First-Of-Its-Kind Handheld and Portable Intracardiac Pressure Monitor to Improve Heart Failure Care

Heart failure, a progressive weakening of the heart's pumping ability, presents a significant diagnostic challenge. The classic symptoms, such as breathlessness, fatigue, and fluid retention, are found across various conditions, creating the need for advanced diagnostic techniques for confirmation. Intracardiac pressure monitoring (ICPM) has proven effective in managing heart failure patients, but current non-invasive methods are unsuitable for routine clinical use. Now, a new non-invasive device has the potential to revolutionize hemodynamic monitoring accessibility in hospitals and clinics, eliminating the need for invasive procedures. With accuracy levels comparable to invasive alternatives, the widespread implementation of this device could result in resource savings while simultaneously improving outcomes for heart failure patients.

Acorai (Stockholm, Sweden) is developing a first-of-its-kind non-invasive IPCM device that boasts a unique patented hardware technology and proprietary machine learning system. Known as the Acorai Heart Monitor, this device is designed to non-invasively estimate diastolic pulmonary artery pressure (dPAP), systolic pulmonary artery pressure (sPAP), and mean pulmonary artery pressure (mPAP) in Stage C heart failure patients undergoing hemodynamic monitoring. The device is designed for use as a companion test by qualified healthcare professionals (HCPs) combined with standard-of-care evaluation in a hospital or clinical setting to detect hemodynamic congestion and facilitate personalized heart failure treatments.

By leveraging a combination of seismic, audible, visual, and electrical sensors, the Acorai Heart Monitor generates a wealth of new data for healthcare professionals. Acorai's Machine Learning Engine captures real-time cardiac by utilizing one of the most expansive clinical datasets of its kind. The device’s handheld design and user-friendly interface make it easy for practitioners to quickly understand their patients' conditions. When positioned on the upper chest for two minutes while the patient is lying down, the Acorai Heart Monitor instantly displays cardiac measurements. Its adaptability enables usage across a wide range of care environments, whether within the emergency room, cardiac ward, doctor's office, or even at home in the community. Acorai's Heart Monitor has secured Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) based on preliminary data from a Swedish pilot study. In the study, 281 patients out of a total of 400 participants demonstrated a strong correlation with the invasive gold-standard measurements of pulmonary pressure.

“Receiving breakthrough designation is a massive inflection point in our device development journey, and we are thrilled for the decision,” said Kasper Bourdette, Chief Operating Officer and Co-Founder of Acorai. “This provides further signaling that we are on the right path and motivation for the [Acorai] team to take the device to approval in the coming few months.”

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