Affera Integrated Mapping System
Medtronic, Inc.The Affera Integrated Mapping System is a software and hardware system designed to help cardiologists map the heart's electrical activity during catheter-based procedures. It uses magnetic and electromagnetic tracking to visualize catheters inside the heart in real time, records electrical signals from the heart, and displays 3D cardiac maps. This assists clinicians in diagnosing and treating heart rhythm disorders with improved accuracy and guidance.
Intended Use
The Affera Integrated Mapping System is intended for catheter-based electrophysiological mapping and stimulation of the heart.
Technology
The system is a computerized storage and display unit with embedded software providing magnetic and hybrid electromagnetic-impedance tracking of catheters, real-time visualization, and multi-format cardiac map display. It can interface with electrophysiology lab equipment and compatible ablation systems.
Performance
Performance testing included design verification, validation, usability studies, pre-clinical animal testing, software validation and cybersecurity testing, electrical safety, EM compliance, and packaging validation, all meeting acceptance criteria with no new safety or effectiveness concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/18/2024
1 month - 2
FDA Approval
1/17/2025
Other devices from Medtronic, Inc.
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