Medtronic (NYSE:MDT) today announced FDA clearance and CE marks for its newest cardiac mapping and ablation software, supporting its fast-growing arrhythmia-treating cardiac ablation business.
The Minnesota-run medtech secured FDA clearance and a CE mark for its Affera Prism-2 cardiac mapping software. There was also a CE mark for its PulseSelect ProxBox adapter with proximity indicator software.
The regulatory wins expand integrated mapping and tissue-proximity capabilities across the Medtronic cardiac ablation portfolio, which has been a key piece of the company’s recent double-digit revenue growth. For the second quarter ended July 31, Cardiovascular sales rose 19.5% year over year to $3.927 billion (with Electrophysiology, which includes pulsed field ablation, up 29.5%).
“Innovation in mapping software is essential to realizing the full potential of cardiac ablation technologies and supporting the precision physicians seek during procedures,” Dr. Khaldoun Tarakji, VP and chief medical officer of Medtronic Cardiac Ablation Solutions, said in a news release. “We are integrating catheters, hardware and software to give physicians a more connected experience and help improve care for patients with heart rhythm disorders.”
More about the Affera mapping and ablation system with Prism-2 software
The Affera Prism-2 mapping software enables electrophysiologists to create detailed three-dimensional maps of the heart’s electrical activity during cardiac ablation procedures. Doctors use the Affera mapping and ablation system with Medtronic’s Sphere-9 catheter, an all-in-one catheter that enables toggling between pulsed field and radiofrequency ablation.
Using magnetic and impedance-based tracking, the software provides a three-dimensional map displaying the location of specialized and conventional diagnostic catheters, including coronary sinus catheters. The result, according to Medtronic, can be procedures using little or no fluoroscopy, reducing reliance on X-ray imaging during cardiac ablation.
Recent software enhancements are adding advanced cardiac mapping tools to Affera, including:
- Beat matching, which helps physicians compare heartbeats and identify those that have abnormal signals;
- Pace tagging, makring locations when pacing is performed during a procedure;
- Boosting procedural workflow by improving the system’s internal pacing stimulator.
Medtronic’s 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 system, enabling doctors to assess whether the catheter is near the targeted heart tissue before delivering energy. 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, SVP and president of Electrophysiology Therapies at Medtronic. “These regulatory milestones advance our software capabilities alongside the continued expansion of our cardiac ablation portfolio.”
