The company has already begun commercial PFA cases with physicians who previously gained experience with the Volt system from Abbott’s PFA clinical trials. Abbott plans to expand the system’s availability to additional EU markets in the second half of 2025.
Volt integrates with Abbott’s EnSite X EP system and is designed to improve workflows by allowing mapping, pacing and ablation with a single catheter. The company said it has enhanced visualization and real-time contact assessment to optimize catheter positioning.
“The launch of Abbott’s Volt PFA system marks a major milestone in the evolution of electrophysiology across Europe and signals we’re moving beyond early therapy approaches to new systems that incorporate key physician feedback and clinical insights to optimize PFA therapy,” said Prof. Helmut Puererfellner at Ordensklinikum Hospital in Linz, Austria. “PFA is significantly changing our approach to treating patients, and it’s exciting to see the Volt PFA System build on the therapy’s potential and bring new benefits to clinical teams so we can improve the lives of more patients battling conditions like AFib.”
Puererfellner was one of four physicians who conducted initial commercial cases following approval, alongside Prof. Roland Tilz at the University Heart Center in Lübeck, Germany; Prof. Gian-Battista Chierchia at the University of Brussels in Belgium; and Prof. Peter Loh at the University Medical Center Utrecht in the Netherlands.
Abbott wants to improve PFA outcomes
PFA is a non-thermal ablation technique that delivers high-energy electrical pulses to targeted areas of cardiac tissue to disrupt abnormal electrical signals that cause arrhythmias. Compared to traditional thermal ablation approaches, PFA reduces the risk of damaging adjacent tissue, making it an attractive option for patients with complex cardiac anatomy or conditions.
Boston Scientific (Farapulse), Medtronic (PulseSelect and Affera), and Johnson & Johnson (Varipulse) already have PFA systems on the market in the U.S. and Europe. Abbott is marketing Volt as a next-generation system that addresses challenges seen with first-generation PFA technologies. In Abbott’s Volt CE Mark study, the system achieved pulmonary vein isolation (PVI) in 99.1% of treated veins, with fewer therapy applications than other PFA systems on the market, according to the company.
The Volt system’s balloon-in-basket catheter design is meant to efficiently deliver energy directly to targeted tissue, reducing the number of therapy applications required during ablation. It also provides greater procedural flexibility, allowing physicians to perform procedures with light sedation or general anesthesia.
Integrating with Abbott’s EnSite X system, the Volt PFA catheter offers clearer visualization and more accurate navigation for catheter positioning. The EnSite X platform accommodates all EP procedures, providing a “one system solution” for physicians performing PFA and other ablation procedures.
“While PFA is a relatively new therapy option, we’ve incorporated lessons learned from first-generation devices and designed the Volt system to simplify PFA procedures while making them more efficient,” said Christopher Piorkowski, chief medical officer of Abbott’s electrophysiology business. “Clinical data has also shown that the Volt catheter’s cutting-edge design helps physicians achieve pulmonary vein isolation in fewer ablation attempts and less therapy applications for improved patient outcomes.”
Progress across Abbott’s PFA portfolio
The CE Mark approval comes as Abbott makes regulatory and clinical progress across its broader PFA portfolio. The company’s Volt PFA system is also under evaluation in the VOLT-AF Investigational Device Exemption (IDE) Study, which completed enrollment of nearly 400 patients four months ahead of schedule. The twelve-month follow-up for the study is expected to conclude later this year.
Abbott said it is also advancing its focal PFA technology that delivers targeted energy to specific points in the heart. The company recently completed enrollment in its FOCALFLEX CE trial evaluating the TactiFlex Duo Ablation Catheter, Sensor Enabled, and enrollment is underway in the FlexPulse IDE trial in the U.S.
In addition, Abbott recently received U.S. and European regulatory approval for its Agilis NxT Steerable Introducer, Dual Reach, which supports larger catheters, including those used for PFA procedures.
Medical Design & Outsourcing: How Abbott dialed in the waveform for its Volt PFA system
