Abbott has announced that the US Food and Drug Administration (FDA) has approved the company’s Volt pulsed field ablation (PFA) system to treat patients with atrial fibrillation (AF). Abbott says it will soon begin commercial PFA cases in the USA and will continue its expansion of sites in the European Union following Volt’s CE-mark approval earlier this year.
US FDA approval for the Volt PFA system was secured based on “strong results” from Abbott’s VOLT-AF investigational device exemption (IDE) study—a clinical trial involving 392 patients conducted at 40 centres in the USA, Europe, Canada and Australia. The data showed that the Volt PFA system demonstrated clinically meaningful performance in both safety and effectiveness in two different patient groups: people with paroxysmal as well as persistent AF.
“AF is a progressive condition where timely intervention is critical to disease management and, ultimately, the patient’s quality of life. When I perform a cardiac ablation, I look for a tool with an excellent patient safety profile that can simplify the treatment of AF,” said DJ Lakkireddy (Kansas City Heart Rhythm Institute, Overland Park, USA), one of the first physicians to use Volt in the USA. “Volt is a promising option for patients. Its real-time contact visualisation and unique balloon-in-basket design provide superior tissue contact and focused energy delivery, while addressing some of the limitations of the early-generation PFA systems.”
Abbott claims that its Volt PFA system builds upon the company’s leading electrophysiology (EP) portfolio by providing an all-in-one product that allows physicians to safely map, pace and ablate with the same catheter. Volt’s proprietary balloon-in-basket design features multiple handling options for ease of use and allows for efficient energy transfer directly to the targeted tissue to stop the heart’s erratic signals.
With improved physician workflow in mind, the Volt PFA system was designed to integrate with Abbott’s EnSite X EP system by providing physicians accurate 3D cardiac mapping and fewer catheter exchanges during an ablation. According to Abbott, while current on-market, competitive PFA systems often require several therapy applications with a catheter positioned in various locations, the Volt PFA system’s integration with EnSite X was designed to address such limitations.
Abbott further states that the system has been clinically proven to provide a minimal number of therapy applications and enhanced patient outcomes. It is designed to deliver precise, targeted energy during ablation, which helps achieve durable lesions with fewer pulses. This level of accuracy supports effective first-time procedures, reducing the likelihood of repeat ablations and minimising the risk of complications, the company says.
Volt PFA is also intended to provide more procedural options, as patients who undergo a minimally invasive ablation procedure with the Volt PFA catheter can be placed under conscious sedation instead of general anaesthesia, which is a “significant benefit” for patients in whom anaesthesia is a barrier to performing ablations. The Volt PFA system also reduces exposure to radiation via fluoroscopy and limits haemolysis, Abbott claims.
“We heard the physician feedback that patients need an alternative to general anaesthesia during a PFA procedure that doesn’t sacrifice strong outcomes,” said Christopher Piorkowski, chief medical officer of Abbott’s EP business. “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.”
