Medtronic Receives Regulatory Clearances for Affera Prism-2 and PulseSelect ProxBox Software
Medtronic has announced regulatory milestones for software used with two cardiac ablation platforms, including FDA clearance and CE Mark for the latest Affera Prism-2 Mapping Software, and 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.
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. 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, supporting procedures that use little or no fluoroscopy. Recent enhancements add advanced cardiac mapping tools to the Affera system, including Beat Matching, which helps physicians compare heartbeats and identify those with abnormal signals; Pace Tagging, which compares heartbeats and marks locations when pacing is performed; and improvements to the system’s internal pacing stimulator. Together, these tools help physicians visualize, analyze, and compare the heart’s electrical activity. The Affera Mapping and Ablation System is the platform used with the Sphere-9 Catheter, an all-in-one catheter combining high-definition mapping with dual-energy pulsed field and radiofrequency ablation.
The PulseSelect ProxBox Adapter with Proximity Indicator software adds real-time, impedance-based feedback to the PulseSelect pulsed field ablation System, helping 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.
Khaldoun Tarakji, MD, MPH, Vice President and Chief Medical Officer of Cardiac Ablation Solutions at Medtronic, said innovation in mapping software is essential to realizing the full potential of cardiac ablation technologies and supporting the precision physicians seek during procedures. Tarakji noted that Medtronic is integrating catheters, hardware, and software to give physicians a more connected experience and help improve care for patients with heart rhythm disorders.
Rebecca Seidel, Senior Vice President and President of Electrophysiology Therapies at Medtronic, said software excellence is a priority across the electrophysiology business and is central to the integrated experience physicians expect. Seidel noted that these regulatory milestones advance the company’s software capabilities alongside the continued expansion of its cardiac ablation portfolio.
