Sustained performance of the Volt PFA System Volt also delivered strong results as a treatment option for AFib episodes that last longer than seven days (Persistent AFib or PersAF), with nearly 68% of patients remaining free from an additional episode following a Volt ablation.1\u00a0<\/p>\n Additional key findings of the single-arm trial conducted at approximately 40 centers\u00a0in the United States, Europe, Canada and Australia through one year include: 1<\/p>\n Physicians were able to use fewer therapy applications (just 4.6 applications per vein on average) than other on-market competitive PFA systems.The trial found less than 6% of patients required a repeat ablation, one of the lowest rates in the industry.Patients reported a significant improvement in quality-of-life (QoL) as measured by the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) score. This self-assessment \u2013 which evaluates changes to a person’s overall symptoms and social well-being \u2013 show scores rose from\u00a063.6\u00a0to 91.4 for PAF patients treated with Volt and from 64.2 to 91.4\u00a0for PersAF patients. The study also found zero patient complications related to either an unintended injury to the esophagus, or the breakdown of red blood cells (hemolysis), which can cause sudden kidney damage.<\/p>\n “The data for Volt confirms what I see firsthand in the procedure room with this next-generation PFA device,” said Atul Verma, M.D., director of the Division of Cardiology at McGill University Health Centre and McGill University in Montreal, Canada, who treated patients as part of the VOLT-AF IDE study and presented the late-breaking data at AF Symposium. “The system’s unique design enables a high degree of freedom from AFib for patients, and its impressive safety profile reduces PFA-specific complications such as hemolysis, which negatively impacts other parts of the body.”\u00a0<\/p>\n The Volt PFA System\u00a0secured U.S. Food and Drug Administration (FDA) approval<\/a>\u00a0and CE Mark in Europe<\/a> last year. Commercial cases have begun in the U.S. and expansion in Europe continues.\u00a0<\/p>\n Strong data supports TactiFlex Duo Ablation Catheter, Sensor Enabled Patient self-reported quality-of-life scores also climbed from 64.4 to 86.4.2 This data from more than 20 centers in the European Union, United Kingdom and Australia contributed to the device’s recent CE Mark approval.\u00a0<\/p>\n TactiFlex Duo is designed for focal ablation, using a dual-energy platform, which gives physicians the ability to tailor AFib therapy delivery in two ways instead of a single energy mode. Experts use the catheter to target and treat an irregular heart rhythm with either extreme heat (radiofrequency) or high-energy electrical pulses (PFA) based on a patient’s individual needs and anatomy, including the most challenging cases.\u00a0<\/p>\n In addition to the CE Mark study, Abbott also completed enrollment last year for the FLEXPULSE Global IDE trial to evaluate\u00a0TactiFlex\u00a0Duo as an AFib therapy. Last October, the FDA granted Breakthrough Device Designation for TactiFlex Duo to treat Ventricular Tachycardia \u2013 a potentially life-threatening fast heart rate requiring immediate medical attention \u2013 using PFA.<\/p>\n “With the rising rates of AFib around the world, data from the Volt PFA and TactiFlex Duo trials help empower physicians with further confidence in using these devices to treat\u00a0people with AFib \u2013 from the recently diagnosed to the most complex cases,” said Christopher Piorkowski, M.D., chief medical officer of Abbott’s electrophysiology business. “These studies help solidify our treatment offerings for AFib as we\u00a0strive to challenge the status quo to develop even better tools that physicians\u00a0can rely on to care for their patients.”\u00a0<\/p>\n In addition, a late-breaking data presentation on Abbott’s Amulet device will be presented on Friday, Feb. 6 between 5:30 \u2013 7 p.m. Eastern from the VERITAS Amulet 360 Pivotal Study.<\/p>\n For U.S. important safety information go to: TactiFlex\u2122 Duo Ablation Catheter, Sensor Enabled\u2122\u00a0is approved for investigational use only in the U.S.<\/p>\n About Abbott: Connect with us at\u202fwww.abbott.com<\/a>\u202fand on\u202fLinkedIn<\/a>,\u202fFacebook<\/a>,\u202fInstagram<\/a>,\u202fX<\/a>\u202fand\u202fYouTube<\/a>.\u202f<\/p>\n 1\u00a0Verma, A. (2026, February 5) 12-Month Safety and Effectiveness of a balloon-in-basket PFA system for de novo PVI to treat PAF and PsAF: Results from the VOLT-AF IDE Study [Late Breaking Presentation]. AF Symposium 2026, Boston MA, USA.
Twelve-month data from the\u00a0VOLT-AF Global IDE study found that the Volt PFA System<\/a> had an industry-leading success rate (84.2%) of freedom from documented rhythm recurrence among all\u00a0competitive\u00a0PFA products to treat AFib episodes that come and go (Paroxysmal AFib or PAF).1<\/p>\n
Six-month data presented from the FOCALFLEX Global CE Mark trial confirmed the safety and effectiveness of TactiFlex Duo for treating more complex cases of AFib.\u00a0The trial found a clinically meaningful success rate (81%) of freedom from documented rhythm recurrence among PAF patients. 2<\/p>\n
Volt\u2122 PFA System\u00a0
https:\/\/www.cardiovascular.abbott\/us\/en\/ep-clinical-evidence\/volt-clinical-evidence.html<\/a><\/p>\n
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.\u00a0<\/p>\n
2\u00a0Deisenhofer, I. (2026, February 5) Safety and Effectiveness of the TactiFlex Duo System: 6-Month Results of the FOCALFLEX Study [Late Breaking Presentation]. AF Symposium 2026, Boston MA, USA.<\/p>\n
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