Affera Integrated Mapping System; Impedance Localization Patch Kit
Medtronic, Inc.The Affera Integrated Mapping System with the Impedance Localization Patch Kit is a computer-based diagnostic tool designed to assist clinicians in catheter-based cardiac electrophysiological mapping. It provides real-time visualization of catheters, maps cardiac signals, and helps guide therapeutic interventions by displaying detailed cardiac maps and signals, enhancing cardiac procedure accuracy and patient care.
Intended Use
The Affera Integrated Mapping System and Impedance Localization Patch Kit are intended for catheter-based electrophysiological mapping and stimulation.
Technology
The system uses magnetic-based tracking of embedded sensors and hybrid electromagnetic-impedance tracking of catheter electrodes, with software to visualize catheter location and cardiac maps. It includes an interface unit, magnetic field generator, software workstation, and surface localization patches to aid catheter visualization and to detect patient position and respiratory motion.
Performance
Performance testing included design verification, validation, usability evaluation, pre-clinical animal testing, software validation, cybersecurity, electrical safety, EMC, biocompatibility, and packaging validation. All acceptance criteria were met, supporting the safety and effectiveness of the device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/24/2024
4 months - 2
FDA Approval
11/1/2024
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