US-based Acutus Medical has obtained the CE Mark for its proprietary real-time 3D diagnostic imaging and dipole density mapping catheter.
‘The Katheter’ is one part of the new stand-alone system being developed by Acutus Medical.
Designed to be inserted into the upper heart chambers, the catheter combines 48 ultrasound crystals for creating real-time 3D chamber geometries and 48 novel biopotential electrodes that overlay the charge sources on the geometry to show electrical activation.
Acutus Medical president and CEO Randy Werneth said this is the first step toward commercializing the entire system designed to map the true electrical source of the heart wall’s electrical activation.
"This first-generation product will be used to collect clinical evidence in support of the anticipated benefits of this novel stand-alone system," Werneth added.