Medical devices and health care company Abbott (NYSE:ABT) announced on Thursday that it has received CE Mark approval in Europe for its Volt Pulsed Field Ablation (PFA) System, designed to treat atrial fibrillation (AFib).

Following approval, Abbott has begun commercial PFA cases in the European Union and plans to expand its use across European markets in the second half of the year.

The Volt PFA System offers a single-catheter approach that integrates mapping, pacing and ablation, simplifying workflow and improving contact visualisation. Clinical trials demonstrated that the system achieved pulmonary vein isolation in 99.1% of veins with fewer energy applications compared to competing PFA systems.

PFA delivers high-energy electrical pulses to cardiac tissue, reducing the risk of damage to surrounding tissue. Abbott's Volt PFA System, integrated with the EnSite X EP system, enhances procedural flexibility and accuracy, offering real-time visualisation and minimising the number of therapy applications required.

Abbott is also advancing clinical studies of its focal PFA technology, including the TactiFlex Duo Ablation Catheter, and expects to complete a 12-month follow-up for the VOLT-AF Investigational Device Exemption study later this year. The company has also secured US and EU regulatory approval for the Agilis NxT Steerable Introducer, which is compatible with larger catheters including those used for PFA therapy.