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FDA Clears Abbott's Volt PFA System For AFib, Expanding US Treatment Options

Benzinga · 1d ago

On Monday, the U.S. Food and Drug Administration (FDA) approved Abbott Laboratories’ (NYSE:ABT) Volt PFA System to treat patients battling atrial fibrillation (AFib).

AFib is the most common type of irregular heart rhythm (arrhythmia) where the heart’s upper chambers (atria) quiver rapidly and chaotically instead of beating effectively, leading to a fast, irregular pulse, palpitations, shortness of breath, and fatigue, and significantly increasing the risk of blood clots, stroke, and heart failure due to poor blood flow.

Abbott will soon begin commercial PFA cases in the United States and will continue its expansion of sites in the European Union following Volt CE Mark approval earlier this year.

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Revolutionizing AFib Treatment With Volt PFA System

Approximately 12 million people in the United States over the age of 65 have AFib, a number expected to double over the next 20 years.

FDA approval for the Volt PFA System was secured based on strong results from Abbott’s VOLT-AF IDE study, a clinical trial of 392 patients.

The data showed that the Volt PFA System demonstrated clinically meaningful performance in both safety and effectiveness in paroxysmal atrial fibrillation (PAF) – episodes that come and go – as well as persistent AFib (PersAF) – episodes that last longer than seven days.

With improved physician workflow in mind, Volt’s PFA System was designed to integrate with Abbott’s EnSite X EP System by providing physicians with accurate 3D cardiac mapping and fewer catheter exchanges during an ablation.

How Will Abbott’s Innovation Impact Patients?

While current on-market competitive PFA systems often require several therapy applications with a catheter positioned in various locations, the Volt PFA System integration with EnSite X was designed to address such limitations.

The Volt PFA System is designed to deliver precise, targeted energy during ablation, which helps achieve durable lesions with fewer pulses. This supports effective first-time procedures, reducing the likelihood of repeat ablations and minimizing the risk of complications.

Patients who undergo a minimally invasive ablation procedure with the Volt PFA Catheter can be placed under conscious sedation instead of general anesthesia, which is a significant benefit for patients where anesthesia is a barrier to performing ablations.

The Volt PFA System also reduces radiation exposure (fluoroscopy) and limits the breakdown of red blood cells (hemolysis).

ABT Price Action: Abbott Laboratories shares were up 0.51% at $126.08 at the time of publication on Monday, according to Benzinga Pro data.

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