Catheter ablation is a common procedure for treating arrhythmias, but it carries a risk of collateral damage to surrounding healthy tissue. Pulsed field ablation (PFA) is emerging as the latest catheter ablation treatment method, providing improvements in both procedure speed and safety. Although the technology is still largely under development, it has caught the attention of several leading device manufacturers, who have launched clinical investigations in a race to commercialize. The successful development of PFA technology has the potential to improve patient outcomes and dramatically transform the cardiovascular catheter market.
Atrial fibrillation is the most common arrhythmia observed and treated in the electrophysiology laboratory and is responsible for more than 450,000 hospitalizations each year in the United States alone. Faulty electrical signals that originate in the heart’s two upper chambers can lead to an irregular, fast heartbeat and increase the risk of stroke. Catheter-based ablation treatments deliver radiofrequency (RF) or cold thermal energy to problematic heart tissue to break down defective circuits and restore normal function.
GlobalData currently estimates the worldwide electrophysiology catheters market to be worth $3.5 billion, and expects it to reach approximately $4.5 billion by 2030 with a compound annual growth rate (CAGR) of 3.4%. To date, radiofrequency ablation catheters remain the dominant technology, accounting for approximately 80% of total revenue.
PFA differs from current techniques by achieving ablation using non-thermal electrical pulses, which do not cause significant heating or freezing of the target tissue. A major benefit of this approach is tissue selectivity, meaning that it can be tuned to target the heart muscle while sparing nearby nerves, arteries, and veins, greatly improving the safety of the procedure. Although the technology is still in its developmental stage, early clinical results have been promising. Studies to date have focused on evaluating PFA devices in the treatment of atrial fibrillation, but the positive results here may pave the way for their use in the treatment of other arrhythmias.
Interest in this technology has been shared by several major manufacturers in the cardiac electrophysiology device market in recent years. Early last year, Farapulse became the first manufacturer to market a PFA system in Europe, and received the CE marking for its device for use in the treatment of atrial fibrillation. Clinical investigations to evaluate devices from other manufacturers such as Medtronic, Acutus Medical and Biosense Webster in Europe and the United States are also currently underway. Late last month, manufacturer AccuPulse announced that it had secured more than $10 million in Series A funding to drive development of the PFA catheter system to compete with the largest companies in the Chinese market.
Since radiofrequency ablation has long been established as an effective approach to treating arrhythmias, the switch away from the technology will not happen overnight. Many questions regarding the safety and efficacy of long-term procedures for PFA devices remain to be answered. But nevertheless, the potential of PFA has been clearly recognized by manufacturers, and the technology will continue to mature as the devices reach successful commercialization across the US and European markets.