Boston Scientific has successfully ended Medtronic’s brief one-month monopoly in the US pulsed-field ablation (PFA) space after receiving FDA approval for its Farapulse System in January 2024. The medical device giant has experienced a compound annual growth rate of 138% in market value between January and February 2024, according to the Electrophysiology Devices March 2024 SKU tracker of GlobalData, a leading data and analytics company.

Medtronic received FDA approval for its PulseSelect System in December 2023, meaning it had a one-month head start than Boston Scientific in the US PFA market. Despite receiving regulatory approval one month later, Boston Scientific managed to acquire over 74% of shares from Medtronic.

Joselia Carlos, Medical Device Analyst at GlobalData, comments: “Medtronic’s PulseSelect System and Boston Scientific’s Farapulse System are currently the only two PFA catheters that are commercially available in the US. Sales for both products did not start until February 2024—despite the PulseSelect receiving FDA approval one month earlier than the Farapulse. Even so, physicians are showing a stronger preference for the Farapulse over the PulseSelect.”

Since the Farapulse’s release in the US, Boston Scientific has aggressively gained shares in the electrophysiology devices market.

Carlos continues: “PFA has already cannibalized the electrophysiology ablation space in Europe since receiving CE mark in 2021. According to primary research conducted on European electrophysiologists, PFA technologies are used in over 50% of electrophysiology ablation procedures. This same trend is expected to occur in the US as well.”

While Boston Scientific has certainly experienced quite an aggressive growth this year, Johnson and Johnson (J&J), by far, still remains the top player in the electrophysiology devices space. Boston Scientific currently has 9% of shares, while J&J possesses 54% of shares.

Carlos concludes: “J&J is a company that constantly innovates and is aware of the current trends. Unsurprisingly, J&J has its own PFA system, the Varipulse, which received both CE and Japanese regulatory approval at the beginning of this year. Receiving FDA approval for its Varipulse System will solidify its position as the market leader in the electrophysiology market.”