New Software Tools Support Precision Mapping and Guidance in Cardiac Ablation

Electrophysiologists also need integrated tools that streamline mapping, pacing, and energy delivery to improve procedural efficiency. Addressing these needs, a new pair of software releases expands three-dimensional mapping capabilities and provides real-time feedback on catheter-to-tissue proximity during ablation procedures.

Medtronic announced that its Affera Prism-2 Mapping Software received U.S. Food and Drug Administration (FDA) clearance and CE Mark, and that the PulseSelect ProxBox Adapter with Proximity Indicator software received CE Mark. The milestones expand integrated mapping and tissue‑proximity capabilities across the company’s cardiac ablation portfolio. Both software packages are designed for use within established ablation platforms.

The Affera Prism-2 Mapping Software generates detailed three-dimensional maps of cardiac electrical activity during arrhythmia procedures. Using magnetic and impedance-based tracking, it displays the location of specialized and conventional diagnostic catheters, including coronary sinus catheters, on a three-dimensional map. This capability can support procedures performed with little or no fluoroscopy, reducing reliance on X-ray imaging during cardiac ablation.

Recent enhancements to the Affera platform include Beat Matching, which helps compare heartbeats and identify abnormal signals; Pace Tagging, which marks locations where pacing is performed; and improvements to the internal pacing stimulator to support mapping and workflow. Together, these tools are designed to help physicians visualize, analyze, and compare electrical activity during procedures. The Affera Mapping and Ablation System is used with the Sphere-9 Catheter, an all-in-one device that combines high-definition mapping with dual-energy pulsed field ablation (PFA) and radiofrequency ablation.

The PulseSelect ProxBox Adapter with Proximity Indicator software adds real-time, impedance-based feedback to the PulseSelect PFA System, helping physicians assess whether the catheter is close to targeted heart tissue before energy is delivered. The PulseSelect PFA System was the first PFA catheter approved by the FDA and is now used in more than 60 countries. The new proximity feature is intended to add tissue-targeting feedback directly within the existing PulseSelect workflow.

“Innovation in mapping software is essential to realizing the full potential of cardiac ablation technologies and supporting the precision physicians seek during procedures. We are integrating catheters, hardware and software to give physicians a more connected experience and help improve care for patients with heart rhythm disorders,” said Khaldoun Tarakji, MD, MPH, vice president and chief medical officer, Cardiac Ablation Solutions at Medtronic.

“Software excellence is a priority across our electrophysiology business and is central to the integrated experience physicians expect. These regulatory milestones advance our software capabilities alongside the continued expansion of our cardiac ablation portfolio,” said Rebecca Seidel, senior vice president and president, Electrophysiology Therapies at Medtronic.