Abbott is soon going to enter the competitive U.S. pulsed field ablation – PFA market, having just attained an FDA approval for its Volt PFA System in order to treat atrial fibrillation.
The highly looked-out-for regulatory nod follows the Volt CE mark approval of Abbott earlier in 2025.
It is well to be noted that the FDA approval when it comes to the Volt PFA System was supported by the VOLT-AF IDE study by Abbott, which is a clinical trial of 392 patients that was conducted across 40 centers throughout the United States, Europe, Canada, and Australia. As per the company, the data went on to show that the system went on to showcase clinically meaningful performance when it comes to both safety as well as effectiveness in different patient groups- people having paroxysmal atrial fibrillation, the episodes that come and go, and also persistent atrial fibrillation, episodes that last longer than seven days.
Abbott went ahead and said that the Volt PFA System offers an all-in-one product that enables physicians to safely map and pace as well as ablate with the same catheter. The balloon-in-basket design of Volt features numerous handling options and also enables efficient energy transfer, and that too directly to the targeted tissue so as to stop the erratic signals of the heart.
The company also went on to note that the system was crafted so as to integrate with the EnSite X EP System of Abbott by offering physicians precise 3D cardiac mapping and also fewer catheter exchanges in an ablation. Abbott opined that the present on-market competitive PFA systems often need many therapy applications with a catheter that is positioned in various locations; however, the Volt PFA System integration with EnSite X has been designed in order to address such limitations.
The system was also designed so as to offer more procedural choices for patients, noted Abbott. The company remarked that patients who go through ablation with the Volt PFA catheter can be placed under conscious sedation rather than general anesthesia, which is quite a major benefit for patients for whom anesthesia is indeed a barrier to performing ablation.
According to Abbott’s electrophysiology business, chief medical officer Christopher Piorkowski, MD, they heard the physician feedback that patients require an alternative to general anesthesia at the time of the PFA ablation procedure that doesn’t sacrifice strong outcomes, and the Volt PFA System is indeed an option for patients who go on to prefer conscious sedation, which can also go ahead and lead to faster recovery times as well as shorter procedures for millions of Americans who go on to suffer from abnormal heart rhythm.
Abbott, apparently, is going to be competing for PFA market share against Boston Scientific, Medtronic, and Johnson & Johnson, along with certain smaller private players, such as Kardium.
Marie Thibault, who is an analyst at BTIG, went on to note in a report that the firm had anticipated Abbott to get the FDA approval for the Volt PFA System in Q1 of 2026, so this news does come slightly ahead of the expectations.
Thibault noted that early physician feedback across the EU has been pretty positive, helping ablation catheter business of Abbott outside the United States to return to the double-digit year-over-year sales growth within the third quarter.
Their October 2025 physician survey pointed to major PFA market share shifts in 2026, and with Volt all set to enter the U.S. market, they do expect the competitive landscape to further intensify. She further added that they remain bullish on PFA and also believe the U.S. approval of Volt is going to help drive much broader uptake when it comes to the technology class.