Abbott’s (ABT) The Volt™ PFA System has acquired CE Mark in Europe for treating patients with atrial fibrillation (AFib). With the earlier-than-expected CE Mark, Abbott has commenced commercial PFA cases in the EU with physicians who have already earned experience with the Volt PFA System through Abbott’s PFA clinical studies. Throughout the second half of the year, the company plans to extend its use of Volt in European markets.
AFib affects around 8 million Europeans over the age of 65, and this figure is anticipated to grow over the next 30 years. 1,2 People with AFib are at a higher risk of stroke, heart failure, and mortality, and many rely on cardiac ablation to treat the condition efficiently. The Volt PFA System expands Abbott’s premier electrophysiology (EP) portfolio by offering a single-catheter PFA method, which improves workflow by allowing for mapping, pacing, and ablation with a single catheter to safely and efficiently treat patients with AFib.
The Volt PFA System received CE Mark clearance following outstanding results from Abbott’s Volt CE Mark research, a worldwide clinical trial conducted at facilities in Europe and Australia. The trial demonstrated that the Volt PFA System accomplished pulmonary vein isolation (PVI) – the process of eliminating tissue that causes a patient’s AFib – in 99.1% of veins during ablation operations while using significantly less energy than competitor PFA systems on the market.
Following approval, initial cases were completed by Prof. Helmut Puererfellner at the 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, Belgium; and Prof. Peter Loh at the University Medical Center Utrecht, 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.
Prof. Puererfellner
Volt™ PFA System
PFA differs from standard ablation procedures in that it delivers high-energy electrical pulses to specific portions of cardiac tissue, resulting in aberrant heart rhythms. As a result, PFA can lessen the chance of harming surrounding tissue in patients with complex illness or anatomy.
Source: Abbott
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