Abbott has received CE Mark in Europe for the Volt™ PFA System to treat patients battling atrial fibrillation (AFib).

With the earlier-than-expected CE Mark, Abbott has begun commercial PFA cases in the EU with physicians who have already gained experience with the Volt PFA System within Abbott's PFA clinical studies. The company will further expand use of Volt in EU markets throughout the second half of the year.

Today, approximately 8 million Europeans over the age of 65 are living with AFib, a number expected to double over the next 30 years. People living with AFib face an increased risk of stroke, heart failure and death, and many rely on cardiac ablation to treat the condition effectively. The Volt PFA System builds upon Abbott's leading electrophysiology (EP) portfolio by providing a single-catheter PFA approach, improving workflow by allowing for mapping, pacing, and ablating with a single catheter to safely and effectively treat patients with AFib.

CE Mark approval for the Volt PFA System was granted based on strong results from Abbott's Volt CE Mark study, a global clinical trial conducted at centers in Europe and Australia. The trial showed the Volt PFA System achieved pulmonary vein isolation (PVI) – the method of destroying tissue causing a patient's AFib – in 99.1 percent of veins during ablation procedures with far fewer energy applications than on-market competitive PFA systems.

Following approval, initial cases were completed by Helmut Puererfellner at Ordensklinikum hospital in Linz, Austria; Roland Tilz at the University Heart Center in Luebeck, Germany; Prof. Gian-Battista Chierchia at the University of Brussels in Belgium; and Peter Loh at the University Medical Center Utrecht in the Netherlands.

"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. 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," said Puererfellner.

PFA works differently from traditional ablation approaches by delivering high energy electrical pulses to targeted areas of cardiac tissue causing abnormal heart rhythms. As a result, PFA can reduce the risk of damaging adjacent tissue in patients with complex disease or anatomy.

"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. 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," said Christopher Piorkowski, MD, Chief Medical Officer of Abbott's electrophysiology business.