Acorai Earns Breakthrough Designation for Intracardiac Pressure Monitor

The device is intended as a companion test for qualified healthcare professionals.

I Stock 1359314170

Acorai, a start-up medical device manufacturer from Sweden, today announced the FDA has granted Breakthrough Device Designation for Acorai's Heart Monitor, a device for the non-invasive estimation of diastolic pulmonary artery pressure (dPAP), systolic pulmonary artery pressure (sPAP), and mean pulmonary artery pressure (mPAP) in patients with Stage C Heart Failure who have been referred for hemodynamic monitoring.

Acorai is developing an intracardiac pressure monitoring (IPCM) device with a patented hardware technology and proprietary machine learning system. The device is intended as a companion test for qualified healthcare professionals (HCPs). It is designed to be used alongside standard-of-care assessment in a hospital or clinical setting to identify hemodynamic congestion and support personalized treatment of HF.

The Breakthrough Device application was supported by preliminary data of 281 patients from their 400-patient Swedish pilot study, which demonstrated a strong correlation to the invasive gold-standard measurements of pulmonary pressure. The full analysis of this study is currently being prepared for publication. Acorai has ethics approval in 5 countries, including the U.S., to conduct a larger 1200-patient study to ensure the device is generalizable across a global heart failure population.

More in Cardiovascular