AtCor Medical (ASX: ACG), the developer and marketer of SphygmoCor® systems, which non-invasively measures central aortic blood pressure and arterial stiffness, today announced that it had received 510(k) marketing clearance from the US Food and Drug Administration (FDA) for its SphygmoCor® XCEL device.
SphygmoCor® XCEL, is a new blood pressure cuff- based system that allows brachial and central aortic blood pressure to be measured quickly and simply. With the new system, traditional brachial blood pressure measurement and pulse wave analysis, which measures central aortic pressure, can be performed quickly and easily. The SphygmoCor® XCEL system also provides a simpler and more convenient method of performing pulse wave velocity measurement, a test used to measure aortic stiffness.
SphygmoCor® XCEL, already available for sale in European, Australia and India, and in other Asian markets, was introduced in the US in demonstrations at the American Society of Nephrology conference in San Diego earlier this month.
"The reaction from physicians and from our pharmaceutical clinical trials customers has been extremely positive," said Duncan Ross, AtCor Medical CEO. "SphygmoCor® XCEL offers users the gold standard in pulse wave analysis and pulse wave velocity measurement, featured in over 600 published studies, in a cuff-based system that is very easy to use. SphygmoCor® XCEL sequentially measures brachial blood pressure and central aortic pressure, providing comprehensive cardiovascular data for diagnosis, risk assessment and drug therapy management.
"Study after study, has shown that measuring central aortic blood pressure and arterial stiffness is vitally important in drug selection, in understanding patient response to drug therapy and in accurately assessing the patient's cardiovascular risk," Ross continued. "New research suggests that arterial stiffness is a precursor to the development of hypertension, holding out the possibility of preventive treatment for hypertension."
About AtCor Medical
AtCor Medical develops and markets products for the early detection of cardiovascular risk and management of cardiovascular disease. Its technology allows researchers and clinicians to measure central aortic blood pressure non-invasively. The company's SphygmoCor® system visibly identifies the effects of reflected blood pressure in the central aortic pressure wave, effects which cannot be detected wiith standard blood pressure monitoring. More than 3,000 SphygmoCor® systems are currently in use worldwide in leading medical centers, in clinical trials with pharmaceutical and medical device companies, and in physicians' offices. The company's technology has been featured in over 600 studies published in peer-reviewed medical journals. AtCor has operations in the United States, Australia and in Europe. For further information, please visit our web site at www.atcormedical.com.