STAR Apollo Mapping System

The STAR Apollo™ Mapping System is a software-based diagnostic tool designed to assist in understanding atrial fibrillation by processing intracardiac electrogram data to identify potential sources of atrial activation. It employs proprietary fixed algorithms based on fundamental electrophysiological principles to generate 3D anatomical and electrical maps displaying Early Sites of Activation and Repetitive Patterns of Activation, thereby aiding physicians in manually annotating complex cardiac signals.

The STAR Apollo™ Mapping System is a software-driven diagnostic tool designed to assist clinicians in the analysis of atrial fibrillation (AF). Its methodology involves processing multipolar intracardiac atrial electrogram data, along with anatomical geometry, ECG recordings, and electrode coordinates, acquired using compatible electroanatomic mapping systems (specifically, Ensite Precision or Ensite X EP System) and an Advisor HD Grid Mapping Catheter. Data collection involves 30-second recordings from multiple, non-overlapping atrial locations; this data is subsequently anonymized and transferred via a portable storage device to a standalone laptop running the STAR Apollo software. The system's science is rooted in the electrophysiological principle that sources of atrial activation during AF will exhibit electrical activity emerging in multiple directions, rather than activity progressing towards them; its proprietary, fixed algorithms analyze the datasets to identify the anatomical locations of these originating activations without aiming to elucidate the specific AF mechanism. Upon processing, the STAR Apollo system generates 3D anatomical and electrical maps of the human atria, which are overlaid with identified Early Sites of Activation (ESAs) and Repetitive Patterns of Activation (RPAs), presented as a single global map from the sequentially acquired data. This output provides supplementary information to assist users in the manual annotation of these complex maps, guiding physicians to areas within the atria that may warrant closer examination using their primary mapping system. It is important to note that the system functions as an adjunctive tool, and its findings require further clinical validation by the physician before any treatment decisions are made; the clinical significance of utilizing the system to identify these specific electrogram characteristics in atrial arrhythmias like AF has not yet been established through clinical investigations. Non-clinical testing, including blinded physician validation, indicated that manual ECG annotation yielded results similar to the STAR Apollo system’s output, and electrophysiologists found the software appropriate for its intended use in simulated settings.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. How do the "fixed algorithms and equations" used by STAR Apollo to identify ESAs and RPAs compare in diagnostic accuracy or localization precision to established manual annotation techniques or other algorithmic approaches (e.g., deep learning based systems) for complex AF patterns?; Given that data transfer is one-way and not real-time, what is the typical turnaround time from data export from the Ensite system to the availability of the STAR Apollo map, and how does this workflow integrate into time-sensitive electrophysiology procedures?; The system identifies "localized sources of atrial activation" based on activation emerging in multiple directions; what specific quantitative criteria or thresholds does the algorithm use to define an "emerging activation" versus a "progressing activation," and how sensitive are these to signal quality or catheter contact variability?; While the system assists in manual annotation, what level of inter-observer and intra-observer variability exists when different physicians use the STAR Apollo maps to identify areas for closer examination, and how does this compare to manual annotation without the system's aid?; Since the clinical significance of identifying ESAs and RPAs with this system for atrial arrhythmias like AF has not been established, what types of clinical investigations would be necessary to demonstrate a tangible benefit in terms of procedural guidance, patient outcomes, or understanding AF mechanisms?