After receiving CE approval in 2021, Boston Scientific’s Farapulse system was the only pulsed-field ablation (PFA) catheter system that has been commercially available to treat atrial fibrillation (AF), which currently affects nearly 60 million people worldwide. Unlike standard ablation procedures, PFA relies on non-thermal electric fields that selectively ablate heart tissue without affecting other critical surrounding areas. Since the benefits of PFA catheter systems clearly outweigh the benefits of traditional ablation procedures, several big medtech companies are trying to break into the market and develop their own PFA system product line.

Without tracking PFA catheter system sales, the electrophysiology ablation catheter market is already valued at $1.6bn and is expected to reach $2.7bn by 2033, with a compound annual growth rate of 4.8%. However, as more PFA catheter systems get approved and reach the market, GlobalData projects that these forecast values will most likely double.

Recognising how lucrative this market will be, Medtronic acquired Affera in August 2022 to expand its own cardiac ablation portfolio. Through this acquisition, Medtronic now offers a wide range of products and solutions that help physicians treat atrial and ventricular arrhythmic diseases with efficient and safe cardiac ablation procedures. As of last week, Medtronic received CE approval for its Affera Mapping and PFA catheter system, which consists of Affera’s two original products, specifically the Prism-1 Mapping Software and Sphere-9 Catheter. With this event, there are now two PFA catheter systems available in Europe, namely Medtronic’s Affera Mapping and PFA catheter system and Boston Scientific’s Farapulse system.

Interestingly, the FDA has not approved any PFA systems, and as a result, none of these products is available in the US yet. Even though the Farapulse system has been on the market much longer, Medtronic’s Affera Mapping and Ablation system may receive FDA approval before Boston Scientific’s Farapulse system.

In Medtronic’s Pulsed AF pivotal trial, which tested its Affera Mapping and Ablation system, patients experienced an adverse event rate of just 0.7%. This was supposedly one of the lowest adverse event rates of any prior US AF multicenter FDA study. With these positive results, Medtronic may indeed outcompete Boston Scientific in the PFA catheter system market.