New Method of Noninvasive Blood-Flow Analysis for Heart Failure Marks Breakthrough in Vital Monitoring

Heart failure is a global health issue, affecting millions and is one of the primary causes for elderly patient hospitalizations. Complications often arise in patients with heart failure due to the development of congestion, or fluid overload within the vascular system. This fluid imbalance exacerbates symptoms, leads to increased hospitalization rates, and is associated with higher readmission figures. Existing limitations in heart failure monitoring render it difficult for healthcare providers to effectively and precisely measure congestion levels, whether at home, in a clinic, or in a hospital setting. Most patients are tracked through clinical symptoms and weights, but these indicators prove unreliable and tend to manifest late in the disease progression. Although monitoring cardiac filling pressures is considered the gold standard in heart failure management, it requires invasive procedures or the implantation of devices. Hemodynamic monitoring is often not employed for most patients due to the absence of affordable, accurate, portable, and non-invasive monitoring solutions. But that could now change with the development of a wrist-worn device capable of providing non-invasive, real-time estimates of cardiac filling pressure across various care settings.

VoluMetrix (Nashville, TN, USA) has pioneered the NIVAHF, a device specifically designed for non-invasive volume status monitoring in heart failure patients. The company's innovative Non-Invasive Venous Waveform Analysis (NIVA) technology, a proprietary venous waveform system, presents a significant breakthrough in the field of vital monitoring technology. The venous waveform is a heart- and respiratory-activity-generated energy-based signal that reflects various physiological conditions, including pulse rate, respiration, and intravascular and extravascular dynamics.

VoluMetrix is evolving NIVA technology to enhance hemodynamic assessment via three major steps: signal capture with a non-invasive wrist sensor, signal deconstruction to map individual waveform amplitudes within a patient, and signal decoding. The NIVAHF device from VoluMetrix has been granted the U.S. Food and Drug Administration's (FDA) Breakthrough Device designation. Additionally, a USD 3 million NIH SBIR Phase IIb grant has been awarded to VoluMetrix to support the development and validation of NIVAHF, thus facilitating the device's availability to patients and healthcare providers.

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