FDA clears Acutus’ real-time cardiac imaging system

Acutus' AcQMap system creates a high-resolution 3D map of the heart and its electrical activity in real time for use during ablation procedures. (Acutus Medical)

Acutus Medical scored an FDA nod for its cardiac mapping system that monitors a patient’s atrial fibrillation in real time while he or she is undergoing treatment. With this tool, the San Diego-based company aims to improve the success rate of ablation treatments for the condition.

Atrial fibrillation, or afib, is an irregular heartbeat that can lead to complications such as stroke and heart failure. It is typically treated with catheter ablation, which makes small scars in the heart tissue, making it unable to carry the arrhythmia. But current voltage-based mapping methods only allow for a limited view of the heart ahead of these procedures.

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"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,” said Acutus Chief Technology Officer Graydon Beatty, in a statement.

Acutus’ AcQMap system monitors a patient’s arrhythmia in real time, providing a high-resolution, three-dimensional view of the heart chamber and its electrical activity. Its mapping algorithm is based on dipole density, or the localized source of electrical activity. These measurements are more accurate than voltage-based ones, which include not only the localized charge, but also the charge in the surrounding area.

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"This clearance will allow electrophysiologists (EP's) in the United States access to a new technology that uses ultrasound to visualize cardiac anatomy and dipole density to map the pathway of every heartbeat,” said Steven McQuillan, Acutus Medical’s senior vice president of regulatory and clinical affairs, in the statement. “The System can also be used with existing commercially available cardiac ablation platforms."

2016 was a big year for Acutus—it raised $75 million in series C funding in March and received a CE mark for AcQMap in May. With the new FDA clearance, the company plans to roll the system out early next year.

 

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