Abbott gains European clearance for single-catheter AFib ablation

USA—Abbott Laboratories has achieved a significant breakthrough in the treatment of atrial fibrillation (AFib) with the recent CE Mark approval of its Volt Pulsed Field Ablation (PFA) System in Europe.

This approval marks a major milestone in the evolution of electrophysiology across the continent, as it introduces a new and innovative approach to treating heart rhythm disorders.

The Volt PFA System is designed to provide a single-catheter solution, simplifying the workflow for physicians by allowing them to map, pace, and ablate using just one catheter, thereby enhancing the safety and effectiveness of AFib treatments.

The CE Mark approval was granted based on strong results from Abbott’s global clinical trial, conducted at centers in Europe and Australia.

 The trial demonstrated that the Volt PFA System achieved pulmonary vein isolation (PVI) in an impressive 99.1% of veins during ablation procedures.

Notably, this was accomplished with far fewer energy applications compared to existing PFA systems on the market.

This efficiency is crucial, as it reduces the risk of damaging adjacent tissue, particularly in patients with complex heart conditions or anatomy.

Following the approval, Abbott has initiated commercial PFA cases in the European Union with physicians who have gained experience with the Volt PFA System through clinical studies.

The company plans to expand the use of Volt across EU markets throughout the second half of the year.

This expansion is timely, given that approximately 8 million Europeans over the age of 65 are currently living with AFib—a number expected to double over the next three decades.

AFib significantly increases the risk of stroke, heart failure, and death, making effective treatment options like cardiac ablation essential for many patients.

The Volt PFA System works differently from traditional ablation methods by delivering high-energy electrical pulses to targeted areas of cardiac tissue causing abnormal heart rhythms.

 This approach can reduce the risk of damaging surrounding tissue, which is a common concern with traditional ablation techniques.

However, current competitive PFA systems often require multiple therapy applications with the catheter positioned in various locations due to limitations in visualization and contact assessment.

To address these limitations, the Volt PFA System integrates with Abbott’s EnSite X EP system, providing several key benefits.

 Firstly, it simplifies the clinical workflow by offering real-time contact visualization, which helps physicians accurately position the catheter for therapy delivery.

Secondly, the proprietary balloon-in-basket design of the Sensor-Enabled Volt PFA Catheter ensures efficient energy transfer directly to the targeted tissue, minimizing the number of therapy applications needed.

Lastly, the system offers procedural flexibility, allowing patients to undergo minimally invasive ablation procedures under either light sedation or general anesthesia, depending on physician and hospital preferences.

Prof. Helmut Pürerfellner, who completed initial cases with the Volt PFA System at Ordensklinikum hospital in Linz, Austria, noted that this technology marks a significant advancement in electrophysiology.

He emphasized that PFA is revolutionizing the treatment of heart rhythm disorders and that the Volt PFA System builds upon this therapy’s potential by incorporating key physician feedback and clinical insights to optimize treatment outcomes. 

Christopher Piorkowski, Chief Medical Officer of Abbott’s electrophysiology business, emphasized that while PFA is a relatively new therapy option, the Volt system has been designed to simplify PFA procedures and increase their efficiency.

Clinical data have shown that the Volt catheter’s cutting-edge design enables physicians to achieve pulmonary vein isolation in fewer attempts and with fewer therapy applications, resulting in improved patient outcomes.

In addition to the Volt PFA System, Abbott is also making progress in other clinical studies.

The company has completed enrollment in the VOLT-AF Investigational Device Exemption (IDE) Study, which involves nearly 400 patients and is expected to complete its 12-month follow-up later this year.

Furthermore, Abbott has made significant strides in evaluating its focal PFA technology, designed to deliver focused energy for creating targeted lesions in the heart.

Enrollment was recently completed ahead of schedule in the FOCALFLEX CE trial, assessing the TactiFlex Duo Ablation Catheter, and enrollment is underway in the FlexPulse IDE trial in the United States.

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