Abbott Laboratories (ABT) said Thursday it has received CE Mark certification in Europe for its Volt pulsed field ablation system to treat patients with heart rhythm disorders, such as atrial fibrillation.
The company said Volt's CE Mark approval was based on strong results from a global clinical trial that demonstrated Volt's capacity for pulmonary vein isolation, the method of destroying tissue that causes atrial fibrillation.
Abbott said it has started commercial PFA cases in Europe following the CE Mark approval, and plans to expand the use of Volt in Europe throughout H2.
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