Medtronic has secured U.S. Food and Drug Administration clearance and CE Mark approval for its latest Affera Prism-2 mapping software, alongside a CE Mark for the PulseSelect ProxBox Adapter with Proximity Indicator software on September 30, 2026. These regulatory milestones expand integrated mapping and tissue-proximity capabilities across the medical technology company’s cardiac ablation portfolio, according to announcements from the Galway, Ireland-headquartered firm.
Inside the Affera Prism-2 Mapping Upgrades
The Affera Prism-2 software helps physicians create detailed three-dimensional maps of electrical activity inside the heart during ablation procedures for abnormal rhythms, or arrhythmias. The platform relies on magnetic and impedance-based tracking to display specialized and conventional diagnostic catheters—including coronary sinus catheters—on a 3-dimensional interface. According to Medtronic, this tracking capability supports procedures requiring little or no fluoroscopy, which helps reduce X-ray exposure during operations.
Recent software updates bring several advanced tools to the system. Beat Matching allows physicians to compare heartbeats and flag abnormal signals. Pace Tagging compares heartbeats and marks locations where pacing occurs during an operation. Improvements to the internal pacing stimulator also support procedural workflow and mapping efficiency. The Affera Mapping and Ablation System is the platform used with the Sphere-9 Catheter, a device that combines high-definition mapping with dual-energy pulsed field and radiofrequency ablation.
Real-Time Impedance Feedback with PulseSelect
The PulseSelect ProxBox Adapter with Proximity Indicator software introduces real-time, impedance-based feedback to the PulseSelect pulsed field ablation (PFA) system. This feedback mechanism assists physicians in evaluating whether the catheter sits close enough to targeted heart tissue prior to energy delivery. Medtronic noted that the PulseSelect system was the first PFA catheter approved by the FDA and operates in more than 60 countries.
Leadership Perspectives on Electrophysiology 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.
Rebecca Seidel, senior vice president and president, Electrophysiology Therapies at the company, added that software excellence remains a central priority for integrating the electrophysiology portfolio.
Streamlining Global Heart Rhythm Procedures
The dual software approvals underline Medtronic’s push to connect catheters, hardware, and software into a unified procedural experience. By pairing real-time impedance feedback on the PulseSelect system with the advanced mapping features and reduced fluoroscopy options of the Prism-2 software, the company aims to streamline workflows for electrophysiologists treating heart rhythm disorders globally.
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