Medtronic Gains US and EU Regulatory Clearances for Cardiac Ablation Software
Medtronic has received US Food and Drug Administration (FDA) clearance and CE Mark approval for its latest Affera Prism-2 Mapping Software.
The company has also secured CE Mark approval for the PulseSelect ProxBox Adapter with Proximity Indicator software, expanding mapping and tissue-proximity capabilities across its cardiac ablation portfolio.
The Affera Prism-2 software is designed to create three-dimensional maps of the heart’s electrical activity during procedures to treat abnormal heart rhythms.
It uses magnetic and impedance-based tracking to display the position of diagnostic catheters and can support procedures requiring limited or no fluoroscopy.
The latest software includes Beat Matching, which helps compare heartbeats and identify abnormal signals, and Pace Tagging, which marks locations where pacing is performed.
Updates to the internal pacing stimulator also aim to support cardiac mapping and procedural workflow.
The PulseSelect ProxBox Adapter provides real-time, impedance-based feedback to help physicians assess the catheter’s proximity to targeted heart tissue before delivering energy.
The software is designed for use with Medtronic’s PulseSelect pulsed field ablation system.
These regulatory milestones strengthen Medtronic’s integrated approach to cardiac electrophysiology by combining mapping, ablation and software technologies to support procedural planning and precision.
