Approved CE! Abbott's First Balloon-shaped PFA Officially Launched

On March 27, 2025, Abbott (NYSE: ABT) announced that its Volt Pulsed Field Ablation (PFA) System has received CE Mark approval in Europe.

The company has begun collaborating with doctors who previously used the Volt system in Abbott's PFA clinical trials to conduct commercial PFA cases. Abbott plans to expand the system's promotion in the European market in the second half of 2025.

# Volt PFA System

PFA is a non-thermal ablation technique that delivers high-energy electrical pulses to targeted areas of heart tissue, disrupting abnormal electrical signals that cause arrhythmias.

Compared with traditional thermal ablation methods, PFA reduces the risk of damaging adjacent tissues, making it an attractive option for patients with complex cardiac anatomy or diseases.

Product Features

• The distal end of the Volt PFA ablation catheter is a balloon, rather than other atypical shapes (such as ring-shaped or flower-shaped). The balloon is fitted with eight ablation band electrodes, allowing the catheter to closely adhere to the pulmonary vein vestibule, efficiently delivering energy directly to the target tissue and reducing the number of treatment applications required during the ablation process.

• Patients who undergo the Volt PFA catheter (sensor-enhanced) minimally invasive ablation procedure can choose either mild sedation or general anesthesia according to the preference of the doctor and hospital.

• The Volt PFA system integrates with Abbott's EnSite X EP system, enabling mapping, pacing, and ablation with a single catheter, providing clearer visualization and more accurate navigation. It enhances visualization capabilities and real-time contact assessment to optimize catheter positioning. The EnSite X platform is suitable for all EP procedures, offering physicians performing PFA and other ablation procedures a "one-stop solution."

Dr. Christopher Piorkowski, Chief Medical Officer of Abbott's electrophysiology business, stated, "Clinical data also demonstrate that the tip design of the Volt catheter can achieve pulmonary vein isolation with just a single ablation, thereby improving patient outcomes."

Currently, Boston Scientific, Medtronic, and Johnson & Johnson have PFA products approved by the FDA, CE, and NMPA for market release. Other competing PFA systems on the market require multiple treatments when the catheter is positioned at different locations due to a lack of visualization or contact assessment.

Abbott's Volt PFA system features a balloon-shaped design, achieving a pulmonary vein isolation (PVI) success rate of up to 99.1%, with significantly fewer energy releases required compared to competing PFA systems on the market. The launch of Volt PFA may drive the development of the entire PFA industry, and balloon-based PFA ablation technology is expected to become an important school in the evolution of PFA.

# Research data

At the 30th International Atrial Fibrillation Symposium (AF Symposium 2025) held on January 17, 2025, Prof. Roland Tilz reported the acute results of the Volt CE Mark feasibility study.

The Volt CE Mark Feasibility Sub-Study aims to evaluate the safety and acute effectiveness of the Volt™ Pulsed Field Ablation System for the treatment of Atrial Fibrillation (AF).

• Pulmonary vein isolation status: Among the 128 pulmonary veins treated, 127 achieved acute efficacy, accounting for 99.2%. In most pulmonary veins, PFA successfully achieved electrical isolation of the pulmonary veins, blocking the conduction of abnormal electrical signals, thereby helping to control atrial fibrillation.

  

• At the subject level: Among 32 subjects, 31 achieved acute efficacy, accounting for 96.9%.

• PFA application frequency: Each subject underwent an average of 23.8 ± 4.2 PFA applications, with each subject needing approximately 23.8 pulse field ablation operations on average.

• Safety: No esophageal injuries have been found to be causally related to the Volt™ PFA system. In traditional thermal ablation treatments, the ablation energy may cause damage to the adjacent esophagus, leading to serious complications such as esophageal ulcers, esophageal stenosis, and even atrioesophageal fistulas.

# PFA Product Portfolio Progress

While obtaining CE certification, Abbott has also made regulatory and clinical progress in its other PFA product portfolio.

The company's Volt PFA system is also being evaluated in the VOLT-AF investigational device exemption (IDE) study, which completed enrollment of nearly 400 patients four months ahead of schedule. The 12-month follow-up for this study is expected to conclude later this year.

The financial report shows that Abbott's global sales in the fourth quarter of 2024 reached $11 billion, with an organic growth of 8.8% year-over-year. The adjusted diluted earnings per share for the fourth quarter were $1.34.

From the annual data, Abbott's global sales reached $42 billion in 2024, with a 7.1% organic growth year-over-year. The full-year sales achieved a 9.6% organic growth. The adjusted diluted earnings per share for the full year of 2024 were $4.67.

Looking ahead to 2025, Abbott is expected to achieve organic sales growth of 7.5% to 8.5% globally, with full-year adjusted diluted earnings per share ranging from $5.05 to $5.25.