The US Food and Drug Administration (FDA) has granted approval for Abbott’s Volt PFA System, expanding treatment options for patients with atrial fibrillation (AFib).
The approval follows earlier CE Mark approval in the European Union, with commercial PFA cases set to begin in the US and continued expansion planned in Europe.
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It was based on data from the company’s VOLT-AF IDE trial, which enrolled 392 patients and carried out across 40 centres in Australia, Canada, Europe, and the US.
The study demonstrated the system’s clinically meaningful performance in both effectiveness and safety for two patient groups: those with paroxysmal AF (PAF), characterised by episodes that come and go, and those with persistent AFib (PersAF), where episodes last longer than seven days.
The system is designed to support physicians by providing an all-in-one solution for mapping, pacing, and ablation using a single catheter.
Its balloon-in-basket design is said to offer several handling options, aiming to facilitate efficient transfer of energy directly to targeted tissue to disrupt irregular heart signals.
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By GlobalDataThe Volt PFA System was developed to integrate with the company’s EnSite X EP System, enabling accurate three-dimensional (3D) cardiac mapping and reducing the need for multiple catheter exchanges during ablation procedures.
According to Abbott, current PFA systems on the market often need multiple therapy applications with the catheter repositioned in different locations, whereas the Volt PFA System, when used with EnSite X, is tailored to address these limitations.
The Volt PFA System also offers more procedural options for patients, as those undergoing minimally invasive ablation with the Volt PFA Catheter can be placed under conscious sedation rather than general anaesthesia.
This is particularly beneficial for patients for whom anaesthesia presents a barrier to ablation procedures.
Additionally, the Volt PFA System is designed to reduce radiation exposure (fluoroscopy) and limit haemolysis, the breakdown of red blood cells, during procedures.
Abbott’s electrophysiology business chief medical officer Christopher Piorkowski said: “We heard the physician feedback that patients need an alternative to general anaesthesia during a PFA ablation procedure that doesn’t sacrifice strong outcomes.
“The Volt PFA System is an option for patients who prefer conscious sedation, which can also lead to faster recovery times and shorter procedures for the millions of Americans who suffer from an abnormal heart rhythm.”
