The regulatory nod brings Abbott Volt to the U.S. PFA market to compete against the likes of Medtronic, Boston Scientific, Johnson & Johnson MedTech and Kardium. It follows CE mark approval for Volt earlier this year.
Abbott said it plans to begin commercial PFA cases with Volt in the U.S. soon and continue expanding across Europe, too. Approval in the U.S. came on the back of strong data from the VOLT-AF IDE study, which evaluated 392 patients across 40 centers in the U.S., Europe, Canada and Australia. The study demonstrated clinically meaningful performance from Volt in both safety and effectiveness for paroxysmal AFib (PAF) and persistent AFib (PersAF).
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Volt provides a single-catheter PFA approach to improve workflow and provide procedural flexibility. The company designed Volt to address the limitations of existing PFA technologies. It paired a balloon-in-basket catheter with the EnSite X EP heart mapping system. Ensite X helps physicians visualize and position tools like the Volt PFA catheter in the heart.
“We heard the physician feedback that patients need an alternative to general anesthesia during a PFA ablation procedure that doesn’t sacrifice strong outcomes,” said Dr. Christopher Piorkowski, chief medical officer of Abbott’s electrophysiology 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.”
More about the Abbott Volt PFA system
Volt builds upon Abbott’s existing electrophysiology portfolio to deliver an all-in-one product. Physicians using Volt can safely map, pace and ablate, all within the same catheter. The balloon-in-basket design offers multiple handling options for ease of use and efficient energy transfer. Volt delivers energy directly to the targeted tissue to stop the heart’s erratic signals.
Abbott said it designed Volt with improved workflows in mind, incorporating EnSite X EP to support effective first-time procedures, reduce the likelihood of repeat ablations and minimize the risk of complications while achieving durable lesions with fewer pulses.
The company also says Volt delivers more procedural options for patients. They can be placed under conscious sedation instead of general anesthesia, while Volt also reduces exposure to radiation (fluoroscopy) and limits the breakdown of red blood cells (hemolysis).
“AFib 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 AFib,” said Dr. DJ Lakkireddy, executive medical director of the Kansas City Heart Rhythm Institute and one of the first physicians to use Volt in the U.S. “Volt is a promising option for patients. Its real-time contact visualization 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.”
The analysts’ take
BTIG analysts Marie Thibault, Sam Eiber and Alexandra Pang maintain a “Buy” rating for Abbott on the back of the news.
They wrote that the approval came slightly ahead of expectations, as they projected approval in the first half of 2026. The analysts note positive physician feedback and they await more outcomes from the VOLT-AF IDE study that supported approval. Presentations for those outcomes could come at AFS or HRS in 2026.
“Our October physician survey pointed to significant PFA market share shifts in 2026 and with Volt set to enter the U.S. market, we expect the competitive landscape to intensify,” the analysts wrote. “We remain bullish on PFA and believe the U.S. approval of Volt will help drive broader uptake of the technology class.”
