Pulsed Field Ablation System Provides New Therapy Option for Abnormal Heart Rhythms

Atrial fibrillation, commonly referred to as AFib, is a common type of irregular heartbeat treated through a method known as cardiac ablation. This procedure involves damaging small areas of heart tissue to stabilize the electrical signals that control the heart's rhythm. By targeting these tissues, electrical current flow is improved in AFib patients. Traditionally, patients with AFib undergoing cardiac ablation have been treated using radiofrequency (RF) ablation, which employs heat to destroy the erratic signal-producing tissue, or cryogenic ablation, which uses freezing techniques.

In contrast, pulsed-field ablation (PFA) represents a novel approach, applying high-energy electrical pulses to precisely destroy the cells causing abnormal heart rhythms, which can reduce the risk of damaging adjacent tissue in patients with complex disease or anatomy. Whereas thermal energy can damage the site and organs around the pulmonary vein, PFA technology delivers controlled pulses, in milliseconds, that only ablate heart muscle tissue and spare other organs. However, first-generation PFA systems have required multiple ablations with the catheter positioned in various locations to effectively treat targeted tissue. Now, a new PFA system designed to overcome the limitations of first-generation systems can address hard-to-treat irregular heartbeats with a level of accuracy and precision that's never before been possible.

Abbott’s (Abbott Park, IL, USA) new Volt PFA system is designed for treating patients with common abnormal heart rhythms like AFib. This system improves upon the shortcomings of initial models by combining its unique balloon-in-basket catheter with Abbott's EnSite X EP System, a leading-edge heart mapping technology. This integration allows for enhanced visualization and positioning of the Volt PFA Catheter within the heart. The Volt's innovative design aids in more precise ablation procedures, as it provides doctors with better indicators for optimal contact with the targeted heart tissue, thanks to its distinct positioning, handling, and steering capabilities. The catheter's balloon feature facilitates effective energy transfer to the tissue, enhancing the creation of lesions that interrupt the heart's erratic signals.

The EnSite X mapping system offers detailed visualization, enabling physicians to accurately pinpoint the heart areas needing ablation and precisely position the Volt PFA Catheter for treatment. This high level of precision leads to a more efficient workflow and reduces the patient's exposure to radiation. The first global uses of the Volt PFA system have been carried out, treating patients with common abnormal heart rhythms such as AFib. Recently, over 30 patients were treated in Abbott's Volt CE Mark study, a pre-market, multi-center clinical trial assessing the safety and efficacy of the Volt PFA System. With additional procedures planned across Asia Pacific and Europe, Abbott also expects U.S. clinical trial approval (IDE) for the Volt PFA System within the first half of this year.

"Daily life for the millions of people with AFib can be difficult as symptoms often include palpitations, shortness of breath, dizziness and chest pain, making it critical that physicians treat the issue as soon as possible," said Christopher Piorkowski, M.D., chief medical officer of Abbott's electrophysiology business. "With AFib cases expected to rise continuously, Abbott's Volt PFA System meets a growing demand for a more innovative solution that reduces the patient procedure time and overall hospital stay, getting them back to living a fuller, longer life."

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