US pulsed field ablation market revenue surpasses $500 million in 2024: GlobalData

Pulsed field ablation (PFA) is a treatment for atrial fibrillation, an irregular heartbeat disorder, with a lower chance of damaging surrounding structures than previous methods. PFA uses electrical pulses that allow for a more targeted approach in order to only destroy abnormal tissue. PFA revenue exploded in Q1 2024 after FDA approvals for Boston Scientific’s FARAPULSE and Medtronic’s PulseSelect. Over the last year, the PFA market has grown to over $500 million, reveals GlobalData.

In Q4 2024, Medtronic launched its new PFA device, the Affera Sphere-9, after receiving FDA approval in late October. In its first month, Sphere-9 made about half of the revenue that FARAPULSE made in its first month after approval, according to GlobalData’s US Healthcare Facility Invoicing Database. In December, two months after approval, Sphere-9’s revenue was at about a quarter of FARAPULSE’s revenue at the same point in its launch cycle.

Amy Paterson, Medical Analyst at GlobalData states, “Medtronic’s Sphere-9 launched at a lower price than Boston Scientific’s Farapulse originally did. It appears that Medtronic is intending to be price competitive with Boston Scientific in order to gain some of the market share.”

Boston Scientific and Medtronic are currently the two major players in the PFA market. Boston Scientific dominated the market with the release of the Farawave in Q1 2024, despite PulseSelect’s earlier approval.

Paterson adds, “Despite accumulating less revenue than the Farawave, Sphere-9 has doubled in sales in its second month after launch. So far, we have not seen this increase in sales have an impact on Boston Scientific sales, which currently hold the majority of the PFA market.”

Paterson concludes, “It will be interesting to see if Medtronic is able to take over some of the market share that Boston Scientific has led since the beginning of 2024. As well, we will continue to monitor how new players like Johnson & Johnson’s Varipulse will shake up the market.”