Medtronic recently secured CE approval for its Affera Mapping and Pulsed-Field Ablation (PFA) catheter system. Consisting of the Sphere-9 catheter and Affera Prism-1 mapping software, Medtronic’s ablation system is developed to treat atrial fibrillation (AF). With CE approval, Medtronic can challenge Boston Scientific’s Farapulse system, the only PFA catheter system that is readily available currently, says GlobalData, a leading data and analytics company.

According to GlobalData, the electrophysiology ablation catheter market is valued at $1.6 billion and is expected to reach $2.7 billion by 2033 with a compound annual growth rate of 4.8%. Unlike other ablation catheter procedures, PFA relies on non-thermal electric fields that selectively ablate heart tissue without affecting other critical surrounding areas.

Joselia Carlos, Medical Device Analyst at GlobalData, comments: “Our current forecast values for the electrophysiology ablation catheter market are likely to double, once more PFA catheter systems enter the market. Given that PFA procedures are safer and more efficient than traditional thermal ablation procedures, PFA catheter systems are likely to disrupt the AF market and are predicted to eventually account for half of the market.”

Boston Scientific’s Farapulse system consists of three components—the Faraware catheter, Faradrive sheath, and Farastar generator. In contrast to the Farapulse System, Medtronic’s Affera system enables physicians to map, ablate, and validate with just the Sphere-9 catheter. This eliminates the need to change catheters mid-procedure and allows physicians to choose the energy source (i.e., radio frequency versus pulsed-field) based on the patient’s needs.

Carlos continues: “Within two years of its launch in the market, the Farapulse system has shaken up the ablation catheter market, as many other big companies like Medtronic were trying to penetrate it. Seeing how the Affera system provides a more efficient and safer way for conducting ablation procedures, Medtronic may gain an upper hand against Boston Scientific in the PFA market.”

Interestingly, the FDA has not approved any PFA catheter systems in the US, including the Farapulse system. Even though the Farapulse system has been on the market much longer, Medtronic may become the first medtech company to receive FDA-approval for their PFA system portfolio.

Carlos concludes: “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%—supposedly, this was one of the lowest adverse event rates of any prior US multi-center FDA study. With these results, Medtronic’s system may indeed become the first PFA catheter system to receive FDA approval following its CE approval.”