Magnetic Localization Patch Kit (AFR-00021)
Medtronic, Inc.The Magnetic Localization Patch Kit by Medtronic is an accessory device used with the Affera Integrated Mapping System to accurately track and navigate catheters during cardiac electrophysiology procedures. It uses electromagnetic-based tracking technology to provide real-time catheter localization and cardiac mapping, helping clinicians perform heart rhythm diagnoses and treatments more precisely.
Intended Use
The Magnetic Localization Patch Kit is intended for catheter-based electrophysiological mapping and stimulation.
Technology
The Magnetic Localization Patch Kit consists of two surface electrode patches that are placed on the patient’s skin to provide stable mounting points for magnetic sensors. These sensors enable electromagnetic-based tracking and navigation of catheters during mapping procedures, supporting the visualization of catheter location within the heart. The system collects body surface ECG and intracardiac electrogram signals that are displayed in real-time along with the reconstructed cardiac anatomy. The system uses magnetic localization technology with a magnetic field generator and passive electromagnetic sensors embedded in the catheters.
Performance
Performance testing included design verification, design validation, pre-clinical animal testing, biocompatibility, and packaging validation. All acceptance criteria were met, demonstrating substantial equivalence and safety compared to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/5/2024
1 month - 2
FDA Approval
12/5/2024
Other devices from Medtronic, Inc.
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