Real-time cardiac mapping technology cleared by FDA

Acutus Medical has announced that the US Food and Drug Administration (FDA) cleared the AcQMap high resolution imaging and mapping system as well as the AcQMap 3D imaging and mapping catheter for use in patients for whom electrophysiology procedures have been prescribed.

“Despite decades of procedural and technical advancement in the electrophysiology field, only about 50% of patients with persistent complex atrial arrhythmias treated with ablation therapy can expect to remain arrhythmia free at 12 months”, Acutus’ Grydon Beatty, chief technology officer, says in a statement released by the company.

“This clearance will allow electrophysiologists (EP’s) in the USA 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,” says Steven McQuillan, senior vice president for regulatory and clinical affairs at Acutus.

McQuillan states that new system will “enable [practitioners] to rapidly map and re-map in order to visualise changes throughout the ablation procedure.”

The AcQMap high resolution imaging and mapping system detects and displays both standard voltage-based and higher resolution dipole density (charge-source) maps. The system combines ultrasound anatomy construction with an ability to map the electrical-conduction of each heartbeat to identify complex arrhythmias across the entire atrial chamber. Following each ablation treatment, the heart can be re-mapped in seconds to continually visualize any changes from the prior mapping.

The AcQMap system has been used in Europe over the past two years in a number of clinical trials and commercial settings, including the DDRAMATIC-SVT trial.

“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,” said Tom Wong, Royal Brompton Hospital, London, UK. “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.”