OptiMap™ System
Boston Scientific CorporationThe OptiMap™ System is a medical device used during electrophysiology procedures to help physicians analyze and visualize complex cardiac arrhythmias. It uses a 64-electrode basket catheter to capture electrogram signals within the heart, which are processed with proprietary algorithms to create detailed maps of electrical flow and activation pathways. This assists clinicians in diagnosing and understanding heart rhythm disorders more effectively.
Intended Use
The OptiMap System is used to analyze electrogram (EGM) signals and display results in a visual format for evaluation by a physician in order to assist in the diagnosis of complex cardiac arrhythmias.
Technology
The system consists of hardware components including an Amplifier, Cart, Monitor, and a Workstation with proprietary mapping software. It uses signals from a 64-electrode unipolar mapping basket catheter, transforming time-domain waveforms into spatial Electrographic Flow vectors and Activation Cycle Path maps for visualizing electrical activity in the atria during arrhythmias.
Performance
Software verification and validation testing demonstrated that the OptiMap System Version 1.3 software performs as designed at unit, integration, and system levels. Cybersecurity testing was also completed per FDA guidance. The device met all acceptance criteria and is suitable for intended use with no unresolved issues.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/30/2025
28 days - 2
FDA Approval
5/28/2025
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