Medtronic today announced regulatory milestones for software used with two cardiac ablation platforms, including US Food and Drug Administration (FDA) clearance and a CE mark for the latest Affera Prism-2 mapping software. The company has also obtained a 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 company notes.
“Innovation in mapping software is essential to realising the full potential of cardiac ablation technologies and supporting the precision physicians seek during procedures,” said Khaldoun Tarakji, vice president and chief medical officer of 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.”
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. It uses magnetic and impedance-based tracking to display the location of specialised 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, according to Medtronic.
Recent software enhancements add advanced cardiac mapping tools to the Affera system, including beat matching, which helps physicians compare heartbeats and identify those that have abnormal signals; pace tagging, which compares heartbeats and marks locations when pacing is performed during a procedure; and improvements to the system’s internal pacing stimulator, which assists with cardiac mapping and procedural workflow.
Together, these tools can help physicians visualise, analyse 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 Medtronic’s Sphere-9 catheter—an all-in-one catheter that combines 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 (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 US FDA and is used in more than 60 countries, Medtronic states in a press release.
“Software excellence is a priority across our electrophysiology business and is central to the integrated experience physicians expect,” commented Rebecca Seidel, senior vice president and president of electrophysiology therapies at Medtronic. “These regulatory milestones advance our software capabilities alongside the continued expansion of our cardiac ablation portfolio.”
