Acutus Medical said today it won expanded CE Mark approval in the European Union for its AcQMap contact mapping software and FDA clearance in the U.S. for its second-gen AcQMap system.
Carlsbad, Calif.-based Acutus Medical’s AcQMap system is 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 company said that its expanded CE Mark approval clears the software to provide more options for personalizing patient therapy. It expects to install updated contact mapping software on all European systems during the third quarter of this year.
Acutus Medical added that its second generation AcQMap system, which is built to support future software releases, will be available in the U.S. during the third quarter.
“The contact mapping speed with the new Acutus system was extremely fast, which made it very easy to use. Clinically, having this capability available on one system that also does non-contact mapping allows me to do exactly what makes sense case-by-case. For routine cases, my treatment strategy can be confirmed using conventional mapping catheters. In more complex cases, such as atrial fibrillation, I can gather more comprehensive data about each patient’s anatomy and arrhythmia in real time with the non-contact charge density catheter, making AcQMap the complete atrial mapping solution,” Dr. Christian Meyer of Germany’s University Medical Center Hamburg-Eppendorf said in a press release.
“With the introduction of contact mapping software in Europe, AcQMap is unquestionably the most agile and comprehensive cardiac imaging and mapping system available, offering full spectrum arrhythmia visualization in under three minutes. No other technology offers the suite of solutions incorporated into AcQMap. Our second generation system is engineered to be the cornerstone platform for electrophysiology labs for many years to come. We worked alongside physician partners to understand complex challenges and simple needs to improve the efficiency and safety of electrophysiology procedures. This next-gen AcQMap system has the capability to exponentially improve the day-to-day clinical utility of cardiac mapping and deliver long-term value by offering health systems a comprehensive solution for electrophysiologists and their patients,” CEO Vince Burgess said in a prepared statement.
In January, Acutus Medical released 12-month data from the Uncover-AF trial of its AcQMap cardiac imaging and mapping system exploring its use in persistent atrial fibrillation ablation procedures.