“A good waveform and a good catheter design is worth nothing if the physician doesn’t know where this catheter is located inside the heart,” says Abbott’s Dr. Christopher Piorkowski.
The Abbott Volt PFA System can tell a physician whether the catheter’s electrodes are in good contact with heart tissue to maximize ablation effectiveness. [Image courtesy of Abbott]
Concluding our series about how Abbott developed and designed its Volt pulsed field ablation (PFA) system, we’ll now look at the final piece of the puzzle for treating atrial fibrillation (AFib): integration with the EnSite X EP system.
Abbott’s EnSite X EP system generates high-density, 3D cardiac mapping for electrophysiologists as they use the minimally invasive Volt ablation catheter (and other Abbott ablation catheters) to scar tissue in the heart to block the erratic signals that cause AFib.
“When you look at first-generation PFA solutions, many of these solutions were just catheters,” Dr. Christopher Piorkowski, the chief medical officer of Abbott’s electrophysiology division, said in an interview with Medical Design & Outsourcing. “But a catheter — even with a good waveform and a good catheter design — is worth nothing if the physician doesn’t know where this catheter is located inside the heart. So it needs 3D mapping, it needs 3D tracking technology to position that catheter well, and that was part of our fundamental design approach from the very beginning.”
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The Volt PFA catheter’s integration with EnSite X EP includes impedance tracking as well as magnetic tracking for additional accuracy as the physician deploys the catheter.
The Abbott Volt pulsed field ablation (PFA) catheter features a balloon-in-basket design and eight nitinol splines. [Image courtesy of Abbott]
“One feature that we embedded is contact assessment,” Piorkowski said. “Volt has eight splines in the basket, and each spline is an individual electrode. For each electrode, we have an individual contact assessment technology which measures and visualizes whether the physician has contact [with] the tissue over each electrode, and that is shown to him very intuitively.”
Previously: How Abbott dialed in the waveform for its Volt PFA system
That feature allows the electrophysiologist to adjust the position of the Volt catheter inside the patient to improve contact of specific electrodes to maximize energy delivery into the tissue for effective lesion creation while minimizing energy into the blood pool, which increases the risk of harm from hemolysis.
If the patient’s pulmonary vein is suitable for single-shot ablation, the electrophysiologist can choose to deliver energy through every electrode simultaneously.
But for the quarter of patients who have a large common antrum, the Volt catheter can’t cover their entire antrum for single-shot ablation. In that case, the electrophysiologist can selectively deliver energy only through the splines that are in contact with the target tissue, deactivating the splines that would waste energy into the blood pool.
Previously: Why Abbott went with a balloon-in-basket design for its Volt PFA catheter
Abbott Electrophysiology Chief Medical Officer Dr. Christopher Piorkowski [Photo courtesy of Abbott]
Asked for advice he would offer to other device developers building PFA systems, he urged them not to do so just to keep up with the competition, but to find opportunities to improve care.
“Ask the physicians for their unmet needs,” he said. “… Ask them, ‘What are your unmet needs in today’s clinical practice? Why should we introduce PFA and what should it improve?’ And based on their answers, build your device.”
Abbott secured a CE mark for the Volt PFA system in March 2025 and has said it expects FDA approval in 2026.
Related: Design for access, says Abbott’s Lisa Earnhardt, medtech’s most powerful woman
