Pulsed-field ablation technology to shift the electrophysiology ablation device market

Catheter-based ablation is a common procedure for the treatment of cardiac arrhythmias, but carries a risk of additional 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. While the technology is still largely under development, it has caught the attention of many leading device manufacturers, who have entered clinical trials in a race for commercialization. Successful development of PFA technology has the potential to improve patient outcomes and significantly change the market for cardiovascular electrophysiology ablation catheters.

Atrial fibrillation is one of the most common cardiac arrhythmias observed and treated in the electrophysiology lab and is responsible for more than 450,000 hospitalizations per year in the US alone. Faulty electrical signals coming from the upper chambers of the heart can cause an irregular, fast heartbeat and increase your risk of stroke. Existing catheter-based ablation therapies deliver radiofrequency (RF) or cryothermal energy to problematic heart tissue to break faulty circuitry and restore normal function.

GlobalData currently estimates the electrophysiology ablation catheter market at $3.5 billion worldwide, and expects it to reach approximately $4.5 billion by 2030 at a combined annual growth rate (CAGR) of 3.4%. To date, RF ablation catheters remain the dominant technology, accounting for nearly 80% of total revenues.

PFA differs from existing technologies in that ablation is achieved using non-thermal electrical pulses, which do not cause significant heating or freezing of the target tissue. A major advantage of this approach is its tissue selectivity, meaning it can be tuned to the heart muscle while sparing adjacent nerves, arteries and veins, greatly improving procedure safety. Although the technology is still in the development phase, the first clinical results are 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 their use in the treatment of other cardiac arrhythmias.

Interest in the technology has been shared in recent years by several major manufacturers in the cardiac electrophysiology device market. Early last year, Farapulse became the first manufacturer to market a PFA system in Europe and received CE marking for its device for use in the treatment of atrial fibrillation. Clinical trials evaluating devices from other manufacturers such as Medtronic, Acutus Medical and Biosense Webster are also currently underway in Europe and the US. Late last month, manufacturer AccuPulse announced it had secured more than $10 million in Series A funding to advance the development of its PFA catheter system to compete with larger players in the Chinese market.

Since RF ablation has long been an effective approach to treating cardiac arrhythmias, a technology shift will not happen overnight. Many questions remain to be answered regarding the long-term safety and efficacy of PFA devices. Nevertheless, the potential of PFA has been clearly recognized by manufacturers, and the technology will continue to mature as devices achieve successful commercialization in the US and European markets.

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