Vectorious Medical Technologies today announced that the FDA has granted breakthrough device designation for the company’s left atrial pressure (LAP) monitoring device.
The V-LAP system is the first digital, wireless, battery-free device that can communicate from deep within the body using high-resolution waveform morphology, according to the Tel Aviv-based startup. Because the pressure of the heart’s left atrium is the earliest and most accurate real-time indication of heart failure exacerbation, company officials believe the feedback provided by the V-LAP will enable a significant improvement in heart failure management.
Vectorious began conducting clinical studies in Italy, Germany, the UK and Israel in 2019 for the purpose of obtaining a CE mark. It expects to launch a U.S. clinical study in 2022.