Pulsed Field Ablation (PFA)

Volt™ PFA System is commercially available in Europe.
CAUTION – This product is limited by U.S. Federal Law to investigational use. Product is not approved globally and may not be available in your market.

Volt™ PFA System

The Volt™ PFA System consists of the following components:

Volt™ PFA Catheter, Sensor Enabled™: A novel balloon-filled basket with 8 active splines. It is designed for therapy delivery, pacing, and the collection of electrical and anatomical data when used with the EnSite™ X EP System.
Current™ PFA Generator: The streamlined user interface includes waveform selection, tissue proximity LivePoint™display, electrode selectivity, and therapy count tracking. Abbott's Current PFA Generator is designed for intuitive use and is built to be extensible for future PFA catheter types.
Agilis™ NxT Steerable Introducer, Dual Reach™ (13 F): The best-in-class Agilis™ platform now in a 13 F inner diameter for use with larger French size catheters. In addition, the Volt PFA catheter is compatible with a 13 F inner diameter introducer such as Agilis NxT Steerable Introducer. Visit the product page.

Volt PFA System Clinical Studies

Volt CE Mark Study

Before being used with patients, the Volt PFA System underwent extensive laboratory testing. Following this, the Volt CE Mark Study was the first clinical research study to investigate the Volt PFA System's safety and performance in treating human patients. The purpose of this study was to gather data demonstrating that the Volt PFA System functions as intended in a clinical setting and to establish its safety and effectiveness for treating atrial fibrillation.

CE Mark 6-Month Results

Safety and Effectiveness of balloon-based PFA system for de novo PVI to treat PAF and PersAF: 6-Month Results of the Volt CE Mark Study.

Data from the Volt CE Mark study demonstrates that PVI with the Volt™ PFA System is both safe and effective for treating PAF and PsAF over a 6-month follow-up period.¹

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subjects free from documented AF/AFL/AT recurrence at 6-months

Durably Isolated PVs: The repeat ablation rate in the CE Mark cohort was only 1 in 20 patients (4.8%, n=7/146). In repeat ablations after the blanking period, 93.3% of veins were durably isolated¹
Primary Safety Endpoint: 2.7% of subjects experienced a primary safety endpoint event¹
- 0% of subjects reporting hemolysis, acute kidney injury, phrenic nerve injury¹

CE Mark Sub-Analysis

Acute safety and procedural characteristics of conscious and deep sedation compared to general anesthesia workflows with novel balloon-based PFA system.

This sub-analysis of the CE Mark data, presented by Prof. Roland Tilz, demonstrates that PVI with the Volt™ PFA Catheter, Sensor Enabled™ in subjects under deep or conscious sedation (CS/DS) does not significantly impact safety or acute outcomes compared to procedures with general anesthesia (GA).²

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CE Mark Feasibility Sub-Study Results

In the Volt CE Mark feasibility sub-study, acute effectiveness was achieved in 99.2% (127/128) of treated PVs (96.9% of subjects, 31/32) with 23.8 ± 4.2 PFA applications/subject. No esophegeal lesions causally related to Volt™ PFA System.

CE Mark Feasibility Sub-Study Results

Volt AF IDE Study

This clinical research study is intended to demonstrate safety and effectiveness of the Volt™ PFA System for the treatment of symptomatic, recurrent, drug-refractory paroxysmal and persistent atrial fibrillation.

View Volt AF IDE Study Design

Clinical Sub-Analysis Publications

Pre-Clinical Abstracts

2023 APHRS Abstract: Volt with LivePoint

Computer Modeling of PFA Waveform Design

2024 Manuscript Assessing PFA Design Considerations

Comparison of efficiency of PFA catheter designs by computer modeling. Computer models demonstrate a wide range in efficiency among PFA catheters. Form factors such as exposure of PFA electrodes to blood pool significantly influence efficiency. Higher efficiency designs, such as balloon-based designs, have less collateral current.

Safety and Effectiveness of the First Balloon-in-Basket Pulsed Field Ablation System for the Treatment of Atrial Fibrillation: VOLT CE Mark Study 6-Month Results. 10.1093/europace/euaf072.
Acute safety and procedural characteristics of conscious and deep sedation to general anesthesia workflows with novel balloon-based PFA system. Oral presentation at EHRA 2025 by Prof. Roland Tilz (Luebeck, DE).
Hemolysis Biomarkers After Pulmonary Vein Isolation via a Balloon-In-Basket PFA Catheter. https://doi.org/10.1111/jce.16608.

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CARDIOVASCULAR