Investigational Device Monitors Venous Waveform

A novel non-invasive venous waveform analysis (NIVA) device provides a proprietary score that corresponds to pulmonary capillary wedge pressure (PCWP).

The VoluMetrix (Nashville, TN, USA) NIVA HF device is designed to capture the venous waveform, an energy-based signal generated by the heart and respiratory activity that reflects numerous physiologic conditions, including pulse rate, respiration, and intravascular and extravascular dynamics. It serves as a non-invasive indicator of volume status and the presence of congestion in patients with heart failure (HF).

The device is based on a non-invasive wrist sensor that identifies multiple frequencies that are first deconstructed by mapping individual amplitudes within a patient's waveform, and subsequently decoded by a proprietary algorithm. The result is the NIVA score, which provides cardiologists and other healthcare professionals (and their patients) with a simple measure that parallels to PCWP, a well-recognized and clinically relevant assessment of volume status. Using PCWP to evaluate blood volume status is especially important when fluids are administered during hypotensive shock.

“NIVA HF is the culmination of our organization's talent, intellect, passion, and hard work. It represents the first of many potential vehicles for our NIVA vital monitoring technology,” said Kyle Hocking, PhD, President and CEO of VoluMetrix. “Ultimately, our mission is to improve the care experience for as many heart failure patients as possible, as quickly as possible.”

PCWP provides an indirect estimate of left atrial pressure (LAP), and can help quantify the severity of left ventricular failure and the degree of mitral valve stenosis, aortic valve stenosis and regurgitation, mitral regurgitation, and pulmonary hypertension. By measuring PCWP, the physician can titrate the dose of diuretic and other drugs that are used to reduce pulmonary venous and capillary pressure, and thereby reduce pulmonary edema.

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