Abbott’s Pulsed Field Ablation System Now Available in Spain for Atrial Fibrillation Treatment

Abbott has announced the availability of its pulsed field ablation (PFA) system in Spain, offering a new therapeutic option for atrial fibrillation (AF), the most common cardiac arrhythmia. The PFA system utilizes a minimally invasive approach and allows for conscious sedation, eliminating the require for general anesthesia in many cases.

Understanding Atrial Fibrillation and its Impact in Spain

Atrial fibrillation is characterized by irregular electrical impulses in the heart, causing the atria to tremble or flutter. In Spain, nearly one million people suffer from AF, with approximately 100,000 new cases diagnosed annually. The prevalence rises to 4% of the adult population and up to 15% in individuals over 85 years vintage.^{1, 4} Beyond its symptoms, AF significantly increases the risk of stroke or embolism (five to seven times) and heart failure (three times), too contributing to increased mortality.^{1, 4}

How Pulsed Field Ablation Works

When medications and other treatments are insufficient, cardiac ablation is often considered to restore a normal heart rhythm. Abbott’s PFA system is designed to overcome limitations of traditional thermal ablation techniques. It uses high-energy electrical pulses to precisely target and treat abnormal heart tissue, minimizing the risk of damage to surrounding structures like the esophagus or blood vessels.² The system features an integrated solution for mapping, stimulation, and ablation, all within a single catheter, and a patented ‘balloon in basket’ design for efficient energy delivery.²

Benefits of the Abbott PFA System

• Conscious Sedation: Patients can often undergo the procedure with conscious sedation rather than general anesthesia, which can be a significant benefit for those where anesthesia poses a barrier.^{5, 6}
• Reduced Radiation Exposure: The system reduces exposure to fluoroscopy (radiation) during the procedure.
• Minimized Tissue Damage: PFA aims to limit the destruction of healthy red blood cells (hemolysis).
• Enhanced Safety Profile: The technology offers an advanced safety profile compared to traditional ablation methods.

Expert Perspectives

Dr. José L. Merino, head of the Arrhythmias and Robotic Cardiac Electrophysiology Unit at La Paz University Hospital (Madrid), stated, “The use of this system represents a qualitative leap in the management of atrial fibrillation in Spain.” He further explained that AF can cause symptoms like shortness of breath, dizziness, and chest pain, and untreated arrhythmias increase the risk of stroke and heart attack.²

Dr. Ignasi Anguera, director of the Electrophysiology and Arrhythmias Unit at the Bellvitge University Hospital (l’Hospitalet de Llobregat, in Barcelona), added, “Pulsed field ablation is changing the therapeutic paradigm by creating very selective lesions using electrical pulses, reducing the risk on adjacent tissues in complex anatomies.” He emphasized the potential for more predictable and safe procedures, along with the benefits of conscious sedation, to improve both patient experience and procedural efficiency.²

Recent Clinical Data

Positive 12-month results from the VOLT-AF IDE Study, presented at the AF Symposium and published in JACC: Clinical Electrophysiology, reinforce the Volt™ Pulsed Field Ablation (PFA) System’s success rate for treating AFib.³ The study showed an 84.2% success rate of freedom from documented rhythm recurrence among all competitive PFA products for paroxysmal AFib (PAF).³ The Volt PFA System also demonstrated positive results for persistent AFib (PersAF), with nearly 68% of patients remaining free from additional episodes following ablation.³

Data from the FOCALFLEX CE Mark trial also demonstrate the safety and efficacy of the TactiFlex™ Duo Ablation Catheter, Sensor Enabled™, in significantly reducing AFib episodes for complex cases.³

Looking Ahead

The introduction of Abbott’s PFA system in Spain marks a significant advancement in the treatment of atrial fibrillation, offering a potentially safer and more effective option for patients. Continued research and clinical experience will further refine the use of this innovative technology and improve outcomes for individuals living with AF.

References:

1. Atrial Fibrillation: what it is, causes, symptoms and treatment | Cardioalliance. https://www.cardioalliance.org/atrial-fibrillation/. Accessed January 2026.
2. Abbott. https://www.prnewswire.com/news-releases/late-breaking-data-presentations-showcase-the-safety-and-efficacy-of-abbotts-ablation-catheters-to-treat-people-with-atrial-fibrillation-302680826.html. February 6, 2026.
3. Tilz R, et al. Long term safety and effectiveness of balloon based PFA system for de novo PVI to treat PAF and PersAF: Results from the VOLT CE Mark Study. BSI, Notified Body Number 2797 Heart Rhythm Journal. 2025. https://clinicaltrials.gov/study/NCT06707688. Accessed January 2026.
4. Torres-Llergo, J., Bailén, MC, Aumente, JMS, Olmo, MRF, Chiachío, MP, Guerrero, JCF, & Ortiz, MR (2023). Incidence and prediction of hospitalization for heart failure in patients with atrial fibrillation: REFLEJA scale. Spanish Journal of Cardiology, 77(9), 710-719.
5. Tilz, R. (2025). Acute safety and procedural characteristics of conscious and deep sedation to general anesthesia workflows with novel balloon-based PFA system [Oral presentation and abstract]. EHRA 2025.
6. Lo M, et al. Procedural efficiency, safety and acute effectiveness of conscious and deep sedation workflows with novel balloon based PFA system. Poster presentation, Heart Rhythm Society 2025, San Diego, CA.