Acutus Medical said today that it won 510(k) clearance from the FDA for its AcQMap high-resolution imaging & mapping system and the 3D mapping catheter that goes by the same name.
Carlsbad, Calif.-based Acutus said it plans to have the system on the U.S. market early next year. It’s designed to detect and display standard voltage-based and higher resolution charge-source maps, and is able to generate real-time, 3D images of the heart chamber using ultrasound. The system won CE Mark approval in the European Union in May 2016.
“This clearance will allow electrophysiologists (EPs) in the U.S. access to a new technology that uses ultrasound to visualize cardiac anatomy and dipole density to map the pathway of every heartbeat. The system can also be used with existing commercially available cardiac ablation platforms,” regulatory & clinical affairs SVP Steven McQuillan said in prepared remarks. “The AcQMap system was designed in close collaboration with some of the most respected names in the field to provide practitioners with a suite of tools that enables them to rapidly map and re-map to visualize changes throughout the ablation procedure. We firmly believe that by working together with EP practitioners and scientists, we will continue to uncover breakthrough innovations to improve and advance cardiac care.”
“We are extremely excited to have participated in the early clinical work and are now using the technology as part of a patient-specific strategy to assess and treat complex arrhythmias,” added Dr. Tom Wong of London’s Royal Brompton Hospital. “The AcQMap system is able to provide global dipole density mapping of irregular and chaotic activation in the atrial chambers, whereas conventional sequential mapping may struggle to provide us with the information that is required. In the cases we have performed thus far, real-time mapping of complex arrhythmias has allowed us to focus on areas of interest and terminate the arrhythmia using ablation therapy. We can now offer individualized, tailored therapy, and are one step closer to identifying the mechanisms of complex arrhythmias.”