ACORYS MAPPING SYSTEM

The ACORYS MAPPING SYSTEM is a non-invasive cardiac mapping device that acquires electrocardiographic signals from 128 body surface sensors and combines them with a 3D torso model to generate three-dimensional electroanatomic maps of the heart. It is intended for acquisition, analysis, display, and storage of cardiac electrophysiological data for patients with cardiac arrhythmias and/or electrical disorders in adults, for use in medical consultations or hospitals during electrophysiological interventions on intact skin only.

The ACORYS system uses 128 sensors (versus the predicate's 256) and generates cardiac geometry automatically via 3D torso reconstruction from integrated sensors, or accepts pre-existing CT scans. The predicate device requires external CT segmentation and manual sensor localization. Both systems solve the cardiac inverse problem to transform body surface signals into epicardial maps; mathematical modeling showed ACORYS achieved equivalent or improved localization accuracy compared to the predicate.

EN 60601-1:2005+A2:2020, IEC 60601-2-27:2014, IEC 60601-1-6:2010+A2:2021, EN60601-1-2:2014+A1:2020, IEC 62304:2006+A1:2015, ISO 14971:2019/A11:2021, ISO 10993-1:2020, ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-18:2020, and ISO 10993-23:2021. Testing included electrical safety, electromagnetic compatibility, software verification, biocompatibility, and 3D scan accuracy validation.

The ACORYS MAPPING SYSTEM is substantially equivalent to the Medtronic CardioInsight predicate device because both are programmable diagnostic computers for non-invasive cardiac electrical mapping with identical indications for use, intended patient populations, and clinical purpose. Clinical evaluation in 199 patients demonstrated performance comparable to the predicate with no device-related adverse events, and bench testing showed mathematical equivalence or superiority in localization accuracy despite technological differences.