Medtronic has received clearance from the U.S. Food and Drug Administration (FDA) and CE Mark approval for its Affera Prism-2 mapping software, which is used during cardiac ablation procedures for arrhythmias.
The software creates 3D maps of the heart's electrical activity and uses magnetic and impedance-based tracking to display catheter locations, which can support procedures that use little or no fluoroscopy, according to the company. New tools include the following:
- Beat Matching, which compares heartbeats to identify those with abnormal signals
- Pace Tagging, which marks locations when pacing is performed during a procedure
- Improvements to the system's internal pacing stimulator
Medtronic also received CE Mark approval for its PulseSelect ProxBox adapter with Proximity Indicator software. This provides real-time, impedance-based feedback to help physicians assess whether the catheter is near targeted tissue before energy is delivered by the PulseSelect pulsed field ablation system.
