PhysioWave Receives FDA Clearance for Breakthrough Pulse Wave Velocity Cardiovascular Analyzer
“The new device measures PWV, shown to be an independent biomarker for assessing cardiovascular risk, with no appreciable change to patient workflow.”
PhysioWave, Inc, a developer of cardiovascular risk assessment biomarkers and Stanford University spin-out, announced the company has received FDA clearance for its PhysioWave Pro™ cardiovascular analyzer. This breakthrough device, many years in development, allows easy and quick measurement of an important new vital sign, pulse wave velocity (PWV). With Nokia’s recent withdrawal of the non-FDA-cleared PWV feature of its Body Cardio consumer scale, PhysioWave now has the only scale-based PWV device on the market, backed by an extensive patent portfolio.
“We are thrilled to be bringing this new technology to clinical practices worldwide and look forward to partnering to develop a lower-cost version for consumers,” said Greg Kovacs, PhysioWave’s founder and acting CEO, who has led the company for more than a year leading up to clearance. “This measurement provides real, actionable information on cardiovascular health to everyone, and can work in concert with all manner of wearables and health apps. We believe we are at the beginning of a highly significant development in medicine.”
PWV is a measurement of the stiffness of the blood vessels transporting blood from the heart to the body. Increased stiffness, associated with increased cardiovascular risks (e.g., coronary heart disease, stroke, hypertension), causes the blood pulses to travel faster, resulting in a higher measured PWV. Previously difficult to measure, PWV can now be measured simply by standing on the PhysioWave Pro™ device for less than a minute. The device, similar to a body weight scale, also measures pulse rate, weight and BMI. Early deliveries to clinical customers are planned for later in 2018.
PhysioWave Introduces PhysioWave Pro™ for Pulse Wave Velocity Measurement at the Annual American Heart Association Meeting
PhysioWave, Inc, a developer of cardiovascular risk assessment instruments, is introducing the company’s new PhysioWave Pro™ device at the annual American Heart Association meeting being held in Anaheim, CA, November 11 through 15, 2017. The new device is designed to provide a straightforward method for healthcare providers to measure Pulse Wave Velocity (PWV) quickly and easily during patient intake (during weighing) for routine physical examinations. PWV is a clinically validated biomarker for the detection of potential cardiovascular (CV) risk.
“Multiple studies over the past several years, including the Framingham study published in 2010, have identified the measurement of PWV as one of the key biomarkers in assessing CV risk,” said Judith Swain, MD, Chief Medical Officer of PhysioWave. “Until recently, measurement of this biomarker would require a dedicated room and technician at substantial expense. With the PhysioWave Pro™, it will soon be as simple as stepping on a weighing scale to capture this critical measurement and help guide the physician’s next course of action.”
PWV measures arterial stiffness, which can be a precursor to possible future cardiac events. Arterial stiffness relates to the material properties of the arterial wall which, according to a scientific statement from the American Heart Association published in Hypertension in 2015, has functional consequences for the artery because it affects how pressure, blood flow and arterial diameter change with each heartbeat. The statement also indicates arterial stiffness is a major determinant of vascular impedance, and can modulate the pressure/flow relationship.
“Such studies have led researchers to conclude that higher aortic stiffness assessed by PWV is associated with increased risk for a first cardiovascular event,” said Laurent Giovangrandi, PhD, Chief Technical Officer and co-founder of PhysioWave. “The PhysioWave Pro™ is meant to provide a first-line assessment which can be used in the office. Depending on the assessment results, the clinician will be able to make more informed decisions on additional testing or additional therapy, which can be as direct as simple lifestyle changes.”
The PhysioWave Pro™ is an arterial pulse sensing technology, that is designed to provide PWV measurements in less than a minute, without disrupting clinical workflow. The technology is covered by multiple patents, and PhysioWave executives are anticipating a decision on their 510(k) application by the FDA early next year.