The landscape of electrophysiology (EP) ablation catheters has seen significant advancements in recent years, especially with the introduction of pulsed-field ablation (PFA).
In December 2023, Medtronic received US Food and Drug Administration (FDA) approval for its PFA system, PulseSelect, making this the first PFA catheter to be commercially available in the US.
Medtronic is not the first company to enter the PFA space, since Boston Scientific already has shares in Europe after receiving Conformité Européenne approval for its Farapulse system in 2021.
However, the US currently has the highest share at almost 50% in the EP ablation market. In comparison, Europe only has a market share of approximately 39% in this $2.8bn market.
The lucrativeness of the US PFA market has attracted large medtech players such as Medtronic, Boston Scientific, and Johnson & Johnson. However, Medtronic is the first company to gain FDA approval for its PFA catheter system.
Despite Medtronic winning this race, Boston Scientific is expected to launch its Farapulse system in the US during the first quarter of 2024.
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If Boston Scientific’s intended timeline succeeds, it will then be the only company to have shares in the PFA market in two major regions (the US and Europe), ending Medtronic’s brief PFA monopoly period.
Unlike its two other counterparts, Johnson & Johnson has not had much success in its clinical trials that could lead to FDA approval with its PFA system, the Varipulse.
Instead, the company managed to receive approval for the Varipulse system in Japan.
This means that all three companies currently dominate a specific geographic region in the PFA space: Medtronic in North America, Boston Scientific in Europe, and Johnson & Johnson in Asia.