STAR Apollo Mapping System
Rhythm Al, LtdThe STAR Apollo Mapping System is a software tool designed to help physicians analyze detailed electrical and anatomical heart maps collected during cardiac procedures for atrial fibrillation. By processing data from mapping catheters and displaying key activation patterns in the atria, it provides supplementary information that may assist clinicians in identifying areas of irregular heart activation, although its clinical significance is not yet established.
Intended Use
Assists users in manual annotation of 3D anatomical and electrical maps of human atria using data from multipolar, intracardiac, atrial electrograms during atrial fibrillation.
Technology
Software driven system using proprietary algorithms to analyze exported electroanatomic data from Ensite Precision or Ensite X EP systems collected with HD Grid catheter; runs on a Windows laptop; processes electrograms, electrode coordinates, ECG and geometry models to display maps showing Early Site of Activation (ESA) and Repetitive Patterns of Activation (RPA) in atria.
Performance
Conducted software design verification and validation including algorithm accuracy tests and blinded physician validation comparing manual annotation to system output, demonstrating similar results and appropriate usability.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/17/2022
8 months - 2
FDA Approval
12/1/2022
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