Acutus Medical Completes Enrollment in UNCOVER AF Study

Acutus Medical has completed enrollment in its pivotal Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation (UNCOVER AF) study evaluating the AcQMap High Resolution Imaging and Mapping System in patients with persistent atrial fibrillation (AF) in Europe and Canada.
 
The UNCOVER AF clinical study is a prospective, multi-center, multi-national study designed to provide clinical evidence regarding the use of the AcQMap System in the treatment of persistent AF. The trial is being conducted at 13 sites throughout Europe and Canada and has successfully completed enrollment of 129 patients.
 
“We are encouraged by the rate at which we were able to enroll this study and the outcomes thus far,” said Randy Werneth, president and CEO of Acutus. “We believe strongly in AcQMap’s ability to address critical unmet needs in mapping AF. AcQMap enables patient specific diagnosis, treatment guidance and confirmation of the delivered treatment that is intended to greatly benefit millions of patients who, until now, face a 50/50 chance of a successful outcome after an initial ablation procedure.”
 
Acutus received CE Mark approval for AcQMap in May 2016 and is currently pursuing U.S. Food and Drug Administration clearance for the system.
 
The Acutus AcQMap High Resolution Imaging and Mapping System, a diagnostic platform, is a technology that reveals the electrical conduction of the whole heart chamber along with the heart wall motion (functional structure). The AcQMap System utilizes the unique combination of ultrasound to create a CT quality anatomy and non-contact, dipole density propagation maps to visualize previously unmappable complex arrhythmias (AF, Atypical Flutter) without the confounding effects of far field signals. This allows physicians for the first time to see real-time electrical activity within the heart chamber, with the ability to remap in seconds to confirm successful substrate modification via ablation therapy.
 
Additionally, the company is developing a significantly differentiated ablation technology designed to provide functionality that will further advance and support an electrophysiologist’s desire to produce improved, durable, patient-specific benefits.
 
Acutus Medical is a company developing technology to provide electrophysiologists with a dual-platform portfolio of breakthrough products that image, diagnose and treat complex arrhythmias. Acutus is pioneering ElectroFunctional procedures that provide electrophysiologists an ability to establish and execute highly informed, patient-specific treatment strategies for complex cardiac arrhythmias.
 
Acutus Medical is a privately held company located in Carlsbad, Calif.