & Prevention, American Heart Association. Heart Disease and Stroke Statistics, 2010