Due to its improvements in procedure times, its safety over existing techniques and its early clinical success, pulsed field ablation (PFA), a new type of catheter-based ablation, has caught the attention of many electrophysiology device manufacturers, observes GlobalData, a leading data and analytics company.

Catheter-based ablation is a procedure routinely carried out in cardiac electrophysiology labs to treat atrial fibrillation; an irregular heartbeat caused by defective electrical signals originating in the heart’s upper chambers. Existing catheter-based ablation therapies deliver radiofrequency (RF) or cryothermal energy to problematic heart tissue to break faulty circuits and restore normal rhythm but can also cause collateral damage to surrounding structures. PFA is one of the newest technologies for ablation and aims to reduce procedure complications associated with current approaches.

Jacob Fletcher, Medical Analyst at GlobalData, comments: “What differentiates PFA from existing catheter ablation technologies is that it is nonthermal in nature and is more selective towards cardiac tissue. The result is safer energy delivery with a reduced risk of off-target damage to nearby structures. Although the tech is still largely in a developmental stage, early clinical results have been promising, demonstrating its efficacy in the treatment of atrial fibrillation.”

Interest in PFA technology has been shared by both large and small manufacturers in the cardiac electrophysiology device market. Clinical investigations evaluating devices from Medtronic, Acutus Medical, Farapulse, and Biosense Webster are currently underway in the US and Europe. Smaller manufacturers are also racing to develop PFA devices to gain share in cardiac electrophysiology device markets. Recently, manufacturer AccuPulse announced that it had secured over $10 million in series A funding to advance the development of its PFA catheter system to compete in the Chinese market, which is currently dominated by Abbott, Medtronic, and Biosense Webster.

GlobalData currently values the Electrophysiology Ablation Catheters market at $3.5 billion worldwide, and forecasts that it will reach $4.5 billion by 2030 at a compound annual growth rate (CAGR) of 3.4%. RF ablation catheters remain the dominant technology, representing nearly 80% of total revenues.

Fletcher concludes: “It is not immediately clear how the arrival of PFA devices will shape the cardiovascular electrophysiology market over the coming years. RF ablation is well-established as an effective approach for treating cardiac arrhythmias, so a shift away from the technology won’t happen overnight. Cost, long-term efficacy, and integration with existing mapping systems will be key determinants for its adoption over current approaches. Nonetheless, the potential of PFA has clearly been recognized by manufacturers and electrophysiologists alike, and lingering questions will continue to be answered as research efforts progress.”