Medtronic has announced regulatory milestones for software supporting two of its cardiac ablation platforms, including US Food and Drug Administration (FDA) clearance and CE Mark for the latest Affera Prism-2 Mapping Software.
The company has also received CE Mark for the PulseSelect ProxBox Adapter with Proximity Indicator software.
According to Medtronic, the regulatory milestones expand integrated mapping and tissue-proximity capabilities across its cardiac ablation portfolio.
“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, 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,” he added.
Affera Mapping and Ablation System with Prism-2 Software
The Affera Prism-2 Mapping Software is designed to help 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 specialised and conventional diagnostic catheters, including coronary sinus catheters, on a three-dimensional map. Medtronic said the capability can support procedures using little or no fluoroscopy, potentially reducing reliance on X-ray imaging during cardiac ablation.
The Affera Mapping and Ablation System is used with the Sphere-9 Catheter, which combines high-definition mapping with dual-energy pulsed field ablation (PFA) 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 is designed to help physicians assess whether the catheter is near the targeted heart tissue before energy is delivered.
Medtronic said the PulseSelect PFA System was the first PFA catheter approved by the FDA and is now 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,” she added.
