CE Mark for Volt PFA System

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% of veins during ablation procedures with far fewer energy applications than on-market competitive PFA systems.

Following approval, initial cases were completed by Prof. Helmut Puererfellner at Ordensklinikum hospital in Linz, Austria; Prof. Roland Tilz at the University Heart Center in Luebeck, 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.

"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. Puererfellner. "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."

Volt PFA System: Driving New Advancement in the PFA Market; 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. Yet current on-market competitive PFA systems have required several therapy applications with a catheter positioned in various locations due to a lack of visualization or contact assessment. By integrating with Abbott's EnSite X EP system, the Volt PFA System is designed to address such limitations and provide:

• i. Simplified workflow. The single-catheter integrated approach of the Volt PFA system improves clinical workflow and provides real-time contact visualization to help physicians position the catheter for therapy delivery.
• ii. Efficient energy delivery. The proprietary balloon-in-basket design of the Volt™ PFA Catheter, Sensor Enabled™, allows for efficient energy transfer directly to the targeted tissue to stop the heart's erratic signals, minimizing the number of therapy applications needed.
• iii. Procedural flexibility. Patients undergoing a minimally invasive ablation procedure with the Volt PFA Catheter, Sensor Enabled, can be placed under light sedation or general anesthesia based on physician and hospital preference.

In addition, the Volt PFA catheter's integration with EnSite X system allows for clearer visualization and navigation for accurate positioning of the Volt PFA catheter to treat tissue. The One System Solution provided by EnSite X can accommodate all EP procedures and compatible technologies.

"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."