In short
AtCor Medical, the developer and marketer of SphygmoCor® systems, which non-invasively measures central aortic blood pressure and arterial stiffness, has announced that it has received 510(k) marketing clearance from the US FDA for its SphygmoCor® XCEL device.
Background
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 with standard blood pressure monitoring.
SphygmoCor® XCEL, is a new blood pressure cuff- based system that the company says allows brachial and central aortic blood pressure to be measured quickly and simply. Traditional brachial blood pressure measurement and pulse wave analysis, which measures central aortic pressure, can be performed quickly and easily with the system, which also provides a simpler and more convenient method of performing pulse wave velocity measurement, a test used to measure aortic stiffness.
Company comments
“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.”
Regulatory status
SphygmoCor® XCEL, already available for sale in European, Australia and India, and in other Asian markets, was introduced in the US at the American Society of Nephrology conference in San Diego earlier this month.
published: November 28, 2012 in: Approval/Clearance, Healthcare, Technology