Pulsed Field Ablation (PFA) is a method of cardiac ablation used to correct irregular heart rhythms, primarily Atrial Fibrillation. Unlike older methods that rely on extreme heat or cold energy, PFA uses brief, high-energy electrical pulses to target and eliminate specific heart tissue. This non-thermal technique, called irreversible electroporation, selectively destroys heart muscle cells (cardiomyocytes). Crucially, PFA aims to leave surrounding structures like the esophagus and nerves unharmed. This unique mechanism potentially offers a safer procedure with fewer complications compared to traditional ablation methods. Patients often seek to know where this innovative technology is currently offered.
Global Regulatory Status
The initial availability of PFA outside of clinical trials occurred in international markets, driven by the European regulatory process. The Conformité Européenne (CE) Mark approval allowed manufacturers to bring PFA systems to market years before the technology was widely available in the United States. For instance, the Farapulse system from Boston Scientific received its CE Mark as early as 2021, which facilitated its use across the European Union.
This early regulatory clearance positioned Europe as the initial hub for PFA adoption, allowing physicians to gain significant real-world experience with the technology. Other systems followed, including Medtronic’s Affera system, which received its CE Mark in March 2023, and its PulseSelect system, which obtained the mark in November 2023. This timeline established PFA as a commercially available treatment option in many European countries well before the end of 2023.
Beyond Europe, other nations and regions have also moved to integrate PFA into their healthcare systems. Australia and Japan have shown rapid adoption, with regulatory bodies granting approvals for specific PFA devices throughout 2023 and 2024. For example, the PulseSelect system was approved in Japan in May 2024, and the Affera system was approved in Australia in September 2024, broadening geographic access for patients in the Asia-Pacific region.
The distinction between regulatory approval and widespread clinical adoption remains important. While a system may be approved, its practical availability depends on individual hospitals acquiring the equipment and training their electrophysiology staff. These early international clearances firmly established the groundwork for subsequent market entry in North America.
US Market Implementation
The availability of PFA in the United States followed a concentrated timeline, with Food and Drug Administration (FDA) approvals occurring in rapid succession beginning in late 2023. Medtronic’s PulseSelect was the first PFA system cleared in December 2023 for use in both paroxysmal and persistent Atrial Fibrillation. This marked the official start of PFA commercialization in the US market.
Boston Scientific quickly followed suit, with their Farapulse system gaining FDA approval in January 2024. This established immediate competition and provided US electrophysiologists with two distinct systems for treating patients. The commercial rollout of these devices typically begins with a phased approach, where the technology is first deployed at high-volume cardiology centers and major academic medical institutions.
The implementation logistics require hospitals to not only purchase the specialized PFA equipment but also to dedicate time and resources to training their clinical teams. The most recent major entry came in October 2024, when Medtronic secured FDA approval for its Affera system. This system is a dual-energy platform capable of delivering both PFA and traditional radiofrequency ablation, providing physicians with a third commercially available option that includes advanced mapping capabilities.
Current availability in the US is therefore tied directly to which of these specific devices a hospital or electrophysiology lab has acquired and implemented. While all three major systems are now approved, the process of hospital acquisition, staff training, and integration into clinical workflows means the geographical spread of PFA centers is still expanding across the country.
Finding PFA Treatment Centers
For a patient seeking PFA, the procedure is not yet offered at every hospital. PFA is primarily performed at specialized, high-volume cardiology centers that house dedicated electrophysiology (EP) laboratories. These centers are more likely to have the necessary capital to invest in the newest technology and the specialized staff required to operate it safely.
The most effective first step is to consult with a primary cardiologist or, preferably, an electrophysiologist. An electrophysiologist is a heart rhythm specialist who will assess a patient’s specific condition and determine if PFA is a suitable treatment option. These specialists are often the first to be trained on new ablation technologies and are best positioned to know which local or regional hospitals are actively performing the procedure.
Patients should focus their search on major academic medical centers and large health systems in their region. These institutions are typically at the forefront of adopting new technologies following FDA approval. A practical way to find a center is to search the websites of these large hospitals for specific procedure listings under their cardiac or electrophysiology departments. The language used in these listings will often explicitly mention “Pulsed Field Ablation” or the specific device names, such as “Farapulse” or “PulseSelect.”
When speaking with a doctor about a potential PFA center, it is helpful to ask about the center’s experience level with the specific technology. Key questions include how many PFA procedures the electrophysiologist has performed and whether the center has fully integrated the system into its standard practice. Locating a high-volume center with an established PFA program helps ensure that the patient receives care from a highly experienced team.