Abbott Laboratories has earned CE mark approval for its Volt PFA (pulsed field ablation) system to treat patients suffering from atrial fibrillation (AFib).

The company has begun commercial PFA cases in the EU with physicians who already have experience with Volt in its clinical studies. Abbott plans to further expand Volt’s use in EU markets throughout the second half of the year.

CE mark approval was awarded based on results from the company’s Volt CE mark study conducted in Europe and Australia. The trial showed it achieved pulmonary vein isolation (PVI)—the method of destroying tissue causing AFib—in 99.1% of veins during ablation procedures. It also had fewer energy applications that on-market competitive PFA systems, according to Abbott.

Volt PFA builds on Abbott’s electrophysiology (EP) portfolio with a single-catheter PFA approach. It allows mapping, pacing, and ablating with a single catheter to safely, effectively treat AFib patients. Current on-market PFA systems require several therapy applications with a catheter positioned in various locations because of a lack of visualization or contact assessment.

By integrating with Abbott’s EnSite X EP system, Volt PFA offers real-time contact visualization to help position the catheter for therapy delivery. The balloon-in-basket design of the Volt PFA catheter, Sensor Enabled minimizes the number of therapy applications needed via efficient energy transfer directly to targeted tissue to stop the heart’s erratic signals.

Patients undergoing a minimally invasive ablation procedure with the catheter can be placed under light sedation or general anesthesia based on physician and hospital preference.

“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, M.D., 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.”

The Volt PFA system is currently being evaluated in the VOLT-AF investigational device exemption (IDE) study. The study finished enrolling patients last year, four months ahead of the expected timeline.