Medtronic announces regulatory milestones for newest cardiac mapping and ablation software – Medtronic

Medtronic announced regulatory milestones for software used with two cardiac ablation platforms. This includes FDA clearance and CE Mark for the latest Affera Prism-2 Mapping Software. The company also obtained CE Mark for the PulseSelect ProxBox Adapter with Proximity Indicator software.

These milestones expand integrated mapping and tissue-proximity capabilities across the Medtronic cardiac ablation portfolio.

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

Affera Mapping and Ablation System with Prism-2 Software
The Affera Prism-2 Mapping Software helps physicians create detailed three-dimensional maps of the heart’s electrical activity during cardiac ablation procedures for arrhythmias, or abnormal heart rhythms.

The software uses magnetic and impedance-based tracking to display the location of specialized and conventional diagnostic catheters, including coronary sinus catheters, on a three-dimensional map. This capability can support procedures that use little or no fluoroscopy, reducing reliance on X-ray imaging during cardiac ablation.

Recent software enhancements add advanced cardiac mapping tools to the Affera system, including:

• i) Beat Matching, which helps physicians compare heartbeats and identify those that have abnormal signals.
• ii) Pace Tagging, which compares heartbeats and marks locations when pacing is performed during a procedure.
• iii) Improvements to the system’s internal pacing stimulator, which assists with cardiac mapping and procedural workflow.

Together, these tools can help physicians visualize, analyze and compare the heart’s electrical activity, supporting efficient mapping and informed decision-making during cardiac ablation procedures.

The Affera Mapping and Ablation System is the platform used with the Sphere-9 Catheter, an all-in-one catheter that combines high-definition mapping with dual-energy pulsed field and radiofrequency ablation.

PulseSelect PFA System with Proximity Indicator
The PulseSelect ProxBox Adapter with Proximity Indicator software adds real-time, impedance-based feedback to the PulseSelect pulsed field ablation (PFA) System. The feedback helps physicians assess whether the catheter is near the targeted heart tissue before energy is delivered.

The PulseSelect PFA System was the first PFA catheter approved by the FDA and is used in more than 60 countries.

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