One-Third Of Patients Who Receive Stents And Have Evidence Of Arterial Dysfunction At High Risk For Major Cardiovascular Events, Study Finds EndoPAT™ Technology can identify near-future cardiovascular events post-stenting or other therapy, beyond conventional tests
NEW YORK, Dec. 3, 2013 /PRNewswire/ -- Data from a new study indicate that the results of an FDA-approved test for endothelial (arterial) function significantly correlated with near-future cardiovascular events, including revascularization, chest pain, heart attack, heart failure, stroke and even death in high-risk patients, of which the majority have had stents implanted. Early diagnosis of near-future cardiovascular events is critical for the physicians who manage these high-risk patients. The study was published in the December issue of the Journal of the American Heart Association. The diagnostic device, the EndoPAT™, is manufactured by Itamar Medical (TASE:ITMR).
A total of 528 high-risk patients with stable chest pain and abnormal electrocardiogram (ECG) that have been referred to angiography were followed up for almost three years, on average. Those whose EndoPAT Test revealed endothelial (arterial) dysfunction experienced up to four times more cardiovascular events compared to those with normal endothelial function. Of the 528 patients enrolled in the study, 65 percent (344) had stents implanted; in these patients, the test revealed that nearly one-third (32 percent) were still at high risk for a major cardiovascular event. Real-time information on endothelial (arterial) function is important for the approximately 2.5 million people who undergo stenting procedures in the United States each year. Identifying high-risk patients as early as possible allows for immediate lifestyle changes and, potentially, a more vigilant patient management approach that may include modifying the medication regime and adding specific supplements.
"This study builds on the extensive data collected in previous studies and demonstrates the importance of the assessment of endothelial health for the prediction of cardiac events in patients after revascularization procedures," said Amir Lerman, MD, Professor of Medicine, Mayo Clinic, and a member of Itamar Medical's scientific advisory board. "The results of this study underscore the need for and importance of integrating these tests into clinical practice, and the attention the medical community should give to endothelial function as a major indication of cardiovascular disease."
The EndoPAT Test, an innovative, non-invasive FDA-cleared medical device for measuring endothelial (arterial) function, has been validated to be an independent predictor for major cardiovascular events in high-risk patients or patients with heart disease that undergo standard medical treatment, including stenting.
"This research is an important step toward personalized diagnostics for patients with heart disease or related symptoms who are concerned about their residual risk after medical therapy or interventional procedures like stenting," said Gilad Glick, Chief Executive Officer, Itamar Medical. "This study confirms that stenting should be followed by vigilant patient management to improve outcomes and reduce readmissions. Large groups of patients with stents are still at high-risk for a cardiovascular event in the near future. This study shows that the EndoPAT Test provides valuable clinical information and reaffirms its role in helping to offset future cardiovascular events."
The endothelium is the thin layer of cells that line the blood vessels. When these cells do not function properly, known as endothelial dysfunction, the arteries begin to lose their ability to supply more blood to the heart muscle when needed. Insufficient blood supply to the heart muscle can cause chest pain and other symptoms, such as shortness of breath, and can eventually lead to a heart attack if not properly managed.
The two-center prospective study in Japan was performed by an independent research team and independent academic institutes and was not funded by any commercial entity.
For more information and scheduling the EndoPAT™ Test at a hospital or physician's office, individuals can visit www.prevent-heartattack.com or call 1-855-PATMyHeart.
About Heart Attacks
Each year, about 715,000 Americans have a heart attack; of these, 525,000 are a first occurrence. Groups that are at particular risk are families with a history of heart disease, those with a previous heart attack or evidence of heart disease, and those who face tremendous workplace stress. According to one study, if a member of your immediate family – father, mother, brother or sister – has had a heart attack before the age of 55, your risk is increased by 33 percent; if two relatives have had a heart attack, your risk is increased by 50 percent.
What most people don't realize is that a heart attack is largely preventable through early detection. Of the approximate 360,000 sudden cardiac deaths that occurred in the U.S. last year, over half had no symptoms or risk factors. Individuals who have had a heart attack are four to six times more likely to die of another heart attack despite getting medical treatment. According to the American Heart Association, half of men and more than half of women who experienced a sudden cardiac death did so without any prior warning signs.
About Itamar Medical
Established in 1997, Caesarea, Israel-based Itamar Medical (TASE: ITMR) is a medical device company that develops, markets and sells diagnostic medical devices based on the PAT™ (Peripheral Arterial Tone) signal. The PAT signal is a non-invasive "window" to the cardiovascular system and the autonomic nervous system.
The company's EndoPAT™ Device is an innovative diagnostic tool that gives doctors and patients a window to the current functioning of the endothelium and the overall health of the heart. The non-invasive diagnostic tool is the only medical device indicated for use in endothelial function assessment. WatchPAT is an FDA-approved portable diagnostic device that uses the most innovative technology to ensure the accurate screening, detection, and the follow-up on treatment of sleep apnea.
Itamar Medical ranks 14th in the Deloitte Fast 50 for 2008, with a five-year growth of 1,915%. Deloitte Fast 50 is an annual list of the fastest growing companies in Israel.
For more information, please visit www.itamar-medical.com.
Craig Heit, GCI Health
SOURCE Itamar Medical