In December 2023, Medtronic received FDA approval for its pulsed-field ablation (PFA) system, PulseSelect. While the PulseSelect is not the first PFA system to be marketed in the world (Boston Scientific’s Farapulse system received CE approval in 2021), it is indeed the first PFA catheter system to receive FDA approval. However, Medtronic’s success in this race did not deter Boston Scientific from pushing through with its turn in gaining FDA approval for its Farapulse system. In fact, the Farapulse system is expected to launch in the US in the first quarter of 2024, ending Medtronic’s brief monopoly in the PFA space, says GlobalData, a leading data and analytics company,

Joselia Carlos, Medical Device Analyst at GlobalData, comments: “Within the past year, three of the biggest medtech companies—Medtronic, Boston Scientific, and Johnson & Johnson—have been in a race to receive FDA approval for their PFA catheter systems. It’s interesting seeing how Medtronic came on top, despite Boston Scientific already having the Farapulse PFA system marketed in Europe.”

While Johnson & Johnson may be behind its two counterparts when it comes to receiving FDA approval for its PFA catheter (i.e., the Varipulse), the company managed to receive approval in Japan for its PFA system instead. This means that each of the three companies dominates a specific geographic region within the PFA space—Medtronic in North America, Boston Scientific in Europe, and Johnson & Johnson in Asia.

Carlos continues: “Without considering PFA sales, North America has the highest share in market value at just over 50% in the global electrophysiology (EP) ablation market. Given that the US takes up over 90% of this share, this definitely is a huge incentive for companies to gain FDA approval as fast as possible.”

According to GlobalData, the PFA catheter space will most likely take over the $2.8 billion market, given how European doctors are already showing a much stronger preference for PFA technologies over other EP ablation catheters.

Carlos concludes: “Once Boston Scientific penetrates the US PFA market, this will end Medtronic’s brief PFA monopoly. Boston Scientific will then have a competitive advantage over Medtronic by having shares in two highly profitable regions of the world—the US and Europe.”