Aussie heart test given the go-ahead

An Australian-developed, non-invasive test to measure arterial stiffness and heart function has been given the official nod from the United States.

AtCor Medical this month received Food and Drug Administration (FDA) approval to market and sell its SphygmoCor Px system, following on from approvals in Europe and Japan.

Chief executive officer Ross Harricks said the company was already marketing the product in the US, but FDA approval would open many more doors for the homegrown company.

"It is a difficult thing to do pre-approval because people have to go through various other levels of approval if they want to use this," Harricks said. "Now that won't be a problem anymore."

The SphygmoCor Px uses a so-called "doctor's office" to record the radial artery pressure pulse waveform transcutaneously.

Through this measure, general practitioners through to specialists and researchers can monitor arterial stiffness and cardiovascular risk and track changes in left ventricular load, coronary artery perfusion pressure and cardiac timing and reserve.

Harricks said the system was ultimately intended for clinical use in hypertension, diabetes and heart failure.

"It's really going to be something that is used widely in clinical practice," he said, adding that it could become more prevalent than the use of ECG.

He said a further benefit of the system was in patient maintenance, with the technology enabling physicians to prescribe the most appropriate cardiovascular drugs for a given patient.

"This area has been crying out for more sophisticated advice to better manage cardiovascular patients," Harricks said.

He described the technology and the FDA approval as "a major breakthrough".

"As an FDA-approved device it now allows SphygmoCor Px to become as widely used in the medical research and clinical trials market in the USA as it is in Europe," he said.

"In the process, this will accelerate the current strong flow of papers endorsing its clinical applications in the management of hypertension, heart failure, diabetes, and cardiovascular drug therapy."

The privately owned NSW company last year gained FDA approval for its SphygmoCor Mx, a real-time cardiovascular monitor that can be used in conjunction with conventional radial-line BP monitors to track aortic pressures and central cardiac function parameters.