Benzinga | Nov 11, 2021 04:10PM EST

Acutus Medical Initiates CE Mark Study For Focal Pulsed Field Ablation Therapy To Treat Atrial Fibrillation

Acutus Medical, Inc. (NASDAQ:AFIB) ("Acutus"), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced the initiation of AcQForce PFA-CE, a new clinical study that will evaluate the safety and performance of the company's focal force sensing Pulsed Field Ablation (PFA) catheter and system in combination with its novel noncontact 3D mapping system in treating patients with atrial fibrillation. The first patients were successfully treated at Na Homolce Hospital in the Czech Republic by Dr. Petr Neuzil, the Primary Investigator and Head of the Department of Cardiology, along with his colleague Dr. Jan Petru, and Drs. Vivek Reddy and Jacob Koruth from Mount Sinai Health System. Dr. Doug Gibson of Scripps Memorial Hospital is serving as the site's primary technology advisor.



The inception of this study highlights Acutus' unique therapeutic position offering the first and only force sensing gold-tip ablation catheter, AcQBlate Force, designed to deliver either radiofrequency (RF) or PFA therapy -- with the added benefit of fully integrating with therapy guidance provided by the novel AcQMap 3D Imaging and Mapping System.

"The vision for pioneering Pulsed Field Ablation treatment was primarily due to PFA's ability to have high-impact treatment while preserving healthy tissue. As physicians, we know that the majority of our patients that come back for re-treatment following ablation for atrial fibrillation have triggers in various locations beyond the standard course of care, and it's imperative for us to research beyond pulmonary vein isolation-only utilizations," said Dr. Steven Mickelsen, Acutus' Chief Translational Science Officer and founder of PFA pioneer Farapulse, Inc. "PFA lesion volume and contours follow well-defined and predictable electromagnetic rules, and the technology lends itself well to integration into 3D mapping systems like AcQMap. This paves the way for a higher degree of certainty and efficacy when ablating specific areas of the heart inclusive of and outside the pulmonary veins. We're working towards a future where we can quickly create a 3D electroanatomic map of a complex arrhythmia like atrial fibrillation, and deliver precise, individualized and durable therapy with dramatically improved safety, reliability and workflow."

"Pulsed Field Ablation as applied to the field of cardiac electrophysiology has enormous potential, given the expected improvements in safety, efficacy and speed over current therapies," said Vince Burgess, President and CEO of Acutus Medical. "Our vision for the future of this new energy source is to deliver it via a force sensing focal point ablation catheter and to guide that delivery with advanced 3D cardiac mapping, rather than fluoroscopy. This approach is different from many others entering this field, in that it will allow precise applications of PFA in highly targeted tissue across the full range of arrhythmias, including atrial fibrillation and flutter and atrial and ventricular tachycardias -- while preserving as much fully functional cardiac tissue as possible. Competing multi-electrode, large format catheters guided by fluoroscopy will have inherently limited precision upon delivery."