Catheter-based ablation is a common procedure for treating cardiac arrhythmias but carries a risk of collateral damage to healthy surrounding tissue. Pulsed-field ablation (PFA) is emerging as the newest treatment modality for catheter ablation, offering improvements in both procedure speed and safety. Though the technology is still largely in development, it has caught the attention of many leading device manufacturers, which have launched clinical investigations in a race for commercialisation. Successful development of PFA technology has the potential to improve patient outcomes and shift the cardiovascular electrophysiology ablation catheter market significantly.
Atrial fibrillation is among the most common cardiac arrhythmias observed and treated in the electrophysiology lab and is responsible for more than 450,000 hospitalizations each year in the US alone. Defective electrical signals originating in the heart’s upper chambers can create irregular, rapid heartbeats and increase the risk of stroke. Existing catheter-based ablation therapies deliver radiofrequency (RF) or cryothermal energy to problematic heart tissue to break faulty circuits and restore normal function.
GlobalData currently values the electrophysiology ablation catheters market at $3.5bn worldwide, and projects it to reach around $4.5bn by 2030 at a combined annual growth rate (CAGR) of 3.4%. To date, RF ablation catheters remain the dominant technology, representing nearly 80% of total revenues.
PFA differs from existing technologies by achieving ablation using nonthermal electrical pulses, which do not cause significant heating or freezing of the target tissue. A major benefit to this approach is its tissue selectivity, meaning that it can be tuned to target cardiac muscle while sparing neighboring nerves, arteries and veins, greatly improving procedure safety. 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 positive results here may pave the way for its use in the treatment of other cardiac rhythm disorders.
Interest in the 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 commercialize a PFA system in Europe, receiving a CE mark for its device for use in atrial fibrillation treatment. Clinical investigations evaluating devices from other manufacturers like Medtronic, Acutus Medical and Biosense Webster are also currently underway in Europe and the US. Late last month, manufacturer AccuPulse announced that it had secured more than $10m in series A funding to advance the development of its PFA catheter system to compete with larger players in the Chinese market.
As RF ablation has long been established as an effective approach for treating cardiac arrhythmias, a shift away from the technology will not happen overnight. Many questions are yet to be answered surrounding the long-term procedure safety and efficacy of PFA devices. But nevertheless, the potential of PFA has clearly been recognized by manufacturers, and the technology will continue to mature as devices reach successful commercialization across US and European markets.